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At LGC Maine Standards, we are committed to bringing you the latest products and services for your linearity and calibration verification testing needs.  Our team works hard to provide our customers with the most efficient and easy-to-use products the industry has to offer.  In this section you will find the most current news about our latest product innovations, company updates and appearances at events, trade shows and conferences.

News


LGC Maine Standards is proud to announce that we moved to a new facility.  We are now located at:

221 US Route 1

Cumberland Foreside, ME  04110


LGC Maine Standards announces the addition of Glucose to the VALIDATE? Diabetes kit for Roche cobas? with beta-hydroxybutyrate*, C-peptide, Fructosamine, and Insulin for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – March 29, 2021 – LGC Maine Standards1 announces a product update for VALIDATE? Diabetes which meets the linearity and calibration verification needs of clinical laboratories running the Roche cobas? platform. The product (Order No. 204RO), which includes the analytes beta-hydroxybutyrate (BHB)*, C-peptide (C-PEP), Fructosamine (FRUC), Insulin (INS), and now Glucose (GLU), is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Roche cobas? instrument. VALIDATE? Diabetes test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Micro-Albumin (μALB) in VALIDATE? UC5 (705RO), Glycohemoglobin A1c (HbA1c) in VALIDATE? HbA1c (605), and High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) in VALIDATE? LP (501RO), laboratories can challenge the reportable range of Roche cobas? Diabetes-related assays.

VALIDATE? Diabetes is FDA listed and offers five Levels of complete reportable range coverage – eliminating the need for manual dilutions! VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

With the addition of Glucose to VALIDATE? Diabetes, LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Diabetes product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

*Developed and manufactured using Stanbio’s BHB reagent on the Roche cobas?.

About LGC Clinical Diagnostics

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.   

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? FERT 1 and VALIDATE? FERT 2 for Abbott ARCHITECT and Abbott ALINITY with Follicle-stimulating Hormone, Human Chorionic Gonadotropin, Luteinizing Hormone, Prolactin, Testosterone, a1-fetoprotein, Dehydroepiandrosterone Sulfate, Estradiol, and Progesterone for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – March 8, 2021 – LGC Maine Standards1 announces the release of VALIDATE? FERT 1 and VALIDATE? FERT 2 to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT or Abbott ALINITY platform(s). The products (Order Nos. 502AB and 504AB respectively), which include analytes Follicle-stimulating Hormone (FSH), Human Chorionic Gonadotropin (hCG), Luteinizing Hormone (LH), Prolactin (PRL), Testosterone (TSTO), a1-fetoprotein (AFP), Dehydroepiandrosterone Sulfate (DHEA-S), Estradiol (E2), and Progesterone (PROG), are formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Abbott ARCHITECT or Abbott ALINITY instruments. VALIDATE? FERT 1 and VALIDATE? FERT 2 test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? FERT 1 and VALIDATE? FERT 2 to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards’ MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. Peer group comparison is also available upon request.

For VALIDATE? FERT 1 and VALIDATE? FERT 2 product details, click here, or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? High Sensitive Troponin for Abbott ARCHITECT with hsTNI for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – March 3, 2021 – LGC Maine Standards1 announces the release of VALIDATE? High Sensitive Troponin to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT platform. The product (Order No. 405AB), which includes the analyte High Sensitive Troponin I (hsTNI), is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides six distinct concentrations across the claimed and extended range of the Abbott ARCHITECT instrument. VALIDATE? High Sensitive Troponin test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into six sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Creatine Kinase-MB and Myoglobin in VALIDATE? CM1 (Order No. 401AB), Brain Natriuretic Peptide, High-Sensitivity C-Reactive Protein, and Troponin I in VALIDATE? CM2 (Order No. 402AB), and Homocysteine and Lipoprotein (a) in VALIDATE? CM3 (Order No. 409RO), laboratories can challenge the reportable range of Abbott ARCHITECT Cardiac Marker and Cardiac Indicator-related assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? High Sensitive Troponin to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards’ MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. Peer group comparison is also available upon request.

For VALIDATE? High Sensitive Troponin product details, click here, or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.   

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? Anemia for Abbott ARCHITECT and Abbott ALINITY with Ferritin, Folate, and Vitamin B12 for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – February 1, 2021 – LGC Maine Standards1 announces the release of VALIDATE? Anemia to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT or Abbott ALINITY platform(s). The product (Order No. 308AB), which includes the analytes Ferritin, Folate, and Vitamin B12, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Abbott ARCHITECT or Abbott ALINITY instruments.  VALIDATE? Anemia test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Total Iron Binding Capacity in VALIDATE? IBC (Order No. 203RO), Iron in VALIDATE? GC2 (Order No. 1200AB), and Transferrin in VALIDATE? SP1 (Order No. 601BC), laboratories can challenge the reportable range of Abbott ARCHITECT and Abbott ALINITY-related assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? Anemia to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. Peer group comparison is also available upon request.

For VALIDATE? Anemia product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.   

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? HbA1c for Siemens Atellica? and Siemens Dimension? with Hemoglobin A1c for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – January 26, 2021 – LGC Maine Standards1 announces the release of VALIDATE? HbA1c to meet the linearity and calibration verification needs of clinical laboratories running the Siemens Atellica? or Siemens Dimension? platform(s). The product (Order No. 605SA), which includes the analyte Hemoglobin A1c, is formulated in a human, whole blood matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Siemens Atellica? or Siemens Dimension? instruments.  VALIDATE? HbA1c test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Glucose in VALIDATE? GC1 (Order No. 1100SA), Micro-Albumin in VALIDATE? UC5 (Order No. 705RO), and HDL and LDL in VALIDATE? LP (501SA), laboratories can challenge the reportable range of Siemens' diabetes-related assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? HbA1c to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? HbA1c product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? IL-6 kit for Roche cobas? with Interleukin-6 for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – December 21, 2020 – LGC Maine Standards1 announces the release of VALIDATE? IL-6 to meet the linearity and calibration verification needs of clinical laboratories running the Roche cobas? platform. The product (Order No. 509RO), which includes the analyte Interleukin-6, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Roche cobas? instrument. This assay is used to identify severe inflammatory response in patients confirmed with COVID-19 illness to determine the risk of intubation with mechanical ventilation. VALIDATE? IL-6 test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with C-reactive protein in VALIDATE? SP2 (Order No. 602RE), Procalcitonin in VALIDATE? PCT (Order No. 403RO), Troponin I and Troponin T in VALIDATE? CM2 (402RE), and Creatine Kinase and Aspartate Aminotransferase in VALIDATE? GC3 (Order No. 1300RE), laboratories can challenge the reportable range of COVID-19 severity-indicating assays.

VALIDATE? IL-6 is FDA listed and offers five Levels of complete reportable range coverage eliminating the need for manual dilutions! VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? IL-6 to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Cardiac, Diabetes, Fertility, Hemostasis, IL-6, Osmolality, POC, PTH, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? IL-6 product details, click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? Diabetes kit for Roche cobas? with beta-hydroxybutyrate*, C-peptide, Fructosamine, and Insulin for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – December 16, 2020 – LGC Maine Standards1 announces the release of VALIDATE? Diabetes to meet the linearity and calibration verification needs of clinical laboratories running the Roche cobas? platform. The product (Order No. 204RO), which includes the analytes, beta-hydroxybutyrate*, C-peptide, Fructosamine, and Insulin, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Roche cobas? instrument. VALIDATE? Diabetes test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Glucose in VALIDATE? GC1 (1100ro), Micro-Albumin in VALIDATE? UC5 (705ro), HbA1c in VALIDATE? HbA1c (605), and HDL and LDL in VALIDATE? LP (501ro), laboratories can challenge the reportable range of Roche cobas? Diabetes-related assays.

VALIDATE? Diabetes is FDA listed and offers 5 Levels of complete reportable range coverage – eliminating the need for manual dilutions! VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? Diabetes to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, PTH, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Diabetes product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

*Developed and manufactured using Stanbio's BHB reagent on the Roche cobas?.


LGC Maine Standards announces VALIDATE? Anemia kit for Ortho Vitros? with Ferritin, Folate, and Vitamin B12 for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – December 10, 2020 – LGC Maine Standards1 announces the release of VALIDATE? Anemia to meet the linearity and calibration verification needs of clinical laboratories running the Ortho Vitros? platform. The product (Order No. 308VT), which includes analytes Ferritin, Folate, and Vitamin B12, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Ortho Vitros? instrument. VALIDATE? Anemia test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to establish the assays’ reportable range.

When combined with Iron in VALIDATE? GC2 (Order No. 1200VT), Total Iron Binding Capacity in VALIDATE? IBC (Order No. 203VT), and Transferrin in VALIDATE? SP1 (Order No. 601BC), laboratories can challenge the reportable range of Ortho Vitros? anemia assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? Anemia, for the Ortho Vitros?, to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Cardiac, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Anemia product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? Tumor Markers kit for Abbott Architect and Abbott Alinity with analytes CEA, CA 125, CA 15-3, and CA 19-9 for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – December 7, 2020 – LGC Maine Standards1 announces the release of VALIDATE? Tumor Markers to meet the linearity and calibration verification needs of clinical laboratories running the Abbott Architect and Abbott Alinity platforms. The product (Order No. 407AB), which includes analytes CEA, CA 125, CA 15-3, and CA 19-9, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Abbott Architect and Abbott Alinity instruments. VALIDATE? Tumor Markers test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assays’ reportable range.

When combined with B2-Microglobulin (B2M) in VALIDATE? SP3 (Order No. 603RO) and Free PSA and Total PSA in VALIDATE? PSA (Order No. 406RE), laboratories can challenge the reportable range of Abbott Architect and Abbott Alinity cancer-related assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? Tumor Markers to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no-charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Tumor Markers product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.   

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? PTH kit for Roche cobas? with Parathyroid Hormone for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.

CUMBERLAND FORESIDE, Maine – December 7, 2020 – LGC Maine Standards1 announces the release of VALIDATE? PTH to meet the linearity and calibration verification needs of clinical laboratories running the Roche cobas? platform. The product (Order No. 303RO), which includes the analyte, Parathyroid Hormone, is formulated in a human serum matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Roche cobas? instrument. VALIDATE? PTH test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range.

When combined with Calcium, Magnesium, and Phosphorus in VALIDATE? GC1 (Order No. 1100RO) and Vitamin D in VALIDATE? VIT D (Order No. 506), laboratories can challenge the reportable range of Roche cobas? bone-related assays.

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

The addition of VALIDATE? PTH to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, ACTH, Anemia, Bone, Body Fluids, Cardiac, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? PTH product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.

About LGC Clinical Diagnostics

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.  

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.


LGC Maine Standards announces VALIDATE? ACTH kit for Roche cobas? with easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification

CUMBERLAND FORESIDE, Maine – June 23, 2020 – LGC Maine Standards1 announces the release of VALIDATE? ACTH Linearity and Calibration Verification Test Kits for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification of Adrenocorticotropic Hormone (ACTH). The product (Order No. 302MM) is formulated in a human plasma matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed range of the Elecsys-ACTH Method on the Roche cobas?. VALIDATE? ACTH test kits are liquid and ready-to-use: simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to establish the assay’s reportable range.

VALIDATE? ACTH strengthens LGC Maine Standards’ product range for endocrine testing, which now includes 17 analytes:

  • THYROID: Free T3, Free T4, Total T3, Total T4, TSH and Cortisol
  • PSA: free PSA, total PSA
  • FERTILITY 1: FSH, hCG, Luteinizing Hormone, Prolactin
  • FERTILITY 2: AFP; DHEA-S, Estradiol, Progesterone

VALIDATE? products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? ACTH to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? ACTH product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

About LGC

LGC Group is a UK-headquartered life sciences measurement and testing business with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public. LGC’s Clinical Diagnostic Business Unit (CDBU) is comprised of two operating entities - SeraCare Life Sciences and Maine Standards Company – and are in vitro diagnostic (IVD) manufacturers of clinical diagnostic quality solutions to the extended life science industry.

Our 200+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland and support diagnostic professionals in laboratories across the globe. We partner with IVD developers, pharmaceutical, CRO and academic institutions to share our expertise and resources in clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics.

We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.


The Native Antigen Company Joins LGC

  • LGC1, the UK-based global leader in the life sciences sector has acquired the business of Oxford-based The Native Antigen Company (“NAC”), one of the world’s leading suppliers of high-quality infectious disease antigens and antibodies.
  • As a result of the acquisition, NAC will become part of the Clinical Diagnostics Division within LGC. NAC’s business operation will continue in Oxford, UK.
  • NAC’s founder and COO Nick Roesen and Commercial Director Andy Lane will continue in their key roles with NAC following the transaction.

NAC is a developer, manufacturer, and supplier of critical reagents to the in vitro diagnostic (IVD), pharmaceutical, and academic sectors. It offers a comprehensive portfolio of native and recombinant infectious disease antigens and related products including pathogen receptors, virus-like particles and antibodies for use in immunoassay applications, vaccine development, and quality control solutions. NAC was one of the first companies globally to offer antigens for SARS-COV-2 and continues to play an important role in supporting the global response to the COVID-19 pandemic.

The acquisition strengthens LGC’s existing product offering to the IVD sector, which includes a range of quality reference and measurement tools for assay development in serology, molecular, clinical chemistry, immunochemistry, and clinical genomics diagnostics.

Michael Sweatt, Executive Vice President and General Manager, Clinical Diagnostics, LGC, said, “NAC is a natural fit with our clinical diagnostics business and will enable us to provide an expanded portfolio of critical reagents to our customers. NAC’s focus on infectious disease is highly complementary with our existing offer to this segment comprising controls, reference materials, molecular diagnostic tools, and other components. We are excited to welcome our new colleagues into our organization.”

“We are delighted to be joining LGC as an integral part of their fast growing clinical diagnostics business,“ said Nick Roesen, COO of NAC. “Even more so, we are excited to join such a well-respected organization that shares our purpose and mission, and that will support our diagnostic customers by providing even more world-leading products and services.”

For more information please reach out to:

Greg Ballish, SVP, Commercial, LGC Clinical Diagnostics Tel +1 508 801 1035, Email gregory.ballish@lgcgroup.com

1LGC is the parent company to LGC Maine Standards.


LGC Maine Standards announces VALIDATE? SP1 kit, now specifically targeted for Roche cobas? and Roche COBAS INTEGRA? analyzers, for easier Serum Protein linearity and calibration verification.

VALIDATE? SP1, specifically targeted for Roche cobas? and Roche COBAS INTEGRA? analyzers, used in conjunction with VALIDATE? SP2 & SP3, offers easy, fast, efficient linearity and calibration verification of Serum Proteins. 

CUMBERLAND FORESIDE, Maine – November 4, 2019 – LGC Maine Standards1 releases VALIDATE? SP1 linearity and calibration verification kit, specifically targeted for Roche cobas? and Roche COBAS INTEGRA? analyzers, Order No. 601ro. The kit, in a human-serum matrix, evaluates α1-Antitrypsin (ATT), Complement C3 (C3), Complement C4 (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Transferrin (TRFN).  Each VALIDATE? SP1 kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

VALIDATE? SP1 (601ro), for Roche cobas? and Roche COBAS INTEGRA? users, complements our existing VALIDATE? SP2 (Order No. 602re) & SP3 (Order No. 603ro) products, which target recoveries for ALB, CER, CRP, HPT, PAB, RF, and AAG, ASO, B2M, IGE, respectively.  Together, our Serum Protein VALIDATE? offerings provide 17 analytes for easy, fast, and efficient linearity and calibration verification testing – maximizing the reportable range, while minimizing manual dilutions.  Use of these products, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? SP1, for Roche cobas? and Roche COBAS INTEGRA? analyzers, to the LGC Maine Standards expanding portfolio of products, demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipoproteins, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? SP1 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? UC1 & UC4 kits for easier linearity and calibration verification on SIEMENS ATELLICA? analyzers

VALIDATE? UC1 & UC4, for SIEMENS ATELLICA? analyzers, addresses the growing demand by laboratories in need of a product to document Urine Chemistry linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – October 23, 2019 – LGC Maine Standards1 releases VALIDATE? UC1 & UC4 linearity and calibration verification kits, for SIEMENS ATELLICA? analyzers, Order Numbers 701sa & 704sa. The kits, in a human-urine matrix, evaluate CA, CL, CREA, ETOH, GLU, K, MG, NA, PHOS, UA, UTP, and UUN.

Each VALIDATE? kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? UC1 & UC4 for SIEMENS ATELLICA? users, allows clinical laboratories to complete their required Urine Chemistry linearity and calibration verification, and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? UC1 and UC4, for SIEMENS ATELLICA? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 140 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? UC1 and UC4 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? LP2 kit for easier linearity and calibration verification on Roche cobas? analyzers

The addition of VALIDATE? LP2, for the Roche cobas?, offering Apo-A1 and Apo-B, used in conjunction with VALIDATE? LP for HDL and LDL, offers easy, fast, efficient linearity and calibration verification of Lipoproteins. 

CUMBERLAND FORESIDE, Maine – October 7, 2019 – LGC Maine Standards1 releases VALIDATE? LP2 linearity and calibration verification kit, for Roche cobas? analyzers, Order No. 507ro. The kit, in a human-serum matrix, evaluates Apolipoprotein A (Apo-A1) and Apolipoprotein B (Apo-B).  Each VALIDATE? LP2 kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

VALIDATE? LP2 (507ro), for Roche cobas? users, complements our existing VALIDATE? LP (Order No. 501ro) product, which targets recoveries for HDL and LDL.  Together, our Lipoproteins VALIDATE? offering provides for easy, fast, and efficient linearity and calibration verification testing of HDL, LDL, Apo-A1, and Apo-B in order to maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? LP2, for Roche cobas?, to LGC Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 140 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? LP2 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? SP3 kit for easier Serum Protein linearity and calibration verification on Roche cobas? and Beckman Coulter Immage? analyzers

VALIDATE? SP3, for Roche cobas? and Beckman Coulter Immage? analyzers, addresses the growing demand by laboratories in need of a product to document AAG, ASO, B2M, and IgE linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – May 20, 2019 – LGC Maine Standards1 releases VALIDATE? SP3 linearity and calibration verification kit, for Roche cobas? and Beckman Coulter Immage? analyzers, Order Number 603ro. The kit, in a human-serum matrix, evaluates α1-Acid Glycoprotein (AAG), Antistreptolysin O (ASO), B2-Microglobulin (B2M), and Immunoglobulin E (IgE).  Each VALIDATE? SP3 kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? SP3, for Roche cobas? and Beckman Coulter Immage? users, allows clinical laboratories to complete their required Serum Protein linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? SP3, for Roche cobas? and Beckman Coulter Immage? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 141 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? SP3 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? High Sensitive Troponin kit for easier linearity and calibration verification on Beckman Coulter DxI / Access? analyzers.

VALIDATE? High Sensitive Troponin, for Beckman Coulter DxI / Access?, is the only linearity and calibration verification product targeting Beckman’s High Sensitivity Troponin I assay range.

CUMBERLAND FORESIDE, Maine – May 20, 2019 – LGC Maine Standards1 releases VALIDATE? High Sensitive Troponin, linearity and calibration verification kit, for Beckman Coulter DxI / Access?, Order Number 405ro. The kit, in a human serum matrix, is the only linearity and calibration verification product targeting Beckman’s High Sensitivity Troponin I assay range.  Each VALIDATE? High Sensitive Troponin kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations specifically covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? High Sensitive Troponin, linearity and calibration verification kit, for Beckman Coulter DxI / Access? users, allows clinical laboratories to complete their required high-sensitive Troponin linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? High Sensitive Troponin, for Beckman Coulter DxI / Access?, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 141 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? High Sensitive Troponin product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? LP kit for easier linearity and calibration verification on SIEMENS ADVIA? and ATELLICA? analyzers.

VALIDATE? LP, for SIEMENS ADVIA? and ATELLICA? analyzers, addresses the growing demand by laboratories in need of a product to document HDL and LDL linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – April 22, 2019 – LGC Maine Standards1 releases VALIDATE? LP linearity and calibration verification kit, for SIEMENS ADVIA? and ATELLICA? analyzers, Order Number 501sa. The kit, in a human-serum matrix, evaluates High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL).  Each VALIDATE? LP kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? LP for SIEMENS ADVIA? and ATELLICA? users, allows clinical laboratories to complete their required Lipoproteins linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? LP, for SIEMENS ADVIA? and ATELLICA? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 137 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? LP product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces addition of Cerebrospinal Fluid Total Protein to VALIDATE? Body Fluids kit, enhancing the only comprehensive body fluids kit on the market, for easier Laboratory Developed Test (LDT) validation, documentation of linearity and calibration verification, and reportable range verification.

VALIDATE? Body Fluids, now enhanced with CSF-TP, addresses the growing demand by laboratories in need of a product to document Cerebrospinal Fluid Total Protein linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – February 4, 2019 – LGC Maine Standards1 announces addition of Cerebrospinal Fluid Total Protein to VALIDATE? Body Fluids kit (SKUs: 205bf, 205ro), enhancing the only comprehensive body fluids kit on the market, for easier Laboratory Developed Test (LDT) validation, documentation of linearity, calibration verification and verification of the reportable range.  The addition of Cerebrospinal Fluid Total Protein (CSF-TP) will enhance an already robust lineup of available analytes in our simulated body fluid matrix: Albumin (ALB), Amylase (AMY), Cancer Antigen 19-9 (CA 19-9), Carcinoembryonic Antigen (CEA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactate (LAC), Lactate dehydrogenase (LD), Total protein (TP), Triglycerides (TRIG), and Urea Nitrogen (UN).  Each VALIDATE? Body Fluids kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations to establish the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Body Fluids allows clinical laboratories to complete their required Body Fluids linearity and calibration verification, validation of in-house methods or laboratory developed tests (LDT) for analytes in body fluids – establishing the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Body Fluids to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 130 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, Whole Blood Glucose, and Body Fluids. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Body Fluids product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? CM2 kit for easier linearity and calibration verification on Ortho VITROS? analyzers

VALIDATE? CM2, for Ortho VITROS? analyzers, addresses the growing demand by laboratories in need of a product to document hs-CRP, NT-proBNP, and TnI linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – November 1, 2018 – LGC Maine Standards1 releases VALIDATE? CM2 linearity and calibration verification kit, for Ortho VITROS? analyzers, Order Number 402vt. The kit, in a human-serum matrix, evaluates High Sensitive C-Reactive Protein (hs-CRP), Brain Natriuretic Peptide (NT-proBNP), and Troponin I (TnI).  Each VALIDATE? CM2 kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? CM2 for Ortho VITROS? users, allows clinical laboratories to complete their required Cardiac Marker linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? CM2, for Ortho VITROS? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 137 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? CM2 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards expanding VALIDATE? Body Fluids product line for easier and cost effective Laboratory Developed Test (LDT) validation, documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification

The new VALIDATE? Body Fluids kit, 205bf, will make it easier and more cost effective for laboratories to support LDT validation, documentation of linearity, calibration verification and verification of the reportable range and AMR for analytes in cerebrospinal, peritoneal ascites, pleural and pericardial body fluids, via our simulated body fluid matrix.

CUMBERLAND FORESIDE, Maine – October 15, 2018 – LGC Maine Standards1 expands its innovative Body Fluids product line, VALIDATE? Body Fluids, Order Number 205bf, for easier linearity and calibration verification. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification and verification of the reportable range for Albumin (ALB), Amylase (AMY), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactate (LAC), Lactate dehydrogenase (LD), Total protein2 (TP), Triglycerides (TRIG), and Urea Nitrogen (UN). Each VALIDATE? Body Fluids kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations to establish the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

VALIDATE? Body Fluids is the only comprehensive, commercially available calibration verification solution on the market allowing clinical laboratories to complete their required Body Fluids linearity and calibration verification, validation of in-house methods or laboratory developed tests (LDT) for analytes in body fluids – maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Body Fluids to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 137 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, Whole Blood Glucose, and Body Fluids.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Body Fluids product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? hsTnT kit for easier linearity and calibration verification on Roche cobas? analyzers

VALIDATE? hsTnT, for Roche cobas?, is the only linearity and calibration verification product specifically targeting Roche’s Troponin T Gen 5 STAT (TnTG5) assay range.

CUMBERLAND FORESIDE, Maine – September 10, 2018 – LGC Maine Standards1 releases VALIDATE? hsTnT, linearity and calibration verification kit, for Roche cobas?, Order Number 405ro. The kit, in a human serum matrix, is the only linearity and calibration verification material specifically targeting Roche’s Troponin T Gen 5 STAT (TnTG5) assay range.  Each VALIDATE? hsTnT kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations specifically covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? hsTnT for Roche cobas? users, allows clinical laboratories to complete their required high-sensitive Troponin linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? hsTnT, for Roche cobas? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 137 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? hsTnT product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? Heparin kit for easier linearity and calibration verification on Siemens Sysmex analyzers

VALIDATE? Heparin, for Siemens Sysmex analyzers, addresses the growing demand by laboratories in need of a product to document Heparin Anti-Xa linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – August 6, 2018 – LGC Maine Standards1 releases VALIDATE? Heparin linearity and calibration verification kit, for Siemens Sysmex analyzers, Order Number 903se. The kit, in a human plasma matrix, evaluates Heparin Anti-Xa (HP).  Each VALIDATE? Heparin kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Heparin for Siemens Sysmex users, allows clinical laboratories to complete their required Heparin Anti-Xa linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Heparin, for Siemens Sysmex analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 136 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Heparin product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? IBC kit for easier linearity and calibration verification on Ortho VITROS? analyzers

VALIDATE? IBC, for Ortho VITROS? analyzers, addresses the growing demand by laboratories in need of a product to document Iron Binding Capacity linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – July 2, 2018 – LGC Maine Standards1 releases VALIDATE? IBC linearity and calibration verification kit, for Ortho VITROS? analyzers, Order Number 203vt. The kit, in a human-serum matrix, evaluates Total Iron Binding Capacity (TIBC).  Each VALIDATE? IBC kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE IBC for Ortho VITROS? users, allows clinical laboratories to complete their required TIBC linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? IBC, for Ortho VITROS? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for 136 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? IBC product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? Procalcitonin kit for easier linearity and calibration verification on Abbott ARCHITECT analyzers

VALIDATE? Procalcitonin, for Abbott ARCHITECT analyzers, will address the growing demand by laboratories in need of a product to document Procalcitonin linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – June 12, 2018 – LGC Maine Standards1 releases VALIDATE? Procalcitonin linearity and calibration verification kit, for Abbott ARCHITECT analyzers, Order Number 403ab. The kit, in a human-serum matrix, evaluates Procalcitonin (PCT).  Each VALIDATE? Procalcitonin kit, liquid, ready-to-use, multi-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Procalcitonin, for Abbott ARCHITECT users, allows clinical laboratories to complete their required Procalcitonin linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Procalcitonin, for Abbott ARCHITECT analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 130 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Procalcitonin product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? Fibrinogen for easier linearity and calibration verification on IL ACL TOP? 500, Siemens Sysmex? CS-2500 System, and Stago STA-R? Evolution hemostasis test systems

VALIDATE? Fibrinogen will address the growing demand by laboratories in need of a human plasma, Hemostasis product to document Fibrinogen linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – April 25, 2018 – LGC Maine Standards1 announces VALIDATE? Fibrinogen for easier linearity and calibration verification on IL ACL TOP? 500 (Order No. 904il), Siemens Sysmex? CS-2500 (Order No. 904se), and Stago STA-R? Evolution (Order No. 904st) hemostasis test systems.  The kits, in a human, plasma matrix, evaluate Five Levels of recovery across the Fibrinogen (FIB) analytical measurement range (AMR).  Each VALIDATE? Fibrinogen kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Fibrinogen allows clinical laboratories with IL ACL TOP? 500, Siemens Sysmex? CS-2500, Stago STA-R? Evolution or other commonly used hemostasis systems to complete their required Fibrinogen linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Fibrinogen to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 130 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, Whole Blood Glucose, and Body Fluids. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Fibrinogen product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? Body Fluids, the only comprehensive body fluids kit on the market, for easier Laboratory Developed Test (LDT) validation, documentation of linearity, calibration verification and verification of the Analytical Measurement Range (AMR)

VALIDATE? Body Fluids will make it easier for laboratories to support LDT validation, documentation of linearity, calibration verification and verification of the AMR for analytes in cerebrospinal, peritoneal ascites, pleural and pericardial body fluids, via our simulated body fluid matrix.

CUMBERLAND FORESIDE, Maine – March 29, 2018 – LGC Maine Standards1 releases the only comprehensive body fluids kit on the market, VALIDATE? Body Fluids, Order Number 205ro, for easier linearity and calibration verification. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification and verification of linear range for Albumin (ALB), Amylase (AMY), Cancer Antigen 19-9 (CA 19-9), Carcinoembryonic Antigen (CEA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactate (LAC), Lactate dehydrogenase (LD), Total protein (TP), Triglycerides (TRIG), and Urea Nitrogen (UN).  Each VALIDATE? Body Fluids kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations to establish the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Body Fluids allows clinical laboratories to complete their required Body Fluids linearity and calibration verification, validation of in-house methods or laboratory developed tests (LDT) for analytes in body fluids – maximizing the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Body Fluids to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 130 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, Whole Blood Glucose, and Body Fluids. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Body Fluids product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

 


LGC Maine Standards announces VALIDATE? Procalcitonin kit for easier linearity and calibration verification on Roche cobas? analyzers

VALIDATE? Procalcitonin, for Roche cobas? analyzers, will address the growing demand by laboratories in need of a product to document Procalcitonin linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – February 14, 2018 – LGC Maine Standards1 releases VALIDATE? Procalcitonin linearity and calibration verification kit, for Roche cobas? analyzers, Order Number 403ro. The kit, in a human-serum matrix, evaluates Procalcitonin (PCT).  Each VALIDATE? Procalcitonin kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? Procalcitonin, for Roche cobas? users, allows clinical laboratories to complete their required Procalcitonin linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? Procalcitonin, for Roche cobas? analyzers, to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over 115 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? Procalcitonin product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces VALIDATE? HbA1c kit for easier linearity and calibration verification on Tosoh analyzers

VALIDATE? HbA1c, for Tosoh analyzers, will address the growing demand by laboratories in need  of a product to document % Glycohemoglobin A1c linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – January 31, 2018 – LGC Maine Standards1 releases VALIDATE? HbA1c linearity and calibration verification kit, for Tosoh analyzers, Order Number 605to. The kit, in a human, whole blood matrix, evaluates % Glycohemoglobin A1c (HbA1c).  Each VALIDATE? HbA1c kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? HbA1c, for Tosoh users, allows clinical laboratories to complete their required HbA1c linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? HbA1c, for Tosoh analyzers, to the LGC Maine Standards expanding portfolio of products, demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.  Peer group comparison is also available upon request.

For VALIDATE? HbA1c product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces product enhancement to VALIDATE? THY linearity and calibration verification kit with addition of Free Triiodothyronine (FT3)

The enhancement to VALIDATE? THY, now with FT3, will address the growing demand by laboratories in need of a product to document Free Triiodothyronine linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – January 16, 2018 – LGC Maine Standards1 announces enhancement to VALIDATE? THY linearity and calibration verification kit (SKUs: 901bc or 901re), by adding Free Triiodothyronine (FT3) as a component of Total Triiodothyronine (TT3).  The VALIDATE? THY kit, in a human serum matrix, evaluates Cortisol (CORT), Free Thyroxine (FT4), Free Triiodothyronine (FT3), Thyroid Stimulating Hormone (TSH), Total Thyroxine (TT4), and Total Triiodothyronine (TT3).  Each VALIDATE? THY kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? THY, with Free Triiodothyronine (FT3), allows clinical laboratories with Beckman Coulter, Roche cobas? or other commonly used chemistry systems to complete their required Thyroid linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? THY, with Free Triiodothyronine (FT3), to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days

For VALIDATE? THY product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces VALIDATE? VIT D kit for easier linearity and calibration verification on Abbott ARCHITECT analyzers

VALIDATE? VIT D for Abbott ARCHITECT analyzers will address the growing demand by laboratories in need of a product to document Vitamin D linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – December 18, 2017 – LGC Maine Standards1 announces the release of VALIDATE? VIT D linearity and calibration verification kit for Abbott ARCHITECT analyzers.  The VALIDATE? VIT D kit, in a human serum matrix, evaluates Vitamin D.  Each VALIDATE? VIT D kit, prepared using the CLSI EP06-A “equal delta” sample preparation, offers six distinct concentrations covering the reportable range of Abbott ARCHITECT analyzers.  Each kit is liquid and ready-to-use.  Simply dispense the product from each dropper bottle, directly into six sample cups, and run in replicates.

Release of VALIDATE? VIT D for Abbott ARCHITECT analyzers allows clinical laboratories to easily and efficiently complete their required Vitamin D linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? VIT D for Abbott ARCHITECT analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. 

For VALIDATE? VIT D product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces addition of Ceruloplasmin (CER) to VALIDATE? SP2 linearity and calibration verification test kit for Roche cobas? analyzers

VALIDATE? SP2, with Ceruloplasmin, for Roche cobas? analyzers will address the growing demand by laboratories in need of a product to document Serum Proteins linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – November 29, 2017 – LGC Maine Standards1 announces the release of VALIDATE? SP2 linearity and calibration verification kit.  The VALIDATE? SP2 kit, in a human serum matrix, evaluates Albumin, Ceruloplasmin, C-Reactive Protein, Haptoglobin, Prealbumin and Rheumatoid Factor.  Each VALIDATE? SP2, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable ranges of Roche cobas? analyzers.  Each kit is liquid and ready-to-use.  Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? SP2, with Ceruloplasmin for Roche cobas? analyzers allows clinical laboratories to complete their required Serum Proteins linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.  Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? SP2, with Ceruloplasmin for Roche cobas? analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. 

For VALIDATE? SP2 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces release of VALIDATE? D-Dimer linearity and calibration verification test kit for Siemens Sysmex? CS-2500 System analyzers.

VALIDATE? D-Dimer for Siemens Sysmex? CS-2500 System analyzers will address the growing demand by laboratories in need of a product to document their D-Dimer linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – July 12, 2017 – LGC Maine Standards1 announces that its VALIDATE? D-Dimer linearity and calibration verification test kit has received US FDA 510 (k) clearance for use on Siemens Sysmex? CS-2500 System analyzers. The VALIDATE? D-Dimer kit, in a human plasma matrix, evaluates D-Dimer. Each VALIDATE? D-Dimer kit, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range for Siemens Sysmex? CS-2500 System analyzers. Each kit is liquid and ready-to-use. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? D-Dimer for Siemens Sysmex? CS-2500 System analyzers allows clinical laboratories to complete their required D-Dimer linearity and calibration verification and maximize the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? D-Dimer for Siemens Sysmex? CS-2500 System analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? D-Dimer product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces release of VALIDATE? IBC linearity and calibration verification test kit.

VALIDATE? IBC will address the growing demand by laboratories in need of a product to document their Iron Binding Capacity linearity and calibration verification.

CUMBERLAND FORESIDE, Maine – June 05, 2017 – LGC Maine Standards1 announces the release of VALIDATE? IBC linearity and calibration verification kit. The VALIDATE? IBC kit, in a human serum matrix, evaluates Total Iron Binding Capacity (TIBC) and Unsaturated Iron Binding Capacity (UIBC). Each VALIDATE? IBC kit, prepared using the CLSI EP06-A "equal delta" sample preparation, offers five distinct concentrations covering the reportable range of most chemistry analyzers. Each kit is liquid and ready-to-use. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

Release of VALIDATE? IBC allows clinical laboratories to complete their required TIBC and UIBC linearity and calibration verification and maximize the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE? IBC to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? IBC product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC


LGC Maine Standards announces release of VALIDATE? HEPARIN calibration verification / linearity test kit for IL ACL TOP? 500 hemostasis test systems.

VALIDATE? HEPARIN for Instrumentation Laboratory ACL TOP? 500 hemostasis test systems will address the growing demand by laboratories in need of a product to document their coagulation calibration verification / linearity testing.

CUMBERLAND FORESIDE, Maine – March 21, 2017 – LGC Maine Standards* is pleased to announce our VALIDATE? HEPARIN calibration verification / linearity test kit has received US FDA 510(k) clearance for use on Instrumentation Laboratory ACL TOP? 500 hemostasis test systems. The VALIDATE? HEPARIN kit evaluates Heparin Anti-Xa activity in a human plasma matrix. Each VALIDATE? HEPARIN kit is prepared using CLSI’s EP06-A recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in replicates. 

Release of this product will allow clinical laboratories using Instrumentation Laboratory ACL TOP? 500 hemostasis test systems to complete their required Heparin calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE? HEPARIN to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Coagulation and Whole Blood.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? HEPARIN product details click here or call 1-800-377-9684.

*LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces release of VALIDATE? D-Dimer calibration verification / linearity test kit for Stago STA-R? Evolution analyzers.

VALIDATE? D-Dimer for Stago STA-R? Evolution analyzers will address the growing demand by laboratories in need of a product to document their calibration verification / linearity testing.

CUMBERLAND FORESIDE, Maine – February 06, 2017 – LGC Maine Standards1 is pleased to announce our VALIDATE? D-Dimer calibration verification / linearity test kit has received US FDA 510(k) clearance for use on Stago STA-R? Evolution analyzers. The VALIDATE? D-Dimer kit evaluates D-Dimer in a human plasma base. Each VALIDATE? D-Dimer kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in replicates.

Release of this product will allow clinical laboratories using Stago STA-R? Evolution analyzers to complete their required D-Dimer calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE? D-Dimer for Stago STA-R? Evolution analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility and Coagulation.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? D-Dimer product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces addition of Rheumatoid Factor (RF) to VALIDATE? SP2 calibration verification / linearity test kit.

VALIDATE? SP2, with RF, will address the growing demand by laboratories for a product to document calibration verification / linearity of their testing system.

CUMBERLAND FORESIDE, Maine – January 17, 2017 – LGC Maine Standards1 is pleased to announce the addition of Rheumatoid Factor (RF) to our VALIDATE? SP2 calibration verification / linearity test kit. VALIDATE? SP2 evaluates Albumin, C-reactive protein, Haptoglobin, Prealbumin and Rheumatoid Factor in a human serum base. Each VALIDATE? SP2 kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in replicates.

Release of this product, with the addition of RF, will allow clinical laboratories to complete their required Serum Protein calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The enhancement of VALIDATE? SP2 with Rheumatoid Factor demonstrates a continued commitment by LGC Maine Standards to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility and Coagulation.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? SP2 product details click here or call 1-800-377-9684.

1LGC Maine Standards is the brand name for Maine Standards Company, LLC.


LGC Maine Standards announces release of VALIDATE? TUMOR MARKERS and VALIDATE? WHOLE BLOOD GLUCOSE calibration verification / linearity test kits.

VALIDATE? Tumor Markers and VALIDATE? Whole Blood Glucose will address the growing demand by laboratories for a product to document calibration verification/linearity of their testing system.

CUMBERLAND FORESIDE, Maine – August 1, 2016 – LGC Maine Standards is pleased to announce the release of our VALIDATE? Tumor Markers and VALIDATE? Whole Blood Glucose calibration verification / linearity test kits. VALIDATE? Tumor Markers evaluates Carcinoembryonic Antigen and Cancer Antigens 15-3, 19-9, and 125 in a human serum-based matrix. VALIDATE? Whole Blood Glucose evaluates Glucose in human whole-blood on blood glucose meter systems used in hospital point-of-care settings.

Recently, the US FDA has issued warnings regarding deaths due to interferences with glucose meters used with hospitalized patients and have released a draft guidance that defines new testing and performance requirements for hospital glucose meters and for non-hospital self-monitoring blood glucose devices. Release of VALIDATE? Whole Blood Glucose will allow hospitals to better complete their calibration verification / linearity testing – maximizing reportable ranges while minimizing manual dilutions.

Each VALIDATE? test kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply dispense product from dropper bottle and run in replicates.

The addition of VALIDATE? Tumor Markers and VALIDATE? Whole Blood Glucose to the LGC Maine Standards portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over 100 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Whole Blood Glucose, and D-Dimer.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? Tumor Markers product details click here or call 1-800-377-9684.

For VALIDATE? Whole Blood Glucose product details click here or call 1-800-377-9684.


LGC Maine Standards Company announces release of VALIDATE? D-Dimer calibration verification / linearity test kit.

VALIDATE? D-Dimer will address the growing demand by laboratories for a product to document calibration verification /linearity of their testing system.

LGC Maine Standards is pleased to announce our VALIDATE? D-Dimer calibration verification / linearity test kit has received US FDA 510(k) clearance for use on Instrument Laboratory ACL TOP? hemostasis test systems. The VALIDATE? D-Dimer kit evaluates D-Dimer in a human-plasma base matrix. Each VALIDATE? D-Dimer kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in replicates.

Release of this product will allow clinical laboratories to complete their required D-Dimer calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE? D-Dimer to the LGC Maine Standards portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over ninety analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Prostate Specific Antigen, Anemia, Fertility, and D-Dimer.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? D-Dimer product details click here or call 1-800-377-9684.


LGC Maine Standards Company announces release of VALIDATE? Fertility 1 and Fertility 2 calibration verification / linearity test kits.

VALIDATE? Fertility 1 & Fertility 2 will address the growing demand by laboratories for a product to document calibration verification / linearity of their testing system.

CUMBERLAND FORESIDE, Maine – May 16, 2016 – LGC Maine Standards is pleased to announce the release of our VALIDATE? Fertility 1 and Fertility 2 calibration verification / linearity test kits. VALIDATE? Fertility 1 evaluates Follicle-stimulating Hormone, Human Chorionic Gonadotropin, Luteinizing Hormone, and Prolactin, while VALIDATE? Fertility 2 evaluates a1-fetoprotein, Dehydroepiandrosterone Sulfate, Estradiol, and Progesterone in a human serum-based matrix.

Each VALIDATE? Fertility kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in duplicate or triplicate. Release of this product will allow clinical laboratories to complete their required Fertility calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE? Fertility 1 and Fertility 2 to the LGC Maine Standards portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE? calibration verification / linearity test kits for over ninety analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Prostate Specific Antigen, Anemia, and Fertility.

LGC Maine Standards MSDRx? data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.

For VALIDATE? Fertility 1 and Fertility 2 product details click here or call 1-800-377-9684.


CLIA UPDATE:  Division of Laboratory Services Centers for Medicare and Medicaid Services releases list of Top 10 Deficiencies in the Nation

The Centers for Medicare and Medicaid Services (CMS) recently released their list of Top 10 Deficiencies in the Nation.  Calibration verification / linearity testing was the eighth most common deficiency noted by the CMS.

VALIDATE? materials are FDA 510(k) cleared specifically for calibration verification / linearity testing.  VALIDATE? will challenge the low, mid and high point of your instrument’s full reportable range – ensuring that your laboratory meets CLIA’s calibration verification / linearity requirements.

To view the full CMS list of Top 10 Deficiencies in the Nation, click here.

For VALIDATE? product details click here or call 1-800-377-9684.

 

 

LGC Maine Standards

221 US Route 1
Cumberland Foreside, ME
04110

Phone:   1-800-377-9684
              +1-207-892-1300

Fax:       +1-207-892-2266

Contact us via email

 

Hours:
8:30 AM to 5:00 PM, Eastern Time, Monday through Thursday.  8:30 AM to 4:00 PM on Friday.

 

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