2024 Press Releases & News
July 23, 2024 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® B-CTx for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification, linearity, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 23 July, 2024.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® B-CTx kit for the Roche cobas® platforms. VALIDATE® B-CTx (Order No. 304re) offers Beta-CrossLaps (B-CTx) for easy, fast, efficient calibration verification and linearity. VALIDATE® B-CTx test kits are liquid-frozen 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 calibration verification, linearity, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for calibration verification and linearity under CLIA, CAP, COLA, JCAHO, JCI, and ISO 15189.
The addition of
VALIDATE® B-CTx to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification and linearity products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® calibration verification and linearity kits for over 170 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sars-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to Maine Standards where a technical specialist will complete the data analysis. Peer group comparison is also available upon request.
For
VALIDATE® B-CTx product details,
click here, or call 1-800-377-9684.
July 15, 2024 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® CT for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification, linearity, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 15 July, 2024
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® CT kit for the Roche cobas® platforms. VALIDATE® CT (Order No. 907re) offers Calcitonin (hCT) for easy, fast, efficient calibration verification and linearity. VALIDATE® CT test kits are liquid-frozen 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 calibration verification, linearity, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for calibration verification and linearity under CLIA, CAP, COLA, JCAHO, JCI, and ISO 15189.
The addition of
VALIDATE® CT to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification and linearity products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® calibration verification and linearity kits for over 170 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sars-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to Maine Standards where a technical specialist will complete the data analysis. Peer group comparison is also available upon request.
For
VALIDATE® CT product details,
click here, or call 1-800-377-9684.
February 28, 2024 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® PSA for the Abbott ARCHITECT/ALINITY platforms for easy, fast, and reliable documentation of calibration verification, linearity, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 28 February, 2024.
LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® PSA kit for the Abbott ARCHITECT/ALINITY. VALIDATE® PSA (Order No. 406ab) offers Free Prostate-Specific Antigen (FPSA) and Total Prostate-Specific Antigen (Total PSA) for easy, fast, efficient calibration verification and linearity testing. VALIDATE® PSA test kits are liquid-frozen 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 calibration verification, linearity, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for calibration verification and linearity under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.
The addition of VALIDATE® PSA to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification and linearity products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® calibration verification and linearity kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sars-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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 Clinical Diagnostics where a technical specialist will complete the data analysis. Peer group comparison is also available upon request.
For VALIDATE® PSA product details, click here, or call 1-800-377-9684.
January 31, 2024 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® OCN for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification, linearity, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 31 January, 2024.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® OCN kit for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification and linearity. VALIDATE® OCN (Order No. 305re) offers N-MID Osteocalcin (OCN) for easy, fast, efficient calibration verification and linearity. VALIDATE® OCN test kits are liquid-frozen 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 calibration verification, linearity, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for calibration verification and linearity under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.
The addition of
VALIDATE® OCN to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification and linearity products that meet industry needs. LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® calibration verification and linearity kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sars-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to Maine Standards where a technical specialist will complete the data analysis. Peer group comparison is also available upon request.
For VALIDATE® OCN product details,
click here, or call 1-800-377-9684.
2023 Press Releases & News
December 21, 2023 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® Folate RBC for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification, linearity, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 21 December, 2023.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® Folate RBC kit for the Roche cobas® platforms for easy, fast, and reliable documentation of calibration verification and linearity testing. VALIDATE® Folate RBC (Order No. 309re) offers Folate RBC (FOL RBC) and is liquid whole blood and ready-to-use; simply pretreat with hemolyzing reagent as specified in your method sheet instructions, dispense hemolysate into five sample cups and run in replicates to verify the assay’s reportable range.
VALIDATE® products allow clinical laboratories to complete their required calibration verification, linearity, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for calibration verification and linearity under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.
The addition of
VALIDATE® Folate RBC to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification and linearity products that meet industry needs. LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® calibration verification and linearity kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, SARS-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to Maine Standards where a technical specialist will complete the data analysis. Peer group comparison is also available upon request.
For
VALIDATE® Folate RBC product details,
click here, or call 1-800-377-9684.
September 18, 2023 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® THY2 for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 18 September, 2023.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® THY2 kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® THY2 (Order No. 908ro) offers Thyroglobulin (TG) for easy, fast, efficient linearity and calibration verification. VALIDATE® THY2 test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® THY2 to LGC Clinical Diagnostics’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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 Clinical Diagnostics 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® THY2 product details, click here, or call 1-800-377-9684.
September 6, 2023 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® Anti-CCP for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.\
MAINE, UNITED STATES, 6 September, 2023.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® Anti-CCP kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® Anti-CCP (Order No. 210re) offers Cyclic Citrullinated Peptides IgG Antibody (aCCP) for easy, fast, efficient linearity and calibration verification. VALIDATE® Anti-CCP test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® Anti-CCP to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Rheumatoid Arthritis, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® Anti-CCP product details,
click here, or call 1-800-377-9684.
June 24, 2023 - LGC acquires Kova International, Inc., including Biochemical Diagnostics, Inc., strengthening its portfolio of Quality Measurement Tools
LGC Clinical Diagnostics, a business unit of LGC, announced the acquisition of Kova International, Inc. (Kova), a leading developer and manufacturer of in vitro urinalysis and toxicology quality control products for clinical laboratories.
Kova includes two locations; Garden Grove, California, focused on urinalysis quality controls, and Edgewood, New York, focused on toxicology quality controls. Kova’s quality controls are used in hospitals, employee wellness programmes, forensic testing and medical device manufacturers production and Quality Assurance (QA) programs.
Bharathi Anekella, Executive Vice President & General Manager of LGC Clinical Diagnostics, said, “We are excited to bring Kova’s established clinical urinalysis and toxicology quality controls into LGC Clinical Diagnostics. Kova and LGC Clinical Diagnostics are an excellent fit. Our focus on delivering confidence to clinical laboratories in test precision, accuracy, and conformance to international standards, perfectly aligns us with a common objective of Science for a Safer World.”
Kova’s California and New York manufacturing facilities are certified to ISO 13485:2016 quality management system standards and guidelines, as well as cGMP qualified to manufacture quality control products, and are registered FDA manufacturing sites for the clinical diagnostic laboratory industry.
The acquisition grows LGC Clinical Diagnostics’ portfolio in the clinical quality control space, complementing a wide breadth of existing capabilities across biochemistry, serology, molecular, and clinical genomics quality controls and reference materials. LCC Clinical Diagnostics is also a leading provider of biological materials and viral antigens.
With over 35 years Industry experience, and now serving over 20,000 customers in more than 100 counties, we look forward to combining Kova’s and LGC Clinical Diagnostics’ expertise to deliver unrivalled solutions for our customers with an expanded breadth of capability.
May 31, 2023 - LGC Clinical Diagnostics announces the addition of Troponin I to Maine Standards VALIDATE® CM2 for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 31 May, 2023.
LGC Clinical Diagnostics announces the addition of a Troponin I Range Coverage set to Maine Standards
VALIDATE® CM2 kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® CM2 (Order No. 402re) offers High Sensitivity C-Reactive Protein (hs-CRP), N-Terminal Pro hormone Brain Natriuretic Peptide (NT-proBNP), Troponin T (TnT), and now Troponin I (TnI) for easy, fast, efficient linearity and calibration verification. The NT-proBNP Clinical Range set has been removed as part of this enhancement. VALIDATE® CM2 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® CM2 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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.
April 24, 2023 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® Toxoplasma IgG for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 24 April, 2023.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® Toxoplasma IgG kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® Toxoplasma IgG (Order No. 803re) offers TOXO IgG for easy, fast, efficient linearity and calibration verification. VALIDATE® Toxoplasma IgG test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® Toxoplasma IgG to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® Toxoplasma IgG product details,
click here, or call 1-800-377-9684.
March 13, 2023 - LGC Clinical Diagnostics announces the improved range coverage of FT3 to Maine Standards VALIDATE® THY for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 13 March, 2023.
LGC Clinical Diagnostics announces the
improved range coverage of FT3 to Maine Standards
VALIDATE® THY kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® THY (Order No. 901re) offers Free Triiodothyronine (FT3) in addition to Cortisol (CORT), Triiodothyronine (T3), Thyroxine (T4), Thyroid Stimulating Hormone (TSH) and Free Thyroxine (FT4) for easy, fast, efficient linearity and calibration verification. VALIDATE® THY 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® THY to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® THY product details,
click here, or call 1-800-377-9684.
February 6, 2023 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® UC1 for the Roche cobas® 8000 platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 6 February, 2023.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® UC1 kit for the
Roche cobas® 8000 platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® UC1 (Order No. 701re) offers Uric Acid (UA), Chloride (CL), Ethyl Alcohol (ETOH), Glucose (GLU), Potassium (K), Sodium (NA), Total Protein (UTP) and Urea Nitrogen (UUN) for easy, fast, efficient linearity and calibration verification. VALIDATE® UC1 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® UC1 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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 product details,
click here, or call 1-800-377-9684.
2022 Press Releases & News
December 16, 2022 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® Rubella IgG for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 16 December, 2022.
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® Rubella IgG kit for the
Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® Rubella IgG (Order No. 802re) offers Rubella IgG Antibody (RUB) for easy, fast, efficient linearity and calibration verification. VALIDATE® Rubella IgG test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® Rubella IgG to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® Rubella IgG product details,
click here, or call 1-800-377-9684.
December 7, 2022 - LGC Clinical Diagnostics announces the addition of Cystatin C to Maine Standards VALIDATE® Diabetes kit for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 8 November, 2022.
LGC Clinical Diagnostics announces the
addition of Cystatin C to Maine Standards
VALIDATE® Diabetes kit for the
Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. The product (Order No. 204ro), with the analytes Beta-Hydroxybutyrate (BHB)*, C-Peptide (C-PEP), Insulin (INS), Fructosamine (FRUC), and now Cystatin C (CYS C), is formulated in human serum, using the CLSI EP06 “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Roche cobas® instrument. VALIDATE® Diabetes test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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 Cystatin C to VALIDATE® Diabetes, Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, Point-of-Care, SARS-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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.
*Developed and manufactured using Stanbio’s BHB reagent on the Roche cobas®.
December 5, 2022 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® Growth Hormone for the Roche cobas® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
MAINE, UNITED STATES, 5 December, 2022
LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® Growth Hormone kit for the
Roche cobas® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® Growth Hormone (Order No. 508ro) offers Human Growth Hormone (hGH) for easy, fast, efficient linearity and calibration verification. VALIDATE® Growth Hormone test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® Growth Hormone to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Growth Hormone, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® Growth Hormone product details,
click here, or call 1-800-377-9684
November 1, 2022 - LGC Clinical Diagnostics announces the addition of Maine Standards VALIDATE® CM2 for the Polymedco PATHFAST® platforms for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
Maine, United States - LGC Clinical Diagnostics announces the addition of Maine Standards
VALIDATE® CM2 kit for the
Polymedco PATHFAST® platforms for easy, fast, and reliable documentation of linearity and calibration verification. VALIDATE® CM2 (Order No. 402pf) offers High Sensitivity C-Reactive Protein (hs-CRP), N-Terminal Pro hormone Brain Natriuretic Peptide (NT-proBNP) and Troponin I (TnI) for easy, fast, efficient linearity and calibration verification. VALIDATE® CM2 test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® CM2 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Clinical Diagnostics manufactures Maine Standards VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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.
September 19, 2022 - Maine Standards announces the addition of T-Uptake to the VALIDATE® Thyroid 2 kit for Beckman Coulter Unicel® DxI/Access with Thyroglobulin for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
MAINE, UNITED STATES - Maine Standards announces a product update for
VALIDATE® Thyroid 2 (THY2) to meet the linearity and calibration verification needs of clinical laboratories running the Beckman Coulter Unicel® DxI/Access platform. The product (Order No. 908bc), with the analytes Thyroglobulin (Tg) and now T-Uptake (TU), is formulated in human serum, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Beckman Coulter Unicel® DxI/Access instrument. VALIDATE® THY2 test kits are frozen 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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
T-Uptake to VALIDATE® THY2, Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, Point-of-Care, SARS-CoV-2, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® THY2 product details,
click here, or call
1-800-377-9684.
September 12, 2022 - Maine Standards announces VALIDATE® Vitamin D for Roche cobas® for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
MAINE, UNITED STATES - September 12, 2022 - Maine Standards announces the release of
VALIDATE® VIT D to meet the linearity and calibration verification needs of clinical laboratories running the Elecsys Vitamin D total III assay on the Roche cobas® platforms. VALIDATE® VIT D (Order No. 506ro) offers Total 25 (OH) Vitamin D for easy, fast, efficient linearity and calibration verification. VALIDATE® VIT D test kits are frozen 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.
VALIDATE® products allow clinical laboratories to complete their required linearity, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® VIT D to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs. Maine Standards is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® VIT D product details,
click here, or call
1-800-377-9684.
August 15, 2022 - Maine Standards announces VALIDATE® aHBs for Roche cobas®, Abbott ALINITY, and Siemens ADVIA Centaur® for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
CUMBERLAND FORESIDE, Maine – August 15, 2022 – Maine Standards announces the release of
VALIDATE® aHBs to meet the linearity and calibration verification needs of clinical laboratories running the Roche cobas®, Abbott ALINITY, and Siemens ADVIA Centaur®, platforms. VALIDATE® aHBs (Order No. 801mm) offers Hepatitis B Surface IgG Antibody (aHBs) for easy, fast, efficient linearity and calibration verification. VALIDATE® aHBs 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® aHBs to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serology, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® aHBs product details,
click here, or call
1-800-377-9684.
April 24, 2022 - Maine Standards announces VALIDATE® SARS-CoV-2 IgG for Abbott ARCHITECT/ALINITY, Beckman Coulter Unicel® DxI/Access, Ortho VITROS, and Siemens ADVIA Centaur immunoassays for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
CUMBERLAND FORESIDE, Maine – April 25, 2022 – Maine Standards announces the release of VALIDATE® SARS-CoV-2 IgG (Order No. 510mm) to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT/ALINITY, Beckman Coulter Unicel® DxI/Access, Ortho Vitros, or Siemens ADVIA Centaur platforms. The product is formulated in a human plasma matrix.
VALIDATE® SARS-CoV-2 IgG test kits are FDA-listed, CE-marked, liquid and ready-to-use; simply dispense the solution from each dropper bottle directly into five or six sample cups and run in replicates to verify the assay’s reportable range. The product is manufactured using The Native Antigen Company’s’ Human IgG1 Anti-SARS-CoV-2 Spike (S1) RBD Antibody (DH6) which is a recombinant humanized monoclonal antibody against SARS-CoV-2 receptor binding domain (RBD) protein, but not against SARS-CoV-1 or MERS-CoV. The antibody was characterized and its concentration quantitated by the UK National Measurement Laboratory at LGC.
VALIDATE® products allow clinical laboratories to complete their required linearity, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® SARS-CoV-2 IgG to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs. Maine Standards’ is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, SARS-CoV-2, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® SARS-CoV-2 IgG product details,
click here, or call
800-377-9684.
March 14, 2022 - Maine Standards announces VALIDATE® THY2 for Beckman Coulter Unicel® DxI/Access for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
CUMBERLAND FORESIDE, Maine – March 14, 2022 – Maine Standards announces the release of VALIDATE® Thyroid 2 (THY2) to meet the linearity and calibration verification needs of clinical laboratories running the Beckman Coulter Unicel® DxI/Access platform. The product (Order No. 908bc), with the analyte Thyroglobulin (Tg), is formulated in human serum, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Beckman Coulter Unicel® DxI/Access instrument. VALIDATE® THY2 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, calibration verification, and Analytical Measurement Range (AMR) verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality 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® THY2 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards’ is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemisty, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® THY2 product details, click here, or call 1-800-377-9684.
February 28, 2022 - Maine Standards announces VALIDATE® ISx for Abbott ARCHITECT/ALINITY and Siemens Dimension for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
CUMBERLAND FORESIDE, Maine – February 28, 2022 – Maine Standards announces the release of VALIDATE® Immunosuppressants (ISx) to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT/ALINITY or Siemens Dimension platform(s). The product (Order No. 608mm), which includes analytes Cyclosporine (CSA)*, Tacrolimus (TAC), and Sirolimus (SIRO), is formulated in human whole blood, 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/ALINITY or Siemens Dimension instruments. VALIDATE® ISx 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, calibration verification, and Analytical Measurement Range (AMR) 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® ISx to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards¹ is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemisty, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® ISx product details, click here, or call 1-800-377-9684.
2021 Press Releases & News
December 16, 2021 - Maine Standards announces the release of VALIDATE® Body Fluids 3 for easy, fast, and reliable documentation of linearity, calibration verification, Analytical Measurement Range (AMR) verification, and Laboratory Developed Test (LDT) validation
CUMBERLAND FORESIDE, Maine – December 16, 2021 – Maine Standards announces the release of VALIDATE® BF3 (Order No. 207ro) to meet the linearity, calibration verification, and validation needs of clinical laboratories running body fluid Laboratory Developed Tests (LDT) for Cancer Antigen 19-9 (CA 19-9) and Carcinoembryonic Antigen (CEA). The product is formulated in human ascites fluid, expanding the VALIDATE® Body Fluids portfolio, which currently consists of VALIDATE® BF (Order No. 205bf) and VALIDATE® BF2 (Order No. 206ro). VALIDATE® BF3 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 regulatory 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® BF3 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Osmolality, POC, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
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® BF, VALIDATE® BF2, and VALIDATE® BF3 product details, click here, or call +1 800-377-9684, or +1 207.892.1300.
June 29, 2021 - Maine Standards announces VALIDATE® UC1, VALIDATE® UC4, and VALIDATE® UC5 for Abbott ARCHITECT and Abbott ALINITY for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification
CUMBERLAND FORESIDE, Maine – June 29, 2021 – Maine Standards announces the release of VALIDATE® UC1, VALIDATE® UC4, and VALIDATE® UC5 to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT or Abbott ALINITY platform(s). The products (Order Nos. 701ab, 704ab, and 705ab respectively), which include analytes Uric Acid (UA), Chloride (CL), Ethyl Alchohol (ETOH), Glucose (GLU), Potassium (K), Sodium (NA), Total Protein (UTP), Urea Nitrogen (UUN), Calcium (CA), Creatinine (CREA), Magnesium (MG), Phosphorus (PHOS), Micro-Albumin (uALB), Amylase (AMY), and Pancreatic Amylase (PAMY), are formulated in a human urine 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® UC1, VALIDATE® UC4, and VALIDATE® UC5 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® UC1, VALIDATE® UC4, and VALIDATE® UC5 to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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, VALIDATE® UC4, and VALIDATE® UC5 product details, click here, or call 1-800-377-9684.
March 29, 2021 - 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 – Maine Standards 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, Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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.
March 8, 2021 - 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 – Maine Standards 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 Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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.
March 3, 2021 - 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 – Maine Standards 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 Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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.
February 1, 2021 - 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 – 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 Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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.
January 26, 2021 - 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 – Maine Standards 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 Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
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.
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.