VALIDATE® products are used to perform verification of new instruments and assays. These instrument-specific kits are used by manufacturers and clinical laboratories to ensure instrument and assay specifications are being met, maintaining reliable and consistent patient results.

Test kits use human-sourced raw materials where available and require no reconstitution

Liquid, ready-to-use solutions are supplied in multi-use dropper bottles for easy dispensing.

Order once per year for extended open-vial stability and additional material for troubleshooting.

Test kits increase productivity, reducing the need for sample preparations and manual dilutions.

Levels 1-5 are prepared according to CLSI’s EPO6-A guidelines.

Fulfills CLIA 88’ CAP, ISO 15189, COLA, JCAHO, JCI, and other accreditation and regulatory requirements.

Provides comprehensive calibration verification assessment.

Instrument-specific configurations maximise range coverage and minimize dilutions.

Used for installations, preventive maintenance, and troubleshooting of reagents, QC and calibrations.

  • Data Submission

LGC Maine Standards’ Data Reduction Program puts the power of analysis at your fingertips. This free statistical software delivers real-time analysis of your linearity and calibration verification test results.

  • Linearity Assessment

Instant results. Easily and quickly perform linear regression analysis, including slope (proportional error), y-intercept (constant error), R2 and view an X-Y graph.

  • Peer Group Analysis

Take peer group analysis to a new level by using VALIDATE® and MSDRx®. Compare your data to Peer Means at each level across the entire range. Assess against Total Allowable Error Limits. If necessary, troubleshoot your assay. Evaluate specific methods in advance of Proficiency Testing (PT) events with any-time-online access to peer recoveries.

  • Reports

MSDRx® provides clear, concise, easily understood and explained statistical analyses and graphic presentations. You, your colleagues, your inspectors and your auditors can assess your laboratory performance quickly and with little interpretation.

Clinical Chemistry and Immunoassay Analysers

  • Abbott Laboratories
  • Alfa Wassermann
  • Beckman Coulter
  • Ortho Clinical Diagnostics
  • Roche Diagnostics
  • Siemens Healthineers
  • Tosoh Bioscience

General Chemistry GC1 Albumin, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Creatinine, Glucose, Lactate, Lithium, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, Uric Acid
GC2 Ammonia, Carbon Dioxide, Ethyl Alcohol, Total Iron, Uric Acid
GC3 Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma-Glutamyltransferase, Lactate Dehydrogenase, Lipase
GC4 Conjugated Bilirubin, Direct Bilirubin, Total Bilirubin
Iron Binding Capacity Total Iron Binding Capacity, Unsaturated Iron Binding
Lipoproteins LP High-Density Lipoprotein, Low-Density Lipoprotein
LP2 Apolipoprotein A1, Apolipoprotein B
ACTH &Anemia ACTH Adrenocorticotropic Hormone
Anemia Ferritin, Folate, Vitamin B12
Ferritin Ferritin
Body Fluids BF Albumin, Amylase, Cerebrospinal Fluid Total Protein, Cholesterol, Creatinine, Glucose, Lactate, Lactate Dehydrogenase, Total Protein, Triglycerides, Urea Nitrogen
BF2 Calcium, Chloride, Potassium, Sodium, Total Bilirubin, Uric Acid
BF3 Cancer Antigen 19-9, Carcinoembryonic Antigen
Bone PTH Parathyroid Hormone
VITD Vitamin D
Cardiac CM1 Creatine Kinase-MB, Myoglobin
CM2 Brain Natriuretic Peptide, High Sensitivity C-Reactive Protein, Terminal Prohormone of BNP, TroponinI, TroponinT
HIGH SENSITIVE TROPONIN High Sensitivity Troponin T, High Sensitivity Troponin I
Diabetes Diabetes Beta-Hydroxybutyrate, C-Peptide, Glucose, Insulin, Fructosamine
HbA1c % Glycohemoglobin A1c
Fertility FERT1 Follicle-stimulating Hormone, Human Chorionic Gonadotropin, Luteinizing Hormone, Prolactin, Testosterone
FERT 2 a1-fetoprotein, Dehydroepiandrosterone Sulfate, (DHEA S04), Estradiol, Progesterone
FERT 3 anti-Müllerian Hormone, Sex Hormone-binding Globulin
Hemostasis D-DIMER D-Dimer
HEPARIN Heparin Anti-Xa
Immunosuppressants ISX Cyclosporine, Sirolimus, Tacrolimus
Osmalality & POC OSMO Serum Osmolality, Urine Osmolality
WBG GLU (Glucose)
SARS-CoV-2 & Sepsis SARS-Cov-2 IgG SARS-COV-2 IgG
IL-6 Interloukin-f
PCT Procalcitonin
Serum Proteins SP1 al-Antitrypsin, Complement C3, Complement C4, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Transferrin
SP2 Albumin, C-Reactive Protein, Ceruloplasmin, Haptoglobin, Prealbumin, Rheumatoid Factor
SP3 a1-Acid Glycoprotein, Antistreptolysin O, B2-Microglobulin, Immunoglobulin E
Therapeutic Drugs TDM1 Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lidocaine, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, Vancomycin
Thyroid Analytes THY Cortisol, Free 13, Free T4, Thyroid Stimulating Hormone, Total T3, Total T4
THY2 Thyroglobulin
Tumor Markers PSA Free Prostate-Specific Antigen, Total Free Prostate-Specific Antigen
TM Cancer Antigen 15-3, Cancer Antigen 19-9, Cancer Antigen 125, Carcinoembryonic Antigen
Urine Chemistrys UC1 Chloride, Ethyl Alcohol, Glucose, Potassium, Sodium, Total Protein, Urea Nitrogen, Uric Acid
UC4 Calcium, Creatinine, Magnesium, Phosphorus
UC5 Amylase, Micro-Albumin, Pancreatic Amylase
UC6 Micro-Albumin, Creatinine