LGC Maine Standards Controls and Linearity Verification
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Linearity and Calibration Verification

By Maine Standards

Calibration Verification, performed at regular intervals, ensures that your clinical analyser is performing to the manufacturer’s claims, ensuring reliable and consistent patient test results.

Every VALIDATE® linearity and calibration verification product is developed and produced with the Maine Standards unwavering commitment to precision and accuracy. Their facility’s Quality Management System is certified to ISO 13485:2003 by DEKRA Certification B.V.

Ready to use

Liquid samples require no reconstitution. Simply add product to your sample cup and run in replicates.

MULTIPLE PRODUCT CONFIGURATIONS

LGC Maine Standards specifically formulates its VALIDATE® product line into specialised configurations with different analyte concentrations that challenge your analyzers' full reportable range

EASY-TO-USE FOR RETESTING OR TROUBLESHOOTING

With long open-vial stability, you'll have adequate product for repeats or troubleshooting. These are unique samples to have available for troubleshooting, since VALIDATE® products challenge your full reportable range.

EQUAL-SPACED LEVELS

Levels 1 through 5 are prepared to create “equal deltas” as recommended by the CLSI EP06-A guideline for linearity and calibration verification.

TWO TESTING CYCLES FOR ONE INSTRUMENT

We will provide adequate product volume to complete two linearity and calibration verification cycles.

Maine Standards Validate
ACCREDITATION REQUIREMENTS

Maine Standards facility is Quality Management System is certified to ISO 13485:2003, registered with the U.S. FDA and complies with the U.S. FDA Quality System Regulation (QSR) and almost all products are CE marked.

VALIDATE® ready-to-use kits are designed to assist in the documentation of linearity, calibration verification and verification of linear range required by many inspection agencies.

VALIDATE® will also provide assistance when troubleshooting instrument systems, reagent problems and calibration anomalies.

Multiple product configurations are available to meet the different needs of the many instrument systems available.  Configurations are specifically formulated to maximize reportable ranges with minimum dilutions.

Please click on a header to find out more:

GC1
ALB (Albumin)
BUN (Blood Urea Nitrogen)
CA (Calcium)
CL (Chloride)
CHOL (Cholesterol)
CREA (Creatinine)
GLU (Glucose)
LAC (Lactate)
LI (Lithium)
MG (Magnesium)
K (Potassium)
NA (Sodium)
TP (Total Protein)
TRIG (Triglyceride)
UA (Uric Acid)
GC2
NH3 (Ammonia)
CO2 (Carbon Dioxide)
ETOH (Ethyl Alcohol)
FE (Total Iron)
UA (Uric Acid)
GC3
ALT (Alanine Aminotransferase)
ALP (Alkaline Phosphatase)
AMY (Amylase)
AST (Aspartate Aminotransferase)
CK (Creatine Kinase)
GGT (Gamma-Glutamyltransferase)
LD (Lactate Dehydrogenase)
LIP (Lipase)
GC4
BC (Conjugated Bilirubin)
DBIL (Direct Bilirubin)
TBIL (Total Bilirubin)

IBC
TIBC (Total Iron Binding Capacity)

UIBC (Unsaturated Iron Binding
Capacity)

HbA1c
% Glycohemoglobin A1c (HbA1c)

LP
Apo-A1 (Apolipoprotein A)
Apo-B (Apolipoprotein B)
HDL (High Density Lipoprotein)
LDL (Low Density Lipoprotein)

TDM1
ACTM (Acetaminophen)
AMIK (Amikacin)
CARB (Carbamazepine)
DIGN (Digoxin)
GENT (Gentamicin)
LIDO (Lidocaine)
NAPA (N-Acetylprocainamide)
PHNO (Phenobarbital)
PHYT (Phenytoin)
PRIM (Primidone)
PROC (Procainamide)
QUIN (Quinidine)
SALY (Salicylate)
THEO (Theophylline)
TOB (Tobramycin)
VALP (Valproic Acid)
VANC (Vancomycin)

UC1
CL (Chloride)
Ethyl Alcohol (ETOH)
GLU (Glucose)
K (Potassium)
NA (Sodium)
UTP (Total Protein)
UUN (Urea Nitrogen)
UA (Uric Acid)
UC4
CA (Calcium)
CREA (Creatinine)
MG (Magnesium)
PHOS (Phosphorus)
UC5
AMY (Amylase)
μALB (Micro-Albumin)
PAMY (Pancreatic Amylase)
UC6
ALB (Albumin)
CREA (Creatinine)

OSMO
SOSMO (Serum Osmolality)
UOSMO (Urine Osmolality)

THY
CORT (Cortisol)
FT4 (Free T4)
TSH (Thyroid Stimulating Hormone)
T4 (Thyroxine (Total T4))
T3 (Triiodothyronine (Total T3))

SP1
AAT (α1-Antitrypsin)
C3 (Complement C3)
C4 (Complement C4)
IGA (Immunoglobulin A)
IGG (Immunoglobulin G)
IGM (Immunoglobulin M)
TRFN (Transferrin)
SP2
ALB (Albumin)
CRP (C-Reactive Protein)
HPT (Haptoglobin)
PAB (Prealbumin)
RF (Rheumatoid Factor)

PSA
fPSA (free Prostate-Specific Antigen)
tPSA (total Prostate-Specific Antigen)
TUMOUR MARKERS
CA 15-3 (Cancer Antigen 15-3)
CA 19-9 (Cancer Antigen 19-9)
CA 125 (Cancer Antigen 125)
CEA (Carcinoembryonic Antigen)

CM1
CK-MB (Creatine Kinase-MB)
MYO (Myoglobin)
CM2
BNP (Brain Natriuretic Peptide)
hs-CRP (High Sensitivity
C-Reactive Protein)
NT-proBNP (N-terminal Prohormone
of Brain Natriuretic Peptide)
TnI (Troponin I)
TnT (Troponin T)

VIT D
VIT D (Vitamin D)

ANEMIA
FERR (Ferritin)
FOL (Folate)
Vit B12 (Vitamin B12)
FERRITIN
FERR (Ferritin)

FERTILITY 1
FSH (Follicle-Stimulating Hormone)
hCG (Human Chorionic Gonadotropin)
LH (Luteinizing Hormone)
PRL (Prolactin)
TSTO (Testosterone)
FERTILITY 2
AFP (α1-fetoprotein)
DHEA-S (Dehydroepiandrosterone
Sulfate)
E2 (Estradiol)
PRGE (Progesterone)

D-DIMER
D-Dim (D-Dimer)
HEPARIN*
HP (Heparin Anti-Xa)

GLU (Glucose)

General Chemistry

30 ANALYTES AVAILABLE

GENERAL CHEMISTRIES, ENZYMES
& SELECT LIPIDS

LIQUID, READY-TO-USE

FIVE LEVELS

Maine Standards General Chemistry
Maine Standards General Chemistry
Maine Standards General Chemistry
Maine Standards General Chemistry

Iron Binding Capacity

TWO ANALYTES*

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Glycohaemoglobin

% GLYCOHEMOGLOBIN A1c

HUMAN WHOLE BLOOD

LIQUID, READY-TO-USE

FIVE LEVELS

Lipoproteins

TWO ANALYTES

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Whole Blood Glucose

FIVE LEVELS

HUMAN WHOLE BLOOD

LIQUID, READY-TO-USE

FOR POINT OF CARE

Therapeutic Drugs

17 ANALYTES AVAILABLE

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Urine Chemistry

15 ANALYTES AVAILABLE

HUMAN URINE MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Osmolality

TWO SETS — SERUM & URINE

HUMAN-BASED MATRICES

LIQUID, READY-TO-USE

FIVE LEVELS

Cardiac Marker

SEVEN ANALYTES

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Thyroid

5 ANALYTES AVAILABLE

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Vitamin D

TOTAL 25 (OH) VITAMIN D

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Serum Protein Products

12 ANALYTES AVAILABLE

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Tumour Markers

FOUR ANALYTES

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Anaemia

THREE ANALYTES

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Fertility

NINE ANALYTES

HUMAN SERUM MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS

Haemostasis

TWO ANALYTES

HUMAN PLASMA MATRIX

LIQUID, READY-TO-USE

FIVE LEVELS