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Commutable Certified Reference Materials for clinically-relevant biomarkers

Having commutable certified reference materials (CRM) allows you to verify the calibration of your measuring instruments, as required by ISO 15189 and ISO 17511, as well as the (EU) 217/746 Regulation on in vitro diagnostic medical devices. This also allows verifying the accuracy of analyses performed in a laboratory and to assess the comparability of results from other techniques.

Available Certified Reference Materials (CRMs)

LNE CRM Bio 101a Level 1 & Level 2

Frozen serum pools prepared according to CLSI-C37A guidelines.
Concentrations of glucose, creatinine, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol certified with higher order reference methods.
Commutability assessed for the main routine assays.
Listed by the JCTLM as higher order reference materials.

LNE CRM Bio 301a, LNE CRM Bio 302a

Frozen serum pools prepared according to CLSI-C37A guidelines.
Concentrations of glucose, creatinine, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, urea and uric acid, certified with higher order reference methods.
Commutability assessed for the main routine assays.
These certified reference materials were used for national quality control organised by the ANSM in 2016 to assess the accuracy of some general biochemistry tests.

LNE CRM HbA1c 401, 402 & 403

Lyophilised haemolysates certified for HbA1c concentration with the IFCC reference method by LC/MS.
Commutability assessed for the main routine assays.
Certified reference materials referenced by the JCTLM as higher order standards.

Accreditations and recognitions

The target values were certified using high-accuracy reference methods listed in the JCTLM database. LNE is accredited by COFRAC for these methods in accordance with ISO 15195 and ISO 17025 (Calibration accreditation no. 2-54).
LNE is recognised by the JCTLM as a reference laboratory for the measurement of glucose, creatinine, total cholesterol, LDL-cholesterol and HDL-cholesterol in human serum, and HbA1c in haemolysates.
LNE’s expertise is recognized through a CMC (Calibration and Measurement Capability) listed in the BIPM database for the measurement glucose, creatinine and total cholesterol in human serum.
As a member of the CRMLN (Cholesterol Reference Method Laboratory Network), LNE has CDC certification for the determination of total cholesterol by GC-IDMS.
LNE’s CRMs were used in the national mandatory quality control organised in 2016 by the ANSM to assess the accuracy of some general biochemistry examinations.

Why chose LNE's CRMs

All our CRMs are among the very few Certified Reference Materials listed in the JCTLM database as higher order standards.
Our CRMs for cHDL and cLDL are the only ones listed in the JCTLM database as higher order reference materials.
Our CRMs are produced in accordance with the requirements of ISO 15194 with rigorously evaluated commutability for the main routine assays.
Target values are certified using higher order reference methods that are calibrated using primary standards of certified purity or certified reference materials, which allows establishing metrological traceability of results to the SI units.
Accuracy of the reference methods used to certify target values is verified by means of certified matrix reference materials.