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LNEBIO301

Glucose, Creatinine, Glycerides, Cholesterol, Urea and Uric acid in human frozen serum

LNE Certified Reference Material

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form

liquid

shelf life

limited shelf life, expiry date on the label

composition

human serum, 100%

IVD

not for in vitro diagnostic use

storage temp.

−70°C

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General description

LNE CRM Bio 301 is a higher-order certified reference material produced by the French metrological institute LNE in compliance with ISO 17034 requirements. This secondary standard is intended for use as quality control material to assess the measurement bias or measurement uncertainty of established or new measurement procedures for the determination of creatinine, glucose, total cholesterol, total glycerides, HDL-cholesterol and LDL-cholesterol in human serum.
The Certified Reference Material LNE CRM Bio 301 corresponds to a pool of Human Frozen Serum that was prepared according to the Clinical Laboratory Standards Institute (CLSI) C37-A guidelines describing the preparation and validation of commutable frozen human serum pools as Secondary Reference Materials for Cholesterol Measurement. Samples commutability was assessed through a commutability study involving several clinical laboratories. Commutability results are reported in the certificate of analysis.

Cert_ LNE CRM HbA1c 401

Application

The LNE CRM HbA1c 401 is a reference material designed for use as quality control material. It is intended for evaluating the measurement bias or uncertainty of existing or new measurement procedures for determining HbA1c in hemolysate or whole blood.

Features and Benefits

  • A reliable Certified Reference Materials (CRM) for clinically relevant biomarkers 
  • Concentrations of glucose, creatinine, total cholesterol, triglyceride (TG), high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol, urea, and uric acid, are certified with higher-order reference methods. 
  • Derived from real patient samples. 
  • This CRM is pooled, tested, and certified by the LNE, which includes extensive commutability studies. 
  • The accuracy of the reference methods used to certify target values is verified using certified matrix reference materials. 
  • This CRM was used for national quality control organized by the ANSM in 2016 to assess the accuracy of some general biochemistry tests.

Other Notes

  • Details on storage, safety, usage, and operating instructions are provided in the comprehensive Certificate of Analysis. 
  • Concentrations of glucose, total glycerides, and total cholesterol are certified by reference measurement procedures relying on Gas Chromatography Isotope Dilution mass Spectrometry (GC-IDMS) listed in JCTLM database.  
  • Concentrations of HDLC and LDL-C, are certified at the CDC by Beta Quantification with cholesterol being determined by the Abell Kendall method.  
  • Concentrations of creatinine and uric acid are certified by reference measurement procedures relying on Liquid Chromatography Isotope Dilution mass Spectrometry (LC-IDMS) listed in JCTLM database. 
  • This clinical matrix CRM is for research and clinical testing applications.

Storage Class Code

10 - Combustible liquids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

高风险级别生物产品--人源产品

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