form
liquid
quality
commutable, JCTLM listed
shelf life
limited shelf life, expiry date on the label
composition
human serum, >99.7%
IVD
not for in vitro diagnostic use
General description
LNE CRM Bio 101L2 is a higher-order certified reference material produced by the French metrological institute LNE in compliance with ISO 17034 requirements.
The Certified Reference Materials LNE CRM Bio 101L1 and LNE CRM Bio 101L2 correspond to 2 pools of Human Frozen Serum that were 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 2 commutability studies according to the difference in bias approach described in the IFCC recommendations on commutability assessment involving several clinical laboratories. Commutability results are reported in the certificate of analysis.
Cert_ LNE CRM Bio 101L2
The Certified Reference Materials LNE CRM Bio 101L1 and LNE CRM Bio 101L2 correspond to 2 pools of Human Frozen Serum that were 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 2 commutability studies according to the difference in bias approach described in the IFCC recommendations on commutability assessment involving several clinical laboratories. Commutability results are reported in the certificate of analysis.
Cert_ LNE CRM Bio 101L2
Application
LNE CRM Bio 101L2, a 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.
Features and Benefits
- A reliable Certified Reference Material (CRM) for clinically relevant biomarkers
- Concentrations of glucose, creatinine, total cholesterol, triglyceride (TG), high-density lipoprotein (HDL)-cholesterol and low-density lipoprotein (LDL)-cholesterol are certified by 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.
- Listed by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) as higher-order reference materials.
Other Notes
- Details on storage, safety, usage, and operating instructions are provided in the comprehensive Certificate of Analysis (CoA).
- Concentrations of glucose, creatinine, total glycerides, and total cholesterol are certified by reference measurement procedures relying on gas chromatography isotope dilution mass spectrometry (GC-IDMS) listed in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.
- Concentrations of HDL-C and LDL-C are certified at the CDC by beta quantification with cholesterol being determined by the Abell Kendall method.
- This clinical matrix CRM is for research and clinical testing applications.
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存储类别
10 - Combustible liquids
wgk
WGK 3