产品名称
Glucose, Creatinine, Glycerides, Cholesterol, in human frozen serum, LNE Certified Reference Material, commutable, JCTLM listed
form
liquid
quality
commutable, JCTLM listed
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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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 JCTLM as higher-order reference materials.
Application
LNE CRM Bio 101L1, 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.
General description
LNE CRM Bio 101L1 is a JCTLM database listed, 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 101L1
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 101L1
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 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.
存储类别
12 - Non Combustible Liquids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
高风险级别生物产品--人源产品
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