CRMLNCholesterol Reference Method Laboratory Network
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[4] Nonstandard abbreviations: LRC, Lipid Research Clinic; NHLBI, National Heart, Lung, and Blood Institute; NCEP, National Cholesterol Education Program; IDL, intermediate-density lipoprotein; CCSP, Cooperative Cholesterol Standardization Program; NRS/CHOL, National Reference System for Cholesterol; and CRMLN, Cholesterol Reference Method Laboratory Network.
Manufacturers can evaluate the calibration of their HDL cholesterol assay systems through the CRMLN HDL cholesterol certification program.
All of the homogeneous assays have current certifications from the CDC CRMLN (
All five homogeneous assays reported to date have current CRMLN certifications, indicating that at least one instrument application has demonstrated acceptable agreement with the RM on relatively normal specimens.
[4] Nonstandard abbreviations: ATP, Adult Treatment Panel; NCEP, National Cholesterol Education Program; CHD, coronary heart disease; TG, triglyceride; LDL-C and HDL-C, LDL- and HDL-cholesterol, respectively; TC, total cholesterol; TLC, therapeutic lifestyle change; BQ, [beta]-quantification; CRMLN, Cholesterol Reference Method Laboratory Network; Lp(a), lipoprotein a; and CRP, C-reactive protein.
Therefore, the CRMLN laboratories developed and validated a modified dextran sulfate (50 000 Da) procedure as the Designated Comparison Method (DCM) to provide results approximately equivalent to those of the CDC RM but without the need for ultracentrifugation (56).
The CRMLN, coordinated by the CDC and consisting now of five experienced US laboratories and several international partner laboratories in Canada, Europe, Japan, and South America, all closely standardized to the CDC RM, offers a protocol, based on NCCLS guidelines (66), whereby diagnostic manufacturers can assure accuracy by completing a comparison study with the DCM (67).
At its inception, the CRMLN consisted of nine US laboratories.
The performance requirements for CRMLN laboratories have evolved since the CRMLN was formed.
The assay was calibrated as recommended with the Calibrator for automated systems (C.f.a.s.) LDL-C Plus calibrator, which is standardized to the CRMLN reference method, and performed according to the manufacturer's recommendation.
In 1990, CRMLN established a process by which manufacturers can establish traceability to the National Reference System for Cholesterol of their diagnostics products used to measure TC (Myers GL, Kimberly MM, Waymack PP, Smith SJ, Cooper GR, Sampson EJ, manuscript in preparation).
The CRMLN maintains direct traceability to the CDC through a rigorous standardization program.