Cholesterol reference method and HDL cholesterol designated comparison methods as Performed in the US CDC Cholesterol Reference Method Laboratory Network / 中华检验医学杂志

ABSTRACT

Objective To standardize total cholesterol (TC) and HDL cholesterol (HDLC) analytical systems with the US CDC TC reference method and HDLC designated comparison method (DCM). Methods CDC TC reference method and HDLC DCM were set up and the quality was controlled by participating in the CDC Cholesterol Reference Method laboratory Network (CRMLN) bimonthly survey. The performance of 21 TC or HDLC analytical systems from 3 manufacturers were tested with the methods according to the CRMLN certification protocols. Results The coefficient variation (CV) of TC analyses with the reference method in 18 surveys averaged 0.29% and the bias versus CDC target value 0.1%. The DCM HDLC CV in 17 surveys averaged 0.010 mmol/L(0.39 mg/dl) and the averaged biases versus CDC target and group mean were - 0.019 mmol/L (-0.72 mg/dl) and - 0.006 mmol/L (-0.25 mg/dl), respectively. Most of the TC and HDLC analysis events (> 90%) satisfied the CRMLN accuracy and precision criteria for the reference method and DCM. Eighteen of the 21 tested TC or HDLC systems met the performance criteria for analytical systems and were certified for traceability by CDC. Conclusions A reference method for cholesterol and a DCM for HDLC and performed within an international reference laboratory network have been established and used for certification of TC and HDLC analytical systems, Further application of the methods to the standardization of lipid analysis are expected.