临床检验量值的计量学溯源iso17511.ppt

CDC Reference Method Procedures Total Cholesterol: Abell-Kendall (AK) --chemical hydrolysis, spectrophotometric. HDLC: Ultracentrifugation, followed by precipitation with heparin-manganese reagent, quantitation by AK. LDLC: Betaquantification, quantitation with AK. Triglyceride: chemical hydrolysis, spectrophotometic. Free Glycerol: ID-MS CDC-NHLBI Lipid Standardization Program Began in 1958 with the National Heart Institute. The need: Assure true, stable and reproducible results within long-term trials and studies. Assure comparability of results across different trials and studies in space and time. Lipid Standardization Program Lipid Standardization Program Program supports Epidemiologic laboratories involved in clinical trials and population studies. Laboratories involved in lipid methodology research. Standardization involves… Meeting precision specifications. Meeting bias specifications. Maintaining performance over time. Chinese Labs in LSP Beijing Institute of Geriatrics, Ministry of Health Cardiovascular Institute, Fu Wai Hospital, Beijing Genetic Epidemiology Lab, Fu Wai Hospital, Beijing Lipid Research Group, Chinese CDC, Beijing Guangdong Province Cardiovascular Institute Program to Improve Laboratory Performance Focus on manufacturers of diagnostic assays Cholesterol Reference Method Laboratory Network Goals of CRMLN assist manufacturers to minimize calibration bias compared to CDC reference methods provide traceability of clinical laboratory measurements to CVD data base transfer improved performance to clinical laboratories Methods and Performance Criteria External Surveillance CRMLN laboratories are monitored bimonthly by CDC Scheme TC: 3 levels, duplicate, 2 runs (N=12) HDLC: 4 levels, duplicate, 4 runs (N=32) LDLC: 4 levels, quadruplicate, 4 runs (N=64) TG: Monthly, 4 levels, duplicate, 4 runs (N=32) CRMLN Performance Total Cholesterol Bias compared to CDC individual biases of 10 CRMLN laboratories range from -0.6% to +0.3% average group bias of