Abstract:Abstract:Objective:To investigate the current status of reference intervals (RI) applied in the testing of blood lipids and lipoproteins, including the sources of origin and the distribution of upper and lower limits. Methods:Online questionnaires were issued towards 1 045 clinical laboratories participated in the 2014 external quality assessment (EQA) program of blood lipids and lipoproteins. The informations regarding the upper/lower limits, sources of RIs and clinical decision levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), lipoprotein (a), apolipoprotein A1 (Apo A1) and apolipoprotein B (Apo B) were collected and statistically analyzed. Results:A total of 549 laboratories submitted the data on line, rendering a return rate of 52.5% (549/1 045). The top proportion of RIs sources (54.5% to 68.3%) came from the instructions of reagent manufacturers, followed by recommendations from National Guide to Clinical Laboratory Procedures (24.0% to 34.9%). The RIs determined independently by laboratories accounts for 3.3% to 4.4%. The upper and lower limits of RIs in certain indicators were overlapped, so considerably wide ranges of clinical decision levels were shown. The RIs of HDL-C, apo AⅠ and apo B were distinguished as gender subgroups in 26, 25 and 27 participants respectively. The clinical decision levels of TC, TG, HDL-C and LDL-C were reported by 152, 140, 156 and 144 laboratories, of which the medians were 5.70, 1.70, 0.91 and 3.37 mmol/L, respectively. The risk stratification system for LDL-C was employed in 14 laboratories to divide the RIs into "high risk population" and "very high risk population" in terms of cardiovascular diseases. Conclusion:The majority of laboratories did not take gender, age and other influence factors into consideration for establishing RIs of blood lipids and lipoproteins. The gender subgroups for RIs were adopted in merely a handful of laboratories, and risk stratification of cardiovascular diseases was implemented in even fewer laboratories.