目的调查血清视黄醇结合蛋白(serum retinol-binding protein 4,sRPB4)和尿液视黄醇结合蛋白(urine retinol-binding protein 4,uRPB4)在实验室开展情况和检测质量现状。方法通过网络平台下发调查问卷,实验室在线填写并申请参加室间质量评价调查活动。分析sRBP4和uRBP4开展情况,包括试剂、校准品、室内质控等。按合格评价标准:靶值±30%,统计sRBP4和uRBP4的检测质量。结果 46.9%(205/455)的实验室正在开展视黄醇结合蛋白(retinol-binding protein 4,RPB4)检测,并以检测sRBP4居多;国产试剂和配套校准品占95%(195/205)以上;22%(45/205)的实验室没有室内质控;67%(138/205)的实验室既没参加室间质量评价也没进行室间比对。参与sRBP4室间质评调查实验室数为89,回报数78,及格率79.5%(62/78)。参与uRBP4室间质评调查实验室数为71,回报数49,及格率24.5%(12/49)。结论 RBP4检测在我国已有一定市场,市售试剂需要针对检测特异性等方面进行进一步研究,有必要开展相关的室间质量评价活动,以监督该指标的检测质量。
Objective To investigate the status and development of measurement for serum retinol-binding protein 4 (sRBP4) and urine retinal-binding protein 4 (uRBP4) in clinical laboratories. Methods The clinical laboratories should apply for the investigation of retinol-binding protein 4 (RBP4) by the network system of National Center for Clinical Laboratories, External Quality Assessment (NCCL EQA), which may contain filling in a questionnaire and measuring a set of EQA materials, including the manufacturers of reagent and calibrator, internal quality control, etc. The target value + 30% was used as the criteria to evaluate the acceptability of the measured values of EQA materials and analyze the test quality of sRBP4 and uRBP4 in the participated laboratories. Results Among the participated laboratories, 46.9% (205/455) were carrying on the measurement of retinol binding protein, and the measurement of serum retinol-binding protein 4 was in the majority. The reagent kits for serum and urine retinol-binding protein used in above 95% (195/205) of laboratories were from Chinese vendors. No internal quality control was performed in 22% (45/205) of participated laboratories. , and no any external quality assessment was performed in 67% ( 138/205 ) of laboratories. Eighty-nine laboratories had applied for measuring the sRBP4 materials provided by EQA , in which 78 returned their tested values through NCCL EQA system with pass rate of 79.5% (62/78). Seventy-nine laboratories applied for measuring the uRBP4 materials provided by EQA, but only 49 of them returned their tested values with the pass rate of 24.5 % (12/49). Conclusion In China, many medical laboratories carried on the measurement of sRBP4 and/or uRBP4 as routine biochemical indicators for clinical diagnosis. The supervision for the analytical specificity of reagent kits should be necessary to improve the quality of the measurement The external quality assessment project for the quantitative determination of retinol-binding pr