全国干化学胆红素检测室间质量调查结果分析

Results Analysis of Serum Bilirubin Testing in Dry Chemistry External Quality Survey

目的 了解目前我国干化学测定胆红素的检测现状,以改进和提高胆红素检测质量.方法 对2012年自愿参加干化学胆红素检测室间质量调查的148家实验室发放两个批号的冻干粉质控品（批号为A1565和B1567）,要求回报总胆红素（TBIL）、结合胆红素（CB）、未结合胆红素（UB）和Delta胆红素（DELB）,并对回报结果进行统计分析,以评价实验室检测水平.结果 调查回报率为81.8％（121/148）,分别有118,113,113和91家实验室回报了TBIL,CB,UB和DELB的检测结果,这四个检测项目在Vitros系列仪器上检测所得的稳健变异系数（RCV）差异较大.四个项目的实验室间CV的算术平均数分别为5.68％,19.41％,12.37％和53.98％;TBIL和CB的统计结果与2012年干化学第一次EQA比较,实验室间变异相差不大.根据目前干化学室间质量评价的评价标准,TBIL两个批号合格率较高,均为98.3％;CB为78.8％和92.9％;UB为85.8％和93.8％;Delta胆红素合格率较低,分别为46.2％和34.4％.结论 该次调查数据显示出目前我国干化学胆红素检测水平还需进一步提高,实验室应严格按照操作程序进行检测,并采取有效的室内质量控制,参加室间质量评价计划,以减小胆红素检测结果的误差并提高结果间的可比性.

Objective To learn about the current testing status of serum bilirubin in dry chemistry in China in order to improve the testing quality and performance. Methods Totally 148 laboratories attended the survey. Two lots of EQA samples were sent to each laboratory to submit the results of total bilirubin （TBIL）,combined bilirubin （CB）, uncombined bilirubin （UB） and delta bilirubin （DELB） ,which would have been tested in dry chemistry system. The submitted data were statistically analyzed and the testing performances of every laboratory was evaluated. Results The total return rate was 81.8% （121/148）. There were 118,113,113 and 91 laboratories submitting TBIL,CB, UB and DELB testing results respectively. The robust coefficient of variations （RCV） of 3 different vitros measuring systems were different from each other. The average inter-laboratory CVs of 2 lots of samples of TBIL,CB,UB and DELB were 5.68% ,19.41% ,12.37% and 53.98%,re spectively. The average inter-laboratory CVs of TBIL and CB had no significant difference when compared to the results of dry chemistry in 2012 external quality assessment program. The pass rates of TBII. were 98.3% for both 2 lots. However, the pass rate of CB,UB and DELB were not as good as TBIL. Conclusions Refer to this survey and analysis, the testing quality and performances of bilirubin in dry chemistry testing system of laboratories in China need to be improved urgently, so every laboratory should accord to right and the newest standard operation procedures, attend external quality assessment program, take internal quality control continuously,in order to ensure the accuracy and comparability of the results of bilirubin.