从全国室间质量评价结果探讨HCV RNA检测中的问题

Analysis of the results of external quality assessment for hepatitis C virus RNA tests

目的评价2012年第一次HCV RNA检测的全国室间质量结果，以分析探讨我国临床实验室HCV RNA检测中存在的问题，为进一步改进和提高实验室检测质量提供依据。方法卫生部临检中心（以下简称“部中心”）2012年共发放5份样本至927家参评实验室，其中1份为阴性，4份为与国际标准物质比对定值的内含HCV RNA相应片段的病毒样颗粒。参评实验室按照规定的时间检测样本，并向部中心回报结果。然后，计算所有参评实验室和各检测试剂（实验室数≥5家）对每份质评样本定性和定量检测的符合率。计算总体参评实验室和不同试剂对阳性样本检测的均值（GM）和标准差（S）。将所有参评实验室和不同试剂检测的GM和靶值比较，绘制相关性曲线。结果参评实验室检测1211、1212、1213、1214号样本定性结果的符合率分别为99．5％（403／405）、98．5％（400／406）、100．0％（405／405）、100．0％（406／406），阴性样本的符合率为99％（401／405）；检测1211、1212和1213号样本定量结果的符合率相近，分别为93．8％（549／585）、92．3％（541／586）和94．5％（554／586），HCV RNA浓度最高的1214号样本符合率仅为87．7％（514／586）。试剂A对1214号样本定量符合率仅为67．2％（92／137）。总体参评实验室HCV RNA定量结果GM（1211、1212、1213和1214号样本GM分别为4．63、4．11、5．41和6．23）与靶值（1211、1212、1213和1214号样本靶值对数值分别为4．64、4．16、5．40和6．20）结果非常接近。试剂C、试剂E和试剂G的GM均与靶值不一致，试剂C检测1211、1212、1213和1214号样本的GM依次为4．22、3．56、5．16和5．90，试剂E检测1211、1212、1213和1214号样本的GM依次为4．52、3．78、5．55和6．29，试剂G检测1211、1212、1213和1214号样本的GM依次为4．83、4．36、5．72和6．56。结论临床实验室定性和定量检测HCV RNA的结果较为理想。但在检测试剂和临床实验室检测过程中，仍存在试剂GM与靶值偏差较大、使用同一试剂的不同实验室间结果差异较大、临床实验室检测存在系统和随机误差等问题，此外，检测重复性和试剂质量也有待进一步提高。（中华检验医学杂志，2013，36：271-276）

Objective To evaluate the performance of HCV RNA detection in the first EQA program in 2012 and analyze possible problems in clinical laboratories. Methods The panel consisting of L 5 samples was distributed to 927 laboratories. Each panel contains one negative sample and 4 positive samples, which were virus-like particles calibrated by international standard. The percent agreements of all the laboratories for qualitative and quantitative results were calculated. Genomic means （GM） and standard deviations （s） of all laboratories and each reagent were calculated. The overall GM and the GM of each reagent were compared with expected results and correlation curves were calculated. Results The percent agreements of sample 1211,1212,1213,1214 for qualitative results were 99. 5 % （403/405）, 98.5 % （ 400/406） , 100. 0% （405/405）, 100. 0% （406/406） , respectively. The percent agreement of the negative sample was 99% （401/405）. The percent agreements of sample 1211, 1212 and 1213 for quantitive results were similar, whieh were 93.8%-（549/585 ） ,92. 3% （541/586）and 94. 5% （554/586）. However, the agreement of sample 1214 was only 87.7% （514/586）and the agreement of sample 1214 for reagent A was 67.2% （92/137）. The overall GM agreed with expected results, while GMs of reagent C, E and G deviated from expected results. GMs of sample 1211, 1212, 1213 and 1214 reported by labs using reagent C were 4. 22,3.56,5. 16 and 5.90, respectively. GMs of sample 1211 , 1212, 1213 and 1214 reported by labs using reagent E were 4. 52,3.78,5.55 and 6.29, respectively. GMs of sample 1211, 1212, 1213 and 1214 reported by labs using reagent G were 4. 83,4. 36,5.72 and 6. 56, respectively. Conclusions The overall results of HCV RNA qualitative and quantitative detection are satisfactory. However, some problems still exist, such as deviation of GM of some reagents, the interassay variability, systematic deviation and accidental deviation, which show that the quality of reagents should be improved. （ Chin J Lab Med, 2013,36：271-276）