2020年河南省艾滋病CD4^(+)T淋巴细胞检测实验室质量考核结果

Quality assessment results of HIV/AIDS CD4^(+)T lymphocyte laboratories in Henan province in 2020

目的了解河南省艾滋病CD4^(+)T淋巴细胞(CD4细胞)实验室检测质量,发现实验室间检测能力差异及原因,提高全省检测水平。方法制定CD4细胞检测室间质控考评方案,比较实验室间检测结果,按照设备仪器类型统计,分析2020年全省CD4细胞检测质控结果。结果69家参评实验室中,考评结果94.2%(65家)为合格及以上,其中优秀率、良好率和合格率分别为59.4%(41家)、26.1%(18家)和8.7%(6家),不合格率为5.8%(4家)。69家实验室覆盖Mindray E6、ACEA Novo Cyte、BD FACSCount、BD FACSCalibur 4种流式细胞仪设备,不同设备对2个质控品检测结果均存在差异(P均<0.001),但标准差指数(SDI)值区间分布差异均无统计学意义(P均>0.05)。结论河南省CD4细胞检测室间质评合格率总体较高,仪器设备使用年限和质控运行情况影响检测结果,建议各实验室固定检测设备,规范检测流程,提高检测质量。

Objective To understand the testing quality of HIV/AIDS CD4^(+)T lymphocyte laboratories,discover the differences of testing capabilities among laboratories and the causes of the differences,and improve the testing level in Henan province.Methods A quality assessment plan for CD4 cell test was developed;inter-laboratory test results were compared;according to the inter-laboratory test results and equipment types,the quality assessment results across the province in 2020 were analyzed.Results Of the 69 participating laboratories,94.2%(65)were qualified or above,of which the proportions of the laboratories with excellent,good and qualified levels were 59.4%(41),26.1%(18)and 8.7%(6),respectively,and the unqualified rate was 5.8%(4).Four flow cytometers including Mindray E6,ACEA Novo Cyte,BD FACSCount and BD FACSCalibur were used among the 69 laboratories,and test results of two quality control products by different flow cytometers were different(all P<0.001),but there was no statistically significant difference of SDI(P>0.05).Conclusion Overall,the pass rate of the quality assessment among CD4 test laboratories in Henan province is generally high.However,the service life of equipment and quality control operation affect the results.For improving the quality of test,it is recommended that each laboratory should fix the test equipment and standardize the test process.