上海市及其他地区临床实验室B 族链球菌核酸检测室间质量评价分析

目的 通过开展B 族链球菌（group B Streptococcus，GBS）核酸检测室间质量评价计划（简称室间质评），评价参评实验室检测能力，分析存在的问题，提高检测质量。方法 2021 年GBS 核酸检测室间质评计划为一年两次，每次质评计划样本盘包含4 支由灭活的GBS 培养液稀释而成的不同浓度阳性样本和1 支阴性样本。样本冷链寄送至各参评实验室，并要求其在规定时间内按要求检测并回报结果，依据回报结果计算各实验室成绩，汇总不同样本的总体符合率。结果 2021 年两次室间质评分别有33 家实验室报名参加，收到有效报告31 份和32 份。所有实验室室间质评成绩均合格，两次结果完全正确的实验室分别有87.10%（27/31）和96.88%（31/32），样本的总体符合率为97.42%（151/155）和99.38%(159/160)。结果汇总中共出现检测错误5 例，错误类型集中表现为假阴性。结论 各参评实验室GBS 核酸检测能力总体较高，个别实验室检测能力尤其是弱阳性样本检测能力有待提高。通过参加室间质评计划能帮助实验室及时发现问题并持续改进以提高检测质量。

Results of External Quality Assessment for Group B Streptococcus DNA Testing in Shanghai and Other Regions

Objective To evaluate the testing capabilities，analyze problems and improve testing quality of laboratories for group B Streptococcus DNA testing in Shanghai by external quality assessment (EQA). Methods 2021 EQA program was carried out twice a year. Each sample panel contained 4 different concentrations of positive samples which were diluted with inactivated GBS culture medium and 1 negative sample. Samplesweresent to participating laboratories by cold chain. Each laboratory was required to test and report the results within the specified time. Results of each laboratory as well as overall compliance rate of each sample were calculated based on the report results. Results There were 33 laboratories entered for two EQA programs in 2012, 31 and 32 valid laboratories results were received in two EQA programs. All the laboratory EQA results were qualified. 87.10%（27/31）and 96.88%（31/32）of the participating clinical laboratories submitted correct results for all five samples. The overall sample compliance rates were 97.42%（151/155）and 99.38%(159/160). A total of 5 errors occurred in the two EQA programs, and all errorswere false negative. Conclusion The overall accuracy rate of clinical laboratories was high, while some clinical laboratories need to improve their performance capability, especially the weak positive sample detection ability. The laboratory could strengthen its quality management by participating in EQA, so that problems could be discovered in time and improvement could be achieved.