2020~2022年度上海及其他省市临床实验室HPV6与HPV11型核酸检测室间质量评价结果分析

Analysis of External Quality Assessment Results for HPV6 and HPV11 Nucleic Acid Testing in Clinical Laboratories of Shanghai and Other Provinces and Cities from 2020 to 2022

目的 通过开展人乳头瘤病毒(human papillomavirus,HPV)6型、11型核酸检测室间质量评价(external quality assessment,EQA)计划,来评估实验室检测能力,分析其存在问题,提高检测质量。方法 EQA计划一年两次,样本盘含阳性样本4支,包括HPV6,HPV11强阳性、弱阳性各1支,由具有尖锐湿疣(condyloma acuminata,CA)临床表现,HPV6或HPV11阳性患者的宫颈分泌物(上海市第一妇婴保健院提供)制成。阴性样本1支,由C-33A细胞株(中科院购入)培养制成。样本冷链寄送至各参评实验室,要求其在规定时间内检测并上传结果。上海市临床检验中心(以下简称中心)依据回报结果计算各实验室的成绩。结果 6轮EQA活动共计发出样本盘163份,收到有效报告140份。实验室合格率96.43%(135/140),样本符合率97.86%(685/700)。假阴性13个,假阳性2个,弱阳性样本占假阴性结果的76.92%(10/13)。结论 实验室HPV6/11型核酸检测准确率比较高,个别实验室弱阳性样本的检出能力有待提高,通过参加EQA计划可及时发现问题并提高检测质量。

Objective To evaluate the testing capabilities of laboratories,analyze existing issues,and improve testing quality,through carrying out the external quality assessment(EQA)of clinical laboratories for human papillomavirus(HPV)type 6 and 11 nucleic acid detection.Methods EQA plan was carried out twice a year.Each panel contains 4 positive samples,including one strong positive sample and one weak positive sample of HPV6 and HPV11,made from cervical secretions from patients with clinical manifestations of condyloma acuminata(CA)and positive for HPV6 or HPV11(from Shanghai First Maternity and Infant Hospital).One negative sample was cultured from the C-33A cell line(from Chinese Academy of Sciences).Samples were sent to participating laboratories by cold chain,and laboratories were required to detect test samples and upload their results within the specified time.Shanghai Center for Clinical Laboratory(SCCL)calculated the scores of each laboratory based on the return results.Results A total of 163 sample panels were sent out in the 6 rounds of EQA plan and 140 valid reports were received.The laboratory qualification rate was 96.43%(135/140)and the sample compliance rate was 97.86%(685/700).There were 13 false negative results and 2 false positive results,with weakly positive samples accounting for 76.92%(10/13)of the false negative results.Conclusion The detection accuracy of HPV6/11 nucleic acid in each laboratory was relatively high,and the detection ability of weak positive samples in individual laboratories may need to be improved.The laboratory could discover problems and improve its quality management by participating in EQA.