[1]徐 幸,王国飞,杨依绡,等.2020~2022年度上海及其他省市临床实验室HPV6型与HPV11型核酸检测室间质量评价结果分析[J].现代检验医学杂志,2024,39(01):179-185.[doi:10.3969/j.issn.1671-7414.2024.01.034]
　XU Xing,WANG Guofei,YANG Yixiao,et al.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[J].Journal of Modern Laboratory Medicine,2024,39(01):179-185.[doi:10.3969/j.issn.1671-7414.2024.01.034]
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2020~2022年度上海及其他省市临床实验室HPV6型与HPV11型核酸检测室间质量评价结果分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第39卷
期数:
2024年01期
页码:
179-185
栏目:
质量控制·实验室管理
出版日期:
2024-01-15

文章信息/Info

Title:
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
文章编号:
1671-7414（2024）01-179-07
作者:
徐 幸; 王国飞; 杨依绡; 肖艳群; 周 靖
（上海市临床检验中心分子生物学室，上海 200126）
Author(s):
XU Xing; WANG Guofei; YANG Yixiao; XIAO Yanqun; ZHOU Jing
（Department of Molecular Biology, Shanghai Center for Clinical Laboratory, Shanghai 200126，China）
关键词:
人乳头瘤病毒; 尖锐湿疣; 室间质量评价
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2024.01.034
文献标志码:
A
摘要:
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（externalquality 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。
Abstract:
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.

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备注/Memo

备注/Memo:
作者简介：徐幸（1995-），女，本科，主管技师，研究方向：临床分子生物学检测及质量控制工作， E-mail:xuxing@sccl.org.cn。
通讯作者：周靖（1976-），女，硕士，副研究员，研究方向：临床实验室管理工作，E-mail:zhoujing@sccl.org.cn。
更新日期/Last Update: 2024-01-15