2012-2023年我国CD4细胞检测实验室能力验证结果分析

Laboratory proficiency testing results of CD4 count in China,2012-2023

目的 了解我国HIV检测实验室的CD4细胞检测能力,为保证实验室检测质量提供数据参考。方法 回顾性分析2012-2023年国家艾滋病参比实验室组织的CD4细胞检测能力验证结果,应用Fisher精确检验比较不同类型实验室的考核良好率。结果 2012―2023年,国家艾滋病参比实验室共收到4 142份实验室考核结果。参加能力验证的实验室中,地市级城市实验室、疾病预防控制机构实验室和西部地区实验室的平均每年占比分别为68.3%、87.8%和47.6%。考核成绩为不合格的实验室占比呈下降趋势(χ^(2)_(trend)=19.4, P<0.05),其中检测人员操作错误是造成实验室考核成绩不合格的主要原因(73/73)。比较2012-2023年不同类型实验室的考核良好率发现,不同行政区划的实验室考核良好率差异无统计学意义;2012和2013年不同机构类型实验室的考核良好率差异有统计学意义(P<0.05),其中医疗机构实验室的考核良好率(71.4%和73.9%)低于疾病预防控制机构(91.0%和89.8%);2013、2019和2020年不同经济地区实验室的考核良好率具有统计学差异(P<0.05),2013年东部地区实验室的考核良好率较低,为80.0%,2019和2020年东北地区实验室的考核良好率较低,分别为83.3%和72.7%。结论 2012-2023年,参加国家艾滋病参比实验室组织的CD4细胞检测能力验证的实验室主要来自地市级城市,以疾病预防控制机构为主并多处于西部地区。我国HIV检测实验室CD4细胞检测水平总体良好,但仍需加强对实验室检测人员的技术培训,并注重对医疗机构实验室和东北地区实验室CD4细胞检测能力的建设和质量管理。

Objective To understand the capacity of HIV testing laboratories for CD4 count in China,and to provide data reference for ensuring the quality of laboratory testing.Methods The results of the CD4 proficiency testing(PT)program organized by the National AIDS Reference Laboratory(NARL)from 2012 to 2023 were analyzed.Fisher's exact test was used to compare the good rates of different types of laboratories.Results From 2012 to 2023,the NARL received a total of 4142 PT results for laboratory evaluation.Among the participating laboratories,the average annual participation rates in prefectural and municipal cities,the Center for Disease Control and Prevention(CDC),and western regions were 68.3%,87.8%,and 47.6%,respectively.A decreasing trend was observed in the proportion of laboratories with failing PT results(χ^(2)_(trend)=19.4,P<0.05),with operational errors being the main cause of unqualified results(73/73).Comparisons of good rates among different types of laboratories from 2012 to 2023 showed no statistically significant differences across different administrative regions.However,in 2012 and 2013,there were statistically significant differences in good rates among laboratories from different institution types(P<0.05),with medical institution having lower good rates(71.4%and 73.9%)compared to CDCs(91.0%and 89.8%).In 2013,2019,and 2020,a statistically significant difference was observed in the good rate was observed among laboratories from different economic regions(P<0.05).In 2013,laboratories in the eastern region had a lower good rate of 80.0%,while in 2019 and 2020,laboratories in the northeastern region had lower good rates of 83.3%and 72.7%,respectively.Conclusions From 2012 to 2023,laboratories participating in the NARL CD4 PT program were mainly from prefectural and municipal cities,CDCs,and mostly located in the western region.The overall CD4 count capacity of HIV testing laboratories in China was generally good and stable,while there is still a need to strengthen technical training for laboratory staff and focus on building and managing the quality of CD4 count capacity in laboratories in medical institutions and the northeast region.