Department of Laboratory Medicine, Karolinska Institutet, 141 86 Stockholm, Sweden.
Department of Laboratory Medicine, Division of Medical Microbiology, Lund University, 221 85 Lund, Sweden.
J Clin Virol. 2021 Aug;141:104902. doi: 10.1016/j.jcv.2021.104902. Epub 2021 Jun 19.
Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008.
We report the results of the 2019 global proficiency study and evaluate the proficiency over time.
The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives (stricter requirement compared to previous panels).
Seventy-eight laboratories submitted 110 datasets with 38 different assays. Most samples (38/44) were reported with 100% proficiency in most datasets. Mostly commercial assays were used (88/110 datasets). Overall, 47.3% of the datasets were 100% proficient. False positivity was detected in at least one sample in 30.1% of datasets. When analysing all datasets ever since 2008 using exactly the same proficiency criteria, there was a steady improvement up to 2017 (the proportion of datasets being completely proficient increased from 25% to 73%). However, in the 2019 proficiency testing the proportion of fully proficient datasets dropped to 50%.
Although we initially documented a worldwide improvement in comparability and reliability of HPV testing services, the trend now appears to be reversed. In response, the International HPV Reference Center will provide support for improved quality of laboratory services, including issuing of global proficiency panels every year.
准确且具有国际可比性的人乳头瘤病毒（HPV）检测服务对于宫颈癌消除计划至关重要。世界卫生组织 HPV 实验室网络自 2008 年开始发布国际 HPV 检测能力验证小组。
我们报告了 2019 年全球能力验证研究的结果，并评估了随着时间的推移能力验证的情况。
能力验证小组包含 40 个编码样本，其中包含混合了纯化的 HPV 类型（HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b）和 4 个对照品。能力验证要求检测 50IUHPV16/18 的单一和多重感染，其他 HPV 类型的 500 基因组当量（浓度高 10 倍），且无假阳性（比以前的小组要求更严格）。
78 个实验室提交了 110 个数据集，其中 38 个数据集使用了 38 种不同的检测方法。在大多数数据集（38/44）中，大多数样本（38/44）的报告结果均达到 100%的能力验证要求。大多数使用的是商业检测方法（88/110 个数据集）。总体而言，47.3%的数据集达到 100%的能力验证要求。在 30.1%的数据集至少一个样本中检测到假阳性。当自 2008 年以来使用完全相同的能力验证标准分析所有数据集时，能力验证呈稳步提高趋势，直至 2017 年（完全达到能力验证要求的数据集比例从 25%增加到 73%）。然而，在 2019 年的能力验证中，完全达到能力验证要求的数据集比例下降到 50%。
尽管我们最初记录了全球 HPV 检测服务的可比性和可靠性的提高，但现在这种趋势似乎已经逆转。作为回应，国际 HPV 参考中心将提供支持，以提高实验室服务的质量，包括每年发布全球能力验证小组。
