Implementing HPV testing in 9 Latin American countries: The laboratory perspective as observed in the ESTAMPA study.
Implementing HPV testing in 9 Latin American countries: The laboratory perspective as observed in the ESTAMPA study.
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DOI：
10.3389/fmed.2022.1006038
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发表时间：
2022
影响因子：
3.9
通讯作者：
中科院分区：
文献类型：
--
作者：
建议用HPV检测取代细胞学筛查，这对于消除宫颈癌是必要的。作为Estanpa宫颈癌筛查研究的一部分，在9个拉丁美洲国家的12个实验室进行了初步筛查的HPV检测。我们的观察提供了在不同资源环境下实施HPV检测的关键操作方面的信息。我们描述了Estanpa公司HPV检测的实施过程，重点介绍了实验室方面的情况。我们评估了12个实验室开始HPV检测的准备情况，以及它们保持高质量HPV检测的持续能力，直到招募结束或直到2021年12月。准备工作是基于一份核对表。使用了研究数据库提供的信息；定期会议和监测访问；以及2020年5月发出的关于实验室业务方面的问卷，以评估连续性能力。对符合7项基本要求(准备就绪)和8项连续性要求(连续性能力)的情况进行评分(1=符合，0=不符合)，并进行总计，将准备就绪和连续性能力分为非常有限、有限、中等或高度。还描述了实施过程中的经验、挑战和推动因素。在12个实验室中，有7个处于高度准备状态，3个处于中等准备状态，在两个新进行HPV检测的实验室中，一个处于有限准备状态，另一个处于非常有限的准备状态。在七个高度准备就绪的实验室中，有两个也显示出高持续能力，一个实验室显示出中等持续能力，另外四个实验室显示出有限的持续能力，因为它们无法随着时间的推移保持高质量的HPV检测。在三个中等准备状态的实验室中，一个保持了中等连续能力，两个达到了高连续能力。新加入HPV检测的两个实验室实现了很高的连续能力。根据获得的专业知识，五个实验室已成为国家筛查计划的一部分。实验室的高度准备是有效实施HPV检测的重要组成部分。然而，高度准备不足以保证HPV检测的高连续性能力，为此应建立“质量文化”，并根据当地情况定制定期培训、强有力的监测和质量保证系统。加强HPV实验室的所有努力对于保证有效实施基于HPV的宫颈筛查是宝贵和关键的。
Replacement of cytology screening with HPV testing is recommended and essential for cervical cancer elimination. HPV testing for primary screening was implemented in 12 laboratories within 9 Latin American countries, as part of the ESTAMPA cervical cancer screening study. Our observations provide information on critical operational aspects for HPV testing implementation in diverse resource settings. We describe the implementation process of HPV testing in ESTAMPA, focusing on laboratory aspects. We assess the readiness of 12 laboratories to start HPV testing and their continuity capacity to maintain good quality HPV testing until end of recruitment or up to December 2021. Readiness was based on a checklist. Information from the study database; regular meetings and monitoring visits; and a questionnaire on laboratory operational aspects sent in May 2020 were used to assess continuity capacity. Compliance with seven basic requirements (readiness) and eight continuity requirements (continuity capacity) was scored (1 = compliant, 0 = not compliant) and totaled to classify readiness and continuity capacity as very limited, limited, moderate or high. Experiences, challenges, and enablers of the implementation process are also described. Seven of 12 laboratories had high readiness, three moderate readiness, and of two laboratories new to HPV testing, one had limited readiness and the other very limited readiness. Two of seven laboratories with high readiness also showed high continuity capacity, one moderate continuity capacity, and the other four showed limited continuity capacity since they could not maintain good quality HPV testing over time. Among three laboratories with moderate readiness, one kept moderate continuity capacity and two reached high continuity capacity. The two laboratories new to HPV testing achieved high continuity capacity. Based on gained expertise, five laboratories have become part of national screening programs. High readiness of laboratories is an essential part of effective implementation of HPV testing. However, high readiness is insufficient to guarantee HPV testing high continuity capacity, for which a “culture of quality” should be established with regular training, robust monitoring and quality assurance systems tailored to local context. All efforts to strengthen HPV laboratories are valuable and crucial to guarantee effective implementation of HPV-based cervical screening.
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通讯作者：
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