Fenichel Eli P, Koch R Tobias, Gilbert Anna, Gonsalves Gregg, Wyllie Anne L
Yale School of the Environment, New Haven, Connecticut, USA.
Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.
Microbiol Spectr. 2021 Sep 3;9(1):e0031221. doi: 10.1128/Spectrum.00312-21. Epub 2021 Aug 11.
Pooled testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection is instrumental for increasing test capacity while decreasing test cost. Pooled testing programs permit sustainable, long-term surveillance measures, which are essential for the early detection of virus resurgence in communities or the emergence of variants of concern. While numerous pooled approaches have been proposed to increase test capacity, uptake by laboratories has been limited. On 9 December 2020, we invited 362 U.S. laboratories that inquired about the Yale School of Public Health SalivaDirect test to participate in a survey to evaluate testing constraints and pooling strategies for SARS-CoV-2 testing. The survey was distributed using Qualtrics, and three reminders were sent. The survey closed on 21 January 2021. Of 93 responses received (25.7% response rate), 90 were from Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories conducting SARS-CoV-2 testing. The remaining three were excluded from the analyses. Responses indicated that the major barriers to the uptake of pooled testing in the United States may not simply be the number of tests a laboratory can process per day, but rather the lack of clear protocols and adequate resources; laboratories are working with fixed physical and human capital constraints. Importantly, laboratories across the country are heterogeneous in infrastructure and workflow. The need for SARS-CoV-2 testing will remain for years to come. Testing programs can be maintained through pooled PCR testing strategies, and while statisticians, operations researchers, and others with expertise in sampling design have important value to add, laboratories require support on how to transition from traditional diagnostic testing to pooled surveillance. While numerous pooled SARS-CoV-2 testing approaches have been described in an effort to increase testing capacity and decrease test prices, uptake by laboratories has been limited. Responses to our survey of United States-based laboratories highlight the importance of consulting end-users-those that solutions are being designed for-so challenges can be addressed in a manner tailored to meet the specific needs out in the field. It may be surprising to those designing pooled testing strategies to learn that laboratories view pooling as more time-consuming than testing samples individually, and therefore that it is thought to create delays in test reporting.
对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）进行混合检测有助于提高检测能力并降低检测成本。混合检测项目允许采取可持续的长期监测措施，这对于早期发现社区中病毒的再次出现或关注变体的出现至关重要。虽然已经提出了许多混合检测方法来提高检测能力，但实验室的采用率一直有限。2020年12月9日，我们邀请了362家询问耶鲁公共卫生学院唾液直接检测法的美国实验室参与一项调查，以评估SARS-CoV-2检测的检测限制和混合策略。该调查通过Qualtrics进行分发，并发送了三次提醒。调查于2021年1月21日结束。在收到的93份回复中（回复率为25.7%），90份来自进行SARS-CoV-2检测的临床实验室改进修正案（CLIA）认证实验室。其余三份被排除在分析之外。回复表明，在美国，采用混合检测的主要障碍可能不仅仅是实验室每天能够处理的检测数量，而是缺乏明确的方案和足够的资源；实验室在固定的物质和人力资本限制下开展工作。重要的是，全国各地的实验室在基础设施和工作流程方面存在差异。未来几年对SARS-CoV-2检测的需求仍将存在。检测项目可以通过混合PCR检测策略来维持，虽然统计学家、运筹学研究人员和其他在抽样设计方面有专业知识的人员有重要的补充价值，但实验室需要关于如何从传统诊断检测过渡到混合监测的支持。虽然为了提高检测能力和降低检测价格，已经描述了许多混合SARS-CoV-2检测方法，但实验室的采用率一直有限。我们对美国实验室的调查回复强调了咨询最终用户（即设计解决方案所针对的用户）的重要性，以便能够以满足该领域特定需求的方式解决挑战。对于那些设计混合检测策略的人来说，得知实验室认为混合检测比单独检测样本更耗时，因此认为这会导致检测报告延迟，可能会感到惊讶。
