Directorate of Defense Research & Development, Israeli Ministry of Defense, Tel Aviv, Israel.
Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Clin Microbiol Infect. 2022 Jun;28(6):859-864. doi: 10.1016/j.cmi.2022.02.016. Epub 2022 Feb 17.
Despite the success in developing COVID-19 vaccines, containment of the disease is obstructed worldwide by vaccine production bottlenecks, logistics hurdles, vaccine refusal, transmission through unvaccinated children, and the appearance of new viral variants. This underscores the need for effective strategies for identifying carriers/patients, which was the main aim of this study.
We present a bubble-based PCR testing approach using swab-pooling into lysis buffer. A bubble is a cluster of people who can be periodically tested for SARS-CoV-2 by swab-pooling. A positive test of a pool mandates quarantining each of its members, who are then individually tested while in isolation to identify the carrier(s) for further epidemiological contact tracing.
We tested an overall sample of 25 831 individuals, divided into 1273 bubbles, with an average size of 20.3 ± 7.7 swabs/test tube, obtaining for all pools (≤37 swabs/pool) a specificity of 97.5% (lower bound 96.6%) and a sensitivity of 86.3% (lower bound 78.2%) and a post hoc analyzed sensitivity of 94.6% (lower bound 86.7%) and a specificity of 97.2% (lower bound 96.2%) in pools with ≤25 swabs, relative to individual testing.
This approach offers a significant scale-up in sampling and testing throughput and savings in testing cost, without reducing sensitivity or affecting the standard PCR testing laboratory routine. It can be used in school classes, airplanes, hospitals, military units, and workplaces, and may be applicable to future pandemics.
尽管在开发 COVID-19 疫苗方面取得了成功，但疫苗生产瓶颈、物流障碍、疫苗拒绝接种、未接种儿童传播以及新病毒变种的出现，在全球范围内阻碍了疾病的控制。这突显出需要制定有效的策略来识别携带者/患者，这是本研究的主要目的。
我们提出了一种基于气泡的 PCR 测试方法，使用拭子混合到裂解缓冲液中。气泡是一群人，可以定期通过拭子混合进行 SARS-CoV-2 测试。如果一个池的测试呈阳性，则需要对其所有成员进行隔离，然后在隔离期间对每个成员进行单独测试，以确定携带者（多个），以便进一步进行流行病学接触追踪。
我们测试了总共 25831 人的样本，分为 1273 个气泡，每个气泡的平均拭子数量为 20.3±7.7，对于所有的池（≤37 个拭子/池），特异性为 97.5%（下限 96.6%），敏感性为 86.3%（下限 78.2%），事后分析的敏感性为 94.6%（下限 86.7%），特异性为 97.2%（下限 96.2%），与单独测试相比。
与单独测试相比，这种方法在采样和测试通量方面提供了显著的扩展，同时节省了测试成本，而不会降低敏感性或影响标准的 PCR 测试实验室常规。它可以在学校班级、飞机、医院、军队和工作场所使用，并且可能适用于未来的大流行。
