Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community,Clinical Microbiology and Infection

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Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community
Clinical Microbiology and Infection ( IF 10.9 ) Pub Date : 2021-08-04 , DOI: 10.1016/j.cmi.2021.07.039
Joep J J M Stohr ₁ , Vivian F Zwart ₁ , Gabriel Goderski ₂ , Adam Meijer ₂ , Carla R S Nagel-Imming ₃ , Marjolein F Q Kluytmans-van den Bergh ₄ , Suzan D Pas ₅ , Femke van den Oetelaar ₆ , Marloes Hellwich ₆ , Kim H Gan ₆ , Ariene Rietveld ₆ , Jaco J Verweij ₇ , Jean-Luc Murk ₅ , Wouter van den Bijllaardt ₈ , Jan A J W Kluytmans ₉

Affiliation

Department of Infection Control, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
Department of Infection Control, Amphia Hospital, Breda, the Netherlands.
Department of Infection Control, Amphia Hospital, Breda, the Netherlands; Amphia Academy Infectious Disease Foundation, Amphia Hospital, Breda, the Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
Municipal Health Services GGD Hart voor Brabant, 's-Hertogenbosch, the Netherlands.
Microvida Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
Department of Infection Control, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands.
Department of Infection Control, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands; Amphia Academy Infectious Disease Foundation, Amphia Hospital, Breda, the Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.

Objectives

To evaluate the performance of nasal mid-turbinate self-testing using rapid antigen detection tests (RDT) for persons with suspected coronavirus disease 2019 (COVID-19) in the community. Self-testing for COVID-19 infection with lateral flow assay severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RDT, provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2.

Methods

Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for quantitative RT-PCR (qRT-PCR) testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture dropped below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined.

Results

A total of 3201 participants were included (BD-RDT n = 1595; Roche-RDT n = 1606). Sensitivity and specificity of self-testing compared with the qRT-PCR results with a Ct-value below the Ct-value cut-off were 78.4% (95% CI 73.2%–83.5%) and 99.4% (95% CI 99.1%–99.7%), respectively. A higher age was independently associated with a false-negative self-testing result with an odds ratio of 1.024 (95% CI 1.003–1.044).

Conclusions

Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness.

中文翻译：

通过快速抗原检测对社区中疑似 COVID-19 的人进行自我检测以检测 SARS-CoV-2 感染

目标

使用快速抗原检测测试 (RDT) 评估社区中疑似冠状病毒病 2019 (COVID-19) 患者的鼻中鼻甲自检性能。用侧流法检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) RDT 对 COVID-19 感染进行自我检测，可提供快速结果，并可在社区进行频繁和广泛的检测，从而改善对 SARS-CoV-的控制2.

方法

参观市政 SARS-CoV-2 检测中心的参与者收到了包含 BD Veritor 系统 (BD-RDT) 或罗氏 SARS-CoV-2 抗原检测测试 (Roche-RDT) 的自我检测试剂盒。从参与者那里收集口鼻咽拭子用于定量 RT-PCR (qRT-PCR) 测试。作为传染性的代表，对选择的 qRT-PCR 阳性样品进行病毒培养以确定阳性培养的机会下降到 0.5 以下的 Ct 值（Ct 值截止）。将自检的敏感性和特异性与 Ct 值低于 Ct 值截止值的 qRT-PCR 进行比较。确定了与假阴性自检结果独立相关的决定因素。

结果

共纳入 3201 名参与者（BD-RDT n = 1595；Roche-RDT n = 1606）。与 Ct 值临界值以下的 qRT-PCR 结果相比，自检的敏感性和特异性分别为 78.4%（95% CI 73.2%–83.5%）和 99.4%（95% CI 99.1%– 99.7%），分别。较高的年龄与假阴性自我检测结果独立相关，优势比为 1.024（95% CI 1.003-1.044）。