key: cord-0756508-1015rtrg
authors: Schuit, Ewoud; Veldhuijzen, Irene K; Venekamp, Roderick P; van den Bijllaardt, Wouter; Pas, Suzan D; Lodder, Esther B; Molenkamp, Richard; GeurtsvanKessel, Corine H; Velzing, Jans; Huisman, Robin C; Brouwer, Lieke; Boelsums, Timo L; Sips, Gregorius J; Benschop, Kimberly S M; Hooft, Lotty; van de Wijgert, Janneke H H M; van den Hof, Susan; Moons, Karel G M
title: Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study
date: 2021-07-27
journal: BMJ
DOI: 10.1136/bmj.n1676
sha: 150eefd9cdd634ab792a0d2fe90db6f1ff84413d
doc_id: 756508
cord_uid: 1015rtrg

OBJECTIVE: To assess the diagnostic test accuracy of two rapid antigen tests in asymptomatic and presymptomatic close contacts of people with SARS-CoV-2 infection on day 5 after exposure. DESIGN: Prospective cross sectional study. SETTING: Four public health service covid-19 test sites in the Netherlands. PARTICIPANTS: 4274 consecutively included close contacts (identified through test-and-trace programme or contact tracing app) aged 16 years or older and asymptomatic for covid-19 when requesting a test. MAIN OUTCOME MEASURES: Sensitivity, specificity, and positive and negative predictive values of Veritor System (Beckton Dickinson) and Biosensor (Roche Diagnostics) rapid antigen tests, with reverse-transcriptase polymerase chain reaction (RT-PCR) testing as reference standard. The viral load cut-off above which 95% of people with a positive RT-PCR test result were virus culture positive was used as a proxy of infectiousness. RESULTS: Of 2678 participants tested with Veritor, 233 (8.7%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 149 were also detected by the rapid antigen test (sensitivity 63.9%, 95% confidence interval 57.4% to 70.1%). Of 1596 participants tested with Biosensor, 132 (8.3%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 83 were detected by the rapid antigen test (sensitivity 62.9%, 54.0% to 71.1%). In those who were still asymptomatic at the time of sampling, sensitivity was 58.7% (51.1% to 66.0%) for Veritor (n=2317) and 59.4% (49.2% to 69.1%) for Biosensor (n=1414), and in those who developed symptoms were 84.2% (68.7% to 94.0%; n=219) for Veritor and 73.3% (54.1% to 87.7%; n=158) for Biosensor. When a viral load cut-off was applied for infectiouness (≥5.2 log10 SARS-CoV-2 E gene copies/mL), the overall sensitivity was 90.1% (84.2% to 94.4%) for Veritor and 86.8% (78.1% to 93.0%) for Biosensor, and 88.1% (80.5% to 93.5%) for Veritor and 85.1% (74.3% to 92.6%) for Biosensor, among those who remained asymptomatic throughout. Specificities were >99%, and positive and negative predictive values were >90% and >95%, for both rapid antigen tests in all analyses. CONCLUSIONS: The sensitivities of both rapid antigen tests in asymptomatic and presymptomatic close contacts tested on day 5 onwards after close contact with an index case were more than 60%, increasing to more than 85% after a viral load cut-off was applied as a proxy for infectiousness.

Table S1 Baseline characteristics of pre-/asymptomatic close contacts of individuals with a confirmed SARS-CoV-2 infection.

2 

195 Performance evaluation of a SARS-CoV-2 Rapid antigen test: test performance in the 196 community in The Netherlands

Prevalence and Clinical 198 Presentation of Health Care Workers With Symptoms of Coronavirus Disease 2019 in 199 2 Dutch Hospitals During an Early Phase of the Pandemic

Duration and key determinants of 202 infectious virus shedding in hospitalized patients with coronavirus disease-2019 203 (COVID-19)

Wuhan coronavirus 2019 E gene control 2020

Detection of 2019 novel coronavirus (2019-nCoV) 208 by real-time RT-PCR