Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross sectional study

被引:57
作者
Schuit, Ewoud [1 ,2 ]
Veldhuijzen, Irene K. [3 ]
Venekamp, Roderick P. [1 ]
van den Bijllaardt, Wouter [4 ]
Pas, Suzan D. [4 ,5 ]
Lodder, Esther B. [6 ]
Molenkamp, Richard [7 ]
GeurtsvanKessel, Corine H. [7 ]
Velzing, Jans [7 ]
Huisman, Robin C. [7 ]
Brouwer, Lieke [8 ]
Boelsums, Timo L. [8 ]
Sips, Gregorius J. [3 ,8 ]
Benschop, Kimberly S. M. [3 ]
Hooft, Lotty [1 ,2 ]
van de Wijgert, Janneke H. H. M. [1 ,9 ]
van den Hof, Susan [3 ]
Moons, Karel G. M. [1 ,2 ]
机构
[1] Univ Utrecht, Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands
[2] Univ Utrecht, Univ Med Ctr Utrecht, Cochrane Netherlands, Utrecht, Netherlands
[3] Natl Inst Publ Hlth & Environm RIVM, Ctr Infect Dis Control, Bilthoven, Netherlands
[4] Amphia Hosp, Microvida Lab Med Microbiol, Breda, Netherlands
[5] Bravis Hosp, Microvida Lab Med Microbiol, Roosendaal, Netherlands
[6] Publ Hlth Serv West Brabant, Breda, Netherlands
[7] Erasmus MC, Dept Virosci, Rotterdam, Netherlands
[8] Publ Hlth Serv Rotterdam Rijnmond, Rotterdam, Netherlands
[9] Univ Liverpool, Inst Infect Vet & Ecol Sci, Liverpool, Merseyside, England
来源
BMJ-BRITISH MEDICAL JOURNAL | 2021年 / 374卷
关键词
D O I
10.1136/bmj.n1676
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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