Longitudinal Assessment of Diagnostic Test Performance Over the Course of Acute SARS-CoV-2 Infection - PubMed (original) (raw)

. 2021 Sep 17;224(6):976-982.

doi: 10.1093/infdis/jiab337.

Rebecca L Smith 1 2 3, Pamela P Martinez 1 5 6, Ruian Ke 7, Agha Mirza 8, Madison Conte 8, Nicholas Gallagher 9, Abigail Conte 10, Leyi Wang 11, Richard Fredrickson 11, Darci C Edmonson 1, Melinda E Baughman 1, Karen K Chiu 1, Hannah Choi 1, Tor W Jensen 1 12, Kevin R Scardina 1, Shannon Bradley 1, Stacy L Gloss 1, Crystal Reinhart 1, Jagadeesh Yedetore 1, Alyssa N Owens 13, John Broach 14 15, Bruce Barton 16 17, Peter Lazar 16, Darcy Henness 18, Todd Young 18, Alastair Dunnett 18, Matthew L Robinson 8, Heba H Mostafa 9, Andrew Pekosz 10, Yukari C Manabe 8, William J Heetderks 19, David D McManus 20, Christopher B Brooke 1 5

Affiliations

Longitudinal Assessment of Diagnostic Test Performance Over the Course of Acute SARS-CoV-2 Infection

Rebecca L Smith et al. J Infect Dis. 2021.

Abstract

Background: Serial screening is critical for restricting spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by facilitating timely identification of infected individuals to interrupt transmission. Variation in sensitivity of different diagnostic tests at different stages of infection has not been well documented.

Methods: In a longitudinal study of 43 adults newly infected with SARS-CoV-2, all provided daily saliva and nasal swabs for quantitative reverse transcription polymerase chain reaction (RT-qPCR), Quidel SARS Sofia antigen fluorescent immunoassay (FIA), and live virus culture.

Results: Both RT-qPCR and Quidel SARS Sofia antigen FIA peaked in sensitivity during the period in which live virus was detected in nasal swabs, but sensitivity of RT-qPCR tests rose more rapidly prior to this period. We also found that serial testing multiple times per week increases the sensitivity of antigen tests.

Conclusions: RT-qPCR tests are more effective than antigen tests at identifying infected individuals prior to or early during the infectious period and thus for minimizing forward transmission (given timely results reporting). All tests showed >98% sensitivity for identifying infected individuals if used at least every 3 days. Daily screening using antigen tests can achieve approximately 90% sensitivity for identifying infected individuals while they are viral culture positive.

Keywords: RT-qPCR testing; SARS-CoV-2; antigen testing; diagnostic testing; test sensitivity.

© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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Figures

Figure 1.

Figure 1.

Daily sensitivity of each test platform relative to the day of first positive viral culture result. Shaded areas represent the 95% confidence interval around the observed proportion. Abbreviation: RT-qPCR, quantitative reverse transcription polymerase chain reaction.

Figure 2.

Figure 2.

Status sensitivity of each test platform relative to viral culture positivity. Bars indicate the 95% confidence interval around the observed proportion. Prepositive (n = 31) refers to samples taken on days before the first viral culture-positive sample collected from each individual. Positive (n = 153) refers to samples taken on days for which viral culture results were positive. Postpositive (n = 126) refers to samples taken on days with negative viral culture results that occur after the first positive culture result. Abbreviation: RT-qPCR, quantitative reverse transcription polymerase chain reaction.

Figure 3.

Figure 3.

Protocol sensitivity of each test platform to detect an infected person (A) at any time over a 14-day testing period or (B) before or on days where nasal samples were viral culture positive, relative to the frequency of testing. Bars indicate 95% confidence interval around the observed proportion. Abbreviation: RT-qPCR, quantitative reverse transcription polymerase chain reaction.

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References

    1. Krüger LJ, Gaeddert M, Köppel L, et al. . Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2. medRxiv, doi: 10.1101/2020.10.01.20203836, 4. October 2020, preprint: not peer reviewed. - DOI
    1. Pavelka M, Van-Zandvoort K, Abbott S, et al. . The impact of population-wide rapid antigen testing on SARS-CoV-2 prevalence in Slovakia. Science 2021; 372:635–41. - PMC - PubMed
    1. Jääskeläinen A, Ahava M, Jokela P, et al. . Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection. medRxiv, doi: 10.1101/2020.12.30.20249057, 4. January 2021, preprint: not peer reviewed. - DOI - PMC - PubMed
    1. Moreno GK, Braun KM, Pray IW, et al. . SARS-CoV-2 transmission in intercollegiate athletics not fully mitigated with daily antigen testing. Clin Infect Dis 2021: ciab343. doi: 10.1093/cid/ciab343. - DOI - PMC - PubMed
    1. Pray IW, Ford L, Cole D, et al. . Performance of an antigen-based test for asymptomatic and symptomatic SARS-CoV-2 testing at two university campuses—Wisconsin, September–October 2020. MMWR Morb Mortal Wkly Rep 2021; 69:1642–7. - PMC - PubMed

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