Factors that Influence the Reported Sensitivity of Rapid Antigen Testing for SARS-CoV-2

Tests that detect the presence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigen in clinical specimens from the upper respiratory tract can provide a rapid means of coronavirus disease 2019 (COVID-19) diagnosis and help identify individuals who may be infectious and should isol...

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Published inFrontiers in microbiology Vol. 12; p. 714242
Main Authors Parvu, Valentin, Gary, Devin S., Mann, Joseph, Lin, Yu-Chih, Mills, Dorsey, Cooper, Lauren, Andrews, Jeffrey C., Manabe, Yukari C., Pekosz, Andrew, Cooper, Charles K.
Format Journal Article
LanguageEnglish
Published Frontiers Media S.A 05.10.2021
Subjects
diagnostic accuracy
meta-regression analysis
Microbiology
rapid antigen testing
RT-PCR
SARS-CoV-2
test sensitivity
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Summary:Tests that detect the presence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigen in clinical specimens from the upper respiratory tract can provide a rapid means of coronavirus disease 2019 (COVID-19) diagnosis and help identify individuals who may be infectious and should isolate to prevent SARS-CoV-2 transmission. This systematic review assesses the diagnostic accuracy of SARS-CoV-2 antigen detection in COVID-19 symptomatic and asymptomatic individuals compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) and summarizes antigen test sensitivity using meta-regression. In total, 83 studies were included that compared SARS-CoV-2 rapid antigen-based lateral flow testing (RALFT) to RT-qPCR for SARS-CoV-2. Generally, the quality of the evaluated studies was inconsistent; nevertheless, the overall sensitivity for RALFT was determined to be 75.0% (95% confidence interval: 71.0–78.0). Additionally, RALFT sensitivity was found to be higher for symptomatic vs. asymptomatic individuals and was higher for a symptomatic population within 7 days from symptom onset compared to a population with extended days of symptoms. Viral load was found to be the most important factor for determining SARS-CoV-2 antigen test sensitivity. Other design factors, such as specimen storage and anatomical collection type, also affect the performance of RALFT. RALFT and RT-qPCR testing both achieve high sensitivity when compared to SARS-CoV-2 viral culture.
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Edited by: Maurizio Sanguinetti, Catholic University of the Sacred Heart, Italy
This article was submitted to Infectious Diseases, a section of the journal Frontiers in Microbiology
Reviewed by: Piyush Baindara, University of Missouri, United States; Yean Kong Yong, Xiamen University, Malaysia
ISSN:1664-302X
1664-302X
DOI:10.3389/fmicb.2021.714242