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

Valentin Parvu, Devin S. Gary, Joseph Mann, Yu Chih Lin, Dorsey Mills, Lauren Cooper, Jeffrey C. Andrews, Yukari C. Manabe, Andrew Pekosz, Charles K. Cooper

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Article number714242
JournalFrontiers in Microbiology
Volume12
DOIs
StatePublished - Oct 5 2021

Keywords

  • RT-PCR
  • SARS-CoV-2
  • diagnostic accuracy
  • meta-regression analysis
  • rapid antigen testing
  • systematic review and meta-analysis
  • test sensitivity
  • viral culture

ASJC Scopus subject areas

  • Microbiology
  • Microbiology (medical)

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