Molecular and antigen tests, and sample types for diagnosis of COVID-19: a review

Future Virol. 2022 Jun;17(9):675-685. doi: 10.2217/fvl-2021-0256. Epub 2022 Jul 1.

Abstract

Laboratory tests seeking to improve detection of COVID-19 have been widely developed by laboratories and commercial companies. This review provides an overview of molecular and antigen tests, presents the sensitivity and specificity for 329 assays that have received US FDA Emergency Use Authorization and evaluates six sample collection methods - nasal, nasopharyngeal, oropharyngeal swabs, saliva, blood and stool. Molecular testing is preferred for diagnosis of COVID-19, but negative results do not always rule out the presence of infection, especially when clinical suspicion is high. Sensitivity and specificity ranged from 88.1 to 100% and 88 to 100%, respectively. Antigen tests may be more easy to use and rapid. However, they have reported a wide range of detection sensitivities from 16.7 to 85%, which may potentially yield many false-negative results.

Keywords: COVID-19; SARS-CoV-2; US FDA; diagnostic testing; sensitivity and specificity.

Publication types

  • Review