Diagnostic accuracy of rapid antigen test kits for detecting SARS-CoV-2: a systematic review and meta-analysis of 17,171 suspected COVID-19 patients

Shahad Saif Khandker, Nik Haszroel Hysham Nik Hashim, Zakuan Zainy Deris, Rafidah Hanim Shueb*, Md Asiful Islam*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

36 Citations (Scopus)
62 Downloads (Pure)

Abstract

Early diagnosis is still as crucial as the initial stage of the COVID-19 pandemic. As RT-PCR sometimes is not feasible in developing nations or rural areas, health professionals may use a rapid antigen test (RAT) to lessen the load of diagnosis. However, the efficacy of RAT is yet to be investigated thoroughly. Hence, we tried to evaluate the overall performance of RAT in SARS-CoV-2 diagnosis. Based on our PROSPERO registered protocol (CRD42021231432), we searched online databases (i.e., PubMed, Google Scholar, Scopus, and Web of Science) and analysed overall pooled specificity and sensitivity of RAT along with study quality, publication bias, heterogeneity and more. The overall pooled specificity and sensitivity of RAT were detected as 99.4% (95% CI: 99.1–99.8; I2 = 90%) and 68.4% (95% CI: 60.8–75.9; I2 = 98%), respectively. In subgroup analyses, nasopharyngeal specimens and symptomatic patient’s samples were more sensitive in RAT, while cycle threshold (Ct) values were found to have an inverse relationship with sensitivity. In the European and American populations, RAT showed better performance. Although the sensitivity of RAT is yet to be improved, it could still be an alternative in places with poor laboratory set up. Nevertheless, the negative samples of RAT can be re-tested using RT-PCR to reduce false negative results.

Original languageEnglish
Article number3493
Number of pages19
JournalJournal of Clinical Medicine
Volume10
Issue number16
DOIs
Publication statusPublished - 8 Aug 2021

Bibliographical note

Funding Information:
Funding: This research was funded by the Universiti Sains Malaysia Research University Grant 1001/PPSP/8012382.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Keywords

  • COVID-19
  • Rapid antigen test
  • SARS-CoV-2
  • Sensitivity
  • Specificity

ASJC Scopus subject areas

  • General Medicine

Fingerprint

Dive into the research topics of 'Diagnostic accuracy of rapid antigen test kits for detecting SARS-CoV-2: a systematic review and meta-analysis of 17,171 suspected COVID-19 patients'. Together they form a unique fingerprint.

Cite this