4.6 Article

Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda

Journal

PLOS ONE
Volume 17, Issue 5, Pages -

Publisher

PUBLIC LIBRARY SCIENCE
DOI: 10.1371/journal.pone.0265334

Keywords

-

Funding

  1. Uganda Government
  2. WHO
  3. Africa CDC
  4. Jack Ma Foundation
  5. UK Medical Research Council (MRC)/UK Research and Innovation
  6. UK Medical Research Council (MRC)
  7. UK Department for International Development (DFID) is under the MRC/DFID Concordat Agreement
  8. European Union

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This study evaluated the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting. The results showed that one of the tests performed well at high viral load and could be recommended for diagnosing SARS-CoV-2 infection in Uganda.
Objective The objective of this study was to evaluate the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting to identify those that could be recommended for use in the diagnosis of SARS-CoV-2 infection in Uganda. Methods This was a cross-sectional prospective study. Nasopharyngeal swabs were collected consecutively from COVID-19 PCR positive and COVID-19 PCR negative participants at isolation centers and points of entry, and tested with the SARS-CoV-2 Ag RDTs. Test sensitivity and specificity were generated by comparing results against qRT-PCR results (Berlin Protocol) at a cycle threshold (Ct) cut-off of <= 39. Sensitivity was also calculated at Ct cut-offs <= 29 and <= 33. Results None of the Ag RDTs had a sensitivity of >= 80% at Ct cut-off values <= 33 and <= 39. Two kits, Panbio (TM) COVID-19 Ag and VivaDiag (TM) SARS-CoV-2 Ag had a sensitivity of >= 80% at a Ct cut-off value of <= 29. Four kits: BIOCREDIT COVID -19 Ag, COVID-19 Ag Respi-Strip, MEDsan (R) SARS-CoV-2 Antigen Rapid Test and Panbio (TM) COVID-19 Ag Rapid Test had a specificity of >= 97%. Conclusions This evaluation identified one Ag RDT, Panbio (TM) COVID-19 Ag with a performance at high viral load (Ct value <= 29) reaching that recommended by WHO. This kit was recommended for screening of patients with COVID -19-like symptoms presenting at health facilities.

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