Diagnostics (Nov 2021)

Performance Validation of COVID-19 Self-Conduct Buccal and Nasal Swabs RTK-Antigen Diagnostic Kit

  • Mohammad Nur Amin Kalil,
  • Wardah Yusof,
  • Naveed Ahmed,
  • Mohd Hashairi Fauzi,
  • Mimi Azliha Abu Bakar,
  • Afifah Sjamun Sjahid,
  • Rosline Hassan,
  • Chan Yean Yean

DOI
https://doi.org/10.3390/diagnostics11122245
Journal volume & issue
Vol. 11, no. 12
p. 2245

Abstract

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The antigen rapid diagnostic test (Ag-RDT) is an immunodiagnostic test that detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from a patient’s respiratory tract. This study focused on evaluating the performance of self-conduct buccal and nasal swabs RTK-antigen test compared to nasopharyngeal swab RTK-based COVID-19 diagnostic assays, Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) (Abbott Rapid Diagnostics Jena GmbH, Jena, Germany) used in hospitals for first-line screening. The sensitivity and specificity of the paired RTK-Ag test in detecting the an-tigen were calculated at 96.4% and 100%, respectively. Fisher exact tests showed the association between nasopharyngeal swabs RTK-Ag assay and buccal-nasal swabs RTK-Ag from ProdetectTM is significant (p-values < 0.001). The result showed that a self-conducted buccal and nasal RTK-antigen rapid test by the patients is comparable to the results obtained from a rapid test device conducted by trained medical personnel using a nasopharyngeal swab.

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