The evaluation results of proposed antigen rapid diagnostic tests for COVID-19: some possible factors might influence

Juniastuti, Abdul Hadi Furqoni, Mochamad Amin, Yanna Debby Restifan, Serius Miliyani Dwi Putri, Virginia Ayu Ferandra, Maria Inge Lusida

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Purpose: In addition to existing gold standard qRT-PCR methods, there is a need to develop reliable rapid tests for infection control with early notification of COVID-19 cases to enable effective outbreak management. We evaluated the validity of the three Ag-RDT kits proposed by some companies in different countries by using qRT-PCR and analyzed its results. Methods: Each of the three Ag-RDT kits (namely A, B, and C) was tested with 90 samples, consisting of samples with Ct ≤ 25, samples with Ct > 25, and negative SARS-CoV-2 PCR samples. Results: This study showed that for samples with Ct > 25, all the three kits could not detect SARS-CoV-2 Ag (0% sensitivity) but showed 100% specificity. Meanwhile, for samples with Ct ≤ 25, kit C was the best (76.7% sensitivity and 100% specificity). The PPV of the three kits was 100%, but their NPV ranged 63–84.8%. Kit C showed the best accuracy (89.9%). Some factors might influence the results of evaluation, such as variation of virus proteins and transportation–storage of the kits. Conclusion: The overall specificity of the three kits for all samples was high; however, all of them have not met the minimum performance requirements of ≥ 80% sensitivity for samples with Ct ≤ 25. The validation test is much necessary to be carried out by the authority in national health care to ensure the feasibility of the kit for point-of-care testing (POCT) of COVID-19. Some factors that might influence should be anticipated to increase their sensitivities and specificities.

Original languageEnglish
Pages (from-to)1285-1291
Number of pages7
JournalInfection
Volume51
Issue number5
DOIs
Publication statusPublished - Oct 2023

Keywords

  • COVID-19
  • Rapid antigen detection test
  • SARS-CoV-2

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