The Evaluation Results of Proposed Antigen Rapid Diagnostic Tests for COVID-19: Some Possible Factors Might Influence

Purpose: In addition to existing gold standard qRT-PCR methods, it needs 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, 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 they showed 100% specificity. Meanwhile, for samples with Ct ≤ 25, the 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%. The 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 very necessary to be carried out by the authority in national healthcare to ensure the feasibility of the kit for POCT of COVID-19. Some factors that might influence should be anticipated to increase their sensitivities and specificities.