The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia

Abstract

Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR.

Keywords

• accuracy
• covid-19
• diagnostic performance
• rapid antigen test