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

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Hatta Hazlienor Mohd; HAFIZ MOHD FUZI NIK MOHD; Sulaiman Suhaiza; Muhammad Abdul Haris; Hussin Zaini

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Journal: Epidemiology and Health System Journal Year:2022 | Volume:9 | Issue:4 Page(s): 164-170

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Title

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

Author(s)

Keywords

Accuracy

COVID-19

Diagnostic performance

Rapid antigen test

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 < 0. 001). The overall specificity was 97. 9% (95% CI: 94. 1%-99. 6%), sensitivity was 63. 3% (95% CI: 55. 3%-70. 8%), Accuracy Ag-RDTs was 81. 2% (95% CI: 76. 4%-85. 5%), while positive and negative predictive value was 96. 6% (95% CI: 90. 2%-98. 9%) and 74. 1% (95% CI: 70. 0%-77. 9%), respectively. Further, lower median Ct was reported in 100 (33. 0%) true-positive cases compared to 58 (19. 1%) false-negative cases (20. 3 vs 31. 4, P < 0. 001). The sensitivity was higher (P < 0. 001) in those with high viral load (Ct value ≤,25. 0) with better performance and a prevalence > 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.

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APA: Copy

Hatta, Hazlienor Mohd, HAFIZ MOHD FUZI, NIK MOHD, Sulaiman, Suhaiza, Muhammad, Abdul Haris, & Hussin, Zaini. (2022). The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia. EPIDEMIOLOGY AND HEALTH SYSTEM JOURNAL (INTERNATIONAL JOURNAL OF EPIDEMIOLOGIC RESEARCH), 9(4), 164-170. SID. https://sid.ir/paper/1043090/en

Vancouver: Copy

Hatta Hazlienor Mohd, HAFIZ MOHD FUZI NIK MOHD, Sulaiman Suhaiza, Muhammad Abdul Haris, Hussin Zaini. The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia. EPIDEMIOLOGY AND HEALTH SYSTEM JOURNAL (INTERNATIONAL JOURNAL OF EPIDEMIOLOGIC RESEARCH)[Internet]. 2022;9(4):164-170. Available from: https://sid.ir/paper/1043090/en

IEEE: Copy

Hazlienor Mohd Hatta, NIK MOHD HAFIZ MOHD FUZI, Suhaiza Sulaiman, Abdul Haris Muhammad, and Zaini Hussin, “The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia,” EPIDEMIOLOGY AND HEALTH SYSTEM JOURNAL (INTERNATIONAL JOURNAL OF EPIDEMIOLOGIC RESEARCH), vol. 9, no. 4, pp. 164–170, 2022, [Online]. Available: https://sid.ir/paper/1043090/en

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