Comparison of the diagnostic efficacy of the Abbott RealTime SARS-CoV-2 assay and the BGI real-time fluorescent RT-PCR kit for the RT-PCR-based detection of Severe Acute Respiratory Syndrome Coronavirus-2

Autor: Stojčević-Maletić Jelena, Barjaktarović Iva, Bačulov Katarina, Čabarkapa Velibor, Sakač Vladimir, Gojković Zoran
Jazyk: English<br />Serbian
Rok vydání: 2023
Předmět:
Zdroj: Srpski Arhiv za Celokupno Lekarstvo, Vol 151, Iss 9-10, Pp 525-530 (2023)
Druh dokumentu: article
ISSN: 0370-8179
2406-0895
DOI: 10.2298/SARH230201074S
Popis: Introduction/Objective. Based on the WHO Organization guidelines, the current gold standard to diagnose Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is reverse transcription-quantitative real-time polymerase chain reaction (RT-qPCR). The objective of this study was to compare and analyze the detection performance of two different authorized SARS-CoV-2 nucleic acid detection assays: the Abbott RealTime SARS-CoV-2 (ACOV) assay and the BGI Real-Time Fluorescent RT-PCR (BGI) kit. Methods. Our study included 384 randomly selected nasopharyngeal and oropharyngeal swabs previously tested by the ACOV and subsequently tested by the BGI kit for detecting SARS-CoV-2. All patients were adult individuals with symptoms of or suspected Coronavirus disease 2019 (COVID-19). Results. We found that the ACOV assay detected more cases of COVID-19 infection than the BGI assay. The positive percent agreement was 98.3% (95% confidence intervals (95% CI): 95.7–99.3%), while Cohen’s Kappa coefficient was 0.86 (95% CI: 0.80–0.91), indicating a strong level of agreement between these two tests. The negative percent agreement was 85.1% (95% CI: 78.3–90%), while 5.47% of cases were false negative using the BGI test to detect SARS-CoV-2. The sensitivity of the BGI test compared to ACOV was 91.73% (95% CI: 87.64–94.81%), and the specificity of the BGI test was 96.77% (95% CI: 91.95–99.11%). Conclusion. The ACOV showed a bit better diagnostic performance, and due to possible false negative results using the BGI test, we recommend complete testing with the ACOV test.
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