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

Abstract

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.

Keywords: COVID-19; diagnostic efficacy; PCR kits; real-time PCR; RNA isolation; SARS-CoV-2