Abstract
Coronavirus disease 2019 has become a worldwide pandemic. By April 7, 2020, approximately 1,279,722 confirmed cases were reported worldwide including those in Asia, European Region, African Region and Region of the Americas. Rapid and accurate detection of Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) is critical for patient care and implementing public health measures to control the spread of infection. In this study, we developed and validated a rapid total nucleic acid extraction method based on real‐time RT-PCR for reliable, high‐throughput identification of SARS-CoV-2 using the BD MAX platform. For clinical validation, 300 throat swab and 100 sputum clinical samples were examined by both the BD MAX platform and in-house real-time RT-PCR methods, which showed 100% concordant results. This BD MAX protocol is fully automated and the turnaround time from sample to results is approximately 2.5 h for 24 samples compared to 4.8 h by in-house real-time RT-PCR. Our developed BD MAX RT-PCR assay can accurately identify SARS-CoV-2 infection and shorten the turnaround time to increase the effectiveness of control and prevention measures for this emerging infectious disease.
Highlights
Control and Prevention (China CDC) reported a novel coronavirus as the causative agent of this outbreak, which was phylogenetically classified into a novel sister clade of SARS virus and named as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Turnaround time for detecting SARS-COV-2 on the BD MAX System The procedures used for the BD MAX System included sample preparation, device loading, total nucleic acid extraction, reverse transcription polymerase chain reaction (RT-PCR), and results interpretation
Results for 192–216 samples in 11 h, showing improved capacity compared to the laboratory-developed test (LDT) method
Summary
On December 31, 2019, a cluster of pneumonia cases of unknown etiology was reported in Wuhan, Hubei Province, China (Chan et al, 2020a). How to cite this article Perng C-L, Jian M-J, Chang C-K, Lin J-C, Yeh K-M, Chen C-W, Chiu S-K, Chung H-Y, Wang Y-H, Liao S-J, Li S-Y, Hsieh S-S, Tsai S-H, Chang F-Y, Shang H-S. Novel rapid identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) by real-time RT-PCR using BD Max Open System in Taiwan. Control and Prevention (China CDC) reported a novel coronavirus as the causative agent of this outbreak, which was phylogenetically classified into a novel sister clade of SARS virus and named as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by this virus has been called as novel coronavirus disease 2019 (COVID-19)
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