Multicenter study evaluating one multiplex RT-PCR assay to detect SARS-CoV-2, influenza A/B, and respiratory syncytia virus using the LabTurbo AIO open platform: epidemiological features, automated sample-to-result, and high-throughput testing

• Published in: Aging (Albany, NY.) NY.), 2021-12, Vol.13 (23), p.24931-24942
• Main Authors: Chung, Hsing-Yi, Jian, Ming-Jr, Chang, Chih-Kai, Lin, Jung-Chung, Yeh, Kuo-Ming, Yang, Ya-Sung, Chen, Chien-Wen, Hsieh, Shan-Shan, Tang, Sheng-Hui, Perng, Cherng-Lih, Chang, Feng-Yee, Hung, Kuo-Sheng, Chen, En-Sung, Yang, Mei-Hsiu, Shang, Hung-Sheng
• Format: Article
• Language: English
• Subjects: Adult; Aged; Betainfluenzavirus - genetics; Betainfluenzavirus - isolation & purification; COVID-19 - diagnosis; COVID-19 - virology; COVID-19 Nucleic Acid Testing - methods; Female; Humans; Influenza A virus - genetics; Influenza A virus - isolation & purification; Influenza, Human - diagnosis; Influenza, Human - virology; Male; Middle Aged; Multiplex Polymerase Chain Reaction - methods; Research Paper; Respiratory Syncytial Virus Infections - diagnosis; Respiratory Syncytial Virus Infections - virology; Respiratory Syncytial Viruses - genetics; Respiratory Syncytial Viruses - isolation & purification; SARS-CoV-2 - genetics; SARS-CoV-2 - isolation & purification; Sensitivity and Specificity; Young Adult
• ISSN: 1945-4589; 1945-4589
• DOI: 10.18632/aging.203761

Since the Coronavirus 19 (COVID-19) pandemic, several SARS-CoV-2 variants of concern (SARS-CoV-2 VOC) have been reported. The B.1.1.7 variant has been associated with increased mortality and transmission risk. Furthermore, cluster and possible co-infection cases could occur in the next influenza season or COVID-19 pandemic wave, warranting efficient diagnosis and treatment decision making. Here, we aimed to detect SARS-CoV-2 and other common respiratory viruses using multiplex RT-PCR developed on the LabTurbo AIO 48 open system. We performed a multicenter study to evaluate the performance and analytical sensitivity of the LabTurbo AIO 48 system for SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) using 652 nasopharyngeal swab clinical samples from patients. The LabTurbo AIO 48 system demonstrated a sensitivity of 9.4 copies/per PCR for of SARS-CoV-2; 24 copies/per PCR for of influenza A and B; and 24 copies/per PCR for of RSV. The assay presented consistent performance in the multicenter study. The multiplex RT-PCR applied on the LabTurbo AIO 48 open platform provided highly sensitive, robust, and accurate results and enabled high-throughput detection of B.1.1.7, influenza A/B, and RSV with short turnaround times. Therefore, this automated molecular diagnostic assay could enable streamlined testing if COVID-19 becomes a seasonal disease.