PMID- 34897035 OWN - NLM STAT- MEDLINE DCOM- 20220104 LR - 20231213 IS - 1945-4589 (Electronic) IS - 1945-4589 (Linking) VI - 13 IP - 23 DP - 2021 Dec 12 TI - 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. PG - 24931-24942 LID - 10.18632/aging.203761 [doi] AB - 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 N2 of SARS-CoV-2; 24 copies/per PCR for M of influenza A and B; and 24 copies/per PCR for N 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. FAU - Chung, Hsing-Yi AU - Chung HY AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Jian, Ming-Jr AU - Jian MJ AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Chang, Chih-Kai AU - Chang CK AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Lin, Jung-Chung AU - Lin JC AD - Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Yeh, Kuo-Ming AU - Yeh KM AD - Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Yang, Ya-Sung AU - Yang YS AD - Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Chen, Chien-Wen AU - Chen CW AD - Division of Pulmonary and Critical Care Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Hsieh, Shan-Shan AU - Hsieh SS AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Tang, Sheng-Hui AU - Tang SH AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Perng, Cherng-Lih AU - Perng CL AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Chang, Feng-Yee AU - Chang FY AD - Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Hung, Kuo-Sheng AU - Hung KS AD - Center for Precision Medicine and Genomics, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. FAU - Chen, En-Sung AU - Chen ES AD - Department of Clinical Pathology, Cathay General Hospital, Taipei, Taiwan, ROC. FAU - Yang, Mei-Hsiu AU - Yang MH AD - Department of Clinical Pathology, Cathay General Hospital, Taipei, Taiwan, ROC. FAU - Shang, Hung-Sheng AU - Shang HS AD - Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC. LA - eng PT - Evaluation Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20211212 PL - United States TA - Aging (Albany NY) JT - Aging JID - 101508617 RN - SARS-CoV-2 variants SB - IM MH - Adult MH - Aged MH - COVID-19/*diagnosis/virology MH - COVID-19 Nucleic Acid Testing/*methods MH - Female MH - Humans MH - Influenza A virus/genetics/isolation & purification MH - Influenza, Human/*diagnosis/virology MH - Betainfluenzavirus/genetics/isolation & purification MH - Male MH - Middle Aged MH - Multiplex Polymerase Chain Reaction/*methods MH - Respiratory Syncytial Virus Infections/*diagnosis/virology MH - Respiratory Syncytial Viruses/genetics/isolation & purification MH - SARS-CoV-2/genetics/isolation & purification MH - Sensitivity and Specificity MH - Young Adult PMC - PMC8714143 OTO - NOTNLM OT - B.1.1.7 variant OT - COVID-19 OT - SARS-CoV-2 OT - SARS-CoV-2 VOC OT - multiplex testing COIS- CONFLICTS OF INTEREST: The funders had no role in study design, data collection, and interpretation, or the decision to submit the work for publication. The authors declare no conflicts of interest. EDAT- 2021/12/14 06:00 MHDA- 2022/01/05 06:00 PMCR- 2021/12/15 CRDT- 2021/12/13 13:09 PHST- 2021/07/17 00:00 [received] PHST- 2021/11/23 00:00 [accepted] PHST- 2021/12/14 06:00 [pubmed] PHST- 2022/01/05 06:00 [medline] PHST- 2021/12/13 13:09 [entrez] PHST- 2021/12/15 00:00 [pmc-release] AID - 203761 [pii] AID - 10.18632/aging.203761 [doi] PST - ppublish SO - Aging (Albany NY). 2021 Dec 12;13(23):24931-24942. doi: 10.18632/aging.203761. Epub 2021 Dec 12.