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Multicenter Study
. 2021 Dec 12;13(23):24931-24942.
doi: 10.18632/aging.203761. Epub 2021 Dec 12.

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

Hsing-Yi Chung  1 , Ming-Jr Jian  1 , Chih-Kai Chang  1 , Jung-Chung Lin  2 , Kuo-Ming Yeh  2 , Ya-Sung Yang  2 , Chien-Wen Chen  3 , Shan-Shan Hsieh  1 , Sheng-Hui Tang  1 , Cherng-Lih Perng  1 , Feng-Yee Chang  2 , Kuo-Sheng Hung  4 , En-Sung Chen  5 , Mei-Hsiu Yang  5 , Hung-Sheng Shang  1
Affiliations
Multicenter Study

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

Hsing-Yi Chung et al. Aging (Albany NY). .

Abstract

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.

Keywords: B.1.1.7 variant; COVID-19; SARS-CoV-2; SARS-CoV-2 VOC; multiplex testing.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
The correlation between N2, E and Rdrp gene of 102 SARS-CoV-2 positive specimens.
Figure 2
Figure 2
The clinical performance of multiplex RT-PCR in SARS-CoV-2 positive specimens between the two medical centers.
See this image and copyright information in PMC

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