Multicenter study evaluating novel multi-specimen pooling assay for the detection of SARS-CoV-2: High sensitivity and high throughput testing

Autor: Hsing-Yi Chung, Ming-Jr Jian, Chih-Kai Chang, Jung-Chung Lin, Kuo-Ming Yeh, Chien-Wen Chen, Ya-Sung Yang, Shan-Shan Hsieh, En-Sung Chen, Mei-Hsiu Yang, Sheng-Hui Tang, Cherng-Lih Perng, Ji-Rong Yang, Ming-Tsan Liu, Feng-Yee Chang, Hung-Sheng Shang
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Microbiology, Immunology and Infection, Vol 55, Iss 6, Pp 1069-1075 (2022)
Druh dokumentu: article
ISSN: 1684-1182
DOI: 10.1016/j.jmii.2021.08.003
Popis: Background/purpose: Mass screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is important to prevent the spread of coronavirus disease 2019 (COVID-19). Pooling samples can increase the number of tests processed. LabTurbo AIO 48 is an automated platform that allows ribonucleic acid extraction and sample analysis on the same instrument. We created a novel pooling assay on this platform for SARS-CoV-2 detection and demonstrated that the pooling strategy increases testing capacity without affecting accuracy and sensitivity. Methods: Comparative limit of detection (LoD) assessment was performed on the LabTurbo AIO 48 platform and the current standard detection system based on real-time reverse transcription polymerase chain reaction (rRT-PCR) using 55 clinically positive samples. An additional 330 primary clinical samples were assessed. Results: Six samples pooled into one reaction tube were detected in approximately 2.5 h using the World Health Organization rRT-PCR protocol. LabTurbo AIO 48 also demonstrated a higher throughput than our reference rRT-PCR assay, with an LoD of 1000 copies/mL. The overall percentage agreement between the methods for the 330 samples was 100%. Conclusion: We created a novel multi-specimen pooling assay using LabTurbo AIO 48 for the robust detection of SARS-CoV-2, allowing high-throughput results; this assay will aid in better control and prevention of COVID-19. The diagnostic assay was cost-effective and time-efficient; thus, the pooling strategy is a practical and effective method for diagnosing large quantities of specimens without compromising precision.
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