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

Chung, Hsing-Yi; Jian, Ming-Jr; Chang, Chih-Kai; Lin, Jung-Chung; Yeh, Kuo-Ming; Chen, Chien-Wen; Yang, Ya-Sung; Hsieh, Shan-Shan; Chen, En-Sung; Yang, Mei-Hsiu; Tang, Sheng-Hui; Perng, Cherng-Lih; Yang, Ji-Rong; Liu, Ming-Tsan; Chang, Feng-Yee; Shang, Hung-Sheng

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.