Evaluation of Rapid Multiplex Reverse Transcription-Quantitative Polymerase Chain Reaction Assays for SARS-CoV-2 Detection in Individual and Pooled Samples

Although coronavirus disease 2019 (COVID-19) is no longer a Public Health Emergency of International Concern (PHEIC), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has had a vast impact to date. Hence, continuous management is required, given the uncertainty caused by the po...

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Published in:Life (Basel, Switzerland) Switzerland), 2023-08, Vol.13 (8), p.1717
Main Authors: Baek, Young-Hyun, Park, Min-Young, Lim, Ho-Jae, Youm, Dong-Jae, You, Youngshin, Ahn, Seojin, Park, Jung-Eun, Kim, Min-Jin, Lee, Sun-Hwa, Sohn, Yong-Hak, Yang, Yong-Jin
Format: Article
Language:English
Subjects:
Acids
Antigens
Assaying
Automation
Coronaviruses
COVID-19
Diagnostic tests
Evaluation
Genes
Genomes
infection management
Infections
Performance evaluation
Polymerase chain reaction
Public health
rapid RT-qPCR
Reverse transcription
RNA polymerase
SARS-CoV-2
Sensitivity
Severe acute respiratory syndrome coronavirus 2
Sustainability management
Viral diseases
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Summary:Although coronavirus disease 2019 (COVID-19) is no longer a Public Health Emergency of International Concern (PHEIC), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has had a vast impact to date. Hence, continuous management is required, given the uncertainty caused by the potential evolution of SARS-CoV-2. Reverse transcription-quantitative PCR (RT-qPCR) diagnosis has been fundamental in overcoming this issue. In this study, the performances of two rapid RT-qPCR assays (Real-Q Direct SARS-CoV-2 Detection Kit and Allplex™ SARS-CoV-2 fast PCR Assay) with short PCR times were comparatively evaluated using a STANDARD M nCoV Real-Time Detection Kit (STANDARD M, conventional RT-qPCR assay). All kits showed a limit of detection values (102–103 copies/reaction). The evaluation showed that the two rapid assay tests had ≥97.89% sensitivity and ≥99.51% specificity (κ = 0.98) for individual samples and ≥97.32% sensitivity and ≥97.67% specificity for pooled samples compared to STANDARD M. These results indicate that the two rapid RT-qPCR kits, which showed significant time reduction in performance, are as effective as a conventional RT-qPCR assay. They are likely to increase not only the number of tests that can be performed but also the efficiency of sustainable management of COVID-19 in the long term.
ISSN:2075-1729
2075-1729
DOI:10.3390/life13081717