Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System

Autor: Zhang, Jin-Hui Zhu, Chia-Hsing Tai, Chia-Fong Ping, Pin-Hsing Chou, Yun-Long Tsai, Simon Chung, Laura Bradner, Michael Pentella, Phillip Gauger, Jianqiang
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Diagnostics; Volume 13; Issue 13; Pages: 2219
ISSN: 2075-4418
DOI: 10.3390/diagnostics13132219
Popis: The emergence of COVID-19 has caused unprecedented impacts on global public health and many other aspects. Meanwhile, many types of methods have been developed to detect the causative agent, SARS-CoV-2; this has greatly advanced the technologies in the diagnostic field. Here, we describe the development and validation of a sample-in-result-out POCKIT Central SARS-CoV-2 PCR system for detecting SARS-CoV-2 in comparison with a commercial reference real-time RT-PCR assay (TaqPath COVID-19 Combo Kit). Both assays were specific and did not cross-react with non-SARS-CoV-2 agents. Both assays were able to detect various SARS-CoV-2 strains including some variants. Based on testing serial dilutions of SARS-CoV-2 USA-WA1/2020 isolate, the limit of detection was 0.8 TCID50/mL (1.87 × 103 genomic copies/mL) for POCKIT Central SARS-CoV-2 PCR and 0.16 TCID50/mL (3.75 × 102 genomic copies/mL) for the reference PCR. Subsequently, 183 clinical samples were tested by both assays and the diagnostic sensitivity, specificity, and agreement of the POCKIT Central SARS-CoV-2 PCR were 91.7%, 100%, and 94.0%, respectively, when compared to the reference PCR. The compact sample-to-result POCKIT Central SARS-CoV-2 PCR system is a simplified and efficient point-of-care tool for SARS-CoV-2 detection. In addition, this platform can be readily adapted to detect other human and animal viruses.
Databáze: OpenAIRE
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