Журнал инфекционных заболеваний и терапии

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SARS-CoV-2 Rapid Antigen Test: Laboratory Validation of the Performance of POCT Antigen Test Kits of COVID-19

Zhang Lie, Yang Feng, Zhu Junzhe

With the advent of deadly SARS-CoV-2, public health organizations and researchers emphasized the timely detection and identification of the virus to limit the spread. Different tests were designed to detect coronaviruses for timely and rapid identification, including Polymerase Chain Reaction (PCR) that detects the organism's genetic material. This research aims to validate the performance of Point-of-care testingantigen test kits of COVID-19, including the Lateral Flow Test (LFT) and the lateral Flow Immunofluorescent Assay (FIA) is intended for qualitative detection of SARS-CoV-2 nucleocapsid antigen. This evaluation involved six different rapid test kits, including Fia Test ATFNCG21040001, All Test ATNCP21060014, All Test ATNCP21060015, All Test ATNCP21060012, Abbott Panbio Cov-19 Ag Rapid Test, and Siemens Rapid COVID-19 Antigen Test. In addition, another study also compare the SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab) manufactured by Hangzhou All Test Biotech Co., Ltd.; 2019-nCoV Antigen Test, manufactured by Guangzhou Wondfo Biotech Co., Ltd.; SARS-CoV-2 Rapid Antigen Test, manufactured by Roche, the molecular SARS-COV-2 assay (nucleic acid extraction using the automatic system Versant, followed by RT-PCR using the FDT SARS-CoV-2 kit) manufactured by Siemens from Germany that meets EU CE standards, to evaluate the clinical effectiveness of candidate kit. The Nasopharyngeal Swab (NPS) samples were collected and analysed by RT-PCR method. The specificity of all rapid test kits was greater than 99.9%, whereas the sensitivity ranged from 91 to >99%, which is also significant. The finding suggests the rapid antigen test can be used as an effective tool in controlling COVID-19 promptly. Moreover, these tests can also be conducted by a layman or at home for primary identification of COVID-19, which would limit the transmission of disease.