The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) epidemic, which causes the novel coronavirus disease 2019 (COVID-19), was first reported in December 2019 in Wuhan, China, and it has since been declared a pandemic by the World Health Organization. The ongoing outbreak is a global threat to human health. Quantitative reverse-transcription polymerase chain reaction (RT-qPCR) analysis for SARS-CoV2 is considered the gold standard for diagnosing COVID-19. RT-qPCR has been used to analyze specimens from the upper and lower respiratory tracts for clinical diagnosis during outbreaks of other diseases, but it has not been performed widely in the clinical setting because it requires special equipment, a time-consuming protocol, and highly skilled laboratory technicians. In addition, because RT-qPCR requires samples from the upper and lower respiratory tracts, the process of collecting samples and extracting RNA increases the risk of exposure to viral droplets. Therefore, an alternative diagnostic test to RT-qPCR is desirable for the clinical management of COVID-19.

Lung involvement can be detected in patients with COVID-19 on a CT scan in advance of the symptoms typical for pneumonia and a positive result on RT-qPCR. The common radiological characteristics of COVID-19 pneumonia on chest CT have a diagnostic sensitivity of 73 %–93 % and a specificity of 24 %–100 % in distinguishing COVID-19 from other forms of viral pneumonia. An immunochromatographic (IC) assay for IgM and IgG antibodies against the virus is widely accepted as a point-of-care test because it is an easy-to-perform, rapid, and high-throughput method for diagnosing viral infections. Recently, several commercial IC assays that detect IgM/IgG antibodies against SARS-CoV2 have become available for use in the clinical setting.

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