Publications by authors named "Congyin Han"
Article Synopsis
- - The COVID-19 pandemic remains a global challenge, prompting regulatory actions for medical testing.
- - China’s medical administration released guidelines for the registration of SARS-CoV-2 antigen and antibody tests, detailing clinical evaluation requirements.
- - The article discusses evaluation methods for rapid antigen tests, including their intended use and practical applications in diagnosing COVID-19.
Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 antibody testing an important supplement to nucleic acid testing. In the process of emergency approval, the Center for Medical Device Evaluation of the China National Medical Products Administration released The Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents.
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- A study analyzed the detection of IgM and IgG antibodies in 169 COVID-19 patients to compare the clinical performance between the colloidal gold method and the chemiluminescence method.
- The chemiluminescence method detected IgM and IgG antibodies earlier and showed higher positive conversion rates, while colloidal gold had advantages in terms of speed and simplicity.
- Understanding the differences in these methods can help improve COVID-19 diagnosis and monitor disease progression effectively.