RESUMEN
The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued 'Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents' as the guidance of registration of antigen and antibody test reagents for the industry. In this document, clinical evaluation requirements of antigen detection reagents are elaborated. Based on the Key Points document and the authors' review practice, this article explains the evaluation methods and requirements of clinical performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests, then analyzes the application scenarios and intended use of antigen detection reagents.
Asunto(s)
Prueba Serológica para COVID-19/métodos , Manejo de Especímenes/métodos , Antígenos Virales , Prueba de Ácido Nucleico para COVID-19 , China , Ensayos Clínicos como Asunto , Humanos , Indicadores y Reactivos , Juego de Reactivos para Diagnóstico , SARS-CoV-2/inmunologíaRESUMEN
Coronavirus disease-2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread globally since its first report and become a worldwide pandemic. In response to the outbreak of COVID-19, Center for Medical Device Evaluation, NMPA (CMDE) initiated emergency review and approval procedures to accelerate the process of reviewing emergent medical products and issued the Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Tests (Key Points) to provide the requirements on the technical review of the tests. With uncontrolled spread and evolution of COVID-19 in the world, continuous prevention and measurements are necessary for fighting this pandemic and SARS-CoV-2 antigen/antibody tests are still urgently needed. This article is an attempt to expand clarification of the Key Points to wider audiences based on current understanding of SARS-CoV-2 to facilitate the development and application of SARS-CoV-2 antigen/antibody tests.
Asunto(s)
Anticuerpos Antivirales/análisis , Antígenos Virales/análisis , Prueba de COVID-19 , COVID-19/diagnóstico , Reacciones Antígeno-Anticuerpo , Prueba de COVID-19/instrumentación , China , Ensayos Clínicos como Asunto , Reacciones Cruzadas , Humanos , Inmunoglobulina M/análisis , Límite de Detección , Pandemias , Estándares de Referencia , Reproducibilidad de los ResultadosRESUMEN
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. The Clinical Study Requirement section of the Key Point has put forward requirements in terms of reference methods and subject enrolment among others, which can ensure that the test results can meet the clinical needs. This article draws on the experience of the China NMPA in evaluating diagnostic reagents used to supplement the gold standard test method in the early stage of an epidemic of an infectious disease, as well as to serve as reference for clinicians and regulators.
Asunto(s)
Anticuerpos Antivirales/análisis , Prueba de COVID-19/métodos , Indicadores y Reactivos/normas , Reacciones Antígeno-Anticuerpo , COVID-19 , China , Aprobación de Recursos , Agencias Gubernamentales , Humanos , Estudios Multicéntricos como Asunto , Pandemias , Selección de Paciente , Estándares de Referencia , Reproducibilidad de los Resultados , Proyectos de InvestigaciónRESUMEN
The detection data of IgM and IgG antibodies in 169 patients with coronavirus disease-2019 (COVID-19) were analyzed to evaluate differences in clinical performance between the colloidal gold method and chemiluminescence method. In this study, chemiluminescence detection of IgM antibody showed a positive conversion earlier (about 1-2 days earlier), positive conversion rates higher in different stages of disease, and a trend of declining positive rate later than colloidal gold method. For IgG antibody, the chemiluminescence method showed a positive conversion earlier and the positive rate climbing more quickly than the colloidal gold method. No obvious negative-converting tendency of IgG detection was observed within 35 days after the onset of disease. Although colloidal gold method is generally less sensitive than chemiluminescence method, it shows advantages of shorter turn-around time, more simple procedure, and no special equipment required. The two methodologies can be chosen according to different laboratory conditions. A reasonable understanding of the performance of reagents with different methodologies can help in clinical disease diagnosis effectively and assist in the diagnosis of the progression of COVID-19, for which the dynamic changes of antibody will provide reliable evidence.