Key Points of Technical Review for the Registration of Sars-Cov-2 Antigen/Antibody Tests

Abstract

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.

A Novel Computational Model for Detecting the Severity of Inflammation in Confirmed COVID-19 Patients Using Chest X-ray Images

“…Equation (1) shows that each color image will be divided into nineteen sub-grayscale images. This division will make it more efficient to deal with the grayscale images.…”

“…Since its discovery in Hubei province, China, Coronavirus disease 2019 (COVID- 19) has become an international emergency [1,2]. To date, quarantine has been the most significant control intervention for respiratory diseases caused by the virus.…”

China's NMPA Perspective on the Clinical Performance of SARS-CoV-2 Antigen Test Reagents

“…The characteristics of Ag-RDTs require some unique considerations in the premarket clinical performance evaluation of these products. The Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) issued ‘Key Points of Technical Review for Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents’ [ 10 ], which, as a guidance of registration, provides a detailed description of the premarket evaluation methods and indicators for evaluation for such products [ 11 ]. Previously, the authors published an article that analyzed the requirement for antibody detection reagents [ 12 ].…”