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Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Bioanalysis 2021 ; 13 (2): 77-88 Nephropedia Template TP
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Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests #MMPMID33427483
Li H; He J; Bao W; Wang P; Lv Y; Xu C; Hu P; Gao Y; Zheng S; An J; Deng G; Dong J
Bioanalysis 2021[Jan]; 13 (2): 77-88 PMID33427483show ga
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.
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Bioanalysis 2021 ; 13 (2): 77-88
