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10.4155/bio-2020-0188 http://scihub22266oqcxt.onion/10.4155/bio-2020-0188 33326307!7784785!33326307     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 267.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Bioanalysis 2021 ; 13 (2): 69-76 Nephropedia Template TP {{tp|p=33326307|t=2021. China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval |pdf=|usr=}}{{33326307}} gab.com Text China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval JO: Bioanalysis http://www.kidney.de/pget.php?&tw=1&pmid=33326307 #FOAvip 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. Twit Text FOAVip China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval ????Bioanalysis http://www.kidney.de/pget.php?&tw=1&pmid=33326307 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33326307 #FOAvip English Wikipedia <ref>{{Cite pmid|33326307}}</ref> China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval #MMPMID33326307 Lv Y; He J; Liu R; Gao Y; Xu C; Hu P; Zheng S; Fang L; Li R; Han C; An J; Dong J Bioanalysis 2021[Jan]; 13 (2): 69-76 PMID33326307show ga 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. |Antibodies, Viral/*analysis[MESH] |Antigen-Antibody Reactions[MESH] |COVID-19[MESH] |COVID-19 Testing/*methods[MESH] |China[MESH] |Device Approval[MESH] |Government Agencies[MESH] |Humans[MESH] |Indicators and Reagents/*standards[MESH] |Multicenter Studies as Topic[MESH] |Pandemics[MESH] |Patient Selection[MESH] |Reference Standards[MESH] |Reproducibility of Results[MESH]China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody t(epmc).pdf DeepDyve Pubget Overpricing