Key Points of Technical Review for the Registration of Sars-Cov-2 Nucleic Acid Tests in China

Abstract

In response to the outbreak ofCOVID-19, in accordance with the principles of ‘unified command, early involvement, prompt review and scientific approval’ as well as the requirements of ensuring product safety, effectiveness and controllable quality, the Center for Medical Device Evaluation (CMDE)has issued Key Points of Technical Review for the Registration of SARS-CoV-2 Nucleic Acid Tests (Key Points) to provide the requirements of tests. Because of the sustainability of the pandemic, more efforts and attempts are needed for SARS-CoV-2 detection and control. This article interprets the Key Points issued by the CMDE and provides certain refinements to wider audiences.

Keywords::

• nucleic acid
• registration
• SARS-CoV-2
• tests

Financial & competing interests disclosure

This work was supported by a grant from the Ministry of Science and Technology COVID-19 Pandemic Emergency project “Development of SARS-CoV-2 Nucleic Acid Tests” (Field 3-project 5, no. 2020YFC0841200). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.