Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China

Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China

In response to the outbreak of COVID-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 (...

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Bibliographic Details
Main Authors: An, J. (Author), Deng, G. (Author), Dong, J. (Author), Jiao, T. (Author), Li, H. (Author), Sun, L. (Author), Wang, P. (Author)
Format: Article
Language:English
Published: Future Medicine Ltd. 2021
Subjects:
applicable sample applicability
Article
China
COVID-19 Nucleic Acid Testing
cross reaction
deoxynucleoside triphosphate
DNA polymerase
human
Humans
internal control
limit of detection
main production process and reaction system
measurement precision
negative control
nonhuman
nucleic acid
nucleoside triphosphate
parameters
physical parameters
positive control
positive cut off value
procedures
processing
quality control procedures
registered testing
registration
RNA directed DNA polymerase
RNA extraction
RNA purification
SARS-CoV-2
screening
Severe acute respiratory syndrome coronavirus 2
test stability
tests
unclassified drug
uracil DNA glycosidase
validation process
virus detection
virus strain
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