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Li H, Jiao T, Wang P, et al. Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China. Bioanalysis. 2021;13(23):1731-1741doi: 10.4155/bio-2021-0166.
Li, H., Jiao, T., Wang, P., An, J., Deng, G., Sun, L., & Dong, J. (2021). Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China. Bioanalysis, 13(23), 1731-1741. https://doi.org/10.4155/bio-2021-0166
Li, Hongran, et al. "Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China." Bioanalysis vol. 13,23 (2021): 1731-1741. doi: https://doi.org/10.4155/bio-2021-0166
Li H, Jiao T, Wang P, An J, Deng G, Sun L, Dong J. Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China. Bioanalysis. 2021 Dec;13(23):1731-1741. doi: 10.4155/bio-2021-0166. Epub 2021 Nov 15. PMID: 34779648; PMCID: PMC8597659.
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Bioanalysis. 2021 Dec;13(23):1731-1741. doi: 10.4155/bio-2021-0166. Epub 2021 Nov 15.

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

Bioanalysis

Hongran Li, Tong Jiao, Peirong Wang, Juanjuan An, Gang Deng, Lei Sun, Jinchun Dong

Affiliations

  1. Center for Medical Device Evaluation, NMPA, 50 Qixiang Road, Haidian District, Beijing, 100081, China.

PMID: 34779648 PMCID: PMC8597659 DOI: 10.4155/bio-2021-0166

Abstract

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 (CMDE) has issued

Keywords: SARS-CoV-2; nucleic acid; registration; tests

References

  1. Viruses. 2020 May 26;12(6): - PubMed
  2. Bioanalysis. 2021 Dec;13(23):1731-1741 - PubMed
  3. N Engl J Med. 2021 Aug 12;385(7):664-666 - PubMed
  4. Biochem Biophys Res Commun. 2021 Jan 29;538:88-91 - PubMed
  5. J Mol Struct. 2021 Nov 5;1243:130854 - PubMed
  6. Diagnostics (Basel). 2021 Jan 01;11(1): - PubMed
  7. Nature. 2021 Aug;596(7871):276-280 - PubMed
  8. Microbiol Resour Announc. 2021 Jul 15;10(28):e0056021 - PubMed
  9. J Microbiol Immunol Infect. 2021 Apr;54(2):336-338 - PubMed
  10. IDCases. 2020;22:e00936 - PubMed
  11. Clin Chem Lab Med. 2020 Jun 25;58(7):1160-1161 - PubMed
  12. Bioanalysis. 2020 Sep;12(17):1223-1230 - PubMed
  13. Clin Immunol. 2020 Dec;221:108613 - PubMed
  14. Emerg Infect Dis. 2020 Jun;26(6):1324-1326 - PubMed
  15. EMBO Mol Med. 2021 Jun 7;13(6):e14062 - PubMed
  16. Oncoimmunology. 2020 Aug 25;9(1):1807836 - PubMed
  17. Cell Rep. 2021 Jul 20;36(3):109415 - PubMed
  18. Emerg Microbes Infect. 2020 Dec;9(1):837-842 - PubMed
  19. Tohoku J Exp Med. 2020;250(4):271-278 - PubMed
  20. Int Rev Immunol. 2021;40(1-2):5-53 - PubMed
  21. Viruses. 2020 Mar 27;12(4): - PubMed
  22. Vacunas. 2021 Sep-Dec;22(3):173-179 - PubMed
  23. Rev Inst Med Trop Sao Paulo. 2020 Jun 29;62:e44 - PubMed

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