A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan. (September 2022)

• Record Type: Journal Article
• Authors: Lin, Po-Lin; Wu, Ming-Sian; Wu, Po-Chi; Chen, Hsin-Mei; Peng, Yi-Hsuan; Hsu, Jia-Chuan; Wang, Der-Yuan
• Is Part Of: Biologicals. Volume 79(2022)
• Page Start: 31
• Page End: 37
• Publication Date: 2022-09
• Subjects: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) -- Nucleic acid amplification techniques (NAAT) -- National standard (NS) -- International standard (IS); NAAT nucleic acid amplification techniques -- NS national standard -- LDT laboratory-developed test -- ORF open reading frame -- RdRp RNA-dependent RNA polymerase -- E envelope -- S spike -- N nucleocapsid -- TFDA Taiwan Food and Drug Administration -- EUA emergency use authorization -- CPE cytopathic effect -- SD Standard deviation -- CV coefficient of variation -- ECBS expert committee on biological standardization -- NIBSC National Institute for Biological Standards and Control -- IS international standard; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2022.08.002
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: The conventional PCR remains a valuable method to detect the newly emergent coronavirus rapidly and accurately. Our investigation aimed to establish the standard materials of SARS-CoV-2 for NAAT detection. We provided formalin-inactivated SARS-CoV-2 and confirmed RNA copy numbers. In addition, the virus genome was confirmed with whole-genome sequencing and identified as Wuhan/WI04/2019. Seven laboratories were invited for this collaborative study, according to the reporting data, we determined the SARS-CoV-2 with the unit of 6.35 Log10 copies/mL as the national standard. The availability of the national standard (NS) of SARS-CoV-2 will facilitate the standardization and harmonization of SARS-CoV-2 NAAT assays.