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

• Published in: Biologicals 2022-09, Vol.79, p.31-37
• Main Authors: Lin, Po-Lin, Wu, Ming-Sian, Wu, Po-Chi, Chen, Hsin-Mei, Peng, Yi-Hsuan, Hsu, Jia-Chuan, Wang, Der-Yuan
• Format: Article
• Language: English
• Subjects: International standard (IS); National standard (NS); Nucleic acid amplification techniques (NAAT); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1016/j.biologicals.2022.08.002

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.