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

tetano

Editor, Senior Moderator
Biologicals


. 2022 Aug 31;S1045-1056(22)00046-X.
doi: 10.1016/j.biologicals.2022.08.002. Online ahead of print.
A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan


Po-Lin Lin[SUP] 1 [/SUP], Ming-Sian Wu[SUP] 1 [/SUP], Po-Chi Wu[SUP] 1 [/SUP], Hsin-Mei Chen[SUP] 1 [/SUP], Yi-Hsuan Peng[SUP] 1 [/SUP], Jia-Chuan Hsu[SUP] 1 [/SUP], Der-Yuan Wang[SUP] 2 [/SUP]



Affiliations

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 Log[SUB]10[/SUB] 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.

Keywords: International standard (IS); National standard (NS); Nucleic acid amplification techniques (NAAT); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
 
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