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A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan.
Lin, Po-Lin; Wu, Ming-Sian; Wu, Po-Chi; Chen, Hsin-Mei; Peng, Yi-Hsuan; Hsu, Jia-Chuan; Wang, Der-Yuan.
  • Lin PL; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Wu MS; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Wu PC; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Chen HM; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Peng YH; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Hsu JC; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.
  • Wang DY; Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC. Electronic address: dywang@fda.gov.tw.
Biologicals ; 79: 31-37, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2003881
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: RNA, Viral / COVID-19 Type of study: Diagnostic study Limits: Humans Country/Region as subject: Asia Language: English Journal: Biologicals Journal subject: Allergy and Immunology Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: RNA, Viral / COVID-19 Type of study: Diagnostic study Limits: Humans Country/Region as subject: Asia Language: English Journal: Biologicals Journal subject: Allergy and Immunology Year: 2022 Document Type: Article