コロナウイルス緊急対策

FDAは、3月13日、次のコロナウイルスの検査キットに緊急使用(EUA)を認めた。

 

  1. Thermo Fisher: TaqPath COVID-19 Combo Kit

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gives-flexibility-new-york-state-department-health-fda-issues

 

  1. Roche Molecular Systems: cobas SARS-CoV-2 test

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-thermo-fisher

 

 

試験に必要な、ウイルス採取キットとして下記をFDAは、推奨している。

  1. Roche MagNA Pure LC

Kit: Roche MagNA Pure Total Nucleic Acid Kit

 

  1. Roche MagNA Pure Compact

Kit: Roche MagNA Pure Nucleic Acid Isolation Kit I

 

  1. Roche MagNA Pure 96

Kit: Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit

 

  1. QIAGEN QIAcube

Kit: QIAGEN QIAamp® DSP Viral RNA Mini Kit or QIAamp® Viral RNA Mini Kit

 

  1. QIAGEN EZ1 Advanced XL

Kit: QIAGEN EZ1 DSP Virus Kit and Buffer AVL (supplied separately) for offboard lysis

 

  1. QIAGEN EZ1 Advanced XL

Kit: QIAGEN EZ1 Virus Mini Kit v2.0 and Buffer AVL (supplied separately) for offboard

 

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_campaign=2020-03-13%20Mar%2013%20Update%3A%20New%20Information%20on%20Diagnostic%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua#donothavehumanextraction