RE: NOVACYT: FDA / EUA APPROVED GENESIG SARS-COV-2 QPCR DETECTION KIT (ORF1AB) -28 Jan 2021 11:19
A previous press release states:
Novacyt COVID-19 Diagnostic tests remain able to detect all published virus strains
by Erica D'Angelo January 14, 2021
AFSBio is proud to partner with Novacyt Group/Primer Design for North America to offer their SaRS-COV-2 (FDA/EUA approved) and SaRS-COV2 Winterplex assays. Both CE-IVD certified.
They test for both ORF1ab and the S gene with 100% specificity. The Winterplex assay also includes Influenza A, B, and RSV.
Their latest press release shows that both tests can still detect the new COVID-19 variant by the UK's COVID-19 Genomics UK consortium, known as VUI-202012/01 with the same high level of accuracy.
Novacyt notes this new strain of the virus has also been identified in other countries, including the Netherlands, Denmark, and Australia.
https://afsbio.com/blogs/news/novacyt-covid-19-diagnostic-tests-remain-able-to-detect-all-published-virus-strains
and:
About AFSBio
As a leading distributor of life science equipment and reagents, AFSBio works with Canadian researchers, hospitals, and biopharma companies seeking to increase efficiencies, reduce costs, and streamline their workflow in the lab.
Quick questions:
1 is FDA EUA recognised in Canada?
2 Is CE-IVD recognised in Canada?
Some MEA countries (Saudi) recognise CE-IVD in much the same way as any EU country would.