FTD SARS-CoV-2* Assay for the specific detection of SARS-CoV-2 causing COVID-19
Single-well dual target assay for the specific detection of SARS-CoV-2
Utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits
One tube dual-target real time PCR:
- ORF1ab / N gene
- Internal control
This test is for use with extracted nucleoc acids from nasopharyngeal and oropharyngeal swabs of human origins
Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your FTD organization for further details
*CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Product availability varies by country and is subject to local regulatory requirements.