BioCode® CoV-2 Flu Plus Assay

  • Qualitative Assay for use on the MDx-3000 system
  • Authorized for Emergency Use by FDA under Emergency Use Authorization (EUA)*
  • Detect and differentiate four pathogens from one sample, all in one test
BioCode® CoV-2 Flu Plus Assay

The BioCode® CoV-2 Flu Plus Assay is a multiplexed nucleic acid test intended for the qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B, and/or Respiratory Syncytial Virus (RSV) in nasopharyngeal swabs. 

It can be run as an independent assay or in parallel with our FDA-cleared BioCode® Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.

Features and Benefits of the BioCode CoV-2 Flu Plus Assay

Throughput

  • Delivers 188 patient samples in an 8-hour shift

Flexible

  • Data Masking option enables select target reporting based on clinician’s order

Efficient

  • Differentiates between SARS-CoV-2, Flu A, Flu B, and RSV. Parallel testing with FDA-cleared BioCode® assays

*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens; and the emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.