BioCode® SARS-CoV-2 Flu Plus Assay

Detect and differentiate between SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens.

The BioCode® SARS-CoV-2 Flu Plus Assay* is a PCR-based, multiplex molecular diagnostic assay and can simultaneously detect and differentiate between SARS-CoV-2, Influenza A with subtypes (seasonal H1, 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens. The test is designed to assist physicians in evaluating patients with clinical signs and symptoms of respiratory infections.

The BioCode® CoV-2 Flu Plus Assay is Applied BioCode’s third EUA authorization from the US FDA for COVID-19 testing. Applied BioCode previously received FDA EUA authorization for the BioCode® SARS CoV-2 Assay and for pooling of up to 5 samples for that assay. The BioCode® CoV-2 Flu Plus Assay is run on the automated high-throughput BioCode® MDx-3000 Molecular System and provides scalable throughput, allowing clinical labs to run up to 564 sample results per day.

BioCode® CoV-2 Flu Plus Assay builds on the existing portfolio of high-throughput syndromic assays from Applied BioCode including the FDA 510(k) cleared BioCode Respiratory Pathogen Panel (17 targets), FDA 510(k) cleared BioCode® Gastrointestinal Pathogen Panel (17 targets), and its stand-alone EUA authorized BioCode® SARS-CoV-2 Assay.

*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. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.

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