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BioCode® CoV-2 Flu Plus Assay

BioCode® CoV-2 Flu Plus Assay

The BioCode® CoV-2 Flu Plus Assay provides rapid detection of SARS-CoV-2, Influenza A/B, and RSV in one test.

The BioCode® CoV-2 Flu Plus Assay is a molecular assay based on reverse transcription polymerase chain reaction (RT-PCR) intended for the qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B, and/or Respiratory Syncytial Virus A/B (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.

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BioCode® CoV-2 Flu Plus Assay

Features and Benefits of the 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

High-Throughput

  • Delivers 188 patient samples in an 8-hour shift
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Flexible Pathogen Targets

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

  • Differentiates between SARS-CoV-2, Flu A, Flu B, and RSV. Parallel testing with FDA-cleared BioCode® assays
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See the BioCode® CoV-2 Flu Plus Assay in Action

Listen to Dr. Anami Patel, Chief Scientific Officer at PathAI Diagnostics, discuss the implementation of the Applied BioCode® CoV-2 Flu Plus Assay into a diagnostic laboratory’s workflow.

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BioCode® CoV-2 Flu Plus Assay

Reach out to Applied BioCode to get more information about ordering this product.

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Part No. 64-C0305

*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.

BioCode® CoV-2 Flu Plus Assay FAQs

Review these frequently asked questions about Influenza A assays and Influenza B assays. Contact Applied BioCode Inc. for more information.

The BioCode® multiplex influenza assay is authorized for use with nasopharyngeal swab specimens collected by healthcare providers. The BioCode® CoV-2 Flu Plus Assay has not been validated for other specimen types.

BioCode® COVID and flu PCR has not been cleared or approved by the FDA. However, the FDA has authorized this assay for emergency use (EUA). This assay can be used in parallel testing with BioCode® assays that are FDA-cleared.

BioCode® CoV-2 Flu Plus Assay is certified for use by authorized laboratories. These laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet the requirements needed to perform these high-complexity tests.

Compatible extraction systems for the BioCode® COVID and flu PCR are:

  • MagNA Pure 96: MagNA Pure 96 is a fully automated system for nucleic acid purification. It can process up to 96 samples in approximately 57 minutes, delivering consistent and reproducible yields.
  • NUCLISENS® easyMAG®: This IVD-labeled automated system is designed for total nucleic acid extraction for molecular diagnostics testing.

Contact Applied BioCode Inc. for more information or to order BioCode® multiplex influenza assay.

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