BioCode® CoV-2 Flu Plus Assay

Detect four critical respiratory pathogens in a single 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.

Authorized for emergency use by the FDA*, the assay can be run as an independent assay or in parallel with our FDA-cleared BioCode® Respiratory Pathogen Panel (RPP) for a more complete respiratory infection profile of patients.

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

Emergency Use Authorized*: Qualitative multiplex nucleic acid-based in vitro diagnostic test

Critical Pathogen Coverage: Detect and differentiate SARS-CoV-2, Influenza A (including H1 pdm09, H1 seasonal, and H3 subtypes), Influenza B, and RSV from a single sample

High-Throughput: Delivers up to 188 patient sample results in an 8-hour shift

Flexible Pathogen Targets: Data masking option enables target reporting for respiratory pathogens based on the clinician’s order

Efficient: Conduct parallel testing with FDA-cleared BioCode® assays on the MDx-3000

The multiplexed BioCode® CoV-2 Flu Plus 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.

The BioCode® CoV-2 Flu Plus Assay has not been cleared or approved by the FDA. However, the FDA has authorized this assay for emergency use under an Emergency Use Authorization (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® CoV-2 Flu Plus Assay are:

MagNA Pure 96: 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 the BioCode® CoV-2 Flu Plus Assay.

BioCode® CoV-2 Flu Plus Assay

Detect four critical respiratory pathogens in a single test.

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

See the BioCode® CoV-2 Flu Plus Assay in Action

22.09.22

BioCode® CoV-2 Flu Plus Assay kit

24.01.24

Safety Data Sheet: BioCode® CoV-2 Flu Plus Assay

7.09.23

Package Insert – BioCode® CoV-2 Flu Plus Assay

16.12.21

BioCode® CoV-2 Flu Plus Assay – EUA Authorization Letter, December 16, 2021

15.12.21

BioCode® CoV-2 Flu Plus Assay – Fact Sheet for Healthcare Providers

15.12.21

BioCode® CoV-2 Flu Plus Assay – Fact Sheet for Patients