Assays / Respiratory infections

Respiratory infections

Influenza A/B Fluorescent Antigen Assay

A planned instrument-read flu test, designed to run alongside COVID-19 and RSV tests on the same reader during respiratory season.

Planned

At a glance

Targets

Influenza A and influenza B antigens

Sample

Nasal or nasopharyngeal swab

Readout

Instrument-read, logged automatically

Status

Planned

Why it matters

Clinical context

Antiviral treatment for influenza works best when started early, and a fast answer also helps avoid unnecessary antibiotics. Fluorescent readers are widely used to make antigen tests more objective than reading a colored line by eye.

How OncoFirm will measure it

Built on the OncoFirm fluorescent platform

Part of a respiratory menu

Flu A/B is planned with COVID-19 and RSV so one reader covers the season’s most common viral tests.

A strip that checks itself

Every strip carries a fluorescent reference line of known brightness. Reading the test line against it corrects for reader and temperature drift, and the reader flags runs that did not flow correctly.

A traceable digital record

Each result is stored with the date, operator and lot, ready to share with a clinic record or laboratory system instead of being retyped by hand.

Where it's headed

Development roadmap

01

Feasibility

Antibody pairs, fluorescent conjugates and strip layout are selected and tested against the target.

Current focus

02

Assay development

Strip, reagents and reader settings are optimized, and pilot lots are built.

Next

03

Analytical validation

Precision, linearity, interference and lot-to-lot consistency are measured against reference methods.

Next

04

Clinical evaluation and launch

Performance is evaluated with clinical samples. First release is planned for research use only, followed by regulatory submissions.

Next

Development status. This assay and the OncoFirm platform are in development. They have not been cleared or approved by the FDA and are not available for sale. First products are planned for research use only. Descriptions reflect design goals, not demonstrated performance.

Partner on this assay

We welcome research, clinical, manufacturing and distribution partners. Tell us how this assay fits your work.