Assays / Bloodborne infections

Bloodborne infections

Bloodborne Virus Panel — HBsAg, HIV-1/2 and HCV Multiplex Assay

A planned multiplex strip that screens for hepatitis B, HIV and hepatitis C in one run, read and recorded by the OncoFirm reader.

PlannedMultiplex panel

At a glance

Targets

HBsAg (antigen), antibodies to HIV-1/2 and HCV

Sample

Serum, plasma or fingerstick whole blood

Readout

Separate instrument-read result for each target

Status

Planned

Why it matters

Clinical context

Hepatitis B, HIV and hepatitis C share routes of transmission, so they are often screened together in antenatal care, blood-donor and harm-reduction settings. One sample and one run for all three saves time and reduces the chance of a missed test.

How OncoFirm will measure it

Built on the OncoFirm fluorescent platform

Three answers, one strip

The platform’s multiplex architecture is designed to report each target separately from a single sample.

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

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