Assays / Bloodborne infections
Bloodborne infections
Hepatitis C — Anti-HCV and HCV Core Antigen Fluorescent Assay
OncoFirm’s hepatitis C program pairs antibody screening with a planned core-antigen format, aiming to help identify active infection in a single visit.
At a glance
Targets
Anti-HCV antibody; HCV core antigen (planned)
Sample
Serum, plasma or fingerstick whole blood
Readout
Instrument-read; quantitative core antigen planned
Status
In development
Why it matters
Clinical context
Hepatitis C can be cured with short courses of oral medicine, yet many people never learn they are infected or are lost between the screening test and the confirmatory test. An antibody result shows exposure; detecting HCV core antigen indicates the virus is still present. Bringing both closer to the patient is intended to shorten the path from test to treatment.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
From exposure to active infection
A core-antigen format is planned alongside antibody screening to help separate past from current infection.
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.
02
Assay development
Strip, reagents and reader settings are optimized, and pilot lots are built.
03
Analytical validation
Precision, linearity, interference and lot-to-lot consistency are measured against reference methods.
04
Clinical evaluation and launch
Performance is evaluated with clinical samples. First release is planned for research use only, followed by regulatory submissions.
Related assays
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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