Assays / Bloodborne infections
Bloodborne infections
HIV-1/2 (Including Group O) Fluorescent Assay
A planned HIV screening assay on the same reader as the rest of the OncoFirm menu, with a future antigen/antibody format for earlier detection.
At a glance
Targets
Antibodies to HIV-1 (including group O) and HIV-2; p24 antigen planned
Sample
Serum, plasma or fingerstick whole blood
Readout
Instrument-read, logged automatically
Status
Planned
Why it matters
Clinical context
Early HIV diagnosis connects people to treatment that protects their health and prevents transmission. Adding p24 antigen detection to antibody detection shortens the window after infection during which a test can be negative.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Reduced reading errors
An instrument-read result removes the judgement call on faint lines, and the digital record avoids transcription mistakes.
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
We welcome research, clinical, manufacturing and distribution partners. Tell us how this assay fits your work.