Assays / Sexually transmitted infections
Sexually transmitted infections
Syphilis (Treponema pallidum) Antibody Fluorescent Assay
Part of the planned inSTIcheck™ line: a rapid treponemal antibody test designed to support same-visit syphilis screening.
At a glance
Target
Treponemal antibodies to T. pallidum
Sample
Fingerstick whole blood, serum or plasma
Readout
Instrument-read, logged automatically
Status
Planned · inSTIcheck™
Why it matters
Clinical context
Syphilis, including congenital syphilis passed from mother to baby, has risen sharply in the United States. Testing and treating in the same visit closes gaps where patients are lost to follow-up, which is why fast, reliable point-of-care results matter.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Same-visit screening
A reader-read result in minutes is intended to let clinics act while the patient is still there.
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.