Assays / Sexually transmitted infections
Sexually transmitted infections
Neisseria gonorrhoeae Fluorescent Antigen Assay
Part of the planned inSTIcheck™ line: a swab-based antigen test for gonorrhea, designed to run alongside the chlamydia test.
At a glance
Target
Neisseria gonorrhoeae antigen
Sample
Swab
Readout
Instrument-read, logged automatically
Status
Planned · inSTIcheck™
Why it matters
Clinical context
Gonorrhea is common, often silent and increasingly resistant to antibiotics. Finding current infection quickly supports prompt treatment and partner notification, and the digital record supports follow-up.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
One swab workflow
Planned to share sample handling with the chlamydia test so both can be run in the same visit.
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.