Assays / Prenatal and congenital infections
Prenatal and congenital infections
Rubella IgG/IgM Antibody Assay
A pipeline candidate for rubella immunity and infection testing, designed to fit the prenatal side of the OncoFirm menu.
At a glance
Targets
Rubella IgG (immunity) and IgM (possible recent infection)
Sample
Serum, plasma or whole blood
Readout
Instrument-read; quantitative IgG planned
Status
Future pipeline
Why it matters
Clinical context
Rubella in early pregnancy can cause serious birth defects. Checking rubella IgG before or early in pregnancy shows whether a woman is protected, while IgM testing helps investigate a suspected recent infection.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Immunity as a number
A quantitative IgG readout is planned to make immunity checks clearer than a faint visual line.
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
This assay is a candidate for the OncoFirm pipeline. Timing depends on partnerships and funding; the stages below show the path it will follow once prioritized.
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.