Assays / Prenatal and congenital infections
Prenatal and congenital infections
CMV (Cytomegalovirus) Antibody Assay
A pipeline candidate for cytomegalovirus antibody testing in prenatal, transplant and immunocompromised care.
At a glance
Targets
CMV IgM and IgG
Sample
Serum, plasma or whole blood
Readout
Instrument-read (planned)
Status
Future pipeline
Why it matters
Clinical context
CMV is the most common congenital infection and a major concern after transplantation. IgM alone cannot reliably date an infection, so CMV results are interpreted with IgG and, in reference laboratories, avidity testing. A combined IgG/IgM readout is the planned starting point.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Combined IgG/IgM readout
Reporting both classes together is intended to give clinicians more context than an IgM line alone.
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.