Assays / Inflammation and infection

Inflammation and infection

CRP (C-Reactive Protein) — Quantitative Fluorescent Assay

A planned quantitative CRP test designed to give primary care a numeric inflammation marker in minutes.

Planned

At a glance

Target

C-reactive protein (CRP)

Sample

Fingerstick whole blood, serum or plasma

Readout

Quantitative, mg/L (planned)

Status

Planned

Why it matters

Clinical context

CRP rises quickly with inflammation and infection. Point-of-care CRP is used in many countries to help decide when antibiotics are and are not needed for respiratory infections, supporting antibiotic stewardship. That use depends on a number, not a positive/negative line.

How OncoFirm will measure it

Built on the OncoFirm fluorescent platform

A number that guides decisions

Quantitative CRP is designed to fit the thresholds clinicians use when deciding on antibiotics.

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.

Current focus

02

Assay development

Strip, reagents and reader settings are optimized, and pilot lots are built.

Next

03

Analytical validation

Precision, linearity, interference and lot-to-lot consistency are measured against reference methods.

Next

04

Clinical evaluation and launch

Performance is evaluated with clinical samples. First release is planned for research use only, followed by regulatory submissions.

Next

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.