Assays / Heart

Heart

Cardiac Troponin I (cTnI) — Quantitative Fluorescent Assay

A planned quantitative troponin I test designed for serial measurement at the point of care, supported by OncoFirm’s own recombinant cTnI calibrator material.

Planned

At a glance

Target

Cardiac troponin I (cTnI)

Sample

Whole blood or plasma

Readout

Quantitative (planned)

Status

Planned

Why it matters

Clinical context

Troponin is the central blood test for diagnosing heart attack, and today’s care pathways rely on precise values measured more than once over a few hours. The long-term goal is point-of-care performance that moves toward laboratory high-sensitivity assays; the first milestone is a reliable quantitative result on the handheld reader.

How OncoFirm will measure it

Built on the OncoFirm fluorescent platform

Designed for serial testing

The same reader, strip design and calibration at each draw are intended to make changes between measurements meaningful.

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

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