# Biomarker Detection in Urine

> Non-invasive creatinine and blood detection in urine via NIR spectroscopy - early feasibility research. Proposal submitted to a research partner.

- Canonical URL: https://spectrify.ai/research-pipeline/biomarker-detection-urine

- Sector: Sector 04 · Healthcare & Biochemical
- Status: Proposal Sent
- Tags: NIR, Healthcare, Urinalysis, Biomarker, Creatinine

Urinalysis biomarker testing (creatinine, blood, protein, glucose) is one of the most commonly ordered clinical screening tests globally. Current dipstick-based point-of-care tests are semi-quantitative and subject to interference artefacts. NIR spectroscopy has been demonstrated in research settings for quantitative urinalysis, offering a potentially instrument-grade rapid test without chemical reagent consumption. We present this as an architectural range demonstration - not as a planned clinical product.

## What We've Established

### NIR Feasibility for Urine Analysis

Multiple published studies have demonstrated NIR quantification of creatinine in urine with R² > 0.95 in controlled laboratory conditions. Blood (haemoglobin) detection at clinically relevant haematuria thresholds has also been reported. The primary challenges are sample matrix variability (hydration state, diet-driven composition changes) and the need for a large, demographically diverse calibration dataset.

### Scope Clarity

This project is explicitly framed as early-stage feasibility research, not a clinical product development programme. We have been transparent with the research partner that regulatory pathways for clinical NIR urinalysis devices are complex and multi-year - the immediate objective is to establish whether the NIR signal is robust enough to warrant further investment, not to develop a product.

## Technical Approach

NIR transflectance measurement on urine samples using a standard benchtop spectrometer and sample cuvette. Reference values for creatinine by enzymatic colorimetric assay and haematuria by haemoglobin photometry. Calibration dataset designed in collaboration with the clinical research partner to ensure appropriate ethical governance.

## Where We Stand

A formal research proposal has been submitted to the clinical research partner covering scope, ethics framework, dataset design, and feasibility study objectives. The proposal is under institutional review.

## Next Steps

- Obtain institutional ethics clearance for urine sample collection protocol
- Commence initial spectral feasibility measurements on reference standard solutions before clinical samples
- Define the minimum detectable concentration targets for both creatinine and blood biomarkers

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[Research Pipeline](https://spectrify.ai/research-pipeline)