Description
Use Classification
Professional Use Only | CE Marked | In Vitro Diagnostic
Specimen & Format
Whole Blood / Serum / Plasma | Results in ±15 Minutes | 30 Tests per Kit
Intended Use
Semi-quantitative detection of PSA at 4 ng/mL cut-off to aid prostate cancer assessment.
Clinical Performance (Per IFU)
- Relative Sensitivity: 100%
- Relative Specificity: 99%
- Overall Agreement: 98.5%
Kit Contents
- Test Cassettes
- Sample Diluent
- Droppers
- Instructions for Use
Storage / Shelf-Life
Store at 2–30°C. Do not freeze. 24 Months
Product Summary
PSA Semi-Quantitative Rapid Test
Professional Use | Point-of-Care | Mass Screening
A semi-quantitative prostate screening assay delivering clinically relevant PSA threshold differentiation to support rapid referral decisions. Designed for high-volume men’s health screening initiatives and decentralised testing environments.
Well suited for community screening events, occupational health programmes, mobile clinics, and preventative health campaigns targeting early prostate risk detection.
Enables scalable prostate health screening without laboratory dependence.
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