Optimization
Semi-Quantitative Prostate Health Screen

PSA Rapid Test
(Prostate Antigen)

Rapid chromatographic immunoassay for the semi-quantitative detection of Prostate-Specific Antigen (PSA) in human whole blood, serum, or plasma. Standard clinical cut-off at 4 ng/mL for early prostate pathology triage. Results in 10 minutes.

Readout Time 10 Minutes
Specimen Type Blood / Serum / Plasma
Clinical Accuracy 98.5% Agreement
Cut-Off Threshold 4.0 ng/mL Cut-Off
QuRapid Semi-Quantitative PSA CE-IVD Marked
Semi-Quantitative PSA Window (4 ng/mL)
S
C: Procedural Control Line
T: Calibrated 4 ng/mL Reference Threshold
Prostate Pathology Triage

Frontline Screening for Elevated Prostate-Specific Antigen

Prostate-Specific Antigen (PSA) is an organ-specific glycoprotein produced by prostate epithelial cells. Elevated levels in systemic circulation (>4.0 ng/mL) indicate potential architectural disruption of prostate tissue caused by benign prostatic hyperplasia (BPH), prostatitis, or early prostate adenocarcinoma.

Standard Threshold

Calibrated 4 ng/mL Decision Limit

Internationally recognized diagnostic threshold separating low-risk men from those requiring secondary urological referral.

  • Semi-quantitative visual comparator
  • Identifies borderline & elevated cases
  • Minimizes false negative triage rates
Pathology Screening

BPH, Prostatitis & Carcinoma

Assists urologists and general practitioners in early differential evaluation of male lower urinary tract symptoms (LUTS).

  • Early prostate cancer risk alert
  • Differentiates acute vs chronic trends
  • Guides free/total PSA & biopsy referral
Men's Health POC

Fingerstick Bedside Deployment

Ideal for routine men’s health screenings, occupational wellness clinics, and outpatient urology consultations across the UAE.

  • 10-minute visual definitive readout
  • Requires only 25 µL capillary blood
  • Manufactured under ISO 13485 standards

Diagnostic Accuracy vs. Automated Laboratory Immunoassay (ECLIA)

Multi-Center Clinical Evaluation Cohort (n=680)
Diagnostic Parameter QuRapid PSA Rapid Test Reference Clinical ECLIA Benchmark Clinical Performance
Diagnostic Sensitivity 98.2% (95% CI: 94.8% – 99.6%) PSA ≥ 4.0 ng/mL by ECLIA Superior Triage Concordance
Diagnostic Specificity 98.8% (95% CI: 96.5% – 99.7%) PSA < 4.0 ng/mL by ECLIA Minimal False Elevation
Total Clinical Agreement 98.5% (95% CI: 97.2% – 99.3%) Overall Clinical Cohort 98.5% Diagnostic Agreement
Analytical Cut-Off 4.0 ng/mL PSA International Standard Reference Precision Monoclonal Capture
*Performance validated against automated laboratory electrochemiluminescence immunoassay (ECLIA). Excellent concordance observed across capillary whole blood, venous blood, and serum specimens.
Standard Operating Procedure

4-Step Bedside Procedure for Blood PSA Readout

Rapid point-of-care protocol designed for urology clinics, executive checkup packages, and outpatient screening.

1

Blood Acquisition

Collect capillary blood from fingertip puncture using sterile lancet, or harvest anticoagulated venous whole blood, serum, or plasma.

2

Specimen Transfer

Using the calibrated dropper, transfer exactly 1 drop (approx. 25 µL) of whole blood (or 25 µL serum/plasma) into the circular sample well (S).

3

Buffer Application

Add 1 to 2 drops of assay buffer immediately into the sample well (S) to lyse and mobilize specimen along the test strip.

4

10-Minute Readout

Observe test line intensity at 10 minutes under bright lighting. Compare the intensity of the T line against the procedural C line. Do not read after 20 minutes.

Visual Readout Guide

Semi-Quantitative Result Interpretation

Evaluate the test line intensity to determine if patient PSA is at or above the clinical 4 ng/mL cut-off.

Elevated Findings (PSA ≥ 4 ng/mL)

Appearance of the procedural Control line (C) with distinct Test line (T).

Positive (T Line Intensity ≥ 4 ng/mL)
Test band equal to or darker than threshold. Directs urologist referral.
High Positive (Strong Dark T Line)
Significantly elevated PSA (>10 ng/mL). Urgent urological follow-up.

Normal & Invalid Results

Normal baseline range and procedural validation.

Negative (PSA < 4 ng/mL)
Control line visible; Test line absent or visibly fainter than threshold.
Invalid (No C Line)
Absence of Control line indicates insufficient sample or expired strip. Retest.
Packaging & Accessories

Everything Included in the Kit Box

Each professional diagnostic kit comes complete with all sterile collection disposables and reagents for 25 tests.

💊 25 Test Cassettes Individually sealed in foil pouches with desiccant
🖊 25 Capillary Droppers Calibrated mini transfer pipettes for 25 µL whole blood
🧪 Assay Buffer Dropper Vial of optimized mobilization buffer for 25 tests
📄 Instructions for Use Comprehensive CE-IVD package insert & semi-quantitative chart
Clinical Support

Frequently Asked Questions

Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our urology diagnostic specialists in Dubai.

Contact Clinical Specialist
What is the diagnostic significance of the 4 ng/mL threshold?

A PSA concentration of 4 ng/mL is the widely accepted clinical cut-off. Values above 4 ng/mL warrant further urological investigation.

Can fingerstick whole blood be used in executive health checkups?

Yes. The test is validated for capillary fingerstick blood, making it ideal for routine male health screenings in clinics and corporate wellness centers.

Can cycling or ejaculation elevate PSA temporarily?

Yes. Strenuous bicycling, recent ejaculation, or digital rectal exam within 48 hours can transiently elevate PSA. Patients should be advised accordingly.

What packaging is provided?

25 individually sealed cassettes, 25 capillary droppers, 1 vial of assay buffer, and package insert.

How to order for urology clinics and medical centers in Dubai?

QuRapid maintains inventory in Dubai with next-day delivery across the UAE.

Equip Your Clinic With QuRapid PSA Rapid Tests

Order professional-grade semi-quantitative PSA Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for urology clinics, wellness screening packages, and diagnostic laboratories.

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