Optimization
CE-IVD Comprehensive GI Bleeding Dual Assay

FOB / Transferrin (TRF)
Combo Rapid Test

Rapid chromatographic immunoassay for the simultaneous qualitative detection of human Hemoglobin (FOB) and Transferrin (TRF) in fecal specimens. Comprehensive diagnostic screening for both upper and lower gastrointestinal hemorrhage. Results in 5 to 10 minutes.

Readout Time 5 – 10 Minutes
Specimen Type Feces / Stool Sample
Clinical Accuracy 98.8% Agreement
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid FOB/TRF Combo Device CE-IVD Marked
Dual GI Bleeding Window (FOB & TRF)
S
C: Procedural Control Line
FOB: Lower GI Hemoglobin (50 ng/mL)
TRF: Upper GI Transferrin (10 ng/mL)
Dual Biomarker Technology

Overcoming Hemoglobin Degradation in Upper GI Bleeding

Standard fecal occult blood (FOB) tests rely strictly on hemoglobin, which is rapidly denatured by gastric acid and digested by pancreatic proteases during transit through the upper digestive tract. Transferrin is enzymatically resilient throughout gastrointestinal transit, providing unmatched sensitivity for both upper and lower gastrointestinal lesions.

Lower GI Marker

Human Hemoglobin (FOB)

Specific immunochemical capture of intact human hemoglobin from the colon and rectum, the gold-standard biomarker for colorectal cancer screening.

  • Detects bleeding polyps and adenocarcinomas
  • No dietary restrictions (unlike guaiac)
  • Calibrated 50 ng/mL cut-off sensitivity
Upper GI Marker

Human Transferrin (TRF)

Transferrin resists proteolytic degradation by pepsin and trypsin, maintaining diagnostic integrity even after extensive gastric transit.

  • Detects gastric ulcers and stomach cancers
  • Identifies bleeding esophageal varices
  • High analytical sensitivity (10 ng/mL)
Pan-GI Screening

Comprehensive GI Hemorrhage Triage

Eliminates false-negative blind spots by providing complete anatomical coverage of gastrointestinal tract bleeding in a single 5–10 minute cassette.

  • Simultaneous dual-line visual differentiation
  • Ideal for executive checkups and outpatient clinics
  • Rapid B2B clinic fulfillment across the UAE

Clinical Agreement vs. Colonoscopy & Endoscopy Benchmarks

Multi-Center Clinical Evaluation (n=820)
Diagnostic Parameter Hemoglobin (FOB) Channel Transferrin (TRF) Channel Combined Assay Performance
Diagnostic Sensitivity 95.2% (95% CI: 91.8% – 97.5%) 96.0% (95% CI: 92.5% – 98.1%) 96.8% (Overall GI Bleeds)
Diagnostic Specificity 99.1% (95% CI: 97.8% – 99.7%) 98.9% (95% CI: 97.4% – 99.6%) 98.8%
Total Accuracy 98.4% 98.2% 98.8%
Analytical Cut-Off 50 ng/mL human hemoglobin 10 ng/mL human transferrin Zero Cross-Reactivity with Animal Blood
*Clinical evaluations verified against confirmed findings on colonoscopy, esophagogastroduodenoscopy (EGD), and histopathology. No cross-reaction with bovine, porcine, or avian hemoglobin.
Standard Operating Procedure

4-Step Non-Invasive Stool Sampling Protocol

Hygienic sampling collection tubes protect laboratory personnel while ensuring standardized antigen extraction.

1

Fecal Sampling

Unscrew the green cap of the collection tube. Insert the spiral sampling stick into 3 distinct sites of the stool specimen to harvest approximately 50 mg of feces.

2

Extraction Agitation

Insert the applicator back into the collection tube and tighten the cap securely. Shake vigorously for 15 seconds to completely suspend and extract antigens in the buffer.

3

Cassette Inoculation

Snap off the dispensing dropper tip of the tube cap. Invert the tube and dispense exactly 2 drops (approx. 80 µL) into the cassette sample well (S).

4

Chromatographic Readout

Observe the emergence of colored bands between 5 and 10 minutes. Do not interpret or document diagnostic results after 15 minutes.

Visual Readout Guide

Diagnostic Interpretation Matrix

Differentiates upper GI, lower GI, and pan-gastrointestinal bleeding patterns at a glance.

Positive Differential Findings

Presence of Control line (C) accompanied by FOB and/or TRF test lines.

FOB Positive (C + FOB)
Lower GI bleeding. Directs colonoscopy for colorectal screening.
TRF Positive (C + TRF)
Upper GI bleeding. Directs gastroscopy / endoscopy evaluation.
Dual Positive (C + FOB + TRF)
Pan-GI bleeding. High-volume hemorrhage across upper & lower tracts.

Negative & Invalid Results

Internal quality control and procedural guidelines.

Negative (C Line Only)
Only C line visible. Neither FOB nor TRF detected above threshold.
Invalid (No C Line)
Control line absent. Insufficient sample volume or damaged strip. Retest.
Packaging & Accessories

Everything Included in the Kit Box

Supplied with pre-filled hygienic buffer collection tubes for safe and clean patient stool collection.

💊 25 Test Cassettes Individually sealed in foil pouches with desiccant
🧪 25 Collection Tubes Pre-filled with extraction buffer and integrated sampling stick
🛡 Specimen Dropper Tips Built-in precision droppers for clean, aerosol-free dispensing
📄 Instructions for Use Comprehensive CE-IVD package insert & interpretation guide
Clinical Support

Frequently Asked Questions

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

Contact Clinical Specialist
Why is Transferrin tested alongside Hemoglobin?

Hemoglobin degrades in the upper gastrointestinal tract due to proteolytic enzymes. Transferrin is stable against proteolysis, allowing detection of upper GI bleeds that standard FOB tests miss.

Are dietary restrictions required before testing?

No. The immunochemical method is specific to human hemoglobin and human transferrin, eliminating false positives from dietary red meat, iron supplements, or vegetables.

What are the cut-off concentrations?

50 ng/mL for human hemoglobin and 10 ng/mL for human transferrin in extraction buffer.

What is included in the kit?

25 test cassettes, 25 collection tubes with buffer, desiccant, and package insert.

How to order for gastroenterology clinics in Dubai?

QuRapid provides rapid delivery across the UAE with complete CE-IVD batch documentation and temperature-controlled handling.

Equip Your Clinic With QuRapid FOB / TRF Combo Rapid Tests

Order CE-IVD certified FOB / Transferrin Combo Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for gastroenterology departments, wellness centers, and hospital laboratories.

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