Optimization
Gold-Standard Colorectal Cancer Screen

FOB Rapid Test
(Fecal Occult Blood)

Rapid chromatographic immunoassay for the qualitative detection of low levels of human fecal occult blood in stool specimens. Frontline non-invasive screening for colorectal cancer, adenomatous polyps, and gastrointestinal ulcerations. Results in 5 to 10 minutes.

Readout Time 5 – 10 Minutes
Specimen Type Feces / Stool Sample
Clinical Agreement 98.5% Accuracy
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid FOB Device (FIT) CE-IVD Marked
FOB Test Window (Human Hemoglobin)
S
C: Procedural Control Line
T: Human Hemoglobin Line (50 ng/mL)
Preventive Oncology

Early Detection of Colorectal Cancer & Precancerous Lesions

Colorectal cancer (CRC) is the third most common cancer worldwide. Most malignant tumors develop from benign adenomatous polyps over 10 to 15 years, shedding microscopic occult blood into the feces. Early identification via fecal immunochemical testing (FIT) elevates 5-year survival rates to over 90%.

Immunochemical FIT

Human Hemoglobin Specificity

Utilizes dual monoclonal antibodies specific strictly to human hemoglobin, eliminating cross-reaction with animal meat or dietary peroxidase enzymes.

  • No dietary or medication restrictions
  • No false positives from rare steaks or vegetables
  • Calibrated 50 ng/mL clinical sensitivity
High-Risk Lesions

Adenoma & Polyp Detection

Identifies microbleeding from advanced adenomatous polyps and localized malignant tumors before clinical symptoms manifest.

  • Frontline triage for colonoscopy referral
  • Reduces unnecessary invasive procedures
  • Standardized clinical screening in the UAE
Patient Friendly

Hygienic Sampling Collection

Pre-filled buffer tubes with spiral sampling sticks ensure safe, mess-free stool sampling for home collection or outpatient clinic checkups.

  • Results ready in 5 to 10 minutes
  • Direct 2-drop specimen inoculation
  • CE-IVD and ISO 13485 certified

Diagnostic Accuracy vs. Colonoscopy & Guaiac FOBT Benchmarks

Multi-Center Clinical Evaluation Cohort (n=910)
Diagnostic Parameter QuRapid FOB Rapid Test (FIT) Colonoscopy Reference Standard Diagnostic Performance
Diagnostic Sensitivity 94.3% (95% CI: 90.1% – 97.1%) Histologically Confirmed Lesions High Early Stage Detection
Diagnostic Specificity 99.5% (95% CI: 98.7% – 99.9%) Healthy & Non-Bleeding Controls Virtually Zero False Positives
Total Clinical Concordance 98.5% (95% CI: 97.5% – 99.2%) Overall Study Population 98.5% Agreement
Analytical Cut-Off 50 ng/mL (40 µg Hb / g stool) Standard International FIT Threshold WHO & UAE Guideline Compliant
*Performance validated against colonoscopy findings and histological biopsy reports. High specificity verified across diverse diets without dietary restrictions.
Standard Operating Procedure

4-Step Procedure for Fecal Occult Blood Triage

Standardized non-invasive protocol designed for clinical laboratories, wellness screening centers, and gastroenterology clinics.

1

Fecal Specimen Sampling

Unscrew the tube cap. Insert the applicator stick into 3 different sites of the stool specimen to harvest approximately 50 mg of feces. Do not collect toilet water.

2

Buffer Suspension

Insert the applicator stick back into the extraction buffer tube. Tighten the cap securely and shake vigorously for 15 seconds to release hemoglobin into solution.

3

Inoculation

Snap off the dispenser tip on the tube cap. Invert the tube and dispense exactly 2 full drops (approx. 80 µL) into the circular cassette sample well (S).

4

Result Readout

Read diagnostic lines between 5 and 10 minutes under good lighting. Do not interpret or record test results after 15 minutes.

Visual Readout Guide

Diagnostic Interpretation Matrix

Immediate visual assessment of lower gastrointestinal occult bleeding.

Positive Differential Findings

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

Positive (C Line + T Line)
Fecal occult blood detected above 50 ng/mL. Directs colonoscopy.
Faint Test Line (Weak Positive)
Any visible pink/red T band indicates microbleeding. Treat as positive.

Negative & Invalid Results

Quality control validation and procedural guidelines.

Negative (C Line Only)
Only C line visible; no T line. Occult blood not detected.
Invalid (No C Line)
Absence of Control line indicates incorrect technique or faulty 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 moisture-proof foil pouches with desiccant
🧪 25 Collection Tubes Pre-filled with extraction buffer and integrated spiral collector stick
🛡 Dropper Tips Snap-off dropper nozzle for controlled 2-drop specimen application
📄 Instructions for Use Comprehensive CE-IVD package insert & interpretation instructions
Clinical Support

Frequently Asked Questions

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

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Are diet restrictions needed before testing?

No. As an immunochemical fecal occult blood test (FIT), it uses monoclonal antibodies specific to human hemoglobin. Patients do not need to avoid red meat, broccoli, or vitamin C.

What is the calibrated cut-off limit?

50 ng/mL of human hemoglobin in buffer (equivalent to 40 µg hemoglobin per gram of feces).

Can menstrual blood cause a false positive?

Yes. Fecal specimens contaminated with menstrual bleeding, active hemorrhoidal bleeding, or hematuria may test positive. Testing should be scheduled accordingly.

What is included in the package?

25 individually wrapped cassettes, 25 specimen collection tubes with extraction buffer, and instructions for use.

How to order for corporate wellness screening programs in UAE?

QuRapid provides bulk pricing and immediate delivery across Dubai, Abu Dhabi, and Northern Emirates.

Equip Your Clinic With QuRapid FOB Rapid Tests (FIT)

Order CE-IVD certified FOB Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for gastroenterology departments, occupational health screening, and hospital laboratories.

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