- A rapid, qualitative immunochemical fecal occult blood test (iFOBT / FIT). it is used to detect human hemoglobin (hHb) in stool specimens right at the point of care
Uses
- Colorectal Screening Aid:
- Serves as a diagnostic tool to screen for asymptomatic internal gastrointestinal bleeding, aiding in the early detection of colorectal cancer, adenomatous polyps, colitis, diverticulitis, ulcers, and fissures
- In-Clinic Diagnostic Processing:
- Utilized directly by clinical technicians and nursing staff inside physician office laboratories, urgent care centers, and reference labs
- Targeted Blood Detection:
- Isolate and react exclusively to human hemoglobin rather than dietary or non-human animal blood components
Features
- High Analytical Precision:
- Engineered with a definitive analytical sensitivity threshold of 50 ng hHb/mL buffer (or 50 µg hHb/g feces)
- Immunoassay Cassette Format:
- Built using a simple lateral flow visual read cassette layout that requires zero reading equipment or capital instrumentation
- QC Inside® Protection:
- Every kit includes 2 additional test devices dedicated entirely to running external quality control validation
- Complete System Components:
- Shipped in a 25-test box containing 25 test devices, 25 collection tubes containing pre-measured extraction buffer and samplers, collection papers, and instructions for use
Benefits
- Maximized Patient Compliance:
- Requires no pre-test dietary or drug restrictions. Patients do not need to avoid red meat, vitamin C, or NSAIDs prior to sample collection
- Rapid Clinical Results:
- Accelerates the diagnostic pipeline by outputting clear, visual results in 5 to 10 minutes
- Ultra-Low Hands-On Time:
- Demands less than 1 minute of hands-on technical time from staff to set up and initiate the test
- CLIA-Waived Operational Simplicity:
- Features a CLIA-waived classification, allowing the kit to be operated by a broad spectrum of healthcare personnel without requiring complex lab certifications
- Cost-Efficient Compliance:
- The integration of bonus quality control sticks within the packaging saves clinics from the recurring costs of buying separate external verification reagents
