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Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite FOB Rapid Test CE is a lateral flow immunochemical test designed for the qualitative detection of fecal occult blood (FOB) in human stool samples. This test is an effective non-invasive tool to aid in the diagnosis of gastrointestinal (GI) disorders such as colorectal cancer, polyps, colitis, and diverticulitis.
With a detection limit of ≥50 ng/mL human hemoglobin, this immunochemical method offers greater accuracy, sensitivity, and specificity than traditional guaiac-based tests—and requires no dietary restrictions. Its easy-to-read cassette format allows for quick and reliable results in clinical laboratories, physician offices, or screening settings.
Key Features and Benefits
- High Sensitivity: Detects human hemoglobin at concentrations ≥50 ng/mL
- No Dietary Restrictions: Unlike guaiac tests, no need for patient dietary control
- Reliable and Accurate: Greater specificity and fewer false positives
- Simple to Use: Clear visual readout; no specialized equipment required
- Fast Turnaround: Results typically available within 10 minutes
- Ideal for Routine Screening: Supports early detection of GI bleeding and colorectal abnormalities
Kit Contents (25-Test Kit)
- 25 cassette test devices (individually sealed foil pouches)
- 25 desiccants
- 25 stool collection devices with 2 mL extraction buffer (REF SB-R2010)
- Patient ID stickers
- 1 Package insert (Instructions for Use)
Product Specifications
| Attribute | Details |
|---|---|
| Detection Target | Human hemoglobin (hHB) |
| Sensitivity Threshold | ≥50 ng/mL |
| Specimen Type | Fecal (stool sample) |
| Assay Format | Cassette-based lateral flow immunoassay |
| Result Time | ~10 minutes |
| Equipment Required | None |
| Kit Size | 25 tests per kit |
| Sample Preparation | Stool collection device with integrated buffer |
| Storage Conditions | Room temperature |
| Regulatory Status | CE Marked, IVD use only |
Applications
- Routine colorectal cancer screening
- Annual wellness exams in primary care
- Pre-colonoscopy triage and follow-up
- Hospital-based stool testing for GI disorders
- Community and public health screening programs
- Outreach and mobile healthcare services
The OnSite FOB Rapid Test CE provides a highly sensitive, accurate, and user-friendly solution for detecting occult gastrointestinal bleeding. With no dietary interference, quick result times, and no need for instruments, this test is ideal for both clinical and community-based colorectal cancer screening—empowering early intervention and improved patient outcomes.