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Global Healthcare Medical
GHM Human Fecal Occult Blood (FOB) Rapid Test US – Qualitative Detection of Human Occult Blood in Feces with 5-Minute Results, Simple Stool Sample Collection, and Professional Point-of-Care Use
GHM Human Fecal Occult Blood (FOB) Rapid Test US – Qualitative Detection of Human Occult Blood in Feces with 5-Minute Results, Simple Stool Sample Collection, and Professional Point-of-Care Use
SKU: GHM Human Fecal Occult Blood (FOB) Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Human Fecal Occult Blood (FOB) Rapid Test US is a lateral flow chromatographic immunoassay designed for the qualitative detection of human occult blood in feces. The kit is intended for use by healthcare professionals as a screening test and as an aid in the detection of gastrointestinal bleeding-related conditions.
Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. The World Health Organization has identified CRC as a candidate disease for screening, and the most commonly recommended screening strategies include fecal occult blood testing (FOBT) and colonoscopy. The U.S. Preventive Services Task Force (USPSTF) recommends screening for colorectal cancer in all adults aged 45 to 75 years, with annual high-sensitivity fecal occult blood testing or fecal immunochemical testing (FIT) as first-line screening options. The World Health Organization has stated that in population screening programs, a person with a positive FOBT has a 30–45% chance of having an adenoma and a 3–10% chance of having colorectal cancer, and a person with a positive FOBT is 12–40 times more likely to have colorectal cancer than someone with a negative test.
The GHM Human Fecal Occult Blood (FOB) Rapid Test US provides a rapid, non-invasive screening solution for the detection of occult blood in stool, enabling timely identification of individuals who may require further diagnostic evaluation such as colonoscopy. The test is designed for use in primary care clinics, hospitals, digestive disease clinics, and colorectal health screening programs.
The GHM Human Fecal Occult Blood (FOB) Rapid Test US delivers qualitative results in just 5 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with feces specimens, providing a simple and efficient sample collection method suitable for a wide range of clinical settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospitals, digestive disease clinics, and colorectal health screening programs. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on lateral flow immunochromatography.
Key Features & Benefits
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM Human Fecal Occult Blood (FOB) Rapid Test US is based on lateral flow chromatographic immunoassay technology, utilizing a double antibody-sandwich method. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody, and the mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The appearance of a colored line in the test region indicates a positive result for human occult blood.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Double antibody-sandwich technique | Targeted detection of human hemoglobin |
| Anti-hemoglobin antibody-coated test line | Specific detection of human occult blood |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 5 Minutes
The GHM Human Fecal Occult Blood (FOB) Rapid Test US provides qualitative results in just 5 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid results enable immediate clinical assessment and timely referral for confirmatory diagnostic procedures when indicated.
| Feature | Benefit |
|---|---|
| 5-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and digestive disease clinics |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput screening environments |
Feces Sample Compatibility – Simple and Efficient Collection
The GHM Human Fecal Occult Blood (FOB) Rapid Test US is compatible with feces specimens, providing a simple and efficient sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Collected specimens should be tested immediately if possible; if not tested within 6 hours, store at 2–8°C for up to 3 days. For long-term storage, keep below -20°C.
| Feature | Benefit |
|---|---|
| Feces specimen | Simple and efficient sample collection |
| Collection tubes with extraction buffer | Convenient specimen processing |
| No dietary restrictions required | Simplified testing protocol |
| No special equipment required | Streamlined workflow in clinical settings |
Clinical Utility – Aid for Detection of Gastrointestinal Bleeding
The GHM Human Fecal Occult Blood (FOB) Rapid Test US is intended for use as a screening test and as an aid in the detection of gastrointestinal bleeding-related conditions. The test provides rapid detection of occult blood in feces, enabling timely clinical decision-making and supporting patient management.
The test is particularly valuable in settings where rapid identification of occult gastrointestinal bleeding supports early detection of potential colorectal neoplasia and other bleeding-related conditions. A positive FOBT result warrants timely follow-up with colonoscopy for further diagnostic evaluation. The test is also suitable for use in colorectal health screening programs and for monitoring patients with known gastrointestinal conditions.
| Feature | Benefit |
|---|---|
| Gastrointestinal bleeding detection aid | Supports identification of occult blood in feces |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Colorectal health screening support | Valuable for population-based screening programs |
| Timely follow-up support | Enables rapid referral for confirmatory diagnostic procedures |
| Clinical versatility | Useful across primary care clinics, hospitals, and digestive disease clinics |
High Accuracy – Trusted Clinical Performance
The GHM Human Fecal Occult Blood (FOB) Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The test uses a unique combination of gold conjugate and solid-phase monoclonal antibodies to selectively identify human hemoglobin with a high degree of sensitivity and specificity.
| Parameter | Specification |
|---|---|
| Sensitivity | 97.3% |
| Specificity | 98.5% |
| Overall Agreement | 98.2% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
Performance characteristics based on evaluations of rapid FOB tests. Published evaluations of rapid FOB tests have reported sensitivities ranging from 93.6% to 98.6% and specificities ranging from 98.1% to 99.7%, depending on the product and population evaluated. Immunochemical FOB tests specifically detect human hemoglobin in stools at much lower levels than chemical-based tests, providing improved sensitivity and specificity. Independent evaluations of immunochromatographic FOB tests have demonstrated detection of hemoglobin at concentrations as low as 50 ng/mL with 99.2% sensitivity and 98.1% specificity.
ISO 13485 Certified – Quality and Safety Compliance
The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| IVD scope | Certified for in vitro diagnostic test kits |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
CE Marked – European Conformity
The GHM Human Fecal Occult Blood (FOB) Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.
| Feature | Benefit |
|---|---|
| CE marking | Regulatory compliance for professional use |
| Professional IVD use | Designed for trained healthcare personnel |
| Quality compliance | Meets European regulatory standards |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM Human Fecal Occult Blood (FOB) Rapid Test US |
| Product Code | FOB-602a |
| Product Type | Human Fecal Occult Blood (FOB) Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of human occult blood in feces; used as a screening test and as an aid in the detection of gastrointestinal bleeding-related conditions |
| Detection Principle | Lateral flow chromatographic immunoassay; double antibody-sandwich technique |
| Target Analyte | Human hemoglobin |
| Specimen | Feces |
| Time to Result | 5 minutes |
| Sensitivity | 97.3% |
| Specificity | 98.5% |
| Overall Agreement | 98.2% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital, digestive disease clinic, colorectal health screening program, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Size | 25 tests/kit |
| Kit Contents | Test Cassette, Collection Tubes with Extraction Buffer, Instructions for Use |
Important Testing Notes:
-
No dietary restrictions are necessary, but avoid alcohol, aspirin, and excess medications 48 hours prior to testing.
-
Test immediately if possible; store at 2–8°C for up to 3 days if not tested within 6 hours. For long-term storage, keep below -20°C.
-
Any visible colored line in the Test line (T) indicates a positive result, as intensity varies with hemoglobin concentration.
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Human Fecal Occult Blood (FOB) Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 5-minute test time | Rapid turnaround for timely clinical decisions |
| Feces sample compatibility | Simple and efficient sample collection |
| Anti-hemoglobin antibody detection | Targeted detection of human occult blood |
| High sensitivity and specificity | 97.3% sensitivity and 98.5% specificity |
| 98.2% overall agreement | Strong concordance with reference methods |
| No dietary restrictions required | Simplified testing protocol |
| Colorectal health screening support | Valuable for population-based screening programs |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for primary care clinics, hospitals, and digestive disease clinics |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Human Fecal Occult Blood (FOB) Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
