Description
The HemoSure iFOB Test Kit configurations package the HemoSure immunochemical fecal occult blood test for programs of every size, from a 10 test starter box to cassette only refills. One stool sample per patient and a read window of five to ten minutes keep colorectal screening moving without dietary restrictions.
- Format – Immunochemical fecal occult blood test (iFOB/FIT) cassettes.
- Sensitivity – Detects human hemoglobin as low as 0.05 micrograms per mL, per the manufacturer.
- Read window – Read at 5 to 10 minutes, do not read after 10 minutes.
- Configurations – Eight kit and cassette configurations from 10 to 50 tests.
About These iFOB Test Kits
HemoSure built its name on immunochemical fecal occult blood testing, and these kits are the current form of that flagship line. The test is a sandwich dye conjugate immunoassay using monoclonal and polyclonal antibodies specific to human hemoglobin, so it ignores the dietary noise that undermines guaiac cards. The manufacturer states the assay detects elevated human hemoglobin as low as 0.05 micrograms per mL, with strong positives appearing in one to two minutes and a standard read at five to ten minutes.
One sample is all a patient owes the test, and there are no food or medication restrictions to explain, chase or document. Configurations scale from complete mail home kits with tubes and mailers to cassette only boxes for programs already stocked with collection supplies.
Features and Benefits
Assay Design
- Human hemoglobin specific – Antibodies target human hemoglobin directly, which removes the diet and drug interference of guaiac methods.
- Built in control line – Every cassette carries its own control line, so each run validates itself before the result is read.
Program Configurations
- Complete kits – Kit configurations bundle cassettes with collection tubes and home mailers for mail out screening programs.
- Cassette only refills – Cassette only boxes cut cost for programs that already hold tubes and mailers in stock.
Product Specifications
Product Details
- Manufacturer: HemoSure
- Test type: Immunochemical fecal occult blood test (iFOB/FIT)
- Method: Sandwich dye conjugate immunoassay
- Detection limit: 0.05 micrograms per mL human hemoglobin (manufacturer stated)
- Specimen: Stool sample in collection tube with 2.0 mL extraction buffer
- Read window: 5 to 10 minutes, do not read after 10 minutes
- Regulatory status: CLIA waived, FDA 510(k) cleared
- Codes: Diagnostic code 82274QW, screening code G0328QW (manufacturer listed)
- Storage: Room temperature, 36 to 86 degrees Fahrenheit (2 to 30 degrees Celsius)
- Shelf life: 24 months at room temperature
Packaging
- Configurations: Complete kits with tubes and mailers, kits with tubes, prepacked mailer kits, or cassettes only, 10 to 50 tests
- Sold as: 1 box per configuration
Browse related categories: diagnostic test kits and HemoSure products.
Why Choose the iFOB Kits for Colorectal Screening Programs
Screening programs live or die on completion rates, and a one sample test with no diet rules is built to be completed. The configuration range lets a program buy exactly the bundle its workflow consumes.
- Completion friendly – One sample and zero dietary restrictions remove the two biggest reasons patients abandon stool testing.
- Fast bench reads – Strong positives can show in one to two minutes, with the full read complete inside ten.
- Buy only what you use – Cassette only boxes stop programs from paying for tubes and mailers they already stock.
Manuals and Troubleshooting Guides
- HemoSure iFOB Test Product Insert
- HemoSure iFOB Patient Instructions
- HemoSure iFOB Product Flyer
- ACG Practice Guidelines for Colorectal Cancer Screening
Frequently Asked Questions
What is the difference between the kit configurations?
Complete kits bundle cassettes with collection tubes and home mailers, mid configurations pair cassettes with tubes or prepacked mailers, and cassette only boxes refill programs that hold their own supplies. Every configuration runs the same iFOB cassette test.
How many samples does a patient provide?
One stool sample per patient, collected into the buffered tube. The manufacturer is explicit that a single sample is all the test requires.
Do patients need to avoid any foods or medicines?
No, the manufacturer states there are no dietary or medication restrictions for this immunochemical test. That is a core advantage over guaiac based screening.
When should the cassette be read?
Read the cassette at five to ten minutes, and do not read it after ten minutes. High level positives may appear as early as one to two minutes.
Is the test CLIA waived?
Yes, the manufacturer lists the iFOB test as CLIA waived and FDA 510(k) cleared. Sites run it under their own certificate of waiver.
