Instant-View iFOB (Fecal Occult Blood) Test – OTC (2 Tests/Kit)
$26.00
FDA 510(k) Cleared
4–7 Minute Results
2 Tests/Kit
2 tests per kit • $13.00 per test
The Instant-View® iFOB Home Test is an over-the-counter qualitative immunoassay for detecting hidden human blood in stool. It is intended for self-testing by nonprofessional users as an aid in identifying possible gastrointestinal bleeding that should be discussed with a healthcare professional.
- Read results between 4 and 7 minutes
- 50 ng/mL human hemoglobin cutoff
- Includes two test cassettes, two collection tubes and two collection papers
- No dietary restrictions required by the test
- Manufacturer packaging states over 99% accuracy
| 1-5 | 6-10 | 11+ |
| $26.00 | $23.92 | $22.62 |
Instant-View iFOB Home Test Overview
The Instant-View® Immunochemical Fecal Occult Blood (iFOB) Test is an FDA 510(k)-cleared over-the-counter self-test for the qualitative detection of hidden human blood in stool. It is intended for use by nonprofessional individuals as an aid in detecting possible gastrointestinal bleeding associated with conditions that may include diverticulitis, colitis, polyps and colorectal cancer.
This two-test kit uses a lateral-flow immunoassay with a 50 ng/mL human hemoglobin cutoff. Results must be read between 4 and 7 minutes, and a positive result should be discussed with a healthcare professional.
FDA 510(k) Cleared
Human Hemoglobin
2 Tests per Kit
Features and Benefits
FDA 510(k)-cleared over-the-counter test for home use
Qualitatively detects human hemoglobin, or fecal occult blood, in stool
Results are read between 4 and 7 minutes
50 ng/mL human hemoglobin cutoff
No dietary restrictions are required by the immunochemical test
Self-contained kit includes the test and stool-collection components for two uses
Product Details
05-7602-2
DTK-101254
2 Tests per Kit
K070660
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Qualitative lateral-flow immunoassay |
| Analyte | Human hemoglobin, or fecal occult blood |
| Specimen | Human stool |
| Format | Test cassette |
| Cutoff | 50 ng/mL human hemoglobin in the prepared specimen |
| Result time | Read between 4 and 7 minutes; do not read before 4 minutes or after 7 minutes |
| Regulatory status | FDA 510(k) cleared for over-the-counter use |
| Intended user | Nonprofessional, lay individuals performing self-testing |
| Kit storage | 59–86°F (15–30°C); do not freeze or expose the kit to temperatures above 86°F (30°C) |
| Prepared-sample storage | Up to 2 days at 59–86°F (15–30°C), according to the package insert |
| Package size | 2 tests per kit |
Kit Contents
Two test cassettes in sealed foil pouches
Two sample-collection tubes
Two collection papers
One illustrated quick guide
One package insert
How to Perform the Test
Collect the stool specimen: Place the supplied collection paper across the toilet opening and collect the stool without allowing it to contact toilet water.
Prepare the specimen: Remove the sampler from the collection tube, pierce the stool at five or more randomly selected sites, return the sampler to the tube, tighten it and shake to mix.
Apply the specimen: Remove a cassette from its pouch, place it on a flat surface and add four drops from the collection tube to the cassette sample well.
Read the result: Interpret the result between 4 and 7 minutes. Do not read it before 4 minutes or after 7 minutes.
This summary does not replace the illustrated quick guide or package insert. Read all supplied instructions before collecting the specimen or performing the test.
Understanding the Results
Positive: A control line and a test line indicate a positive result. A faint test line is still positive. Contact your healthcare professional for appropriate follow-up.
Negative: A control line with no test line indicates a negative result. A negative result does not rule out a digestive-system problem because bleeding may be intermittent or absent from the collected portion of stool.
Invalid: If the control line does not appear, the result is invalid. Review the procedure and repeat the test with a new cassette, following the package insert.
Accuracy and Usability
| Manufacturer Statement | Reported Result |
|---|---|
| Current product packaging | Over 99% accuracy |
| Laboratory comparison study described in the package insert | 100% accuracy |
| Consumer usability study described in the package insert | 95% of participants were able to follow the instructions and obtain correct results |
These statements describe the manufacturer’s packaging and studies and do not guarantee that every individual result will be correct. Correct specimen collection, timing and interpretation are essential. This test is a screening aid and does not diagnose or exclude colorectal cancer or another gastrointestinal condition.
Important Testing Considerations
Do not perform the test if visible blood is present in the stool; contact a healthcare professional
Do not collect a specimen during menstruation or when experiencing urinary bleeding, bleeding hemorrhoids or constipation-related bleeding
Tell your healthcare professional before testing if you take aspirin or nonsteroidal anti-inflammatory medication because these may cause gastrointestinal bleeding
Keep the collection-tube buffer out of the reach of children and follow the package insert if it is accidentally swallowed
Storage and Handling
Store the unopened kit at 59–86°F (15–30°C)
Do not freeze the kit or expose it to temperatures above 86°F (30°C)
Do not use an expired test; check the expiration date printed on the pouch
A specimen mixed in the collection tube may be stored for up to 2 days at 59–86°F (15–30°C)
Instructions and Product Documents
Frequently Asked Questions
What does the Instant-View iFOB test detect?
It detects hidden human blood, also called fecal occult blood, in stool. Blood may be associated with several gastrointestinal conditions, but the test cannot identify the cause.
Is this test approved for over-the-counter home use?
Yes. The Instant-View Fecal Occult Blood Self-Test is FDA 510(k) cleared under K070660 for use by nonprofessional individuals as an over-the-counter self-test.
How quickly are results available?
Read the result between 4 and 7 minutes after adding the prepared specimen. Do not interpret it before 4 minutes or after 7 minutes.
What does a faint test line mean?
A faint test line together with a visible control line is still considered a positive result. Contact your healthcare professional for follow-up.
Does the test require dietary restrictions?
No dietary restrictions are required by this immunochemical test. Follow the package insert’s warnings about specimen collection, visible bleeding and medications that may cause gastrointestinal bleeding.
Does a negative result rule out colorectal cancer?
No. Gastrointestinal bleeding may be intermittent, and blood may not be present in the collected portion of stool. Contact your healthcare professional if you have symptoms, concerns or questions about screening.
What should I do after a positive result?
A positive result indicates that blood may be present in the stool but does not identify its cause. Contact your healthcare professional for appropriate evaluation and follow-up testing.
How many tests are included?
This configuration includes two test cassettes, two sample-collection tubes, two collection papers, a quick guide and a package insert.
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Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 8 × 5 × 3 in |
