MICHIGAN INNOVATIVE DIAGNOSTICS

Rapid qualitative immunochromatographic assay for the detection of occult blood (human hemoglobin) in stool, used as a screening aid for lower gastrointestinal bleeding, colorectal cancer, colitis, diverticulitis, and polyps.

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LIS TEST CODE: iFOB​

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CPT CODE: 82274

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ALIASES: iFOB, iFOBT, FIT, Fecal Immunochemical Test, Compliance Gold iFOB, Fecal Occult Blood Test (Immunological)

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METHODOLOGIES: Rapid Chromatographic Immunoassay (lateral flow) - Compliance Gold® iFOB (Germaine Laboratories) - CLIA Waived

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SPECIMEN:

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- Type: Random Stool

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- Container: Compliance Gold iFOB collection kit (sample collection bottle with built-in transfer probe/wand and test device)

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- Minimum Volume Required: Sample must fill the grooved portion of the collection probe.

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- Patient Collection Procedure:

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(1) Patient collects a random stool sample using the probe/wand provided, ensuring the grooves are filled.

 

(2) Patient reinserts the probe into the buffer-filled collection bottle and seals it. 

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(3) Label bottle (patient name, DOB, and date/time of collection required) and submit.

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- Storage/Handling: Keep collection bottle upright and sealed at room temperature. Do not allow the specimen to contact toilet bowl water or urine, as dilution can cause erroneous results.

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- Stability:   

 

Room Temperature (20-25 °C): 14 days

Refrigerated (2-8 °C): 1 month

Frozen (-20 °C or colder): Not Accepted

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- Turnaround Time: 24 hours from receipt.

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Special Instructions: This test does not detect upper gastrointestinal bleeding, since hemoglobin breaks down during intestinal transit before reaching the lower GI tract. A negative result does not rule out upper GI bleeding if clinically suspected. Patients with active hemorrhoidal bleeding or who are currently menstruating should not be tested until bleeding has resolved, to avoid a false positive from non-GI blood.

 

No dietary or medication restriction is required prior to collection (unlike older guaiac-based FOBT, which required avoiding red meat, vitamin C, and NSAIDs).

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REJECTION REASONS: Unpreserved/Loose Stool Submitted (not collected via kit probe/buffer bottle), QNS (probe grooves not filled), Contamination, Stability Violation, Expired Container, Incorrect Container, Mislabeled/Unlabeled Specimen

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REFERENCE RANGES:​

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Males & Females:

 

>= 1 year of age: Negative

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