Name: Fecal Occult Blood (FOB) Card
Brand: Reckon Diagnostics
SKU: RDT-FOB.109

Cassette: no photograph of this pack is published yet

Drawing, not a photograph. This pack has not been photographed yet; the stock codes and pack sizes below are the specification.

CARD format. supplied as 10 tests.

Pack size

10 TestRDT-FOB.109

Stock code RDT-FOB.109

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Made and batch-released in Vadodara
ISO 13485:2016 quality system
Datasheet published: see every stock code below

Product details.

The Fecal Occult Blood (FOB) Card is an immunochromatographic sandwich assay for the qualitative detection of human hemoglobin in faeces, for use by laboratories and physicians' offices. An anti-hemoglobin antibody gold conjugate and a test-line antibody form a pink-purple line when human hemoglobin is present; unlike guaiac tests, it is specific to human hemoglobin. Manufactured at Reckon’s Vadodara facility under ISO 13485:2016 quality management, and released against reference standards before dispatch.

The specifications and steps on this page are from the datasheet, last updated 04-2023. The datasheet governs: read it before use, or ask us.

Method: Immunochromatographic sandwich
Detects: Human hemoglobin in faeces
Sample: Faeces
Sample volume: 2 drops of the specimen-buffer mixture
Read at: 5 to 10 minutes
Sensitivity: 50 ng hHb/ml buffer

Full specification15 items

Category: Rapid diagnostics
Format: CARD
Pack: 10 tests
Datasheet: Published
Method: Immunochromatographic sandwich, colloidal gold
Detects: Human hemoglobin in faeces
Sample: Faeces, in the collection bottle with extraction buffer; fresh preferred, or up to 24 hours at 2 to 8 °C
Sample volume: 2 drops of the specimen-buffer mixture
Read at: 5 to 10 minutes; not after 10 minutes
Patient limitation: Do not collect during menstrual, hemorrhoid, constipation or urinary bleeding; aspirin, NSAIDs and alcohol can cause GI bleeding
Limitation: Not a conclusive diagnosis: bleeding can be intermittent, so a negative does not exclude disease; not tested with toilet water, or with thalassemia or sickle cell blood
Contents: 10 cards and 10 sample collection tubes with buffer
Storage: 2 to 40 °C in the sealed pouch
Stock codes: RDT-FOB.109
Made in: Vadodara, Gujarat, India

Performance4 figures

Sensitivity: 50 ng hHb/ml buffer, or 5 µg hHb/g faeces
Agreement: 98% with the predicate device, on 120 spiked specimens
Specificity: Specific to human hemoglobin; no effect from chicken, pork, beef, goat, horse or rabbit hemoglobin at 500 µg/ml, or horseradish peroxidase at 2000 µg/ml
Interference: None from acetaminophen and acetylsalicylic acid at 20 mg/dl; ampicillin, ascorbic acid, atropine, caffeine and gentisic acid at 40 mg/dl; glucose and human albumin at 2000 mg/dl

Procedure at a glance5 steps

Unscrew the collection bottle cap and dip the sampling stick into the faeces at 3 to 4 different places.
Wipe the stick, put it back in the bottle, screw the cap tight, and shake to mix the faeces with the buffer.
Open the pouch, lay the device flat, and break the tip off the collection bottle.
Invert the bottle and add exactly 2 drops of the specimen-buffer mixture to the specimen port.
Read at 5 to 10 minutes, not after 10: C only is negative; C and T is positive; no C line means the test is invalid.