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.
Stock code RDT-FOB.109
- Made and batch-released in Vadodara
- ISO 13485:2016 quality system
- Datasheet published: see every stock code below
Product details.
Intended use: 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.
- Sensitivity
- 50 ng hHb/ml buffer, or 5 µg hHb/g faeces
- 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
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.
Every stock code.
Fecal Occult Blood (FOB) Card ships in one pack size.
| Stock code | Pack | Photograph | Datasheet |
|---|---|---|---|
| RDT-FOB.109 | 10 Test | – | Datasheet PDF, RDT-FOB.109 |
Questions and answers.
Fecal Occult Blood (FOB) Card: what sample does it need?
The datasheet gives the sample as Faeces, in the collection bottle with extraction buffer; fresh preferred, or up to 24 hours at 2 to 8 °C. The sample volume is 2 drops of the specimen-buffer mixture.
Fecal Occult Blood (FOB) Card: what method does it use?
The method on the datasheet is Immunochromatographic sandwich, colloidal gold.
Fecal Occult Blood (FOB) Card: how should it be stored?
The datasheet gives storage as 2 to 40 °C in the sealed pouch.
Fecal Occult Blood (FOB) Card: what pack sizes are available?
It comes in one pack size: 10 Test (RDT-FOB.109).
More rapid diagnostics.
Cassette
Cassette
Cassette
Cassette
Cassette
Cassette
Cassette
Cassette