Name: H. Pylori Antigen
Brand: Reckon Diagnostics
SKU: RDT-HPY.116

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.

Supplied as 25 tests.

Pack size

25 TestRDT-HPY.116

Stock code RDT-HPY.116

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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 H. Pylori Antigen card is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigen in human faeces, as an aid in the diagnosis of H. pylori infection. H. pylori antibody on the test line and antibody-coated particles form a coloured line when the antigen is present. 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 10-2020. The datasheet governs: read it before use, or ask us.

Method: Chromatographic immunoassay
Detects: H. pylori antigen in faeces
Sample: Faeces, 1 to 2 g in a clean dry container
Sample volume: About 50 mg of faeces into the buffer tube
Read at: 15 minutes
Storage: 2 to 40 °C

Full specification13 items

Category: Rapid diagnostics
Pack: 25 tests
Datasheet: Published
Method: Chromatographic immunoassay, antibody sandwich
Detects: H. pylori antigen in faeces
Sample: Faeces, 1 to 2 g in a clean dry container; best tested within 6 hours; 3 days at 2 to 8 °C, below −20 °C for longer
Sample volume: About 50 mg of faeces into the buffer tube; 3 drops (about 100 µl) of the extract on the card
Read at: 15 minutes; not after 20 minutes
Limitation: Qualitative only; if negative with persisting symptoms, test by other clinical methods
Contents: 25 cards and 25 sample collection tubes with buffer
Storage: 2 to 40 °C in the sealed pouch; use within 1 hour of opening
Stock codes: RDT-HPY.116
Made in: Vadodara, Gujarat, India

Performance2 figures

Cross-reactivity: None from albumin 20 mg/ml, bilirubin 10 µg/ml, hemoglobin 15 mg/ml, glucose 20 mg/ml, uric acid 200 µg/ml or lipids 20 mg/ml
Interference: None from 13 common analytes, including acetaminophen, acetylsalicylic acid, caffeine and salicylic acid at 200 µg/ml, EDTA at 800 µg/ml, ethanol at 1% and methanol at 10%

Procedure at a glance5 steps

Stab the collection applicator into the faeces at 5 or more sites to take about 50 mg; do not scoop.
Wipe the stick, put it back in the tube, screw the cap tight, shake to mix, and leave for 2 minutes.
Open the pouch, lay the device flat, and break the tip off the tube.
Add 3 drops (about 100 µl) of the extract to the specimen well and start the timer.
Read at 15 minutes, not after 20: C only is negative; C and T is positive; no C line means the test is invalid.