H. Pylori Ab Rapid Test Strip, Cassette

Product Specifications

Prod Model:	IHPab-14
Markets:	North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe
Format:	Strip, Cassette
Specimen:	W/S/P
Shelf Life:	24 Months
Accuracy:	>99%
Sample:	Free
OEM:	Available
Classification:	Biological Diagnostics
Certification:	Fsc
Type:	Infectious Disease Rapid Test
Group:	All

Product Description

1) INTENDED USE
 
The One Step H.pylor Antigen Test Device ( Feces) is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human feces specimens to aid the diagnosis of H.pylori infection.
 
2) SUMMARY
 
H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and
duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including
duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 Both
invasive and non-invasive methods are used to diagnose H. pylori infection in patients with
symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic
methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture,
and/or histologic staining.3

A very common approach to the diagnosis of H. pylori infection is the serological
identification of specific antibodies in infected patients. The main limitation of serology test is
the inability to distinguish current and past infections. Antibody may be present in the
patient's serum long after eradication of the organisms.4
HpSA (H. pylori Stool Antigen) testing is gaining popularity for diagnosis of H. pylori
infection and also for monitoring the efficacy of the treatment of H. pylori infection.
The One Step H. pylori Antigen Test Device (Feces) is a rapid chromatographic immunoassay
for the qualitative detection of H. pylori antigens in human feces specimens, providing results
in 10 minutes. The test utilizes antibodies specific for H. pylori antigens to selectively detect
H. pylori antigens in human feces specimens.
 
3) PRINCIPLE 
 
The One Step H. pylori Antigen Test Device (Feces) is a qualitative, lateral flow immunoassay
for the detection of H. pylori antigens in human feces specimens. In this test, the membrane is
pre-coated with anti-H. pylori antibodies on the test line region of the test. During testing, the
specimen reacts with the particle coated with anti-H. pylori antibodies. The mixture migrates
upward on the membrane by capillary action to react with anti-H. pylori antibodies on the
membrane and generate a colored line. The presence of this colored line in the test region
indicates a positive result, while its absence indicates a negative result. To serve as a
procedural control, a colored line will always appear in the control line region indicating that
proper volume of specimen has been added and membrane wicking has occurred.
 
4) STORAGE AND STABILITY
 
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30ºC). The
test is stable through the expiration date printed on the sealed pouch. The test must remain in
the sealed pouch containing desiccant until use. DO NOT FREEZE. Do not use beyond the
expiration date.
 
5) SPECIMENS COLLECTION AND PREPARATION
 
？ The feces specimen must be collected in clean, dry, waterproof container containing no
detergents, preservatives or transport media.
？ Bring the necessary reagents to room temperature before use.
 
6) MATERIALS
 
A. Materials Provided
 
？ Test devices                                                                                     ？ Package insert
？ Specimen collection tubes with extraction buffer                      ？ Droppers
 
B. Materials Required But NOT Provided
 
？ Specimen collection containers                                                    ？ Timer
？ Centrifuge and pipette to dispense 80 μL if required
 
7) DIRECTION FOR USE 
 
Allow the test, specimen, buffer, and/or controls to reach room temperature (15-30°C)
prior to testing
 
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection
container to obtain maximum antigens (if present). Best results will be obtained if the assay
is performed within 6 hours after collection. Specimen collected may be stored for 3 days
at 2-8ºC if not tested within 6 hours. For long term storage, specimens should be kept
below -20ºC.

2. To process fecal specimens:
？ For Solid Specimens:
Unscrew the cap of the specimen collection tube,then randomly stab the specimen
collection applicator into the fecal specimen in at least 3 different sites to collect
approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
？ For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops
(approximately 80 μL) into the specimen collection tube containing the extraction buffer.
Tighten the cap onto the specimen collection tube, then shake the specimen collection
tube vigorously to mix the specimen and the extraction buffer. Leave the tube alone for
2 minutes.

3. Bring the pouch to room temperature before opening it. Remove the test device from the
foil pouch and use it as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch.

4. Hold the specimen collection tube upright and break off the tip of the specimen collection
tube. Invert the specimen collection tube and transfer 2 full drops of the extracted
specimen (approximately 80 μL) to the specimen well (S) of the test device, then start the
timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read results at 10 minutes after dispensing the specimen. Do not read results after
20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted
specimens contained in the extraction buffer vial. Collect 80 μL of supernatant, dispense into
the specimen well (S) of a new test device and start afresh following the instructions
mentioned above.