H. Pylori Ag Rapid Test
INTENDED USE
The H.pylori Stool Antigen Test is an in vitro qualitative
immunochromatographic assay for the rapid detection of Helicobacter
pylori antigens in human stool specimen. The test results are
intended to aid in the diagnosis of H. pylori infection, to monitor
the effectiveness of therapeutic treatment and to confirm the
eradication of H. pylori in peptic ulcer patients.
MAIN CONSTITUENT
1. Test Cassette: 20 test / box
Test Strip: 50 tests / box
2. Sample collection tube with diluent 1ml ×20 for cassette
Sample diluent 30ml×1 for strip
3. Product instruction: 1
STORAGE AND STABILITY
The HP Stool Ag Test can be stored at any temperature between
4-30°C. Do not freeze. The stability of the kit under these storage
conditions is 24 months. Use up the reagents as soon as possible
after the kit is unpacked within 3 months.
ASSAY PROCEDURE
1. Bring Membrane Plate and samples to room temperature (20-30°C)
before use (approximately 30 minutes).
2. Remove the test cassette/strip from the sealed foil pouch and
place the plate on flat desk.
3. Bring all materials and specimens to room temperature (8～30℃).
4.1 H. pylori Stool Antigen test Strip
1) Add 500μl sample diluents into the test tube.
2) Add proper specimens (S:5 mm in diameter, L: 50μl) into the tube
to make the concentration of the solution up to 5%～10% and mix
thoroughly.
3) Deliver 100μl (2～3drops ) of diluted stool sample to the sample
pad of the test strip.
4.2 H. pylori Stool Antigen test Cassette
1) To take a portion of feces (about 100mg), insert the sterile
swab into a stool sample that presents the most secretion under
visual inspection.
2) Open the sample collection tube and then insert the swab into
the sample collection tube containing assay diluents.
3) Swirl the swab at least 10 times until the samples has been
dissolved into the assay diluents and discard the swab while
squeezing the swab against the wall of tube, replace the cap.
4) Deliver 100μl (2～3drops ) of diluted stool sample to the sample
well of the test card.
5. Read the result in 5～10 minutes. A strong positive sample may
show result earlier.
Note: Results after 15 minutes may not be accurate.
RESULT
INTERPRETATION OF RESULTS
Negative: One pink line appears in control line, showing the test has been
carried out correctly. There will be no line in test region
Positive: In addition to a pink colored control line, a distinct pink
colored band will also appear in the test region.
Invalid: A total absence of color in both regions is an indication of
procedure error and/or that the test reagent has deteriorated. The
test should be repeated using a new strip.
Assay Specificity
Following bacterial and viral strains were used to test the
specificity of HP Stool Ag Test. Positive and negative stools were
spiked with >1x108 organism/ml and tested by HP Stool Ag Test.
H. pylori positive stool remained positive with the spiked
organisms. Negative stool remained negative with the spiked
organisms.
