Biovantion Inc.
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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.