Basic Info.
Model NO.
HHP033G
Breathing Pattern
None
Animal Anesthesia Machine Control Method
None
Assay Time
5-10 Minutes
Delivery Time
3~5days After Get Payment
Payment
T/T, Western Union, Paypal
Customized
Accpet
Transport Package
Carton
Specification
10Tests/Kit
Trademark
PETX
Origin
Hangzhou
HS Code
38220010
Production Capacity
5000000PCS/Year
Product Description
INTENDED USE
The H. pylori Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigen in human stool specimen. . This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
MATERIALS
Materials Provided
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TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
- Specimen collection and pre-treatment:
- Best results will be obtained if the assay is performed within 6 hours after collection.
- Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
- Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
- Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
- Testing
- Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
- Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.
As the test begins to work, you will see color move across the membrane.
- Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
- POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
PERFORMANCE CHARACTERISTICS
Table: H. pylori Antigen Rapid Test vs. Endoscope-based Method
| Method | Endoscope-based Method | Total Results | ||
| H. pylori Antigen Rapid Test | Results | Positive | Negative | |
| Positive | 131 | 0 | 131 | |
| Negative | 1 | 223 | 224 | |
| Total Result | 132 | 223 | 355 | |
