H. Pylori Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• 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

Individually packed test devices	Specimens dilution tube with buffer
Package insert

Materials Required but Not provided

Centrifuge	Timer
Specimens collection container

 

TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1. Best results will be obtained if the assay is performed within 6 hours after collection.
2. 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).
3. Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4. Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

1. Testing

1. 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.
2. 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.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.

1. 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

Relative Sensitivity: 99.24% (95%CI: 95.41%~>99.99%)  
Relative Specificity: >99.9%  (95%CI:99.96%~100%) 
Accuracy: 99.72% (95%CI:98.26%~>99.99%)