Helicobacter Pylori Antigen Self Test EU Market

• Customization: Available
• Type: IVD Reagent
• Accuracy: 97.8%
• Model NO.: SH-1007
• Sensitivity: 97.6%
• Specimen: Stool
• Format: Cassettes
• Product: H. Pylori Antigen Test
• Specificity: 97.9%
• Transport Package: Carton
• Trademark: SD
• Origin: Hangzhou
• HS Code: 3822190090
• Production Capacity: 300000PCS/Day

Product Description

Helicobacter Pylori Antigen Self Test EU Market

What are helicobacter pylori (H. pylori) tests?

Helicobacter pylori (H. pylori) is a type of bacteria that infects the digestive system. Many people with H. pylori will never have symptoms of infection. But for others, the bacteria can cause a variety of digestive disorders. These include gastritis (inflammation of the stomach), peptic ulcers (sores in the stomach, small intestine, or esophagus), and certain types of stomach cancer. There are different ways to test for an H. pylori infection.

They include blood, stool, and breath tests. If you are having digestive symptoms, testing and treatment may help prevent serious complications.
 

• Stool antigen test. This test looks for substances in your feces (stool) that trigger the immune system to fight an H. pylori infection. (These substances are called H. pylori antigens.)

What are they used for?

H. pylori tests are most often used to: Look for H. pylori bacteria in the digestive tract Find out if your digestive symptoms are caused by an H. pylori infection Find out if treatment for an H. pylori infection has worked

Why do I need an H. pylori test?

You may need testing if you have symptoms of a digestive disorder. Since gastritis and ulcers both inflame the lining of the stomach, they share many of the same symptoms. They include:

• Abdominal pain
• Bloating
• Nausea and vomiting
• Diarrhea
• Loss of appetite
• Weight loss

.

 

Produt name	H. Pylori Antigen Test
Sensitivity	97.6%
Specificity	97.9%
Accuracy	More than 97.8%
Shelf time	24-36 month
OEM time	20 days
Certificate	CE/ISO13485
Specimen	stool
Format	Cassette
Usage	Read results within 5 minutes
Storage Temperature	2-30°C

Feature:
Fast results
Easy visually interpretation
Simple operation, no equipment required
High accuracy



Picture Display:

SPECIMEN COLLECTION AND STORAGE:

1. Collect stool specimen by using the sample collection tube provided.
2. Unscrew the top of the sample collection tube, take out the sample collection stick and collect the specimen by dipping the stick into 3 different places of the stool specimen.
3. Replace the stick in the sample collection tube and screw tightly.

TEST PROCEDURE:

     Before performing the test, stool samples must be collected following the instruction below.
1. Wash your hands with soap and rinse with clear water.
2. To collect fecal specimens:
    The stool specimen should be collected in the stool collection paper or clean collection containers.
    Please use the stool collection paper,        avoiding contamination of the specimen by taking precautions that the specimen or side of paper      containing specimen does not come in contact with any contaminating objects including toilet cleaners.
3. 
To process fecal 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. Do not scoop the fecal specimen.
Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
4.     
Bring the pouch to room temperature before opening it.           Remove the test cassette 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.
5.     
Open the cap of the specimen collection tube and break the tip.      Invert the specimen collection tube and transfer 2 full drops of the extracted specimen to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S).
6.
Read results at 10 minutes. Do not read results after 20 minutes.

Interpreting results:

Positive:
 Two lines appear. Both T (Test) line and C (Control) line appear.
This result means that there is the presence of the H.pylori antigen in feces and that you should consult a physician.         
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of H.pylori antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive

Negative:
 One colored line appears in the control line region (C). No line appears in the test line region (T). This result means that the presence of the H.pylori antigen in feces was not detectable.

Invalid:
 Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
 

 

Package:
 

Product Name	Specimen	Format	Package Size
H Pylori Antigen Test	Stool	Cassette	1Test/foil pouch, 1Test/box

Shipping:

By ship, plane or express according to quantity
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