Self-test for Helicobacter Pylori antigen in stool – 1 test kit

Description

GENERAL:

HELICOBACTER PYLORI
Helicobacter pylori is a bacterium that prefers to settle in the human stomach mucosa. The infection is often asymptomatic, but can sometimes cause gastritis and ulcers in the stomach or duodenal segment of the small intestine. The most common symptoms of these conditions are heartburn or pain in the upper part of the abdomen, especially during fasting or in the early morning when the stomach is empty. Other associated symptoms include nausea, satiety, reflux, loss of appetite, belching, weight loss and diarrhea. Ulcers can sometimes bleed, causing long-term anemia. In the long term, infection with Helicobacter pylori is associated with an increased risk of stomach cancer. Looking for Helicobacter pylori-specific antigens in stool is a valid and non-invasive method to quickly diagnose an infection.

PRINCIPLES OF THE TEST
HELICOBACTER PYLORI ANTIGEN TEST is an immunochromatographic test that detects the smallest amounts of H. pylori antigens in stool samples using highly specific gold-conjugated monoclonal antibodies applied to the reactive strip.

INSTRUCTION MANUAL
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TEST PROCEDURE
Before performing the test, collect a stool sample according to these instructions:

COLLECTING THE SAMPLE

1. Check that the toilet seat is dry – contact with water or cleaning agents may cause the stool collection sheet to not adhere properly and distort the test result.
2. Use the supplied special stool collection sheet as described below:
   1. Slowly loosen the two adhesive ends of the stool collection sheet in the direction of the arrows shown on the sheet. Open the sheet completely;
   2. Attach the two adhesive surfaces of the stool collection sheet to the back of the toilet seat, taking care not to allow the sheet to get wet.– . a
   3. Deposit the sample, taking care not to wet the sheet with urine, and proceed with collection as described in the next steps of this procedure.
3. Unscrew the red cap of the vial and remove the stool collection stick.
4. Insert the stick into the stool sample at 3 different points. – . b
5. Screw the cap back on, immerse the swab in the stool extraction fluid, and shake the vial for at least 10 seconds. – . c
6. At the same time, loosen the adhesive parts of the stool collection sheet from the toilet seat and drop everything into the toilet. To make flushing easier, wait a few seconds for the paper to soften before flushing. Flushing EXECUTION OF THE TEST
7. Open the aluminum pouch, remove only the test cassette and place it on a horizontal surface. Discard the desiccant bag.
8. Break off the end of the red cap to release the drip portion. – . D
9. Place 3 (or no more than 4) drops of the diluted stool sample into the well indicated on the strip. Wait 1-2 seconds between applying one drop and the next – . E
10. Wait 10 minutes.

INTERPRETATION OF THE RESULTS
READ THE RESULT AFTER 10 MINUTES
The intensity of the line colors is not relevant to the interpretation of the test results.

POSITIVE RESULT
Two colored bands appear in the reading window at the characters T (test) and C (control). The T-band may be less intense (lighter) than the C-line. This result means that there is Helicobacter pylori antigen in the stool and that you should consult a doctor.

NEGATIVE RESULTS
A colored band appears only under the C (control) sign. This result means that Helicobacter pylori antigen is not present in the stool or its concentration is below the detection limit of the test (10 ng/ml).

INVALID RESULT
If no bands appear or if there is only a line under the T (Test) sign, it means that it was not possible to read the test result, which should be considered invalid. It is recommended to repeat the test with a new test cassette and a new stool sample.

HOW DOES THE HELICOBACTER PYLORI ANTIGEN TEST WORK?
The HELICOBACTER PYLORI ANTIGEN TEST was designed to selectively determine the presence of Helicobacter pylori antigen in a stool sample using a combination of specific antibodies. The lowest concentration of Helicobacter pylori antigen that the test can detect is 10 ng/ml, although in some cases samples with a Helicobacter pylori antigen concentration of 7-10 ng/ml may produce a positive result.

WHEN CAN THE TEST BE USED?
The HELICOBACTER PYLORI ANTIGEN test can be performed at any time of the day, when you have a bowel movement, and you do not need to follow a specific diet.

COULD THE RESULT BE WRONG?
The result is correct if the instructions are followed carefully. However, the result may not be correct if: the device comes into contact with other liquids before use, if some of the diluent is accidentally spilled, if the number of drops delivered into the well is more than 4 or less than 2.
If you are taking medications, discuss with your doctor whether the medications you are taking change the concentration of H. pylori antigen in the stool.

HOW SHOULD I INTERPRETE THE TEST IF THE COLOR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The color and intensity of the bands are not important for the interpretation of the result. The bands must be complete and homogeneous. The test is positive regardless of the intensity of the color of the test band.

IS THE RESULT RELIABLE IF IT IS READ AFTER 15 MINUTES?
No. The test can be read exactly 10 minutes after the end of the procedure.

WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
If the result is positive, Helicobacter pylori antigen has been found in the stool and you should consult a doctor, who will determine what to do next.

WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
A negative result means that the test did not detect Helicobacter pylori antigen in the stool or that the concentration of the antigen is below the detection limit of the test. A negative result cannot therefore guarantee that there is no abnormal condition. If the result is negative and symptoms persist, contact a doctor.

HOW ACCURATE IS THE HELICOBACTER PYLORIAN TIGEN TEST?
The test is very accurate. Assessment reports show a concordance rate of 96% (CI 95%: 92,2% – 99,4%) with reference methods. Despite the reliability of the test, there can be false positive and false negative results.