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Stomach Ulcer Health Care Test - Instructions

Why is this test important to me?

It is estimated that half of the world's population today is infected by the stomach bacterium Helicobacter pylori. Long-term the infection causes damage to the mucous membrane of the stomach and ulcers in 10% of cases. Those infected with this bacterium have an increased risk of developing stomach cancer.

How do I perform the test?

Prick your finger quickly and easily with the micro-lancet. Place the drop of blood on the test strip. Add the buffer solution after 30 seconds (see picture 'How to perform the test'). A positive or negative result appears in the window.

What does the result tell me?

Two test lines tell you that you probably have a Helicobacter pylori infection. Please consult your doctor as soon as possible for a closer examination and treatment.

Why is treatment so important?

The stomach bacterium Helicobacter pylori is the main cause of stomach tumours and ulcers. However there is no cause for undue worry if your result is positive and your doctor confirms the condition, because specific antibiotic treatment can be prescribed for about a week.

What are my chances of developing stomach ulcers?

It is not certain how the Helicobacter pylori infection is transmitted. Often it is transmitted orally from mother to child. Transmission happens less frequently with age; poor hygiene promotes the spread of the infection.
An infection can go unnoticed for years. Nor does the successful treatment of one episode guarantee a life free from stomach complaints. This test can indicate a significant risk factor for the development of stomach ulcers or stomach cancer, and enable you and your doctor to target the disease with effective therapy.

Instructions for use

Please read these instructions carefully before performing the test.

General Information:

Helicobacter pylori (“H.pylori”) causes conditions such as gastritis and ulcers in human beings, there is no immunisation for this type of bacterial infection and infection occurs as well in adults as in children; however, by suitable medication with antibiotics the bacterium can now be killed.

The stomach lining and duodenum are covered by a protective coating against the stomach acid. If this protective coating is damaged this can lead to disturbance of the stomach mucous membrane ad can lead to ulcers. This typically happens due to H.pylori infection. An infection with H.pylori also increases the chance of getting stomach cancer considerably.

According to estimations about half of the mankind is infected with H.pylori. Not every infection leads to pains. On the one hand the extent of the infection, on the other hand the health condition and the food intake of the individual person influence the development of conditions.

With this test, an infection with H.pylori can easily and reliably be determined. Only one drop of blood is needed and the test result can be read within minutes.

Nowadays an infection with H.pylori can successfully be treated in most cases with antibiotics and acid blockers, which results in the elimination of the bacterium and cure of gastritis.

NOTE:

If you have already been infected with H.pylori in the past, and the infection was eliminated by medication/antibiotics, the test may result in a positive reading up to more than one year afterwards, even if the infection no longer exists.

Test Components:

Sealed foil pouch with test cassette and desiccant, buffer bottle with 0.5ml buffer solution, plaster, lancet, instructions for use.

For this test you need further : a clean tissue and a watch with a second hand.

PERFORMING THE TEST (STEP BY STEP)

1. PREPARATION

Open the sealed foil pouch just shortly before carrying out the test.

Prepare a clean tissue and a watch with a second hand.

Then take the test cassette out of the foil pouch and place it on an even and clean surface. Discard the attached desiccant (a tiny white pouch), which protects the test from humidity, unopened with the regular household waste. Open the sealed foil pouch just shortly before carrying out the test.

Prepare a clean tissue and watch with a second hand.

2. USING THE LANCET

Please study the following images and read the explanations carefully, before carrying out the finger pricking, in order to ensure an optimal test performance.

Do not use the lancet if its extension has been removed or otherwise damaged. Wash your hands thoroughly with soap and warm water (in order to increase blood movement in your finger) and towel of well. If you are using an alcohol swab, make sure that the pricking site is completely dried afterwards.

	2a . Place your middle finger on the extension and your thumb at the end of the lancet. Press the extension into the lancet with your middle finger.
	2b . T urn the extension clockwise (against an initial resistance) without removing it in the beginning. Pull the extension out only when there is no more resistance in the turning motion.
	2c . Press the opening (where you have just removed the extension) against the side of the tip of the middle finger firmly and push on the end of the lever until you hear a “click”. (The needle automatically retracts after usage. In case you released the lancet without pricking your finger, you can rewind the lancet pushing the needle back with the extension. However, for sanitary reasons you must not use the lancet a second time on yourself or anybody else).
	2d . Now wait with your whole arm hanging down and your pricked finger pointing downwards, till a nice drop of blood has formed. It may be necessary to exert pressure on both sides of the finger according to the image at step 2d).
	3 . Bring the drop of blood close to the sample pad “S1” without touching the pad. Drop the blood drop onto the sample pad.
	4 . Wait 30 seconds. During this waiting time you may want to cover the punctured area with the enclosed plaster.
	5 . Unscrew the cap of the buffer solution bottle and place exactly 7 drops of the solution onto the buffer reaction zone (S2).
	6 . Wait 10 minutes respectively till the background in the reaction area turned white again before reading the result according to point 7 (RESULTS).

7. RESULTS

Stomach_Ulcer_Test_9

The test is positive if two violet lines appear at C and T in the reaction field within 10 minutes, also if the linen at “T” is very faint. This indicates an infection with H. pylori. Consult your physician for a detailed examination.

The test in negative, if only one violet line appears at C. In this case an H. pylori infection could not be detected.

The test is invalid, if after 10 minutes, no violet line does appear in the reaction field. Possible reasons for an invalid result include a damaged foiled pouch, improper storage or a mistake when performing the test. Please keep all test components and contact the manufacturer of the test.

After more than 20 minutes the test results cannot be interpreted correctly anymore. Please discard the test cassette after already have interpreted the results.

My test was positive, what should I do?

Consult your physician, He/She can initiate corresponding check-ups, in order to confirm your diagnosis. By an antibiotics–treatment H.pylori generally can be removed completely and then correlating diseases of the stomach can be avoided. It might be helpful to take these instructions for use with you to the physician, because then the physician will have a better idea of what kind of test you have performed.

I have stomach pain but I seem not infected by H.pylori, what should I do?

Consult a physician for a detailed examination.

The test components can be disposed of with the household waste after being used.

Always consult your physician before making any medical decisions.

PLEASE NOTE:

Being not infected by H.pylori does not necessarily mean that you cannot get a stomach ulcer/cancer due to other reasons.
Although the test is very accurate, there might be false results in very rare cases.
This is an immunological test for the detection of antibodies against H.plyori in blood.
Test components of animal origin e.g. (antibodies) have to be viewed as potentially infectious materials, but there is no danger from any test component, providing that you use all components according to these instructions for use, the test buffer contains undangerous amounts of sodium acide.

Read instructions carefully before use!
Keep out of reach of children,
Do not use after expiry date,
Store at 39 to 86ºF (4 -30ºC).
Use the test and lancet only once.
Do not use a damaged lancet.
Do not take apart test cassette.
Do not ingest buffer solution.
For external use only.
In-vitro-diagnostic device for self-testing.