PRIMA Helicobacter Pylori Antigen Test Instruction Manual

PRIMA Helicobacter Pylori Antigen Test

Product Information

• Product Name: Helicobacter Pylori Antigen Test
• Manufacturer: PRIMA LAB SA
• Address: Via Antonio Monti 7, CH-6828 Balerna, SWITZERLAND
• Email: [email protected]
• Website: primalabsa.ch
• Lot Number: 800016
• EC Representative: Qarad EC-REP BV, Pas 257, 2440 Geel, Belgium

Principles of the Test

The Helicobacter Pylori Antigen Test is an immunochromatographic
test that detects the presence of Helicobacter pylori antigens in feces samples. It uses highly specific gold-conjugated monoclonal antibodies attached to a reactive strip to detect even the smallest amounts of H. pylori antigens.

Bibliography

1. Shimoyama T. “Stool antigen tests for the management of Helicobacter pylori infection.” World Journal of Gastroenterology. 2013; 19(45):8188-91.
2. Zagari RM, Rabitti S, Eusebi LH, Bazzoli F. “Treatment of Helicobacter pylori infection: A clinical practice update.” Eur J Clin Invest. 2018 Jan;48(1). doi: 10.1111/eci.12857.

Content

The number of testing devices in the kit may vary. Please refer to the content section on the external box for the exact number of tests contained.

Material required but not supplied:

• Cotton wool
• A device to measure time (e.g. timer, watch)

Instructions:

• Do not open the sealed aluminum pouch until just before performing the test. Open it as marked.
• Do not use the desiccant bag. Dispose of it with household waste without opening it.

Instructions for Use

• Language: English
• Test Name: Helicobacter Pylori Antigen Test
• Intended Use: Self-test for detecting the presence of the Helicobacter pylori antigen in the feces.

Usage Instructions

1. Collect a small sample of feces using a clean container.
2. Open the sealed aluminum pouch just before performing the test, following the marked opening.
3. Take out the testing device from the pouch.
4. Place the testing device on a clean and flat surface.
5. Add a few drops of the collected feces sample onto the sample well of the testing device.
6. Wait for the colored lines to appear on the result window. The presence of colored lines indicates a positive result for Helicobacter pylori antigen.
7. Refer to the user manual for interpretation of results and further instructions.
8. Dispose of the used testing device and any waste materials properly.

HELICOBACTER PYLORI

Helicobacter pylori is a bacterium whose ideal habitat is the human gastric mucosa. The infection is often asymptomatic, but it can sometimes cause gastritis and ulcers in the stomach or in the duodenum segment of the small intestine. The most common symptoms of these conditions are heartburn or pain in the upper part of the abdomen, especially if fasting or in the early morning, when the stomach is empty. Other associated symptoms include nausea, satiety, reflux, loss of appetite, burping, weight loss and diarrhoea. Ulcers can sometimes bleed, causing anaemia over long periods of time. In the long term, Helicobacter pylori infection is associated with an increased risk of gastric cancer.
The search for Helicobacter pylori-specific antigens in the faeces is a valid and non-invasive method to rapidly identify an infection.

PRINCIPLES OF THE TEST

HELICOBACTER PYLORI ANTIGEN TEST is an immunochromatographic test that detects the smallest amounts of H. pylori antigens in faeces samples by using highly specific gold-conjugated monoclonal antibodies attached onto the reactive strip.

BIBLIOGRAPHIE

1. Shimoyama T. „Stool antigen tests for the management of Helicobacter pylori infection.“ World Journal of Gastroenterology. 2013; 19(45):8188-91.
2. Ana Isabel Lopes, Filipa F Vale, Mónica Oleastro. „Helicobacter pylori infection – recent developments in diagnosis.“ World Journal of Gastroenterology. 2014 July 28; 20(28): 9299-9313.
3. Andreas Mentis, Philippe Lehours, and Francis Mégraud. „Epidemiology and Diagnosis of Helicobacter pylori infection.“ Helicobacter. 2015 Sep;20 Suppl 1:1-7.
4. Zagari RM, Rabitti S, Eusebi LH, Bazzoli F. „Treatment of Helicobacter pylori infection: A clinical practice update.“ Eur J Clin Invest. 2018 Jan;48(1). doi: 10.1111/eci.12857.

CONTENT

• The number of the testing devices of the kit may vary. For the exact number of tests contained, please refer to the “content” section on the external box.
• hermetically sealed aluminium pouch containing:
• HELICOBACTER PYLORI ANTIGEN TEST cassette
• desiccant bag
• vial with red screw cap, with collection stick and dripper, containing enough HELICOBACTER PYLORI ANTIGEN TEST diluent for 1 test
• instructions for use leaflet
• Material required but not supplied: cotton wool, a device to measure time (i.e. timer, watch).
• Do not open the sealed aluminium pouch until just before performing the test. Take care to open it as marked.
• The desiccant bag must not be used. Dispose of it with household waste without opening it.

PRECAUTIONS

1. Read these instructions for use carefully before performing the test. The Test is reliable only if all the instructions are followed correctly.
2. Keep the Test out of the reach of children.
3. Do not use the Test after the expiry date or if the package has been damaged.
4. Store the Test components at a temperature between +4°C and +30°C. Do not freeze.
5. Use the test once only.
6. The test is for external use only. DO NOT SWALLOW.
7. In vitro diagnostic device for individual use.
8. After using, please dispose of all components according to your local waste disposal laws. Ask your pharmacist for advice.

TEST PROCEDURE

Before performing the test, collect a faeces sample following these instructions:

COLLECTING THE SAMPLE

1. Check the toilet seat is dry – contact with water or detergents may prevent the faeces-collecting sheet from adhering properly and interfere with the test result.
2. Use the supplied special stool-collecting sheet as described below:
   • a slowly detach the two adhesive ends of the faeces-collecting sheet in the direction pointed by the arrows printed on the sheet. Open the sheet completely;
   • b attach the two adhesive surfaces of the faeces-collecting sheet near the back of the toilet seat, making sure the sheet does not get wet; – fig. A
   • c deposit the sample, carefully avoiding wetting the sheet with urine, and proceed with collec-tion as described in the next steps in this procedure.
3. Unscrew the vial’s red top and extract the faeces-collecting stick.
4. Dip the stick into the faeces in 3 different points of the sample. – fig. B
5. Screw on the cap again, immersing the stick in the faeces extraction liquid, and shake the vial for at least 10 seconds. –fig. C
6. Detach the adhesive parts of the faeces-collecting sheet at the same time from the toilet seat and let everything fall into the toilet. To make flushing easier, before flushing, wait a few seconds for the paper to soften. Flush
   • EXECUTION OF THE TEST
7. Open the aluminium bag, remove the strip only and place it on a horizontal surface. Discard the desiccant packet.
8. Break the end of the red cap, freeing the dropper portion. –fig. D
9. Dispense 3 (or no more than 4) drops of the diluted faeces sample into the well shown on the strip. Wait 1-2 seconds between dispensing one drop and the next – fig. E
10. Wait 10 minutes.

RESULTS INTERPRETATION

READ THE RESULT AFTER 10 MINUTES
The intensity of the line colours is not relevant for the purposes of interpretation of the Test’s results.
POSITIVE RESULT

• Two coloured bands appear in the reading window by the T (test) and C (control) signs. The T band may be less intense (lighter) than the C line.
• This result means there is Helicobacter pylori antigen in the faeces and you must consult a physician.

NEGATIVE RESULTS

• A coloured band appears only under the C (control) sign.
• This result means that there is no Helicobacter pylori antigen in the faeces or that its concentration is below the test’s detection limit (10 ng/ml).

NON VALID 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 result of the test, which must be considered as not valid. It is recommended to repeat the test with a new device and a new faeces sample.

F.A.Q. – QUESTIONS AND ANSWERS

• HOW DOES THE HELICOBACTER PYLORI ANTI-GEN TEST WORK? The HELICOBACTER PYLORI ANTIGEN TEST was made to selectively identi-fy the presence of Helicobacter pylori antigen in a faeces sample using a combination of specific antibodies.
• The lowest concentration of Helico-bacter pylori antigen the test can detect is 10 ng/ml, although in some cases samples with Helico-bacter pylori antigen concentration in the 7-10 ng/ml range may yield a positive result.
• WHEN CAN THE TEST BE USED? The HELICO-BACTER PYLORI ANTIGEN Test can be carried out at any time of the day, when you have a bowel movement, and there is no need to follow a spe-cific diet.
• CAN THE RESULT BE INCORRECT? The result is correct if the instructions are followed carefully. However, the result may not be correct if: the de-vice comes into contact with other liquids before being used, if part of the diluent is accidentally spilt, if the number of drops dispensed in the well is higher than 4 or less than 2.
• If you are taking medication, please talk to your physician to check if the drugs you are taking al-ter the concentration of H. pylori antigen in the faeces.
• HOW DO I INTERPRET THE TEST IF THE CO-LOUR AND INTENSITY OF THE TEST AND CON-TROL BANDS ARE DIFFERENT? The colour and the intensity of the bands are not important for the interpretation of the result. The bands must be full and homogeneous. The test is positive re-gardless of the intensity of the colour of the test band.
• IS THE RESULT RELIABLE IF READ AFTER 15 MIN-UTES? No. The test must be read exactly 10 min-utes after the procedure is completed.
• WHAT SHOULD I DO IF THE RESULT IS POSI-TIVE? If the result is positive, Helicobacter pylori antigen has been detected in the faeces and you must consult a physician, who will establish what to do next.
• WHAT SHOULD I DO IF THE RESULT IS NEGA-TIVE? A negative result means the test has not detected any Helicobacter pylori antigen in the faeces or that the antigen’s concentration is be-low the test’s detection limit. Therefore negative results cannot guarantee there is no abnormal condition. If the result is negative and symptoms persist, talk to a physician.
• HOW ACCURATE IS THE HELICOBACTER PYLO-RI ANTIGEN TEST? The Test is very accurate. As-sessment reports show a concordance rate equal to 96% (95% CI: 92.2% – 99.4%) with reference methods. Despite the test’s reliability, there may be false positive and false negative results.
• Test your health
• PRIMA LAB SA
• Via Antonio Monti 7
• CH-6828 Balerna – SWITZERLAND
• [email protected]
• primalabsa.ch
• Qarad EC-REP BV
• Pas 257
• 2440 Geel – Belgium

References

• Tactica.is
• Bäst i test och testvinnare - Test.se
• TCPDF
• PRIMA® Home Test Helicobacter Pylori Antigen 1 test hier online bestellen | FARMALINE.be
• PRIMA® Home Test Helicobacter Pylori Antigen 1 test commander ici en ligne | FARMALINE.be

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