PRIMA HELICOBACTER Pylori Test Instruction Manual

PRIMA HELICOBACTER Pylori Test

Product Information

• Product Name: Helicobacter Pylori Test
• Manufacturer: PRIMA LAB SA
• Address: Via Antonio Monti 7, CH-6828 Balerna, Switzerland
• Email: [email protected]
• Website: primalabsa.ch
• EC Representative: Qarad EC-REP BV
• EC Representative Address: Pas 257, 2440 Geel, Belgium
• Registered Trademarks
• List Number: 0483

Test Principle:
The Helicobacter Pylori Test is an immunochromatographic test that detects the presence of anti-Helicobater pylori IgG antibodies in the blood using special monoclonal antibodies conjugated with gold and integrated into the reactive strip.

References:

1. Mati Moyat, Dominique Velin. Immune responses to Helicobacter pylori infection. World J. Gastroenterol. 2014 May 21; 20(19): 5583-5593.
2. Khean-Lee Goh, Wah-Kheong Chan, Seiji Shiota, and Yoshio Yamaoka. Epidemiology of Helicobacter pylori Infection and Public Health Implications. Helicobacter, 2011 Sep;16(0 1):1-9.
3. Kyichi Adachi, Tomoko Mishiro, Shino Tanaka, and Yoshikazu Kinoshita. Analysis of negative result in serum anti-pylori IgG antibody test in cases with gastric mucosal atrophy. J. Clin Biochem Nutr.2016 Sep;59(2):145-148.

Product Usage Instructions

• Step 1: Before starting the test, ensure you have all the required materials: Helicobacter Pylori Test kit, antiseptic cleanser gauze (70% alcohol), cotton wool, and a device to measure time (e.g., timer, watch).
• Step 2: Do not open the sealed aluminum bag until just before performing the test. When opening the bag, follow the marked instructions carefully.
• Step 3: Disregard the desiccant packet included in the kit. It should not be used. Dispose of it with household waste without opening it.
• Step 4: Prepare the test area by cleaning the skin with the antiseptic cleanser gauze (70% alcohol). Allow the skin to dry completely.
• Step 5: Take out the Helicobacter Pylori Test device from the kit.
• Step 6: Twist off the blue cap from the device and use it to collect a drop of whole blood.
• Step 7: Place the collected drop of blood into the well of the device.
• Step 8: Twist off the white cap from the device and insert the lancet into the finger to obtain a blood sample.
• Step 9: Apply pressure to the finger to allow blood to flow into the device.
• Step 10: Wait for the test results to appear on the reactive strip of the device. Refer to the user manual for the interpretation of results.
• Step 11: Dispose of the used device and lancet properly according to local regulations.

HELICOBACTER PYLORI INFECTION AND SPECIFIC IgG

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, feeling full, refl ux, loss of appetite, burping, weight loss, and diarrhea. Ulcers can sometimes bleed, causing anemia over long periods of time. In the long term, H. pylori infection is associated with an increase in the risk of gastric cancers. The simplest way to detect infection is by checking for the presence of specifi c antibodies (IgG) that are produced by the immune system after coming into contact with the bacterium and trying to eliminate it. The Helicobacter pylori Test can detect the presence of these antibodies in a few minutes.

PRINCIPLE OF THE TEST

The Helicobacter pylori Test is an immunochromatographic test that detects the presence of anti-Helicobater pylori IgG antibodies in the blood, using special monoclonal antibodies conjugated with gold and integrated into the reactive strip.

REFERENCES

1. Mati Moyat, Dominique Velin. Immune responses to Helicobacter pylori infection. World J. Gastroenterol. 2014 may 21; 20(19): 5583-5593IgE.” Journal of Allergy and Clinical Immunology. 2014;133(2):589-91.
2. Khean-Lee Goh, Wah-Kheong Chan, Seiji Shiota, and Yoshio Yamaoka. Epidemiology of Helicobacter pylori Infection and Public Health Implications. Helicobacter, 2011 Sep;16(0 1):1-9.
3. Kyichi Adachi, Tomoko Mishiro, Shino Tanaka, and Yoshikazu Kinoshita. Analysis of negative result in serum anti-pylori IgG antibody test in cases with gastric mucosal atrophy. J. Clin Biochem Nutr.2016 Sep;59(2):145-148.

PACKAGE 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.

• Material required but not supplied: cotton wool, a device to measure time (i.e. timer, watch).
• Do not open the sealed aluminum bag until just before performing the test. Take care to open it as marked.
• The desiccant packet 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. Follow the procedure exactly, using only the specified quantities of blood and diluent.
5. Store the Test components at a temperature between +4°C and +30°C. Do not freeze.
6. Use the test and lancing device once only.
7. The test is for external use only. DO NOT SWALLOW.
8. In vitro diagnostic device for individual use.
9. Not recommended for people who take anti-coagulant medications (blood thinners) or people suffering from hemophilia.
10. After using, please dispose of all components according to your local waste disposal laws. Ask your pharmacist for advice.

TEST PROCEDURE

1. Wash hands with soap and warm water, rinse with clean water, and allow to dry. If this is not possible, use the provided gauze as an alternative.
   Note: The use of warm water facilitates capillary blood collection as it induces vasodilation.

2. Prepare the necessary material as follows: open the aluminum pouch, take out only the test cassette, and throw away the desiccant bag. Open the plastic packet containing the pipette. FIG. A

3. Carefully rotate the protective cap of the sterile lancet 360° without pulling it. Extract and discard the released cap. – FIG. B

4. Carefully massage the fi nger chosen for the puncture (the side of the ring fi nger is recommended). It is important that the massage is done from the palm of the hand to the phalanx, to improve blood fl ow. Press the open end of the lancet (the side the cap has been extracted from), against the fingertip – FIG. C The tip of the lancet automatically retracts after use. If the lancet does not work properly, discard it and use the second one supplied. If the second one is not required, it can be disposed of without special precautions.

5. Holding the hand down, massage the finger until a large drop of blood forms. It is important to massage from the palm of the hand to the phalanx to improve blood flow. – FIG. D

6. Take the pipette without pressing the bulb. Two sampling methods are suggested:

   • Fig. E1: Hold the pipette horizontally without pressing the bulb and place it in contact with the drop of blood, it will enter the pipette by capillarity. Move the pipette away when the black line is reached. If there is not enough blood, continue to massage the finger until the black line is reached.
   • Fig. E2: Place the pipette on a clean, flat surface with the tip protruding from the shelf, then place the drop of blood in contact with the pipette, it will enter by capillarity. If blood is not sufficient, continue massaging the finger until the blood has reached the black line.
   • Avoid, as far as possible, to continuously move the tip of the pipette away from the finger in order to prevent the formation of air bubbles.

7. Place the blood collected with the pipette into the well indicated on the cassette (S) by pressing the pipette bulb. – FIG. F

8. Unscrew the blue cap from the dropper vial (leave the white cap tightly screwed on). Deposit 2 drops into the well indicated on the cassette (S), and wait for 5 seconds between the first and second drops. – FIG. G

9. Wait 5 minutes and read the results referring to the next section for result interpretation.

RESULTS INTERPRETATION

READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the line colors is not relevant for the purposes of interpretation of the Test’s results.

POSITIVE RESULT

• Two colored 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 are anti-Hp antibodies in the blood and you must consult a physician.

NEGATIVE RESULTS

• A colored band appears only under the C (control) sign.
• This result means that the presence of anti-Hp antibodies cannot be detected in the blood.

NON VALID RESULT

• No bands appear or there is a line only under the T (test) sign and not under the C(control) sign.
• In this case, it is not possible to interpret the result of the test, which must be considered not valid. Repeat the test with a new blood sample.

SYMBOLS

• In vitro diagnostic device
• Read the instructions before use
• Sterilized using irradiation
• Authorised Representative in the European Community
• Temperature limits
• Do not reuse
• Sufficient for tests
• Expiry date (last day of the month)
• List number
• Lot number
• CE marking
• Legal manufacturer

F.A.Q. QUESTIONS AND ANSWERS

HOW DOES THE HELICOBACTER PYLORI TEST WORK?
IgG antibodies are produced in high quantities by our body in response to infections. The Helicobacter pylori Test identifies class IgG antibodies specifi c for Helicobacter pylori and reveals if the concentration in the blood of these antibodies is 15 AU/mL. In some cases, samples with IgG concentrations between 10 AU/mL and 14.99 AU/mL can yield positive results.

WHEN CAN THE TEST BE USED?
HELICOBACTER PYLORI TEST is recommended when the typical symptoms of Helicobacter pylori gastric infection are present, such as stomach pain, heartburn, nausea, feeling full, burping, loss of appetite, diarrhea, and weight loss. The Test can be carried out at any time of the day. If you are taking medication, please talk to your physician to check that the drugs you are taking do not alter the levels of circulating IgG.
CAN THE RESULT BE INCORRECT?
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 being used, if part of the diluent is accidentally spilled, if the amount of blood is not enough or if the number of drops dispensed in the well is more than 3. The pipette supplied allows users to be sure they have collected the right amount of blood.

HOW DO I INTERPRET THE TEST IF THE COLOUR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The color 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 regardless of the intensity of the color of the test band.

IS THE RESULT RELIABLE IF READ AFTER 5 MINUTES?
No. The test must be read 5 minutes after the procedure is completed.

WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
A positive result means that the level of anti-Helicobacter pylori specifi c antibodies belonging to the IgG class is equal to or higher than 15 AU/mL. The test does not discriminate between ongoing infection or past infections, so consult a physician and show him/her the result of the test. Your physician will decide which other tests you should perform and advise you accordingly.

WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
A negative result means that the level of anti-Helicobacter pylori specifi c antibodies belonging to the IgG class is lower than standard. If symptoms persist, consult your physician.

HOW ACCURATE IS THE HELICOBACTER PYLORI TEST?
The Test is very accurate. Assessment reports show a concordance rate above 87% (CI 95%:  80.4 – 93.6%) with reference methods.

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
• inc.no - Inc Resources and Information.
• Bäst i test och testvinnare - Test.se
• TCPDF
• PRIMA® Home Test Helicobacter Pylori 1 test hier online bestellen | FARMALINE.be

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