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HpyloriSA Innovares Card

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HpyloriSA Innovares Card
The “stomach-saver” test, fast and accurate for the diagnosis of Helicobacter pyloriinfection, with no waste of time and no scheduling.
The “stomach-saver” test, fast and accurate for the diagnosis of Helicobacter pyloriinfection, with no waste of time and no scheduling.

HpyloriSA Innovares Card
Packaging: kit for 1 test
Retail price in Italy: € 26.00
Rapid monoclonal immunochromatographic test device for the diagnosis of Helicobacter pylori in feces and early prevention-early detection of infection-associated gastroduodenal disease. The accuracy of this method is comparable to that of UBT (Urea Breath Test).
Certified for in-vitro professional use.
With rapid tests certified for “professional use”, such as HpyloriSA, biological sample collection is carried out by the Consumer, while performing the test, reading the results, and interpreting the results are done by a Health Care Professional.

How to use HpSA Innovares Card, test for infection by Helicobacter pylori
HpyloriSA is a rapid test used to detect the presence of bacteria in the stomach of a subject. Therefore, it is an essential diagnostic tool with occurrence of dyspeptic symptoms such as “stomach acid”, upset stomach, gastro-esophageal heartburn, postprandial bloating, slow and laborious digestion, postprandial drowsiness, nausea, and so on, since these symptoms are often associated with the infection.
Unlike other tests commonly used for the diagnosis of Helicobacter pylori infection, HpyloriSA detects the fecal antigen of the germ, not serum antibodies. Consequently, HpyloriSA is able to diagnose ongoing infections, while serological tests are limited to assessing that a contact has been made with the germ, without confirming if the infection is still ongoing. It is well known that antibodies will remain in the blood for a long time, even after the infection has cleared.

For the above reason, HpyloriSA can be used 30 days after completion of eradication treatment with drugs to check the results.

The results should be interpreted as positive even when the control line color is very light. HpyloriSA is available from all Italian wholesalers and consequently in all pharmacies/drugstores in Italy.

ITEM DESCRIPTION
The test detects antigens of the Helicobacter pylori germ in stool fragments, thus pointing out any ongoing infection accurately. It is based on an IMMUNOCHROMATOGRAPHIC method.

RATIONALE OF THE TEST
Scientific and technological progress gives rapid tests increasing levels of “quality” and “efficacy”, along with easy use and interpretation of results. Therefore, they can provide valuable, immediate, precise help for the doctor to make a diagnosis or the pharmacist to give some “advice”. For more detailed information, please refer to the technical Fact Sheet inside the box.

ADVANTAGES
It is a very accurate method because it diagnoses ongoing infections by detecting the antigen of the germ.
It can be used to check the results of eradication therapy.
Results within 5 minutes.
The test should be performed without transporting stool samples and involving analysis laboratories.

INSTRUCTIONS AND INFORMATION
HpyloriSA Innovares Card “Instructions and Information” are available in Italian, English and Arabic language:

CE MARKING: IVD in compliance with directive 98/79/EC.
INTENDED USE: Professional use.
EDMA CODE: 15 01 04 01 00 Helicobacter pylori antigen detection.
CATEGORY: prEN1874 – EDMA: 06 In vitro diagnostic devices.
ANALYTICAL METHOD: Immunoassay using Helicobacter pylori monoclonal antibodies.
QUALITY ASPECTS OF THE TEST: relative sensitivity: 91.66%; relative specificity: 94.00%. Other data: see instructions inside.
TIME FOR RESULTS: 5-10 minutes after performing the test.
INDICATIONS FOR USING THE TEST: assessment of Helicobacter pylori in subjects with dyspepsia; screening of Helicobacter pylori infection. If you test positive, please see your Doctor.
STABILITY DURATION OF THE DEVICE: 24 months after manufacture.
KIT STORAGE: Room temperature (+2/+30°C). Before the test is performed, if the kit was stored in a refrigerator, bring it to room temperature. The same applies to sample. After the vial for the collection of the stool sample is delivered to the subject, it can be stored at room temperature before use.
STORAGE OF THE FECAL SPECIMEN: If the test is performed within 24 hours after the sample collection, the sample should be kept at room temperature in a cool, dry place, away from direct sunlight. If the test is performed within 48 hours after sample collection, the sample should be stored in a refrigerator at a temperature between +2°C and +8°C. If the test is performed at a later date, the specimen should be frozen immediately and stored at a temperature of -20°C until just prior to testing.
VERSION: November 2013.