INTENDED USE

The H. pylori Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.

INTRODUCTION

Helicobacter pylori (also known as Campylobacter pylori) is a spiral-shaped with a typical flagellum, Gram negative bacteria, infecting gastric mucosa. It causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma, so as to be classified as carcinogen agent type I.

MAIN CONTENTS

• One pouch containing a reaction test Cassette with desiccant.

• Specimens dilution tube with buffer.

• Instructions for use.

STORAGE AND STABILITY

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

PRECAUTIONS

• For in vitro diagnostic use only.

• Do not use after expiration date.

• The test Cassette should remain in the sealed pouch until use.

• The used test Cassette should be discarded according to local regulations.

DIRECTION OF USE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

Specimen collection and pre-treatment:

Best results will be obtained if the assay is performed within 6 hours after collection.

Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).

Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

Testing:

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.

Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane.

Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Note:

If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

 

DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of IVD products.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories. Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.