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H.Pylori Antigen Rapid Test Kit

【INTENDED USE】

The H.pylori Antigen Rapid Test Device is an invitro diagnostic test for a rapid the qualitative detection of H.pylori antigens in human feces specimens to aid in the diagnosis of H.pylori infection.

【PRINCIPLE】

H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.

The H.pylori Antigen Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human feces specimens, providing results in 15 minutes. The test utilizes antibodies specific for H.pylori antigens to selectively detect H.pylori antigens in human feces specimens.

The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against H.pylori; the reaction membrane contains the secondary antibodies for H.pylori and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. The whole strip is fixed inside a plastic device.

When the sample is added into the sample window, conjugates dried in the reagent pad are solubilized and migrate along with the sample. If H.pylori presents in the sample, a complex formed between the anti- H.pylori conjugate and the H.pylori will be captured by the specific anti- H.pylori monoclonal coated on the Test Region(T). Results appear at 15 minutes in the form of a red line that develops on the membrane.

To serve as a procedural control, a red line will always appear in the control region(C) indicating that proper volume of sample has been added and membrane wicking has occurred.

【PRECAUTION】

• For in vitro diagnostic use only,

• Do not use after the expiration date.

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

• If the H.pylori antigen rapid test kit was kept refrigerated, let all the reagents warm up to room temperature (15°C -30°C) before proceeding with the test.

• Wear gloves when handing the samples, avoid touching the reagent membrane with your fingers.

• Discard gloves, swabs, test tubes, and test devices in accordance with the local regulation.

• Visibly Bloody samples should not be used for the testing.

【STORAGE AND STABILITY】

Store the Mycoplasma pneumoniae antigen rapid test kit at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.

【SAMPLE COLLECTION】

1.The feces samples need to be performed as soon as possible after collection. If not, the Specimen collected may be stored for one week at 2~8℃ or stored a longer period at -20℃ .

2.To make sure the specimen are not handled by Formaldehyde solution or its derivative solution.

【SAMPLE PREPARATION PROCEDURE】

(1)Recover the specimen to room tempreture(15-30℃)

(2)Rotate the fecal tube,use the screw to collect the feces specimen 50mg(A),too more(B1) or too less (B2)are both not available. For the liquid or  semi-liquid specimen,use pipettet(not provide) to transfer 80μL specimen into specimen collection tube containing the extraction buffer.

(3)Tighten the cap onto the specimen collection tube, then shake the specimen

collection tube vigorously to mix the specimen (C).Pls note all the specimen should be mixed into solution.

【TEST PROCEDURE】

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.

1) Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

2) Break off the cap top of specimen collection tube(D) .

3) After discarding the first two drops,transfer 3 dropsof the extracted specimen (approximately 80 μL) to the specimen well of the test cassette(E).Avoid trapping air bubbles in the specimen well,See illustration below

4) Read result at 15 minutes. Do not interpret the result after 60 minutes.

【RESULT INTERPRETATION】

POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red line in the test region(T). The shade of color may vary，but it should be considered positive whenever there is even a faint line.

NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T). The negative result indicates that there are noH.pylori in the sample or the number of H.pylori is below the detectable range.

INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.