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Helicobacter Pylori Rapid Detection Kit

1. Use of Helicobacter pylori detection kit


This kit is used to qualitatively detect the presence of HP-IgG antibodies in human serum.


2. Detection principle of Helicobacter pylori detection kit


The antigen on the reaction plate membrane binds to the corresponding IgG antibody in the sample to form a complex, and the addition of colloidal gold-labeled secondary antibody forms a red spot.


If the serum to be tested does not contain the corresponding antibody, there will be no spot formation; only the control quality control spot; if there is no spot formation in the H.pylori blood test kit, the reagent has failed.


3. Composition of Helicobacter pylori detection kit


Antigen reaction plate, 1 instruction manual, 1/2 bottle of washing solution and 1 bottle of colloidal gold conjugate.


4. Collection and preparation of samples of Helicobacter pylori detection kit


(1) The sample is serum and must be fresh. For storage, it can be stored at 2~8°C for 24 hours or frozen at -20°C to avoid repeated freezing and thawing.


(2) If the serum sample is turbid or precipitated, centrifuge at 3000 rpm with a centrifuge, and take the supernatant for use.


5. Operation steps of Helicobacter pylori detection kit


(1) Take the antigen reaction plate out of the refrigerated environment, equilibrate at room temperature for 30 minutes (or place it in a 37°C incubator for 30 minutes) before use.


(2) Add 2 drops of washing solution to the well of the reaction plate and wait for the liquid to penetrate completely;


(3) Add 100ul sample and wait for complete penetration;


(4) Add 4 drops of lotion and wait for complete penetration;


(5) Add 3 drops of the combination of colloidal gold test (invert and mix before adding), wait for complete penetration;


(6) Add 4 drops of lotion and wait for the liquid to penetrate completely;


(7) Observation results.


6. Judgment of the results of the Helicobacter pylori detection kit


(1) Positive: two uniform red round spots appear in the center of the small hole;


(2) Negative: There is a red round spot near the C end in the center of the small hole of the Helicobacter pylori detection kit, and there is no round spot or trace near the T end.


(3) Reagent failure: there is no circular spot on the central membrane of the small hole.


7. Precautions for Helicobacter pylori detection kit


(1) The antigen reaction plate is taken out of the refrigerated environment and must be equilibrated at room temperature for 30 minutes (or placed in a 37°C incubator for 30 minutes) before use, otherwise missed or false negative results will occur.


(2) If the quality control point is too shallow or too light, please add 1-2 more drops of colloidal gold test combination.


(3) When the serum contains a large amount of polymers, acute infection, hyperlipidemia, and blood volume, the background will be reddish, which generally does not affect the judgment. Serum can be diluted 1:3 at this point and the background will improve.


(4) The colloidal gold conjugate should be kept free from contamination, cover it immediately after use, and store it at 4°C. Different batch numbers should not be mixed.


(5) Simultaneous manipulation of multiple specimens is strictly prohibited. The operation steps need to be carried out continuously, and it is not advisable to pause for too long.


(6) For the auxiliary diagnosis of acute infection, please dilute the serum sample 10 times with normal saline, and do not dilute the serum during the epidemic investigation.


(7) This IVD kit is only used for auxiliary diagnosis. The diagnosis of the disease should be combined with medical history, symptoms and other tests.


(8) Expired products cannot be used; all samples to be tested are treated as infectious agents.


(9) The kit is stored at 2-8°C and has a validity period of 6 months.