Instruction manual of Helicobacter pylori detection kit (urease method)

ã€product nameã€‘
Trade name: Helicobacter pylori detection kit (urease method)
[Packing Specifications] 50 servings / box or 100 servings / box [Expected Use] Helicobacter pylori detection kit (urease method) is used to detect Helicobacter pylori in gastric mucosa or tartar. Helicobacter Pylori Hp (Helicobacter Pylori Hp) is one of the common pathogenic bacteria that enters the digestive tract through the mouth, and is the main pathogenic factor leading to chronic gastritis and peptic ulcer. The diagnosis, treatment and prevention of chronic gastritis and peptic ulcer by the detection of this bacterium have become clinical needs.
[Detection principle] Helicobacter pylori can secrete a large amount of highly active urease, urease decomposes urea in the matrix, the pH value increases, the principle of indicator discoloration is used to detect Helicobacter pylori in gastric mucosa tissue or tartar bacteria.
ã€Compositionã€‘
1. Reaction cup: 50 or 100 (can be folded into single serving)
2. Reaction solution: 1 bottle (sodium chloride, Tween)
3. Specimen label: 50 or 100 [storage conditions and expiration date] The kit should be stored in a cool and dry place, valid for 12 months.
[Specimen requirements] The gastroscope room uses a gastroscope to take a small piece of gastric mucosa tissue or take mung bean size tartar before feeding and before brushing.
ã€Testing methodã€‘
1. Tear off the aluminum-platinum bag and take out the reaction cups. Add 2 drops (100ul) of the reaction solution to each cup and shake the reaction cup 3-5 times to dissolve the dry powder.
2. Using a specimen label, place fresh biopsy gastric mucosa tissue or tartar in the reaction cup.
3. After 5 minutes at room temperature, observe the results.
ã€Referenceã€‘
The kit is a qualitative detection kit, and the color of the reaction cup liquid is changed from yellow to red to determine positive. After serial dilution with 1% urease, when the minimum content of urease is 78mg / L, the color of the reaction solution just changes from yellow to red. The higher the content of urease, the faster and darker the color changes.
[Interpretation of test results]
Positive: The liquid or specimen around the reaction cup appears light red to purple red to be judged as positive;
Negative: There is no color reaction around the liquid in the reaction cup or the specimen is judged as negative.
During the operation, if there is acid or alkali pollution, it will affect the test results, and the operation should be checked under clean conditions. When there is any doubt about the test result, the microbial culture identification should be carried out.
[Limitations of test methods] This kit is a qualitative kit for detecting Helicobacter pylori. It has an auxiliary diagnostic value for the detection of Helicobacter pylori, but has no definitive diagnosis function.
ã€Product Performance Indexã€‘
1. Appearance: It should be light yellow solid without deliquescence.
2. Repeatability: The test reagent was tested 10 times and the results were all positive.
3. Blank test: When performing a blank test on the detection reagent, the reagent should have no color change.
4. Sensitivity test: the reagent is tested with 78mg / L urease, the reagent test is positive, and it is red.
5. The conformity rate of negative reference materials is 100%.
6. Stability: The stability of the test reagent is 12 months.
ã€Precautionsã€‘
1. After adding the reaction solution to the reaction cup, the solution is light red. After shaking, it turns to yellow after 5 minutes is normal. Cannot be used if it does not fade to yellow.
2. When the indoor temperature is lower than 10 â„ƒ, it should be placed in a 37 â„ƒ incubator or hold the reaction cup for 10 minutes to observe. If it is weak positive, it can be extended to 30 minutes to observe.

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