Instructions for Helicobacter pylori antibody detection kit (colloid gold method)
ã€Product name】 Helicobacter pylori antibody detection kit (colloidal gold method)
[Packing specifications] 24 servings / box 48 servings / box [Intended use] For detecting Helicobacter pylori antibody (IgM / IgG) in test serum
[Test principle] Use Helicobacter pylori antigen solid phase nitrocellulose membrane and apply the principle of diafiltration indirect method to detect Helicobacter pylori antibody in serum.
[Main components]
Reaction plate 24 parts or 48 parts reagent I 1 bottle of 0.02mol / L PH 7.4 PBS
Reagent Ⅱ 1 bottle of colloidal gold marker [storage conditions and expiration date] The product should be stored at 2 ℃ ~ 8 ℃ conditions, can not be frozen; valid for 24 months.
[Sample requirements]
Serum samples cannot be hemolyzed, and should be kept in fresh serum or stored at 2 ℃ ～ 8 ℃ for no more than one week.
Hyperlipidemia serum cannot be used.
ã€Testing method】
Drop two drops of reagent â… into the central hole of the reaction plate, to be completely infiltrated;
Drop 100µl of serum into the wells of the reaction plate until it is completely infiltrated;
Add three drops of reagent â…¡ into the well of the reaction plate until it penetrates completely;
Infiltrate three drops of reagent â… into the wells of the reaction plate and wait for complete infiltration.
[Interpretation of results]
Positive: A red round spot appears on the C-end and a red round spot appears on the T-end of the reaction plate well, which is positive for H. pylori antibody;
Negative: There are red round spots on the C-end and no red round spots on the T-end of the reaction plate well, which is negative for H. pylori antibody.
Failure: No red round spots appear on the C-end of the reaction plate well, or no red round spots appear on the C-end and T-end.
[Limitations of inspection methods]
This reagent test is only used to detect H. pylori antibodies instead of directly detecting H. pylori. Therefore, a positive result cannot confirm the diagnosis of H. pylori infection. The diagnosis of the patient's condition should be combined with a comprehensive analysis of the patient's clinical signs and symptoms and test results.
It is possible that serum samples with low antibody content cannot be detected. Some patients infected with H. pylori do not produce antibodies or produce a small amount of antibodies. At this time, a negative result may be displayed.
When the test result is suspicious, the culture medium should be used to confirm the diagnosis.
ã€Product Performance Index】
In-batch precision: both the positive and negative coincidence rates should be ≥95%, and the color depth of the reaction spots should be close.
Precision between batches: Both the positive and negative coincidence rates should be ≥95%.
ã€Precautions】
This product has not yet obtained a product registration number and is for research only, without clinical diagnosis.
Once the test starts operation, it should be carried out continuously according to the operation steps until the end.
When the kit is removed from the refrigerator, the reagents should be brought to room temperature.
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