Instructions for Mycoplasma pneumoniae antibody detection kit (colloidal gold method)
[Product name] Mycoplasma pneumoniae antibody detection kit (colloidal gold method)
[Packing specifications] 24 servings / box 48 servings / box [Intended use] Used to detect Mycoplasma pneumoniae antibody (IgG / IgM) in test serum
[Testing principle] Use the solid phase nitrocellulose membrane of Mycoplasma pneumoniae antigen and apply the principle of infiltration method to detect the antibody of Mycoplasma pneumoniae in serum.
[Main components]
1. 24 or 48 reaction plates
2. Reagent â… 1 bottle of 0.02mol / L PH7.4PBS
3. 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; the expiration date is 24 months.
[Sample requirements]
1. Serum samples cannot be hemolyzed, and should be stored in fresh serum or stored at 2 ℃ ～ 8 ℃ for no more than one week.
2. Hyperlipidemia serum cannot be used.
ã€Testing method】
1. Drop two drops of reagent â… into the central hole of the reaction plate and wait for complete infiltration;
2. Drip 100µl of serum into the well of the reaction plate, to be completely infiltrated;
3. Add three drops of reagent â…¡ to the well of the reaction plate until it is completely infiltrated;
4. Infiltrate three drops of reagent â… into the well of the reaction plate and wait for complete infiltration.
[Interpretation of results]
Positive: A red round spot appears in the C end of the reaction plate well, which is positive for Mycoplasma pneumoniae antibody;
Negative: Red round spots appear in the C-terminal of the reaction plate well, which is negative for Mycoplasma pneumoniae antibody.
Invalidation: 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 the T end, which means the kit has failed.
[Limitations of inspection methods]
1. This reagent test is only used to detect M. pneumoniae antibodies instead of directly detecting M. pneumoniae. Therefore, a positive result cannot confirm the diagnosis of M. pneumoniae. 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.
2. It is possible that serum samples with low antibody content cannot be detected. Some patients infected with Mycoplasma pneumoniae do not produce antibodies or produce a small amount of antibodies. At this time, a negative result may be displayed.
3. When the test result is suspicious, the culture medium should be used to confirm the diagnosis.
ã€Product Performance Index】
1. In-batch precision: both the positive coincidence rate and the negative coincidence rate should be ≥95%, and the color depth of the reaction spots should be close.
2. Precision between batches: Both the positive and negative coincidence rates should be ≥95%.
ã€Precautions】
1. This product has not obtained the product registration number, it is only for research, not for clinical diagnosis.
2. Once the test is started, it should be carried out continuously according to the operation steps until the end.
3. When the kit is removed from the refrigerator, the reagents should be returned to room temperature.
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