Anti-ENA antibody detection kit (colloidal gold method)
Description book
ã€Product name】 Anti-ENA antibody detection kit (colloidal gold method)
[Packing specifications] 24 servings / box 48 servings / box [Expected use] Used to detect anti-ENA antibodies (IgM / IgG) in test serum
[Test principle] Use ENA peptide antigen solid phase nitrocellulose membrane, apply the principle of diafiltration indirect method to detect anti-ENA antibody in serum.
[Main components]
1. 24 or 48 reaction plates
2. Reagent â… 1 bottle of 0.02mol / L PH 7.4 PBS
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 on the C-end and a red round spot appears on the T-end of the reaction plate well, indicating positive anti-ENA antibody;
Negative: There is a red round spot on the C-end and no red round spot on the T-end of the well of the reaction plate.
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]
1. This reagent test is only used to detect anti-ENA antibodies, so a positive result cannot be diagnosed as a specific autoimmune disease. 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 with autoimmune diseases 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, use other methods 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 yet obtained a product registration certificate number, which is for research only and does not require 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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