Ureaplasma urealyticum antibody detection kit (colloidal gold method) manual
Ureaplasma urealyticum antibody detection kit (colloidal gold method) ã€Product name】 Ureaplasma urealyticum antibody detection kit (colloidal gold method)
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(Detection of antibodies in secretions)
Description book
[Packing specifications] 24 servings / box 48 servings / box [Intended use] Used to detect Ureaplasma urealyticum antibody (IgM / IgG) in test secretions.
[Test principle] Using Ureaplasma urealyticum antibody as antigen solid phase nitrocellulose membrane, applying the principle of diafiltration indirect method to detect Ureaplasma urealyticum antibody in the secretion.
[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]
Draw 1.0ml of physiological saline into the test tube, dissolve the collected secretions in physiological saline, centrifuge, and take the supernatant for detection.
ã€Testing method】
1. Drop two drops of reagent â… into the central hole of the reaction plate and wait for complete infiltration;
2. Drop 100µl of supernatant into the well of the reaction plate until it is 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, which is positive for Ureaplasma urealyticum 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 Ureaplasma urealyticum 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]
1. This reagent test is only used to detect Ureaplasma urealyticum antibody instead of directly detecting Ureaplasma urealyticum antigen, so a positive result cannot confirm the diagnosis of Ureaplasma urealyticum 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.
2. It is possible that secretion samples with low antibody content cannot be detected. Some patients infected with Ureaplasma urealyticum do not produce antibodies or produce a small amount of antibodies. At this time, a negative result may be displayed.
3. When the test results are suspicious, the diagnosis should be confirmed by the cultivation method.
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.