Rotavirus detection kit (colloidal gold method) manual

Rotavirus detection kit (colloidal gold method)
Description book

[Product name] rotavirus detection kit (colloidal gold method)
[Packing Specifications] 24 servings / box 48 servings / box [Expected Use] Used to detect rotavirus in test feces.
[Test principle] Rotavirus monoclonal antibody solid phase nitrocellulose membrane, using the principle of diafiltration indirect method, to detect rotavirus in stool
[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. Pick 0.5g-1.0g feces (about the size of soybean grains), put in 1.0ml physiological saline and mix well, centrifuge, and take the supernatant for testing.
【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 rotavirus;
Negative: There is a red round spot on the C-end and no red round spot on the T-end, which is negative for rotavirus.
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 used to detect rotavirus, but due to the limitations of monoclonal antibodies, the positive result cannot be completely diagnosed as rotavirus 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 samples with low rotavirus content cannot be detected.
3. When the test result is suspicious, the PCR method is used to confirm the diagnosis.
【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%.
【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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