2019 Beta - Cobs Plasma Covid-19 Neutralizing Antibody Test Kit Rtk Ag Test

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspensions in the reagents affect the experimental results and should be removed by centrifugation.
3. Anticoagulants: Heparin, EDTA, sodium citrate anticoagulants do not work.
4. Venipuncture is performed by a professional medical staff. We recommend that you give priority to serum and blood tests. In emergencies and special cases, a patient's entire blood sample can also be used for rapid testing.
5. Serum and plasma reagents should not be stored at room temperature for more than 8 hours. It is stored at 8 ° C for 5 days for these 2 days and then reaches 80 ° C for 6 months, but repeated freeze-thaw cycles should be avoided. Whole blood specimens cannot be frozen and should be stored at 2 ° C to 8 ° C for 48 hours or longer.

Test Method

Please read the instructions carefully before the test. Test all reagents from room temperature to room temperature.
1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Add L sample (serum, plasma, or whole blood) to the loading hole of the μ test card, and add 2 drops (about 60 drops μL) of sample buffer over time.
3. Observe the reaction for 10 to 15 minutes at room temperature. After 20 minutes, the result was invalid.

Interpretation of Test Results

Test card description
1. Invalid result: The quality control line (C line) is invalid. There is no response line and it needs to be retested.
2. Negative result: The red band is displayed on the test line (T line), and the color development is displayed on the standard line (R line), quality control line (C line), and reference line (R line).
3. Positive result: A red band is displayed on the test line (T line), and the red band from the reference line (R line) and quality control line (C line) to the test line (T line) is color-coded and used as the standard. Color the line (R line).

Limitation of Test Method

This device is used only for in vitro diagnostics.
2. If there are too many or too small samples, the result will be false.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be affected as they can affect test results.
4. Reagent test results are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis of this disease should be based on a comprehensive assessment of all clinical and laboratory results.

Product Performance Indicators

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1. Specificity analysis

1.1 Cross-reaction: Due to the interference of reagents, the following types of antibodies were evaluated, and no cross-reactions occurred as a result.

1.2 Interfering substances: In the new coronavirus (2019ncov) neutralizing antibody test item, the potential interference of the following substances is evaluated by adding the following substances to the sample of a specific concentration. Various interfering substances do not interfere with the detection results of the reagents.

2.Clinical study: The already commercially available 2019 ncov igg ab detection reagent (colloidal gold method) is used as a control reagent, and 120 positive reagents and 300 negative reagents are selected as detection reagents. The results can be summarized as follows.

Precautions