8mins Neutralizing Antibody IVD In Vitro Diagnostic Test Kits For Vaccine

Use Blood as Sample to Diagnose COVID-19 Neutralizing Antibody Rapid Test Kit

Test principle:

Based on the principle of Immunofluorescence analysis, SARS-CoV-2 Neutralizing Antibody Assay Kit by Immunofluorescence Chromatography Method was used to immobilized ACE-2 protein (T line) and goat anti-chicken IgY Antibody (C line) using nitrocellulose membrane (NC) as a solid-phase carrier. Fluorescent microspheres were conjugated to recombinant SARS-CoV-2 S-RBD antigen in the fluorescent labeling pad.

When the buffer solution was added to the sample well, the S-RBD-labeled fluorescent microspheres in the labeling pad were pushed to bind to the corresponding immobilized ACE-2 protein on the NC membrane, and the fluorescent signal could be detected at the marking position. If there is a neutralizing antibody in the sample, it will bind to the labeled S-RBD antigen when passing through the labeling pad. The neutralizing antibody can prevent the binding of S-RBD to ACE-2, resulting in a decrease in the signal value, and the T-line signal value is negatively correlated with the neutralizing antibody content.

Specimen collection and preparation:

1. Human whole blood (heparin anticoagulation recommended), serum, or plasma (heparin anticoagulation recommended) sample.

2. Test the sample as soon as possible after it is collected. If it cannot be measured in time, it should be transported and stored as required.

3. The samples should be transported and stored at 2℃ to 8℃. Whole blood samples can be stored for 7 days at 2℃ to 8℃, and serum/plasma samples can be stored for 3 days at 2℃ to 8℃. Stable at -20 ℃ for 7 days. Refrigerated samples must be left to recover from 20℃ to 28℃ before testing,multiple freeze-thaw cycles should be avoided. The sample should be measured during the stable period, otherwise, the sample must be collected again.

4. The test result may be affected by severe jaundice, hemolysis, and lipemia samples.

Assay procedure:

Please read the instruction manual of the applicable instrument and this manual carefully before use. The reagent should be returned to room temperature before testing, and the testing process should also be performed at room temperature.

1. Testing steps

1.1 Open the kit and insert the test card into the instrument interface.

1.2 Use the Capillarity Tube to aspirate the sample, insert it into the diluent, Mix well and drop three drops of liquid into the test card sample hole. After 8 minutes, place the test card into the instrument and click "Test".

1.3 Select the appropriate sample detection mode for testing on the instrument operation screen.

1.4 After the test is completed, remove the test card from the instrument and process it in accordance with the regulations.

2. Interpretation

Interpret the test result in accordance with the interpretation criteria of the qualitative results in the manual.

Result interpretation