SARS-CoV-2 Neutralizing Antibody Rapid Test
新冠病毒中和抗體快速檢測試劑盒
(CE Marking: NL-CA002-2021-62139)
VIDEO DEMONSTRATION:
English Version (first video above)
Chinese Version (second video above)
INTENDED USE
This kit can be used for the qualitative measurement of SARS-CoV-2 neutralizing antibodies in human serum, plasma and whole blood.
SUMMARY
The SARS-CoV-2 virus is a new type of coronavirus of the genus β, encoding four major structural proteins: spike (S), envelope (E), membrane (M) and nucleocapsid (N). The neutralizing antibodies can target the S1 subunit of S protein and bind to the S1 receptor binding domain (RBD), thereby blocking the interaction between S1RBD of the virus and angiotensin-converting enzyme 2 (ACE2) on the surface of human cells, alleviating the threat from SARS-CoV-2. The detection of neutralizing antibodies can be used to monitor the immune response of vaccinated people or people infected by SARS-CoV-2.
ASSAY PRINCIPLE
This assay is based on the specific antibody-antigen reaction with colloidal gold immunochromatography. Colloidal gold particles conjugated with recombinant SARS-CoV-2 S1RBD is pre-coated on the conjugation pad together with colloidal gold conjugated goat anti-chicken IgY as the control particles. The test line (T) on the strip is coated with recombinant SARS-CoV-2 S1RBD, and the control line is coated with chicken IgY.
During testing, neutralizing antibodies present in the samples bind to the S1RBD conjugated colloidal gold particles. The complex migrates upward by the capillary effect and is captured by the S1RBD immobilized on the membrane forming the test line (T). Meanwhile, the colloidal gold labeled with goat anti-chicken IgY is captured by chicken IgY forming the control line (C). The result is visible within 15-20 minutes.
STORAGE
- The kit needs to be stored at 4 °C-30 °C and in a dry environment.
- Avoiding freezing strips and buffer.
- The test strip is stable until the expiry date only if it has not been opened and kept in the sealed aluminum pouch.
- The assay buffer is valid for 30 days after opening the bottle.
- Do not open the sealed pouch until use. Once opened, the strip should be used within 1 hour.
REAGENTS AND MATERIALS
Components
1 test/kit
25 tests/kit
SARS-CoV-2 neutralizing
antibody test strip
1
25
Assay buffer
0.1 mL/tube
2 mL/tube
Quantitative pipette
1
25
Instruction for use
1
1
ASSAY PROCEDURE
- Video Demonstration in English (see first video above)
- Video Demonstration in Chinese (see second video above)
- Procedure Diagram in English (see first picture above)
- Procedure Diagram in Chinese (see second picture above)