Rapid self-test for the qualitative detection of COVID-19 antibodies produced after vaccination in human whole blood samples
Spike protein is one of the proteins that make up SARS-CoV-2 virus and it is one of the most important in the virus infection process.
Spike protein covers the surface of the virus forming characteristic bumps (making it look like a crown – hence the name “Coronavirus”). Spike protein binds to specific receptors on the surface of target cells and allows the virus to enter the cell itself. For this reason, antibodies against Spike protein (in particular immunoglobulins G, IgG) may be able to inhibit the interaction between viruses and cells, preventing the infection process and, consequently, the development of the associated disease. Therefore, Spike protein or portions of it have been used as an immunological target in the development of vaccines against COVID-19.
WHO IS THIS TEST FOR?
COVID-19 NEUTRALISING IgG SEROLOGICAL TEST is dedicated for anyone who wants to check the antibody reaction after the end of the vaccination cycle.
Serological tests detect the body’s immune response to infection caused by the virus and not the presence of the virus itself. In particular, serological tests that detect Spike protein are of great interest, as they detect the presence of antibodies involved in the virus neutralization process in response to vaccination.
COVID-19 NEUTRALISING IgG SEROLOGICAL TEST is an immunochromatographic assay for the qualitative detection of IgG antibodies against SARS-CoV-2 Spike protein in blood samples. Recent studies have shown that these antibodies usually appear starting from 14 days after the end of the vaccination cycle, with a 100% positivity rate* following the booster dose – the research is still ongoing (* data obtained from subjects vaccinated with Pfizer BioNTech and Moderna booster doses).
Positivity rate after booster dose
1 test cassette
1 vial with dropper containing the diluent
2 sterile lancets
1 pipette for blood sampling
1 cleanser gauze
instructions for use
Draw a blood sample by using the sterile lancet provided;
Collect the sample indicated with the black line by using the capillary pipette provided;
Deposit the collected specimen into the sample well (S) indicated on the test cassette;
Add 2 drops of the diluent and wait 10 minutes before reading the result.
anti-Spike IgG levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device.
anti-Spike IgG antibodies have been detected by the diagnostic system.
1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-background-disease)
3. HUANG, Yuan, et al. Structural and functional properties of SARS-CoV-2 Spike protein: potential antivirus drug development for COVID-19. Acta Pharmacologica Sinica, 2020, 41.9: 1141-1149.
4.SHANG, Jian, et al. Structural basis of receptor recognition by SARS-CoV-2. Nature, 2020, 581.7807: 221-224
5. Sieroconversione Pfizer 98.3% (95% CI: 95.6-99.3%) - Data on file. Q8R318 Study Report. Italian National Cancer Institute (Milan, Italy), Interuniversity Center for Research on Influenza and other Transmissible infections (Genova, Italy), Pharmacological Research Institute Mario Negri (Bergamo, Italy) and PRIMA Lab SA (Balerna, Switzerland); May 2021.
6. Sieroconversione Moderna 95.2% (95% CI: 77.3-99.2%) - Data on file. Q8R334 Study Report. PRIMA Lab SA (Balerna, Switzerland); June 2021.
7. Sieroconversione AstraZeneca 98.5% (95% CI: 92.1-99.7%) - Data on file. Q8R335 Study Report. PRIMA Lab SA (Balerna, Switzerland); June 2021.
8. Performance Validation Post Booster Dose 100% positivity rate (95% Wilson C.I.: 87.1 - 100%) - Data on file. Q8R348 Study Report. PRIMA Lab SA (Balerna, Switzerland); January 2022.
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" secrion of the instructions for use.
The color intensity of the control and test bands may vary depending on the concentration of antigens present in the sample. Therefore, any color hue in the test region (T) should be considered as positive.
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