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Rapid test for the qualitative detection of IgG antibodies against the SARS-CoV-2 Spike protein in human serum, blood, plasma samples. For professional in-vitro diagnostic use only
One of the most important proteins in the infection process of SARS-CoV-2 virus is the Spike protein, which is divided into two parts: S1 contains an RBD region (Receptor Binding Domain) that allows it to bind to the cell target by adhering to the ACE2 receptor and S2 region that allows the virus to enter the cell in a second stage.
read moreThis evidence allows us to assume that an antibody capable of inhibiting the interaction between the Spike protein and the ACE2 receptor would potentially be able to prevent coronavirus infection and, consequently, the associated COVID-19 disease. For this reason, among the various classes of antibodies produced, type G immunoglobulins (IgG) can hinder the interaction between RBD and ACE2 and, because of this ability to hinder the infection process of the virus, they are defined as neutralizers. Consequently, the Spike protein or portions of it have been used as an immunological target in the development of vaccines against SARS-CoV-2.
Easy to use
Results in 10 minutes
COVID-19 emergency support
Rapid evaluation of vaccination coverage
Serological tests detect the body’s immune response to infection caused by the virus and not the presence of the virus itself. Recent studies have shown that IgG antibodies against Spike protein appear from 14 days after the end of the vaccination cycle.
read moreIn particular, serological tests that detect antibodies against Spike protein are of great interest, as they show whether the immune response has produced antibodies involved in the virus neutralization process. However, this type of test is not conclusive for the diagnosis of an infection in progress, as the absence of antibodies does not exclude the possibility of an infection at an early stage, with the risk for an individual to be contagious, despite having tested negative at the serological test.
COVID-19 NEUTRALISING Ab RAPID TEST is a rapid lateral flow immunochromatographic device for qualitative detection of IgG antibodies against the RBD portion of SARS-CoV-2 Spike protein in human plasma, serum or whole blood samples.
Recent studies have shown 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).
| Test format | rapid immunochromatographic lateral-flow assay |
| Instrument | Igloo Reader |
| Results reading time | 10 minutes |
| Sample | whole blood, serum and plasma |
| Antigen | Spike |
| Specificity | 97.4% |
| Sensitivity | 98.1% |
| Accuracy | 96.5% |
| Seroconv. Pfizer | 98.3% |
| Seroconv. Moderna | 95.2% |
| Seroconv. AstraZeneca | 98.5% |
| Positivity rate after booster dose | 100% |
| Negative | 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. |
| Positive | 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)
2. https://www.who.int/emergencies/diseases/novel-coronavirus-2019
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" section of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).
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