Innovation and reliability in immunoassay after vaccination
Innovative immunochromatography design ONE STEP RAPID TEST by Dyonmed!
Immunity Assessment | Direct control | Suitable for screening large groups of population
DyonCovid19-S® (neutro), is a rapid chromatographic immunobiological test for the semi-quantitative detection of IgM & IgG antibodies against severe acute coronary syndrome due to coronavirus 2 (SARS-CoV-2) in human blood plasma / serum samples. which helps diagnose coronavirus (COVID-19) infection caused by SARS-CoV-2 (“passive” immunization).
DyonCovid19-S®, detects the “Neutralizing Antibodies (nAbs)” of the specific protein / “pin” “S” of the surface of SARS COV-2 (spike (S) protein), helping significantly in the diagnosis of “active” Immunization (after vaccination).
INTENDED USE
It is mainly used to identify individuals with an acquired immune response to SARS-CoV-2 and to evaluate the effectiveness of clinical vaccine trials and mass vaccination.
PERFORMANCE CHARACTERISTICS
DyonCovid19-S® (neutro) was compared to the CPE technique using clinical specimens from 136 healthy volunteers and 42 diagnosed patients. The CPE (microdose cytopathic effect) was selected as the comparison method and the comparison results are shown in the table below. Homologous serum, plasma and whole blood samples were also collected from the 50 individuals mentioned above and the results were consistent.
The results are as follows:
The results show:
- sensitivity 48%.
- PPA: 90.48%(95%CI:94%-96.24%)
- specialty 26% and
- NPA: 99.26%(95%CI:95%-99.87%)
- Η Overall Accuracy is at 19%
- OPA: 97.19%(95%CI:59%-98.79%)