SeroCap Anti-SARS-CoV-2 Neutralizing Kit
Manufactured by Synbiotik Biotechnology, Turkey - https://synbiotiktr.com
Device identification number
2901
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Antibody
Targets
spike protein
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Synbiotik SeroCap Anti-SARS-CoV-2 Neutralizing ELISA is an enzyme-linked immunosorbent assay intended fot the qualitative and semi-quantitative detection of neutralizing antibodies to SARS-CoV-2 in human serum in vitro. The SeroCap Anti-SARS-CoV-2 Neutralizing ELISA is intended to us efor identifiying individuals with adaptive immune response to SARS-CoV-2, due to recent/prior infection. The SeroCap Neutralizing ELISA kits are designed to capture specifically neutralizing antibodies against SARS-CoV-2. SeroCap SARS-CoV-2 Neutralizing ELISA kit displayed 94% sensitivity and 100% specificity against clinical samples with known neutralizing antbody titers. The inter-assay and the intra-assay CV of OD ratios are less then 15%.
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Semiquantitative
Time
150 minutes
Subclass
Neutralization Antibody (NAb)
LOD
500 AU
Calibration
Evaluated
Analysis of cross reactivity
Not evaluated
False positives
3 AU
False negatives
0 %
Precision
Evaluated
Accuracy
97 % (NAb)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 % (NAb)
Clinical Specificity
100 % (NAb)
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements