Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA)
Manufactured by Aripa Biotec GmbH, Germany - www.aripa-biotec.com
Device identification number
2633
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antibody, IgG
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The anti-SARS-CoV-2 multi-antibody IgG/Nab Tests (IgG antibody/neutralising antibody) is suitable for the qualitative in vitro detection of SARS-CoV-2 neutralising antibodies and nucleocapsid protein IgG antibodies in human serum, plasma or whole blood. for vaccinated persons and recovered persons.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
98.34 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.67 %
Clinical Specificity
98.01 %
Type of antigen
Spike protein
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