Dediatest IgG-Spike
Manufactured by Devidia GmbH, Germany - www.devidia.de
Device identification number
2193
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG
Specimen
Plasma, Serum, 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
Dediatest IgG-Spike erfasst sowohl die Immunreaktion auf SARS-CoV-2-Infektionen als auch auf SARS-CoV-2-Impfungen. Bei der Immunreaktion auf Impfung ist die Sensitivität 95,7% Spezifität 100% Genauigkeit 97,9%. Der Vergleich erfolgte hier mit einem CLIA.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
6 AU
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
Type of antigen
Other
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