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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SERION ELISA agile SARS-COV-2 IgG

Manufactured by Institut VirionSerion GmbH, Germany - https://www.virion-serion.de/en/ 

Device identification number
2745
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microtiter plate
Target type
IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.617.2 (Delta), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Test is validated for the detection of intrathecally synthesized IgG antibodies against SARS-CoV-2.
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
130 minutes
Subclass
Enzyme-linked
LOD
3 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.75 % (1/133)
False negatives
3.63 % (2/55)
Precision
Evaluated
Accuracy
76.1 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.2 % IgG
Clinical Specificity
99.2 % IgG
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