SERION ELISA agile SARS-COV-2 IgM
Manufactured by Institut VirionSerion GmbH, Germany - https://www.virion-serion.de/en/
Device identification number
2748
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microtiter plate
Target type
IgM
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Composition of Antigen: MIxture of whole spike protein and nucleocapsid protein.
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Self Test
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
130 minutes
Subclass
Enzyme-linked
Analysis of cross reactivity
Evaluated
False positives
0 % 0/139
False negatives
3.84 % (1/26)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.2 % IgM
Clinical Specificity
99 % IgM (> 99)
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