Bio-Shield 2019-nCov IgM
Manufactured by Prognosis Biotech, Greece - www.prognosis-biotech.com/
Device identification number
1500
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
90 minutes
Subclass
Other
LOD
1 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
1 %
Fn
6 %
Precision
evaluated
Accuracy
99.06 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
92.31 %
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