Bio-Shield 2019-nCoV IgG
Manufactured by Prognosis Biotech - https://www.prognosis-biotech.com/
Device identification number
1499
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-03-26 08:24:53
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
2 % ()
Precision
evaluated
Accuracy
99.59 % ()
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
99.85 % ()
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