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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgG/IgM Rapid Test

Manufactured by Prestige Diagnostics UK - www.prestigediagnostics.co.uk 

Device identification number
1070
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
03/26/2021 09:05
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
0 AU 0
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
95 % IgG
Accuracy
96.7 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.8 % IgG
Clinical Sensitivity
95.7 % IgM
Clinical Specificity
96.4 % IgG
Clinical Specificity
97.3 % IgM

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