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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgM/IgG (GICA) Test

Manufactured by GenaBio Diagnostics Inc., United States - www.genabio.com 

Device identification number
1576
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
1
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0
False negatives
1.65 %
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
100 % IgM
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % IgM
Clinical Sensitivity
100 % IgG
Clinical Specificity
99.2 % (combined)
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test cassette colloidal gold

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