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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test (For Reader)

Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com 

Device identification number
1479
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no info in company website
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 IU/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
5 %
False negatives
5.6 %
Precision
Evaluated
Accuracy
94.9 % ((IgG/IgM))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.9 % (94.4(IgG/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