COVID-19 IgG/IgM Test Cassette
Manufactured by CITEST DIAGNOSTICS INC - http://www.citestdiagnostics.com/
Device identification number
1475
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
03/26/2021 03:56
Comments
no info in company website
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
evaluated
Crossreactivity
evaluated
Fp
3.3 %
Fn
3.1 %
Precision
evaluated
Accuracy
96.9 % (IgG/IgM)
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96.7 % (IgG/IgM)
Notes
Rapid diagnostic test lateral flow
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