2019-nCoV IgG/IgM Rapid Test Cassette
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
Device identification number
1390
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
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
LOD
0
Calibration
Not evaluated
False positives
3.7 %
False negatives
3.1 %
Accuracy
96.4 %
Clinical Sensitivity
96.9 %
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