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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette

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

Device identification number
1471
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no info in company website
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.08 % ((0.9% Influenza A); (0.9% Influenza B))
False negatives
3.6 % ((5.0% Influenza A); (7.1% Influenza B))
Precision
Evaluated
Accuracy
98 % ((98.4 Influenza A); (98.1 Influenza B))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 % ((95.0 Influenza A); (92.9 Influenza B))
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