SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
Device identification number
1472
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
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.8 % ((S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus))
False negatives
3.6 % ((5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus))
Precision
Evaluated
Accuracy
98 % ((98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.4 % ((95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus))
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