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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COV-QUANTO

Manufactured by AAZ-LMB, France - www.covid19aaz.com 

Device identification number
1834
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Semi-automated
Physical Support
Microplate
Target
Antigen
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
NA
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
210 minutes
Subclass
Sandwich, Double
LOD
2.97 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.6 %
Fn
7 %
Precision
Evaluated
Accuracy
85 % (CI: range: 85-115 (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
98.4 %

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