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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Attana AVA SARS-CoV-2 IgG Immunoassay

Manufactured by Attana AB, Sweden - www.attana.com 

Device identification number
2335
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Lab-based, Semi-automated
Physical Support
Chip
Target
Antibody, IgG
Specimen
Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-01 09:25:59 CET
Comments
Receptor-binding domain (RBD) of the Spike protein. Attana AVA SARS-CoV-2 IgG Immunoassay for use with the Attana Cell 250 or Cell 200 systems to measure SARS-CoV-2 IgG in patient serum samples. CE-IVD registered. Ability to measure affinity of antibody interactions to RBD target
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
17 minutes
Subclass
Sandwich, Double
LOD
1
Calibration
Evaluated
Crossreactivity
Not evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Specificity
100 % IgG
Type of antigen
Other

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