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 (RAT)
×No
Format
Automated, Lab-based, Semi-automated
Physical Support
Chip
Target type
Antibody, IgG
Specimen
Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Not evaluated
False positives
0 %
False negatives
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