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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgG

Manufactured by Abbott, United States - www.abbott.com/ 

Device identification number
701
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
29 minutes
Subclass
Not found
Fp
Four false positives out of a total of 1070 negative specimens.
Fn
Zero false negatives for specimens collected from positive subjects >/=14 days post-symptom onset.
Precision
Evaluated
Accuracy
99.45 % IgG
Reproducibility
Not Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Specificity
99 % (181/182)

Related Scientific Literature

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