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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 II Quant

Manufactured by Abbott Ireland Diagnostics Division, Ireland - www.corelaboratory.abbott 

Device identification number
2773
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated
Target type
Antibody, IgG
Specimen
Plasma, Serum
Lineages detected
Commercial Status
Commercialised
Last Update
2021-11-19 05:31:44 CET
Comments
SARS-CoV-2 IgG II Quant (also referred to as CoV-2 IgG II or SARS-CoV-2 IgG II on the reagent bottle/cartridge label). The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
29 minutes
LOD
6.8 AU/mL
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.45 % (Nine false positives out of a total of 1999 negative specimens)
Fn
One false negative for specimens collected from positive subjects >/=15 days post-symptom onset.
Precision
Evaluated
Accuracy
99.37 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.37 % IgG
Clinical Specificity
99.55 % IgG
Type of antigen
Spike protein

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