SARS-CoV-2 IgG
Manufactured by DIALAB GmbH, Austria - www.dialab.at/en/home/
Device identification number
1053
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
70 minutes
Detection Principle
Magnetic Electrochemical
Analysis of cross reactivity
No cross reactivity observed with samples positive to RSV IgM/IgG/Antibodies and MP IgM/IgG/Antibodies.No interference with rheumatic factor up to 2000 U/mL, bilirubin 35 mg/dL or haemoglobin 0.9 g/dL observed.No cross specificity with similar pathog
Clinical Sensitivity
100 % ((15/15))
Clinical Specificity
99.87 % ((3018/3022))
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