SARS-CoV-2 IgG (CLIA)
Manufactured by MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD., China - www.medcaptain.com
Device identification number
1709
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Cassette
Target
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
25 minutes
Detection Principle
Chemiluminescence
LOD
2 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
3.7 % IgG
Fn
3.1 % IgG
Precision
evaluated
Accuracy
96.5 % IgG
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96.9 % IgG
Notes
Manual or automated cassette chemiluminiscence
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