MAGLUMI SARS-CoV-2 Ag (CLIA)
Manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd., China - https://www.snibe.com/
Device identification number
2187
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-06-08 10:46:32 CET
Assay Type
Immuno-Antigen
Method
CLIA
Measurement
Quantitative
Time
25 minutes
Detection Principle
Chemiluminescence
LOD
8 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.4 %
Fn
2.3 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
99.6 %
Type of antigen
Nucleoprotein
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