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 (RAT)
×No
Format
Automated, Manual
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Method
CLIA
Measurement
Quantitative
Time
25 minutes
Detection Principle
Chemiluminescence
LOD
8 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.4 %
False negatives
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