MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA)
Manufactured by Snibe Co. Ltd., China - www.snibe.com/
Device identification number
1491
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
30 minutes
Detection Principle
Chemiluminescence
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
100 % ((93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 20)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % ((93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 20)
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