Coronavirus (SARS-CoV-2) Neutralizing Antibodies
Manufactured by Tody Laboratories Int., Romania - www.todylaboratories.com/
Device identification number
1933
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Fingertip
Target type
Antibody, IgG, IgM
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Commercial Status
Unknown
Last Update
2022-08-24 09:08:01 CET
Comments
Anti-Spike Protein, Colloidal Gold
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0.025 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95.7 %
Clinical Specificity
100 %
Type of antigen
Other
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