iRAPID SARS-CoV-2 QUANT “NEUTRALIZING” Ab
Manufactured by DIESSE Diagnostica Senese SPA, Italy - www.diesse.it
Device identification number
2732
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
IgG
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Semiquantitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
125 AU/mL (BAU/ml)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
97.4 % IgG
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.1 % IgG
Clinical Specificity
98.1 % IgG
Type of antigen
Spike protein
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