COVID-19 N.A.T. Neutralizing Antibodies Test
Manufactured by ASSUT EUROPE SPA, Italy - www.assuteurope.com
Device identification number
2195
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Strip
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
Other ()
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0.01 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
93.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.44 %
Clinical Specificity
92.45 % (MAGLIANO DEI MARSI (AQ))
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