SARS-CoV-2 Neutralizing Antibody Rapid Test
Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com
Device identification number
1584
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no info on website about preformance (LOD=0)
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Not available
False negatives
Not available
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.7 %
Notes
Rapid diagnostic test cassette
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