SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette
Manufactured by Hangzhou Sejoy Electronics & Instruments Co. Ltd., China - http://www.sejoy.com.cn/
Device identification number
2062
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Lineages detected
P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We have also evaluated the cross reactivity and interference substances.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
5050 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 AU
False negatives
2 AU
Precision
Evaluated
Accuracy
98.97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.4 %
Clinical Specificity
99.2 %
Type of antigen
Other
Notes
neutralizing antibody
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