SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)
Manufactured by Beijing Applied Biological Technologies Co. Ltd., China - https://www.x-abt.com/
Device identification number
3065
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Lateral flow
Target type
Antibody
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Anti-Nuclear Antibody, Beta Coronavirus OC43 (HCoV-OC43), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Respiratory Syncytial V (RSV)
Lineages detected
AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid 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