SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
4114
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Other (Lateral flow)
Physical Support
Cassette
Target type
Antibody
Antibody type
Monoclonal
Targets
nucleocapsid protein, spike protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Respiratory Syncytial V (RSV)
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
BA.2.12, BA.2.12.1, BA.4, BA.5, BA.2.75
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-31 09:32:15 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
AU
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
99.5 %
Analysis of cross reactivity
Evaluated
False positives
% 0 false positive results are observed in 60 positive samples confirmed by RT-PCR
False negatives
1 % (3 false negative results are observed in 208 negative samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.6 %
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
99.5 %
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