COVID-19 Hybrid Capture Fluorescence Immunoassay Test
Manufactured by Anbang (Xiamen) Biotechnology Co. Ltd., China
Device identification number
32
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody
Antibody type
Monoclonal
Targets
Other (Antibody)
Specimen
Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Other
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2023-06-20 01:33:41 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
Colorimetry
LOD
40 N.A.
Calibration
Not evaluated
Analytical Sensitivity
97.7 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
100 %
False negatives
97.7 %
Precision
Evaluated
Accuracy
99.2 %
Robustness
Not evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
100 %
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