Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography)
Manufactured by AIETech Co. Ltd., China
Device identification number
3036
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza B, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)
Pathogens detected
Coronaviruses (HCoV)
Information on antigen epitope targeted by the antibodies used in the design of the device
44-175aa,74-105aa
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
frist application
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
140 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.48 AU
False negatives
10.68 AU
Precision
Evaluated
Accuracy
96.15 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.32 %
Clinical Specificity
99.52 %
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