SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)
Manufactured by Cofoe Medical Technology Co., Ltd., China
Device identification number
3937
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Card
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Influenza A, Influenza A H1N1, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Rhinovirus
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Influenza A, Influenza A H1N1, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Rhinovirus
Information on antigen epitope targeted by the antibodies used in the design of the device
Target epitopes(amino acid position) 74-105aa,44-175aa
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-11-14 09:03:04 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Calibrant / control sample
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
900 TCID50/ml
Analytical Sensitivity
100 %
Analytical Specificity
100 %
False positives
0.99 %
False negatives
9.901 %
Accuracy
97.228 %
Clinical Sensitivity
90.099 %
Clinical Specificity
99.01 %
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