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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva

Manufactured by Anbio (Xiamen) Biotechnology Co. Ltd., China - www.anbio.com 

Device identification number
2604
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), 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, SARS-CoV-2, Varicella Zoster Virus (VZV)
Pathogens detected
Coronaviruses (HCoV)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 03:42:41 CET
Comments
Certified CE1434 by Notified Body of POLISH CENTRE FOR TESTING AND CERTIFICATION (POLSKIE CENTRUM BADAN I CERTYFIKACJI)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
150 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
98.33 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1.67 %
Precision
Evaluated
Accuracy
99.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.06 %
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