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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)

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

Device identification number
1822
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Throat 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, Varicella Zoster Virus (VZV)
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
150 TCID50/ml
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
99.5 % (Nasopharyngeal Swab)
Accuracy
99.3 % (Nasal Swab)
Accuracy
99.2 % (Throat Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.33 % (Nasopharyngeal Swab)
Clinical Sensitivity
97.33 % (Nasal Swab)
Clinical Sensitivity
97.67 % (Throat Swab)
Clinical Specificity
100 % (Nasopharyngeal Swab)
Clinical Specificity
100 % (Nasal Swab)
Clinical Specificity
100 % (Throat Swab)
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