Rapid COVID-19 Antigen Test（Colloidal Gold）
Manufactured by Anbio (Xiamen) Biotechnology Co. Ltd., China - www.anbio.com
Device identification number
2239
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Saliva, 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), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), 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 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)
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Approved by Germany Approved by Paul-Ehrlich-Institut，list on BfArm self test list，the number is 5640-S-058（saliva）and 5640-S-310（Nasal Swab）.According to the evaluation report of PacGenomics Clinical Genetics Laboratory in the United States, the sensitivity and specificity of Anbio's Rapid COVID-19 Antigen test kit （Colloidal Gold） are 98.51% and 99.63%.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
150 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1 AU
Precision
Evaluated
Accuracy
99.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.18 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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