Gruenbanka SARS-CoV-2 Antigen Testkit
Manufactured by Xiamen Jiqing Biomedical Technology Co. Ltd, China - www.wikang.com.cn
Device identification number
2057
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Pathogens detected
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), Coronaviruses (HCoV), 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, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-17 09:41:18 CET
Comments
www.gruenbanka.eu
Assay Type
Immuno-Antigen
Subcategory
Other
Method
Immunoassay
Time
10 minutes
Subclass
Sandwich, Double
LOD
10 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
6 AU
Fn
0 %
Precision
Evaluated
Accuracy
97 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
94 %
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