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 (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
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), 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
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.gruenbanka.eu
Assay Type
Immuno-Antigen
Subcategory
Other ()
Method
Immunoassay
Time
10 minutes
Subclass
Sandwich, Double
LOD
10 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6 AU
False negatives
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