GENnasal SARS-CoV-2 Antigen Rapid Test
Manufactured by Genius Pharmaceutical AG, Switzerland
Device identification number
3149
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Sensitivity, specificity and accuracy are from the newest performance evaluation - including false-positives and false-negatives. German Paul-Ehrlich-Institur (PEI) evaluated this test under the test-ID AT 1269/21
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
400 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
6 %
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.5 %
Clinical Specificity
99.9 %
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