GA CoV-2 Antigen Rapid Test
Manufactured by GA Generic Assays GmbH, Germany - www.genericassays.com
Device identification number
1855
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
GA CoV-2 Antigen Rapid Test is used for the qualitative determination of SARS-Coronavirus 2 (COVID-19) Antigen in human nasopharynx specimen. The test is intended for use by trained clinical laboratory personnel.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
10 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.8 % (4/500)
False negatives
2.94 % (3/102)
Precision
Evaluated
Accuracy
98 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97.059 %
Clinical Specificity
99.2 %
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