ARISTA COVID-19 Antigen Rapid Test
Manufactured by ARISTA Biotech Pte. Ltd, Singapore - www.aristabio.com
Device identification number
1926
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow, Strip
Target
Antigen
Specimen
Anterior nasal swab, Deep (cough) sputum, Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
ARISTA COVID-19 Antigen Rapid Test can detect the B. 1. 1. 7 SARS-CoV-2 variants.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.81 AU
Fn
9.56 AU
Precision
Evaluated
Accuracy
96.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.44 %
Clinical Specificity
99.71 %
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