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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-24 01:20:03 CET
Comments
Laboratory studies performed with over 400 mutated strains of SARS-CoV-2 N protein antigens including B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617, B.1.617.2 (Delta), AY.1/AY.2/AY.3 (Delta Plus), B.1.617.3, C.37 (Lambda) mutant strains, was detected by the ARISTA™ COVID-19 Antigen Rapid Test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 AU
Fn
0.65 AU
Precision
Evaluated
Accuracy
99.82 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.35 %
Clinical Specificity
100 %
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