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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)

Manufactured by ACON Laboratories, Inc, United States - www.aconlabs.com 

Device identification number
1908
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
N.A.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
Subclass
Membrane-based
LOD
160 AU
Fp
0.46 (2 out of 435(Nasal Swab); 1 out of 236(Saliva))
Fn
2.94 (5 out of 170(Nasal Swab); 9 out of 105(Saliva))
Precision
Evaluated
Accuracy
98.8 % (98.8%(Nasal Swab); 97.1%(Saliva))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 % (97.1%(Nasal Swab); 91.4%(Saliva); )
Clinical Specificity
99.5 % (99.5%(Nasal Swab); 99.6%(Saliva); )
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