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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 (Self-Testing)

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

Device identification number
2452
CE Marking
Yes
HSC common list (RAT)
×No
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1 AT.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
N.A.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
160 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.46 % (2 out of 435)
Fn
2.94 % (5 out of 170)
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.5 %
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