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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 Ag RDT

Manufactured by AnteoTech Ltd, Australia - https://www.anteotech.com 

Device identification number
2376
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
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-08 10:52:02 CET
Comments
The SARS-CoV-2 Ag RDT is a test based on lateral flow technology. The test strips are housed in a cassette for compatibility with the EuGeni fluorescent strip reader. The LoD of the test is 2.8x10^5 genome copies/mL. The SARS-CoV-2 Ag RDT is intended to be used by healthcare professionals for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal specimens collected from individuals who are suspected of COVID-19 infection.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
281000 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.3 %
Clinical Specificity
99.6 %
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