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
Antigen
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
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