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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, Influenza and RSV 8-well

Manufactured by AusDiagnostics, Australia - www.ausdiagnsotics.com/ 

Device identification number
46
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
no cross-reactivity was detected in a 17 fungal pathogen multiplex using 200 blood culture specimens
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
17.3 copies/μl ((SARS-CoV-2a )
LOD
0.7 copies/μl ((SARS-CoV-2b ))
Analytical Sensitivity
100 % ((SARS-CoV-2a ))
Analytical Sensitivity
97.7 % ((SARS-CoV-2b ))
Analitical Specificity
100 % ((SARS-CoV-2a ))
Type of antigen
SARS-CoV-2 spike protein
Notes
https://www.ausdx.com/qilan/Products/20081-r01.1.pdf

Related Scientific Literature

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