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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ActivXpress+ COVID-19 Antigen Complete Testing Kit

Manufactured by Edinburgh Genetics Limited, United Kingdom - eggenetics.com 

Device identification number
1243
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product was evaluated by Paul-Ehrlich-Institute in Germany..
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
3 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Specificity 99.24%
False negatives
Sensitivity 96.17%
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.27 (Nasopharyngeal swab)
Clinical Sensitivity
95.63 (Oropharyngeal swab)
Clinical Sensitivity
96.17 % (Saliva)
Clinical Specificity
99.62 (Nasopharyngeal swab)
Clinical Specificity
99.24 (Oropharyngeal swab)
Clinical Specificity
99.24 % (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