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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

OneCheck Covid-19 Ag

Manufactured by Delta Chemie Biotechnology SAS, Italy - www.deltachemie.it 

Device identification number
2088
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
0 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
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