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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Dia Sure COVID-19 Antigen Rapid Test Device

Manufactured by Azure Biotech, Inc., United States

Device identification number
2060
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-17 10:18:56 CET
Comments
Limit of detection (LOD):502.4 TCID50/ml Pathogens detected: SARS-CoV-2
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
502.4 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.9 %
Fn
5.7 %
Precision
Evaluated
Accuracy
98.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.3 %
Clinical Specificity
99.1 %
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