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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 - www.azure.bio 

Device identification number
2382
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
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Rhinovirus
Commercial Status
Commercialised
Last Update
2021-07-09 09:47:47 CET
Comments
Notes: Supplement the number of clinically naso- or oropharyngeal positive samples to more than 100 cases.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
502 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % none, 100% specific
Fn
0 % no false negatives occurred on antigen level at 0.4 ng/mL or virus level at 2×10 2.4 TCID50/mL
Precision
Evaluated
Accuracy
98.3 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.1 %
Clinical Specificity
99.3 %
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