Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Cassette (Oral Fluid)

Manufactured by Biozek Medical, Netherlands - www.biozek.com 

Device identification number
1991
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Saliva
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Please contact for more information: Robyn White Robyn.white@medusa19.com Data Summary With Additional Information Below: LOD: 100 TCID50/mL COVID-19 Variants: This test has been tested on the UK/South Africa and Kent Strain - all variants are detectable using this device. Sensitivity: 91.67%(95%CI*:85.90%~95.62%) Specificity: 99.72%(95%CI*:98.44%~>99.99%) Accuracy: 97.39%(95%CI*:94.94%~98.87%)
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
LOD
100 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.28 % ((1/354))
Fn
8.33 % ((12/144))
Precision
Not evaluated
Accuracy
97.39 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.67 %
Clinical Specificity
99.72 %
Type of antigen
Nucleoprotein
Notes
This test has been tested on the UK/South Africa and Kent Strain

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