Biozek covid-19 Antigen Rapidtest BCOV-802
Manufactured by Inzek International trading, Netherlands - www.biozek.com
Device identification number
1987
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Check IFU for more information. Clinical studies available. Biozek Sales organisation Mach-E BV the Netherlands
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.28 % ((1 / 354))
False negatives
8.33 % ((12 / 144))
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91 %
Clinical Specificity
99 %
Type of antigen
nucleocapsid protein
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