Biozek covid-19 Antigen Rapidtest BCOV-502
Manufactured by Inzek International trading, Netherlands - www.biozek.com
Device identification number
1988
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza B, MERS-CoV, Mumps Virus (MuV), Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Changes in the IFU and additional information about variants detection. We have received the following message from the DHSC (Department of Health and social care): product progressed through phase 3A validation and has been examined at a Design Authority Review (DAR). We would like to advise you that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) was successful in the phase 3A validation and that the Biozek COVID-19 Antigen Rapid Test Cassette (Swab) showed no drop off in sensitivity when compared with the wild type with respect to the following variants - Alpha (VOC1 Kent, UK, B.1.1.7), Beta (VOC2 South Africa, B.1.351), Gamma (VOC3 Brazil, P1) and Delta (VOC4 India B.1.617.2).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.65 % (4/151)
False negatives
0.67 % (10/1484)
Precision
Evaluated
Accuracy
99.14 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.63 %
Clinical Specificity
99.73 %
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