Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold)
Manufactured by Bioneovan Co. Ltd., China - www.bioneovan.com
Device identification number
2077
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Human Immunodeficiency Virus (HIV), Mycobacterium Tuberculosis
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
95 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.75 %
False negatives
2.86 %
Precision
Evaluated
Accuracy
97.89 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.33 %
Clinical Specificity
97.56 %
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