VISION COVID 19 RAPID ANTIGEN TEST KIT
Manufactured by Vision Biotechnology, Turkey - www.visionbiotechnology.com
Device identification number
2650
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Lineages detected
Commercial Status
Commercialised
Last Update
2021-09-23 01:43:45 CET
Comments
This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen. This test is for clinical laboratory use or emergency medical examination only and is not suitable for home testing. It cannot be used as a basis for pneumonia caused by a new coronavirus infection. A positive test result should also be confirmed. Test results are for clinical reference only.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
after 15 min. it will be appear
Fn
Inadequate or inappropriate sample collection, storage, and transport can lead to false test results
Precision
Evaluated
Accuracy
99.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.3 %
Clinical Specificity
99.4 %
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