VISION COVID-19 RAPID ANTIGEN TEST KIT
Manufactured by Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi, Turkey - www.visionbiotechnology.com
Device identification number
2776
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Beta Coronavirus HKU1 (HCoV-HKU1), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, MERS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for the in vitro qualitative detection of the SARS-CoV-2 antigen.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
100 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
15 AU
Precision
Evaluated
Accuracy
99.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.57 %
Clinical Specificity
97.57 %
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