VISION COVID-19 AG RAPID TEST KIT
Manufactured by Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi, Turkey - www.visionbiotechnology.com
Device identification number
2734
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Human Metapneumovirus (HMPV), MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2
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
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Not evaluated
False positives
2 AU
False negatives
2 AU
Precision
Evaluated
Accuracy
99.4 %
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