VISION® SARS-COV-2 AG RAPID NASOPHARYNGEAL TEST KIT
Manufactured by Vision Biyotenoloji Ar-Ge Lab Sist. San. Ve Tic. Ltd. ÅžTÄ°, Turkey - https://visionbiotechnology.com/
Device identification number
2835
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Beta Coronavirus HKU1 (HCoV-HKU1), Bordetella Pertussis, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV)
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 SARS-CoV-2 antigen. This test is for clinical laboratory use or emergency medical examination only, not for home testing. It cannot be used as a basis for pneumonia caused by a new coronavirus infection. A positive test result must be further confirmed. The kit and test results are intended for clinical reference only.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
If you react later than 15 minutes, this can lead to a false positive result
False negatives
Reacting earlier than 15 minutes can lead to a false negative result.
Precision
Evaluated
Accuracy
98.7 %
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