Unibioscience Covid-19 Nasopharynx Antigen Test
Manufactured by Unioninvest Ltd., Turkey - www.unibioscience.com
Device identification number
2523
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge, Cassette, Lateral flow, Strip
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-03 09:26:59 CET
Comments
The SARS-CoV-2 Antigen Rapid Test is designed for the primary detection of SARS-CoV-2 N antigen and
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
2.87 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
11 %
Fn
7 %
Precision
Evaluated
Accuracy
98.84 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97.9 %
Clinical Specificity
99.15 %
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