Unibioscience® COVID-19 Ag Home Test
Manufactured by Unibioscience AS, Turkey - www.unibioscience.com
Device identification number
2826
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Dipstick, Lateral flow, Strip
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.36
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Unibioscience COVID-19 Ag Home Test is a lateral flow immunoassay intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19 in anterior nasal swabs from individuals age 2 years and older; for prescription use only tests, such as symptomatic individuals who are suspected of COVID-19 by a healthcare provider, or individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
2000 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
99.375 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.67 % (Antigen)
Clinical Specificity
99.67 % (Antigen)
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