Unibioscience Covid-19 Rapid Antigen Saliva Test
Manufactured by Unibioscience AS, Turkey - www.unibioscience.com
Device identification number
2522
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
Saliva, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Saliva tests are self-administered; this means that after you are shown how to perform the test, you’ll do it by yourself. You will spit several times into a funnel attached to a tube, and then screw on a cap to complete the sample collection. Saliva tests are more comfortable than nasal swabs and just as accurate.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich, Double
LOD
2870 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
1.33 % (4/300)
False negatives
0.33 % (1/300)
Precision
Evaluated
Accuracy
99.17 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.67 %
Clinical Specificity
99.67 %
Type of antigen
Nucleocapsid protein
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