Unibioscience Covid-19 Nasopharynx Antigen Test
Manufactured by Unibioscience AS, Turkey - www.unibioscience.com
Device identification number
2523
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Parainfluenza Virus Type, Rhinovirus, 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), B.1.621 (Mu), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS CoV-2 Antigen Rapid Test is a lateral flow immunoassay for the rapid qualitative detection of the N-protein antigen of SARS CoV-2 in swab specimens from both symptomatic and asymptomatic COVID- 19 infected individuals.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
2870 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.42 % (5/350)
False negatives
0.85 % (3/350)
Precision
Evaluated
Accuracy
98.86 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.57 %
Clinical Specificity
99.14 %
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