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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



POLOFLUOR 2

Manufactured by Polonord Adeste Srl, Italy

Device identification number
2583
CE Marking
Yes
HSC common list (RAT)
×No
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
POLOFLUOR 2 is a membrane fluorescence qualitative test for the detection of SARS-Cov-2 nucleocapsid protein antigen in the human rhinopharyngeal swab sample. The COVID-19 antigen test cassette (nasopharyngeal swab) is capable of detecting SARS-COV-2 heat inactivated viral strain from 1 x 102 TCID50/ml. Other studies on performance characteristics: - Detection Level Determination - Interfering Substances - Specificity Testing with Strains - Dose Hook Study - Variability (Inter/Intra/Day to day assay) - Reading Time Flex Study - Specimen Volume Flex Study - Open Pouch Stability Study - Accelerated Stability Study
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Detection Principle
Fluorescence
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
5.4 % (8/148)
Fn
0.46 % (1/217)
Precision
Not evaluated
Accuracy
97.5 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
99.3 %
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