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
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
5.4 % (8/148)
False negatives
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