MeduFlow
Manufactured by Medusa19 Life Sciences, United Kingdom
Device identification number
2905
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Lateral flow
Target type
Antigen
Targets
spike protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product is the first uk test to achieve home use approval.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
98.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.9 %
Clinical Specificity
99.5 %
Type of antigen
Spike 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