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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Vicare Rapid FL

Manufactured by Vicare Solution GmbH, Germany - www.vicare-solution.de 

Device identification number
2930
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC, Semi-automated
Physical Support
Microplate, Microtiter plate, Strip
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, ORF1ab polyprotein/gene
Specimen
Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
VICARE RAPID FL is a qualitative fluorometric or colorimetric detection (in-vitro diagnostics) of SARS-CoV-2-RNA in oropharyngeal / nasopharyngeal swab samples or gargle samples from test subjects. Results are obtained within 35min or isothermal incubation.
Assay Type
Nucleic acid-Other
Self Test
No
Reader Required
No
Method
LAMP
Measurement
Qualitative
Time
30 minutes
LOD
150 cpu
Positive control
included in detection kit
Negative control
included in detection kit
Analytical Sensitivity
95 %
Analytical Specificity
99 %
Clinical Sensitivity
97.8 %
Clinical Specificity
99.5 %

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