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Vivalytic C. auris
– Instructions for use
Introduction
Candida auris (C. auris) is a pathogenic fungus belonging to the Candida
genus. It was first discovered in Japan in 2009 and has spread globally since
then. C. auris is a commensal skin inhabitant frequently found in axilla, groin
or nasal swab samples.
The fungus is notorious for its resistance to many
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common antifungal drugs, making the treatment of infections challenging.
C. auris can survive on artificial surfaces and has a high resilience against
disinfection strategies, allowing it to cause outbreaks and persist in hospi-
tals and other medical facilities.
The clinical symptoms caused by C. auris
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can vary depending on the site of invasive infection. It can lead to infections
of the bloodstream, respiratory tract, urinary tract, and other areas of the
body. Symptoms may include fever, chills, fatigue, and respiratory difficul-
ties. The clinical relevance of C. auris lies in its ability to cause critical infec-
tions in immunocompromised individuals. This particularly affects patients
in hospitals and nursing homes.
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Package Contents
15 Vivalytic C. auris test cartridges for the detection of Candida auris
(ITS2 gene).
Pathogen List
Candida auris (ITS2 gene)
Intended Use
The Vivalytic C. auris test is an automated qualitative in vitro diagnostic test
based on real-time PCR for the detection of Candida auris DNA from human
bilateral axilla, groin and nasal combination swabs and nasal swabs to
screen individuals at risk for colonization and to aid in the prevention and
control of Candida auris outbreaks and infections in healthcare settings.
Negative results do not exclude a Candida auris colonization. Results should
not be used as the sole basis for treatment, or other patient management
decisions. Results must be clinically correlated with patient history, clinical
observations, and epidemiological information. Intended for use with a Viva-
lytic one analyser by healthcare professionals only in a laboratory setting.
Safety Information
These Instructions for Use contain test-specific information only. For additional
warnings and instructions refer to the Instructions for Use provided with your
Vivalytic one analyser (chapter device safety information). Only use Vivalytic
cartridges and accessories approved for the Vivalytic one analyser. Take care to
avoid any contamination when handling patient samples and cartridges. When
sample was spilled on the cartridge, do not use the cartridge, and dispose it.
For in vitro diagnostic use by trained healthcare professional.
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