Publicité
Introduction
Norovirus belongs to the virus class Caliciviridae and is known to be a sea-
sonal disease. It is a highly contagious pathogen that is responsible for the
majority of cases of acute gastroenteritis worldwide. Norovirus infections
in humans are mainly caused by genogroup II and I, while GII being the pre-
dominant cause of Norovirus outbreaks. Infections of the gastrointestinal
tract by Norovirus are characterized by sudden onset symptoms such as nau-
sea, vomiting, diarrhea, and abdominal pain. The virus is particularly prev-
alent in communal settings such as hospitals, schools, and nursing homes,
where it can easily spread from person to person. The illness typically lasts
only a few days but can cause more severe complications in immunocompro-
mised individuals or the elderly. Acute gastroenteritis caused by Norovirus
is a self-limiting disease although if untreated can cause a critical course of
disease especially in the youngest or elderly.
Package Contents
15 Vivalytic Norovirus test cartridges for the detection of human Norovirus
genogroup I/ II.
Pathogen List
Norovirus genogroup I/II
Intended Use
The Vivalytic Norovirus test is an automated qualitative in vitro diagnostic
test based on real-time polymerase chain reaction (PCR) for the detection
of nucleic acids from human Norovirus genogroup I/ II from liquid or soft hu-
man stool swabs to aid in the diagnosis of acute gastrointestinal infections
of symptomatic individuals.
Results should not be used as the sole basis for diagnosis, treatment or
other patient management decisions. Positive results do not exclude co-in-
fection with other pathogens. The agent(s) detected may not be the definite
cause of disease. Negative results do not exclude a Norovirus infection or
another gastrointestinal infection. Results must be clinically correlated with
patient history, clinical observations and epidemiological information. Other
diagnostic information is necessary to determine patient infection status.
Intended for use with a Vivalytic one analyser by healthcare professionals
only in laboratory settings such as hospital laboratories and reference labo-
ratories.
Safety Information
These Instructions for Use contain test-specific information only. For addi-
tional 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 car-
tridge, and dispose it.
For in vitro diagnostic use by trained healthcare professional.
Vivalytic Norovirus
1,2,3,4
2
– Instructions for Use
Publicité
