Intended use:

For in vitro diagnostic use. The RIDA®UNITY Flu test, performed on the RIDA®UNITY
platform, is a multiplex real-time PCR for the direct qualitative detection and
differentiation of influenza virus (influenza A, influenza B) RNA in untreated human
nasal/throat swabs from persons with signs and symptoms of acute respiratory
infection.
The RIDA®UNITY Flu test is intended to support the differential diagnosis of influenza
virus infections in patients with symptoms of respiratory infection in connection with
other clinical and laboratory findings.
Negative results do not rule out infection with influenza virus and should not be used
as the sole basis for diagnosis.
The product is intended for professional use.

General information:

Also known as the flu, influenza is a contagious respiratory infectious disease caused
by influenza A and influenza B in humans. Influenza A and B viruses are
responsible for seasonal flu epidemics each year and can cause mild to severe
disease, involving serious sequelae that can lead to hospitalization or death. All
influenza viruses are enveloped, single-stranded RNA viruses with a segmented
genome and belong to the family Orthomyxoviridae. The genus of influenza
viruses is divided into types A, B, and C on the basis of their core proteins. Influenza
A and B are the most relevant for humans because they are highly contagious and
are responsible for seasonal epidemics. Characteristic for influenza viruses is their
high variability of the surface antigens hemagglutinin (HA) and neuraminidase (NA)
due to mutations (antigenic drift). Primarily seasonal influenza A viruses H1N1 and
H3N2 are currently circulating among people. Such seasonal influenza outbreaks
usually occur in the winter months because low air humidity and low temperatures
favor transmission.
Influenza viruses are primarily transmitted through tiny droplets produced during
coughing, sneezing, or talking, and they are rather unlikely to be transmitted via
surfaces. Children seem to be the main transmitters of influenza viruses. The time
between exposure and infection and the occurrence of symptoms is 1 to 4 days.
Clinical symptoms of influenza virus infection include both mild complaints limited to
the upper respiratory tract, such as fever, sore throat, cough, nasal congestion,
headache, muscle pain, and fatigue, as well as severe cases often leading to fatal
pneumonia. In some cases, this type of infection can also lead to diseases outside of
the respiratory tract, primarily affecting the heart and central nervous system.

Accessories:

Specifications
Art. No. UN0505
Test format real-time PCR with 96 reactions
Shelf life 12 month after production
Files

Dear customers,

we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.

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