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Package Contents
15 Vivalytic MG, MH, UP/UU test cartridges for the qualitative detection of
Mycoplasma genitalium (MG), Mycoplasma hominis (MH) and Ureaplasma
parvum/Ureaplasma urealyticum (UP/UU).
Intended Use
The Bosch Vivalytic MG, MH, UP/UU test is an automated qualitative in vitro
diagnostic test based on real-time polymerase chain reaction (PCR) for the
detection of nucleic acids from Mycoplasma genitalium, Mycoplasma hominis
and Ureaplasma parvum/urealyticum from human urine samples or human
vaginal, cervical, urethral, rectal swab samples to aid in the diagnosis of sex-
ually transmitted infections of symptomatic and asymptomatic individuals.
Results should not be used as the sole basis for diagnosis, treatment
or other patient management decisions. Positive results do not exclude
co-infection with other pathogens. The agent detected may not be the defi-
nite cause of disease. Negative results do not exclude a Mycoplasma- and
Ureaplasma related infection or another 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 both near patient testing such as doctor's offices, emergency depart-
ments and nursing homes as well as laboratory settings such as hospital
laboratories and reference laboratories.
Safety Information
The present Instructions for Use contains test-specific information only. For
additional warnings and instructions refer to the Instructions for Use provid-
ed 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 sam-
ples 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 professionals.
WARNING
• Always follow good laboratory practice to ensure the proper
performance of this test.
• Make sure to wear appropriate personal protective equipment.
• Do not use a cartridge if the sealed pouch or the cartridge itself is
visibly damaged.
• Do not touch or scratch the detection area of the cartridge.
• Do not reuse a cartridge.
• Do not use expired cartridges. The expiration date can be found on the
packaging and the cartridge label.
• Do not wait longer than 15 minutes after opening the cartridge pouch to
begin the test. This maintains hygiene and avoids performance loss due
to humidity. Prolonged exposure to humidity has a negative impact on
test performance.
• Do not shake a cartridge that contains a sample.
• Do not turn the cartridge upside down.
• Place the cartridge on a clean and flat surface only.
• Do not use sample types, media and volumes that are not approved for
the test.
• Biological specimens, transfer devices, and used cartridges should
be considered capable of transmitting infectious agents requiring
standard precautions. Handle potentially infectious patient samples
and cartridges according to national laboratory standards and dispose
samples and cartridges according to regional and laboratory standards.
• Be compliant with the national safety regulations and practices.
Note: Further information can be found in the safety data sheet (SDS) of the
product. Please contact the customer support of your local distributor.
Vivalytic MG, MH, UP/UU
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– Instructions for Use
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