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Vivalytic Bordetella
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.
WARNING
• Always follow good laboratory practice to ensure the proper
performance of this test.
• Make sure to wear appropriate personal protective equipment (PPE).
• 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.
Additional Equipment & Consumables Required but not Provided
• Bosch Vivalytic one analyser (reference number F09G300115)
• Pipettor (100–1000 μl)
• Sterile filter pipette tips 100–1000 µl
• Swab collection kits:
Flexible Flocked Swab FLOQSwabs® 553C (COPAN Italia s.p.a.)
• Transport medium:
eNAT® 608C (COPAN Italia s.p.a.)
• Suitable protective clothing
Test Principle
Vivalytic Bordetella is a qualitative real-time PCR based test.
Storage und Usage Conditions
Product is stable until the expiry date if stored at + 15 °C to + 25 °C. Storage
and usage conditions can be taken either from the cartridge, pouch, or box
label. Cartridge has to be used at + 15 °C to + 25 °C, relative humidity < 65 %,
within 15 min upon pouch opening. This maintains hygiene and avoids
performance loss due to humidity. Prolonged exposure to humidity has a
negative impact on test performance.
– Instructions for Use
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