Publicité
Vivalytic Norovirus
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.
• Always follow good laboratory practice to ensure the proper
performance of this 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
– Regular Flocked Swab FLOQSwabs® 552C (COPAN Italia s.p.a.)
• Transport medium
– eNAT® 606C (COPAN Italia s.p.a.)
• Suitable protective clothing
Test Principle
Vivalytic Norovirus is a qualitative real-time RT-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 per-
formance loss due to humidity. Prolonged exposure to humidity has a nega-
tive impact on test performance.
Reagents
All reagents necessary for the sample processing are integrated into the
cartridge. The processing includes cell lysis, nucleic acid extraction, DNA
amplification and detection.
Reagents are PCR bead, binding buffer, washing buffer, and elution buffer.
The PCR bead contains the DNA polymerase, primers, and probes. Binding
buffer facilitates binding of nucleic acids during the purification process.
Washing buffer is a formulation of different salts and solvents to remove
impurities e. g. proteins during the extraction process. Elution Buffer is a
low-salt buffer and contains the purified nucleic acids at the end of the ex-
traction process.
– Instructions for Use
3
Publicité
