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Vivalytic C. auris
– Instructions for use
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 material safety data sheet
(MSDS) 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)
•
Pipette (100–1000 μl)
•
Sterile filter pipette tips 100 –1000 µl
•
2x Copan Liquid Amies Elution Swab (eSwab®) Collection and Transport
System (Ref: 480CE, 1 ml liquid Amies with Regular Flocked Swab FLO-
QSwabs®)
Test Principle
Vivalytic C. auris 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.
Reagents
All reagents necessary for the sample processing are integrated into the car-
tridge. The processing includes cell lysis, nucleic acid extraction, DNA amplifi-
cation 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 extraction process.
Sample Type/Medium
The test is intended for use with a human bilateral axilla, groin and nasal com-
bination swab or nasal swabs in liquid Amies medium (Copan Liquid Amies
Elution Swab (eSwab®) Collection and Transport System Ref. 480CE, COPAN
Italia s.p.a.).
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