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Vivalytic MG, MH, UP/UU
Additional Equipment & Consumables Required but not Provided
• Bosch Vivalytic one analyser (reference number F 09G 300 115)
• Pipettor (100–1000 μl)
• Sterile pipette tips 100 –1000 µl
• Swab collection kits
– Regular Flocked Swab FLOQSwabs® 552C (COPAN Italia s.p.a.)
– Minitip Flocked Swab FLOQSwabs® 551C (COPAN Italia s.p.a.)
• Transport medium
– eNAT® 608C (COPAN Italia s.p.a.)
• Suitable protective clothing
Test Principle
Vivalytic MG, MH, UP/UU 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 %,
and within 15 minutes 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
cartridge. The processing includes cell lysis, nucleic acid extraction, DNA
amplification, and detection.
Reagents within the cartridge include 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 Types / Medium
The test is intended for use with urine in eNAT® transport medium (eNAT®
608C, COPAN Italia s.p.a.) or vaginal, cervical, and rectal swab samples
(Regular Flocked Swab FLOQSwabs® 552C, COPAN Italia s.p.a.) or urethral
swab samples (Minitip Flocked Swab FLOQSwabs® 551C, COPAN Italia
s.p.a.) in 1 ml eNAT® transport medium (eNAT® 608C, COPAN Italia s.p.a.).
Collect and store samples as indicated in the manufacturer's instructions.
Sample Preparation
Vaginal, Cervical, Rectal and Urethral Swabs
Use a COPAN Regular Flocked Swab (FLOQSwabs® 552C) for collection of
vaginal, cervical, rectal patient samples or a COPAN Minitip Flocked Swab
(FLOQSwabs® 551C) for collection of urethral patient samples. Each swab
is transferred into 1 ml eNAT® transport medium.
Break the swab, close the tube, and shake the sample tube containing the
swab sample and eNAT® medium for homogenization (avoid foaming).
Fill in 300 μl of homogenized patient sample in the sample input of the
cartridge and close the cartridge lid. Insert the cartridge in the Vivalytic one
analyser.
Do not use viscous samples that are difficult to pipette.
Urine
Fill in 1 ml of urine into the 1 ml eNAT® transport medium to achieve a mix-
ing ratio of 1:1 of urine in eNAT® medium.
Shake the sample tube containing the urine and eNAT® medium for homo-
genization (avoid foaming) and fill in 300 μl of homogenized patient sample
in the sample input of the cartridge and close the cartridge lid. Insert the
cartridge in the Vivalytic one analyser.
Do not use viscous samples that are difficult to pipette.
– Instructions for Use
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