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Package Contents
15 Vivalytic STI test cartridges for detection of sexually transmitted infections
(STI)
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 analyser (chapter device safety information). Only use Vivalytic car-
tridges and accessories approved for the analyser. Make sure to insert samples
properly. Remove spilled samples with a cloth soaked with the appropriate
solution. You can use 70 % ethanol. If you need to disinfect the cartridge by
spraying (for example after heavy spillage of sample) do not use the cartridge
afterwards since it might be damaged by disinfectant.
WARNING
• 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 use sample types, media and volumes that are not approved for
the test application.
• Do not shake a cartridge that contains a sample.
• Do not turn the cartridge upside down.
• Handle potentially infectious patient samples according to laboratory
standards and dispose samples according to regional and laboratory
standards. Make sure to wear appropriate personal protective
equipment (PPE).
• Place the cartridge on a clean surface.
• Be compliant with the national safety regulations and practices.
Additional Equipment required but not provided
Bosch Vivalytic one Analyser
Intended Use
The Bosch Vivalytic STI test is a qualitative PCR-based assay for simultaneous
detection of 10 common sexually transmitted pathogens (table 1) from either
urine samples or urogenital swabs to aid in the diagnosis of sexually transmitted
infections from both symptomatic and asymptomatic patients. Configured for
use with a Vivalytic analyser.
Sample Type/Medium
This test is validated with urine samples in eNAT™ medium (COPAN Italia
S.P.A.) and in Roche cobas® PCR medium, with swabs in eNAT™ medium
(COPAN Italia S.P.A.), in Roche cobas® PCR medium and in phosphate buffered
saline solution (PBS) as well as with exudates in Roche cobas® PCR medium.
Collect and store samples as indicated in the manufacturer's data sheet.
Sample Preparation
Shake the sample tube containing the urine or swab sample and the liquid
medium for homogenization and fill 300 μl of homogenized patient sample in
the sample input of the cartridge. Do not use viscous samples that are difficult
to pipette.
Test Result
The test result (list of positively/negatively detected pathogens) is shown on
the screen. For further information, you are guided through different levels of
detail by the software. The microarray data level shows a software-modified
and normalized picture of the microarray with the immobilized target-specific
DNA probes.
Vivalytic STI Test
pipette (1000 µl)
2
– Instructions for use
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