Bosch Randox Vivalytic VRI Test Instructions For Use Manual page 3

Package Contents
15 Vivalytic VRI test cartridges for the detection of SARS-CoV-2
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
cartridges 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.
• Do not shake a cartridge that contains a sample.
• Do not turn the cartridge upside down.
• Handle potentially infectious patient samples according to national
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 (required but not provided)
Bosch Vivalytic one Analyser
Intended Use
The Bosch Vivalytic VRI test is a qualitative PCR-based assay for the detection
of SARS-CoV-2 from nasopharyngeal and oropharyngeal swabs to aid in the
diagnosis of respiratory tract infections. Intended for use with a Vivalytic
analyser by healthcare professionals.
Sample Type/Medium
The test is intended for use with nasopharyngeal and oropharyngeal swab
samples in eNAT™ medium (COPAN Italia S.P.A.). Collect and store samples as
indicated in the manufacturer's data sheet.
Sample Preparation
Shake the sample tube containing the 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.
In case of a valid test, the internal controls for a successful extraction,
amplification and conjugation can be viewed in the tab control. In the absence
of the extraction/amplifica tion control, the test is automatically rated as
invalid. In the absence of the conjugation control, the microarray cannot be
evaluated, and the test is rated as failed.
Vivalytic VRI Test
Pipette (1000 µl)
2
– Instructions for use