Safety Information - Bosch Vivalytic SARS-CoV-2 Guia De Inicio Rapido

Package Contents
15 Vivalytic SARS-CoV-2 test cartridges for the detection of SARS-CoV-2
specific E gene sequence.

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 and cartridges according
to national laboratory standards and dispose samples and cartridges
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 SARS-CoV-2 test is a qualitative PCR-based assay for the
detection of SARS-CoV-2 from human nasopharyngeal and oropharyngeal
swabs to aid in the diagnosis of a SARS-CoV-2 infection. Positive and negative
results must be clinically correlated with patient history and other diagnostic
information is necessary to determine patient infection status. Intended for
use with a Vivalytic analyser by healthcare professionals.
Test Principle
Vivalytic SARS-CoV-2 is a real-time based PCR test utilizing reverse
transcription (RT).
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.
Reagents
All reagents necessary for the sample processing are integrated into the
cartridge. The processing includes cell lysis, nucleic acid extraction, reverse
transcription, DNA amplification and detection.
Reagents are PCR bead, binding buffer, washing buffer and elution buffer.
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.
Vivalytic SARS-CoV-2
Pipette (1000 µl)
2
– Instructions for use