Quality Control - Bosch Vivalytic SARS-CoV-2 Guia De Inicio Rapido

Vivalytic SARS-CoV-2
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 PCR curve data level shows software-modified PCR
curves. The curves are classified as positive or negative by the software. In
case of positive curves, the respective C
Detection of the human control shows a successful extraction procedure and
excludes an inhibition of the PCR reaction.
A test is rated as invalid if both target RNA and human control are not
detected. Possible reasons for an invalid run might be poor sample quality due
to a partial or complete absence of human cellular material in the sample.
Results are displayed for an invalid test but are not allowed to be used for
diagnostic interpretation.
In the printed test report, pathogen, results, control and information on user,
patient and analyser are listed with a signature field. In case of positive results,
the respective C value is displayed on the report.
q
Pay attention to use the correct sample type, sample collection and storage of
the sample and cartridges prior to the test run. Repeat the analysis with a new
aliquot of the same sample if required.
In case of a failed test, first check for correct operating conditions of the
analyser (refer to analyser's instructions for use, chapters device safety
information and technical data). Restart the analyser. If the problem persists,
contact the customer service.
As soon as a valid, positive result is shown on the screen, the user has the
option to finish the test. Pending results are not displayed!
Results/Control
SARS-CoV-2
+
–
–
Retesting is recommended.
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Quality Control

If required by your local or laboratory standards, quality control testing has
to be performed. You can either use pre-characterized patient samples that
were investigated by a reference testing method or purchase quality control
materials (e. g. AMPLIRUN® SARS-CoV-2 RNA CONTROL, Ref. MBC137-R,
Vircell S. L. Spain). In case of unexpected results, repeat the analysis with
another sample. If the result of a quality negative control sample e. g. pure
eNAT™ medium remains positive, the analyser or its environment might be
contaminated. Stop using the analyser and call the customer service. In case
of repeated negative results for positive quality control samples, also call the
customer service.
Limitations
The results of the Vivalytic SARS-CoV-2 test should be interpreted by a trained
healthcare professional. The results of the Vivalytic SARS-CoV-2 test should
not be used as the sole parameter for diagnosis.
• A negative result does not exclude pathogens being present in the sample
at a level below assay sensitivity or a pathogen that is not covered by this
assay.
– Instructions for use
q
Human control
+/–
+
–
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value is displayed.
Validity
valid
valid
invalid
Result
Sample is considered
SARS-CoV-2 positive.
Sample is considered
negative.
Not evaluable.
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