Bosch VIVALYTIC Gebrauchsanweisung Seite 3

Vivalytic SARS-CoV-2 Test
Test Result
The test result is shown on the screen.
Detection of the human control shows a successful extraction procedure and
excludes an inhibition of the PCR reaction.
A test is rated as invalid only if both criteria are fulfilled; no detection of target
RNA and no detection of human control.
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.
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In case of an invalid test, check if any notices are displayed after the run.
Possible reasons for an invalid run might be poor sample quality or no RNA.
Repeat the analysis with a new aliquot of the same sample if required.
Pay attention to correct sample type, the right sample collection and storage
of the sample and cartridges prior to the test run.
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.
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. In case of unexpected results, repeat the analysis with another
sample. If the result of a quality negative control sample 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, call also 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 pathogen being present in the sample at a
level below assay sensitivity or a pathogen that is not covered by this assay.
• There is a risk of false negative values resulting from improperly collected,
transported, or handled samples.
Analytical Sensitivity (Limit of Detection, 95 % Detection rate)
The concentration at a detection rate of 95 % (LoD) was determined (table 1).
Inclusivity and Exclusivity
Specificity was ensured by the selection of primers and their in silico
analysis for possible cross-reactions based on publicly available nucleic acid
sequences derived from the NCBI database.
To evaluate inclusivity, positive SARS-CoV-2 material (table 2) were purified
and spiked into a PCR reaction and processed by a workflow using liquid
components.
To exclude cross-reactivity (exclusivity), various strains of microorganisms
representing common respiratory pathogens or closely related species
were tested (table 3) by a workflow using liquid components. There was no
evidence of microbial interference.
Interferences
Interferences were evaluated for endogenous and exogenous substances
(table 4) that are potentially present in the patient sample. No interferences
were detected.
Clinical Sensitivity and Specificity
The results derived from patient samples (positive and negative samples in
Copan eNAT™ medium) collected in a clinical setting were compared with
those of a reference method (table 5). In total, 50 samples were analysed.
– Instructions for use
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