Bosch Vivalytic VRI Gebrauchsanweisung Seite 4

Vivalytic VRI Test
In the printed test report, all pathogens, results and information on user,
patient and analyser are listed with a signature field. Controls are not listed
in detail. A valid test corresponds to successful extraction, amplification and
conjugation.
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/
DNA. Repeat the analysis with a new aliquot of the same sample if required.
Pay attention to use the correct sample type, the right sample collection and
storage of the sample and cartridges prior to the test run. The test is shown
as invalid if not enough human cells are present in the sample (extraction/
amplification control). Detected pathogens are displayed for an invalid test.
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, also call the customer service.
Limitations
The results of the Vivalytic VRI test should be interpreted by a trained
healthcare professional. The results of the Vivalytic VRI 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.
• 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 probes and their in
silico analysis for possible cross-reactions based on publicly available nucleic
acid sequences derived from the NCBI database.
To evaluate inclusivity, SARS-CoV-2 RNA reference material (table 2) was
spiked into transport medium 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 at 10 CFU/mL (bacteria) and at 10
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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.
Sensitivity and Specificity
The results derived from patient samples (positive and negative samples
in viral transport media) collected in a clinical setting were compared with
those of a reference method (table 5). In addition, negative patient samples
spiked with positive reference material were tested. In total, 51 samples were
analysed.
– Instructions for use
GEq/mL (viruses) (table 3) by
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