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Vivalytic STI Test
In case of a valid test, the internal controls for a successful extraction, amplifi-
cation and conjugation can be viewed in the tab control. In the absence of the
extraction/amplification 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.
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. Possi-
ble reasons for an invalid run might be poor sample quality or no 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/ampli-
fication 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 cus-
tomer 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 materi-
als. 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 con-
trol samples, also call the customer service.
Limitations
The results of the Vivalytic STI test should be interpreted by a trained health-
care professional. The results of the Vivalytic STI test should not be used as
the sole parameter for diagnosis.
• A negative result does not exclude STI 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)
To define the LoD, concentrations of the target analytes were determined at a
detection rate of 95 % (table 2). Each target was tested individually at different
concentrations in a range close to the preliminary LoD.
Analytical Specificity (Inclusivity and Exclusivity)
To evaluate inclusivity, different target strains of various pathogens (table 3)
with a total number of 100 DNA copies were evaluated. To exclude cross-
reactivity (exclusivity), phylogenetically related and non-related strains (table 4)
were tested by using nucleic acids that were added at a concentration of 3x10
genome equivalents per testing.
Interferences
Interferences were evaluated for endogenous and exogenous substances
(table 5) 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) col-
lected in a clinical setting were compared with those of a reference method
(table 6). In addition, negative patient samples spiked with positive reference
material were tested.
– Instructions for use
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