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Vivalytic STI Test
– Instructions for use
In case of a valid test, the internal controls for a successful extraction, ampli-
fication 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 evaluat-
ed, and the test is rated as failed.
In the printed test report, all pathogens, results and information on user, pa-
tient 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 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 analy-
ser (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 analy-
ser 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 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 dif-
ferent 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-re-
activity (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.
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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)
collected in a clinical setting were compared with those of a reference meth-
od (table 6). In addition, negative patient samples spiked with positive refer-
ence material were tested.
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