Publicité
Vivalytic C. auris
– Instructions for use
PCR – Curve and C
Real-time PCR curves (software-modified) are shown and classified as pos-
itive or negative by the software. In case of positive curves, the respective
C
value is displayed. Inconclusive results are marked by the software ().
q
Retesting is advised.
Invalid or Failed Tests
A test is rated as invalid if neither target DNA nor Human Control is detect-
ed. 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 di-
agnostic interpretation. Pay attention to use the correct sample type, sample
collection and storage of the sample and cartridges prior to the test run. If
required, repeat the analysis with a new sample.
In case of a failed test, first check for correct operating conditions of the Viv-
alytic one analyser (refer to Vivalytic one analyser's Instructions for Use). Re-
start the Vivalytic one analyser. If the problem persists, contact the customer
support of your local distributor.
Test Termination
As soon as a valid, positive result is shown for the pathogen on the screen,
the user has the option to finish the test.
Test Report
In the printed test report, pathogen, results, control and information on user,
patient and Vivalytic one analyser are listed with a signature field.
Notice to Users in EU
Any serious incident that has occurred in relation to the device, should be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
Limitations
The result of the Vivalytic C. auris test must be interpreted by a trained
healthcare professional only. The results of the Vivalytic C. auris test must
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 other pathogens being present but not
covered by this assay.
• There is a risk of false negative or false positive results due to improperly
collected, transported, or handled samples.
• In borderline cases atypical PCR characteristics (e. g. flat curve with low
or high C
-value) can occur. In case of atypical characteristics results are
q
not allowed to be used for diagnostic interpretation. Inconclusive results
are marked by the software. Retesting is advised.
• Vivalytic C. auris is a qualitative real-time PCR test and does not provide a
quantitative result.
• A positive result does not necessarily mean that a viable pathogen is
present.
• In artificial sample setups an inhibitory effect of aluminium chlorohydrate
was observed on PCR as ingredient in deodorants. This was not be
observed in clinical samples but could still cause invalid results.
Analytical Performance Evaluation
Analytical Sensitivity (Limit of Detection)
The limit of detection of the Vivalytic C. auris test was determined as the
lowest concentration of analyte that can be consistently detected (≥95% of
samples tested under routine laboratory conditions using a defined type of
sample) (Table 1).
Inclusivity
To evaluate inclusivity, an in silico analysis (BLAST alignment) of the genomic
sequence of various relevant Candida auris strains against the sequence of
the PCR primers and hydrolysis probe used in the Vivalytic C. auris test for
amplification and detection of the respective pathogen was performed. Inclu-
sivity could be shown for strains listed in Table 2.
Value
q
5
Publicité
