Publicité
Vivalytic C. difficile
Invalid or Failed Tests
A test is rated as invalid if neither target DNA nor Human Control is detected.
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
diagnostic 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
Vivalytic one analyser (refer to Vivalytic one analyser's Instructions for Use).
Restart the Vivalytic one analyser. If the problem persists, contact the
customer support of your local distributor.
Test Termination
As soon as a valid, positive C. difficile result is shown 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.
Quality Control
If required by your local or laboratory standards, quality control testing must
be performed.
In case a reference testing method for quality control is needed the following
reference materials can be used:
CLOSTRIDIUM DIFFICILE RT027 100K TOTAL CONTROL (NEUTRAL), Vircell
S.L. Spain).
Please follow the manufacturer's instructions.
In case of unexpected results, repeat the analysis with another sample. If
the result of a negative quality control sample e. g. pure eNAT® medium
remains positive, the Vivalytic one analyser or its environment might be
contaminated. Stop using the Vivalytic one analyser and clean the device as
described in the Instructions for Use of the Vivalytic one analyser.
In case of repeated false results for quality control samples please contact
the customer support of your local distributor.
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 results of the Vivalytic C. difficile test must be interpreted by a trained
healthcare professional only. The results of the Vivalytic C. difficile test must
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 other pathogens being present 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. difficile is a qualitative real-time PCR test and does not provide
a quantitative result.
• A positive result does not necessarily mean that viable pathogens are
present.
• The test detects C. difficile carrying tcdA/tcdB genes, but does not
differentiate between toxin producing and non-toxin producing strains
• A negative result does not preclude C. difficile infection. It is
recommended that negative tested samples are interpreted in the context
with additional laboratory data
• An excess amount of stool may have inhibitory effects on the assay
performance.
– Instructions for Use
5
Publicité
