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Test Termination (Early Finish)
As soon as a valid, positive result for B. parapertussis or B. holmesii is shown
on the screen, the user has the option to finish the test. Only finish the test if
no further targets need to be analyzed. Pending results will not be displayed.
Test Report
In the printed test report, pathogen, results, control and information on user,
patient sample 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. The integrated control (Human Control) covers the processes
of sample collection, nucleic acid purification, amplification, and detection.
In case a reference testing method for quality control is needed the following
reference materials can be used:
AMPLIRUN® BORDETELLA PERTUSSIS TOTAL CONTROL (NEUTRAL MATRIX)
(MC078, Vircell S.L. Spain).
AMPLIRUN® BORDETELLA PARAPERTUSSIS TOTAL CONTROL (NEUTRAL
MATRIX) (MC077, Vircell S.L. Spain).
AMPLIRUN® BORDETELLA HOLMESII TOTAL CONTROL (NEUTRAL MATRIX)
(MC168, Vircell S.L. Spain).
Please follow the manufacturer's instructions. Reconstitute the reference
material in Copan eNAT® medium.
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 contaminat-
ed. 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. The summary of safety
and performance (SSP) will be available in the European database on med-
ical devices (Eudamed), where it is linked to the Basic UDI-DI. If the respec-
tive module in Eudamed will be fully functional the SSP will be available at
the public website (https://ec.europa.eu/tools/eudamed).
Limitations
The results of the Vivalytic Bordetella test must be interpreted by a trained
healthcare professional only. The results of the Vivalytic Bordetella 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. Retesting is advised.
• A positive result does not necessarily mean that viable pathogens are
present.
• Vivalytic Bordetella is a qualitative real-time PCR test and does not provi-
de a quantitative result.
• A positive IS481 and hIS1001 can either be caused by the presence of B.
holmesii or by presence of B. pertussis and B. holmesii in the sample.
• A positive IS481 can be considered as probable B. pertussis positive, al-
though B. bronchiseptica may also lead to a positive IS481 signal. If needed,
additional testing should be performed to differentiate B. bronchiseptica
and B. pertussis.
Vivalytic Bordetella
6
– Instructions for Use
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