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Vivalytic MG, MH, UP/UU
Pay attention to use the correct sample type, sample collection kit and
storage conditions of 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 result for one of the targets M. genitalium, M.
hominis, or U. parvum/urealyticum 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, pathogens, 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. 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® MYCOPLASMA GENITALIUM DNA CONTROL,
Ref. MBC085 (Vircell)
• AMPLIRUN® MYCOPLASMA HOMINIS DNA CONTROL,
Ref. MBC084 (Vircell)
• AMPLIRUN® UREAPLASMA DNA CONTROL,
Ref. MBC133, Ref. MBC112 (Vircell)
• AMPLIRUN® TOTAL CT/NG/TV/MGE CONTROL (SWAB),
Ref. MBTC024-R (Vircell)
Please follow the manufacturer's instructions.
In case of unexpected results, repeat the analysis with another sample. If the
result of a quality negative 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 sup-
port 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 MG, MH, UP/UU test must be interpreted by a
trained healthcare professional only. The results of the Vivalytic MG, MH,
UP/ UU 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.
• Inconclusive results are marked by the software. Retesting is advised.
• A positive result does not necessarily mean that viable bacterial cells are
present.
• Do not use the Vivalytic MG, MH, UP/UU test for neonates.
• Vivalytic MG, MH, UP/UU is a qualitative real-time PCR test and does not
provide a quantitative result.
– Instructions for Use
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