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Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
PCR – Curve and C
Real-time PCR curves (software-modified) are shown and classified as posi-
tive or negative by the software. In case of positive curves, the respective C
value is displayed. Based on the classification of targets as either positive or
negative the result is defined. Inconclusive results are marked by the soft-
ware (). Retesting is advised.
Invalid or Failed Tests
A test is rated as invalid if no target RNA and no 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 collec- tion 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 Report
In the printed test report, results, pathogens, tested targets, controls and
information on user, patient and Vivalytic one analyser are listed with a sig-
nature field.
Test Termination
As soon as a valid, positive result 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.
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 (e. g. AMPLIRUN® SARS-CoV-2 RNA CONTROL, Ref. MBC137-R,
AMPLIRUN® Total SARS-CoV-2, Ref. MBTC030, AMPLIRUN Total SARS-CoV-2/
FluA/FLuB/RSV Control (Swab), Ref. MBTC031, Vircell S.L. Spain). RNA
controls cover the processes of nucleic acid purification, reverse transcrip-
tion amplification, and detection, but do not cover sample collection and
sample lysis. Please be aware that parts of the listed reference materials are
for research use only (RUO). 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 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.
Value
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– Instructions for use
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