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Vivalytic Norovirus
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 ().
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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
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 Norovirus 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.
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 Norovirus test must be interpreted by a trained
healthcare professional only. The results of the Vivalytic Norovirus 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
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not allowed to be used for diagnostic interpretation. Inconclusive results
are marked by the software. Retesting is advised.
• Vivalytic Norovirus 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.
• A negative result does not preclude Norovirus 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.
Analytical Performance Evaluation
Analytical Sensitivity (Limit of Detection)
The limit of detection of the Vivalytic Norovirus 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)
– Instructions for Use
Value
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