Novodiag® System User Manual (NVD-SYST-UM)
V4-0 – April 2020
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Once the run is completed, the circle indicates the completion by a green colour and a symbol indicates the
outcome of the run (see Table 7 for colour and symbol coding). Result interpretation is detailed in each Test
specific Instructions for Use.
6.5.
Shutting down the Novodiag® System
The Touchscreen Computer can be shut down by using the close button located in the top right corner of the
Software’s login screen. If you are logged in to the Novodiag® Software, you must first log out to access the close
button. The dialog prompts to confirm the shutdown of the computer. Tap “OK”. The Novodiag® Instrument can
be shut down by switching off the power switch behind the instrument.
7.
Preventive maintenance and controls
7.1.
Preventive maintenance
No general maintenance is required for the Novodiag® System other than periodic cleaning:
Clean the Novodiag® equipment according to the Chapter 8.1.
Periodically (once a month) check and blow dry air onto the ventilation system on the sides of the
Novodiag® Instruments.
CAUTION
Before cleaning the Touchscreen Computer, close the Novodiag® Software application to avoid
accidental opening of the Novodiag® Instrument.
7.2.
Controls
7.2.1.
Internal Control
Each Novodiag® Test Cartridge includes an internal process control, which acts as a control through the whole
analysis. The process control contains synthetic gene target and is applied in dried format on the sample filter in
the cartridge during manufacturing. For this reason, the process control is subjected to the same sample
preparation process as the sample.
The process control detection will fail if inhibition or other disturbing factors affect PCR amplification. For the test
to be successful, either process control, target(s) or both need to give a positive result, otherwise the test result is
invalid.
7.2.2.
External Controls
To ensure the proper functioning of the Novodiag® System, it is highly recommended to periodically run external
controls according to the instructions provided in Chapter 6.
NOTE External controls are not provided by Mobidiag.
It is recommended to use positive controls at regular intervals and in accordance with laboratory guidelines. They
can also be used in case of a suspected malfunction of an instrument or cartridge batch. The user should prepare
specific positive controls for each test according to laboratory guidelines. Positive controls should always give a
positive result. A negative result from a positive control indicates a possible malfunction of the instrument or
defective cartridge. In this case, please contact Mobidiag representative.
As a negative control, appropriate sample buffer may be used as the sample (refer to Novodiag® Test specific
Instructions for Use for more information). A negative control is used after installing the instrument or after
maintenance carried out by a Mobidiag representative, to ensure the proper working of the instrument. It is also
recommended for use at regular intervals, according to laboratory guidelines. A negative control can also be used
in case of suspected nucleic acid or sample contamination in the working area or equipment used.
Negative controls should always give a negative result. A positive result from a negative control indicates a
possible nucleic acid or sample contamination in the working area or equipment used. In this case clean the
working area and used equipment with nucleic acid decontaminants and disinfectants, according to laboratory
guidelines and procedures described in Chapter 8.1. In case of an invalid result from a negative control, the
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