Novodiag® System User Manual (NVD-SYST-UM)
V4-0 – April 2020
7
3.1.
Principles of fluidic operations
The distribution of fluids in the Novodiag® Test Cartridge from tank to tank and to the various processing
chambers are performed by positive and negative pressure operated by an integrated syringe and directed by the
activation of integrated valves by the Novodiag® Instrument. The white membrane is permeable to gases, thereby
allowing air flow but not liquid flow.
3.2.
Extraction
A chemical or physical lysis is carried out in a sample tube before inserting the sample into the Novodiag® Test
Cartridge. Alternatively, for some Novodiag® Tests a chemical lysis is operated by the reagents present in the
Novodiag® Test Cartridge. The sample is either purified by a proprietary silica-based Zymo Research Corporation
technology or by other sample preparation method in the Novodiag® Test Cartridge. Refer to Novodiag® Test
specific Instructions for Use for more information.
3.3.
Amplification
The eluted nucleic acids are transferred to each PCR chambers containing dry primers and probes along with the
appropriate PCR reagents. Each chamber is then submitted to independent thermocycling protocols by two
independent Peltier thermocyclers. The fluorescence from labelled probes is monitored though excitation and
detection of emission for each chamber using two channels (blue and red) based on a proprietary optical module.
3.4.
Microarray hybridisation
For Novodiag® Test panels, the amplified material is transferred to the microarray for hybridisation. Amplicons
bind to a set of complementary probes targeting specific regions of the genes serving for target detection.
3.5.
Detection and analysis
The microarray is imaged by two proprietary technologies of:
Contact fluorescence imaging.
Evanescent excitation.
The Novodiag® Assay Plugin, specific to the Novodiag® Test Cartridge, analyses both the real-time PCR signal and,
for Novodiag® Test panels, the microarray image. The presence of target nucleic acids is determined by:
The detection of positive amplification by real time-PCR.
And/or the detection of a set of specific hybridisation probes.
The proper detection of internal controls (a process control by real time-PCR and/or microarray detection,
gridding controls and hybridisation control by microarray detection).
4.
Configuration and setup
4.1.
Environmental requirements
4.1.1.
For Novodiag® Instrument and Touchscreen Computer
The Novodiag® System is intended for indoor use only.
CAUTION
For proper operation, the Novodiag® System requires the following environmental conditions:
Operating temperature between 18°C and 30°C.
Operation humidity between 15 – 95% r.H. not condensing and pressure down to 795 mbar.
CAUTION
The electromagnetic environment may interfere with proper Novodiag® Instrument operation.
Do not use the Novodiag® Instrument in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional radio frequency sources).
Summary of Contents for Novodiag NVD-BCS-A NVD-TSCA-A
Page 2: ......
