MicrobScan Diagnostic system
The high efficiency and the main cost / benefit advantages of the diagnostic device MICROBSCAN compared to systems that use standard platforms derive from a research phase that has allowed the development of an innovative technology aimed at improving the performance and robustness of molecular diagnostic techniques.
The principle that guided the research and design of the MICROBSCAN diagnostic system (MS100) was to reach values close to the maximum theoretical sensitivity (a single DNA molecule) regardless of the type of microorganism and / or the type of clinical sample in which is contained.
The high degree of purity of the extracted nucleic acids determines an optimal efficiency of the amplification reactions (PCR / RT-PCR) allowing the development of extremely sensitive multiplex tests starting from small quantities of sample.
MICROBSCAN-KAIROS instrumentation integrates all phases of the analytical process:
- Identification of samples by automated bar code reading
- Extraction and purification of nucleic acids
- Preparation of the PCR plate by introducing the nucleic acids and the reaction mixture containing primers, fluorescent probes, enzymes and internal control
- Identification of the pathogen by multiplex qPCR
- Interpretation of the analytical signal using a dedicated software that allows the display of the amplification curves, the generation of a final report, the trasmission of the results to the LIS
- Quality control of all stages of the process, by means of specific sensors
The benefits of the new technology derive from its innovative elements:
New microfluidic extraction cell - comprising:
a) An upper compartment to contain the sample, the magnetic particles, the reagents necessary for the extraction of nucleic acids and to obtain an efficient removal of the PCR inhibitors;
b) A capillary compartment (volume 5-10 μl), to allow the handling and exact positioning of magnetic particles immersed in a small volume of liquid, to allow the concentration of nucleic acids and their transfer to an analytical instrumentation.
To parallelize the process and facilitate its automation, the geometry of the cell was replicated in an orthogonal model (array) to form an extraction cartridge consisting of 24-192 cells. The increase in sensitivity due to the innovative geometry is equal to 1-2 orders of magnitude.
Process automation / miniaturization.
The extraction cartridge has been designed to be inserted into a robotic module that contains all the functional elements necessary for the extraction / purification of nucleic acids (liquid dispensing / aspiration, temperature control, vibration, variable magnetic fields, etc.).
This allowed:
a) to increase the degree of purification of nucleic acids (increase of washing cycles)
b) reduce the use of disposable tips by 70%
c) load a sufficient number of tips for three runs of 96 samples
d) load a quantity of washing solutions that allows about 1000 extractions
Scalability / modularity.
The instrumentation can be easily sized by adding additional modules depending on the number of samples that must be analyzed in 24 hours.
a) For small routines (up to 144 samples / 12 hours): KAIROS-24 instrumentation
b) For medium routines (up to 600 samples / 12 hours): KAIROS-96 instrumentation
c) For medium to large routines (up to 1800 samples / 12 hours): KAIROS-384 instrumentation (under development)
Increase of the quality standards of all mechanical and electronic components to allow:
a) Electromechanical components completely sealed to allow rapid sterilization and avoid the release of contaminating materials
b) Increase of the positioning accuracy of the mechanical axes <10-20μm (absolute positioning system that does not require calibration)
c) Components resistant to wear generated by the H24 use of the instruments.
Thanks to these characteristics, a brief check-up is foreseen every 600 sessions (or six months). After 1000 analytical sessions, the instrumentation requires extraordinary maintenance for the preventive replacement of some components.