Technology
SpinChip has developed a game-changing multi-analyte platform allowing lab-quality in vitro diagnosis to be performed quickly, easily and reliably in point-of-care settings.
This is achieved by combining:
- a unique micro-fluidic concept based on dual axle centrifugation
- a vision system for real-time fluidics control and monitoring
- state of the art labels, reagent formulations and assaying concepts
- two complementary readout systems integrated with the platform
This allows for unmatched flexibility and efficiency in microfluidic handling and multiple readout possibilities. This further enables analysing a variety of sample types according to a wide range of assay principles.
Flexibility and efficiency
The SpinChip platform constitutes of a compact fully integrated analyser for automatic processing and readout of disposable self-contained cartridges. All sample and reagent processing occur within these cartridges with unique efficiency, accuracy, and control. The cartridges contain both liquid and dried reagents required for assaying as well as an integrated sampling device. The exterior shape of the cartridge is identical for all tests, while the interior microfluidic designs are tailored to process according to sample type, the assaying principle and multiplicity (number of tests per cartridge). The platform is hence designed to become the broadest platform in the POC industry allowing measurement of a variety biomolecules according to a variety of assay principles, in a variety of combinations (multiplexing) and based on various sample types.
Current product focus - with a wide range of potential
Ease of use
Sample type and volumes drawn with the sampling device integrated in the cartridge, will vary with the test requested. In the high sensitivity tests, including cardiac Troponin I (hs-cTnI), the integrated sampling device collect just 14 µL of whole blood from a finger, or whole blood or plasma directly from tubes. This implies the same procedure and volumes for all types of specimens. This very small volume need not be exact, and the instrument will inform the user when there is too little or too much sample. Upon closing the cartridge with the sampling device, the cartridge is sealed and the liquid reagent container within the cartridge is activated.
To start the test, the cartridge is placed in a cartridge drawer (loading module) and thereby automatically transferred to and locked into the rotor disc inside the analyser. The vision system will then read the 2D data matrix code printed on the cartridge and inspect the intactness of the cartridge, as well as the state of the sample and the reagents. This 2D code contains all relevant information required for running the test cartridge, including test ID, lot calibration data and expiry date.
Dual axle centrifugation allows for micro-scaling lab-machines processing
Centrifugal force is used to control the microfluidics within the sealed test cartridge. The cartridge is placed off-centre in the rotor disc and the orientation of the cartridge relative to the centrifugal force is altered by bi-directional rotation of the cartridge. Liquids (sample and reagents) will follow the available paths and cavities within the cartridge that at any time are farthest from the centre of the rotor disc. This allows for extremely efficient and exact fluidic processing without any pumps or valves. These include transportation, splitting and mixing capabilities tailor made for the requested microfluidic assaying.
Further, the centrifugal force allows for extremely efficient separation of fluidic components including the separation of blood cells from plasma within seconds. The fact that the blood cells are separated from plasma by centrifugal forces (same as for lab-tests), and that exact metering of 3 µL plasma for further assaying is automatically performed upon the dual-axle processing, further adds to the user-friendliness, accuracy and robustness of the assaying. Considering that only 3 µL plasma of the 14 µL sample is used for assaying and measurements, makes the test very robust with respect to high haematocrit levels.
Microfluidics optimised for assay principles
The microfluidic designs are tailored to match the sample types and assaying principles required for optimal processing, all occurring at a fixed temperature of 37°C.
In the high sensitivity immunometric assaying as used for measuring hs-cTnI, BNP and NT-proBNP, microbeads and fluorescent nanoparticles are used and readout performed using the unique fluorescent readout - all in less than 10 minutes.
In an exploratory prototype of a CRP-test, a porous membrane and gold colloids using the spectral readout system were used in a less than 3-minute test.
The flexibility and efficiency of dual-axle microfluidics, combined with the various optical readout modes of the Analyzer allow for developing a variety of assaying principles covering a very wide sensitivity range.
Reliability and robustness
The vision control system of the analyzer is key in the control of all fluidic operations within the cartridge. Throughout the assay processing, the vision system supervises the correctness of liquid processing, including separation of plasma from blood cells, exact metering, dissolving reagents, mixing, splitting and interacting samples and reagents as well as washing any solid phase used in the assay. This enables detection of erroneous situations (fail-safes) that would otherwise lead to inaccurate assay results. The vision system is hence used for real-time process control whenever required.
Ultra-sensitivity and wide range
The SpinChip Analyzer holds two complementary optical readout systems:
1) The vision system is designed for cartridge inspection, fluidics monitoring and control and for spectral reflectance and transmittance measurements.
2) The high sensitivity fluorescent readout system is designed for measuring signals from unique fluorescent nanoparticles and bio-luminescent labels.
Both these optical readout systems can operate in different modes covering a very wide sensitivity range. In the hs-cTnI test, only 3 µL plasma automatically isolated and metered from the 14 µL blood draw, is further processed in the test cartridge. Still the SpinChip platform allows within less than 10 minutes measurements down to 2 ng/L (LoQ) of cardiac Troponin I.
The optical readout systems are controlled by a unique self-calibration concept securing high readout uniformity between analyzers and repeatability over time and under different conditions.
Versatile connectivity
The user communicates with the instrument via a touch display. Furthermore, the instrument holds connectivity features for communication with lab-journal systems as well as off-the-shelf equipment such as barcode readers, printers and more.
In-house development and production
The Analyzer: SpinChip has developed all elements of the analyzer including mechanics, optics, electronics and software and is also doing the production and control in-house. This implies that SpinChip holds all relevant know-how related to the analyzer and further development of the platform.
The test cartridges: SpinChip has developed all elements of the cartridges in-house. This includes state-of-the-art fluidics assay design based on simulation and CAD, in-house prototyping of cartridges and unique formulation technologies for the dry and liquid reagents. An automated pilot production line is installed for the assembly of plastic parts and integration of reagents, and a high-volume commercial production line is in the pipeline.
This implies that SpinChip has all relevant know-how and IP required for developing a broad range of new tests as well as producing test cartridges in high volumes.
Summary
SpinChip has developed a reliable, fully integrated patent protected POC IVD-platform, delivering lab-quality performances within a few minutes, including extreme sensitivity, wide sensitivity range and high precision based on integrated self-calibration and fail-safe systems.
The SpinChip platform technology includes high flexibility and efficiency within controlled microfluidic processing of various sample types and reagents, a variety of reagent formulation alternatives in addition to several possibilities within readout. Moreover, the platform concept is user-friendly based on easy and robust sampling using the self-contained cartridges and the fully automated processing by the Analyzer.
These features should allow for making the SPINCHIP platform become one of the broadest and most reliable platforms on the near patient market. This includes its use for most types of immunoassays, clinical chemistry type assays, haematology assays, coagulation assays and within molecular diagnostics. The SpinChip platform is hence designed for becoming a truly multi-analyte IVD platform applicable in most clinical fields, including the very advanced sample processing and assaying, extremely high sensitivity assays and various concepts for multiplexing, all within one cartridge.
