SpinChip High Sensitivity

SpinChip (www.spinchip.no) is developing a game changing in vitro diagnostic platform for point of care use. The dual axle platform technology allows the most advanced assays to be performed fast and reliable within sealed lab-on-a-chip cartridge fully automated using just a fraction of a whole blood droplet. This project is developing a unique high sensitivity technology applied to the SpinChip platform, the reagents for specific immunometric measurement of cardiac Tropnin I (cTnI), a new patented concept for assaying allowing for the measurement of high sensitivity cTnI within 15 minutes and a unique cartridge for processing the sample and reagents according to the patented assay principle. SpinChip has through the project become a pioneer and leading actor in the field of high sensitivity assaying by developing a unique fluorescent readout system including state of the art optics, electronics and appurtenant software system. The readout system allowing measurement of down to 400 fluorescent nanoparticle with 5% CV, has recently been integrated into the compact SpinChip micro-centrifugal instrument. A concept for calibration of the readout system has been designed. In parallel, state of the art chemistry is used for the stabilization and functionalizing the fluorescent nanoparticles. SpinChip is today making stabile monomeric fluorescent nanoparticle functionalized with antibodies formulated as lyophilized units of spheres which are stable and defined in content. Some 20 monoclonal antibodies (mAb) have been characterized both with respect to specificity and affinity to cTnI. mAbs were selected for use in an immunometric sandwich using beads as solid phase and the fluorescent nanoparticle as tracer in a sequential heterogeneous assay. Fab2 fragments are used on the beads. The beads have been formulated as lyophilized spheres for the integration into the cartridges. Assaying buffer for optimal high specific binding and low unspecific binding is developed. Upon the automatic processing of the cartridge by the instrument, this buffer is released from a specifically designed container and used for automatic sample dilution, rehydrating the reagent spheres, washing and readout within the cartridge while assaying. A new concept for assaying is invented and patented and applied to SpinChips dual axle concept. This allows for very efficient binding of reactants, washing and readout. Lab-on a-chip assaying cartridges for sample processing and with integrated reagents and microfluidics for running a complete cTnI assay according to the SpinChip dual-axle concept have been designed and prototypes are produced in house. The operations as carried out within the hs-cTnI cartridge upon automatic processing by the SpinChip instrument includes: Sampling of 14µL whole blood, Sample processing including separation of plasma from blood cells and exact metering of a plasma fraction, Dried and liquid reagents preservation, rehydration and processing, Assaying according to patented assay concept, Waste handling and finally readout using the unique readout system developed in this project. The cartridge prototypes are made in house by SoA technologies (milling, bonding and feeding of reagents) as developed through BIA-project 219693. The program for processing of the sample and reagents within the cartridge is now being optimized.

Point of Care (PoC) "In vitro" diagnosis (IVD) platforms available today have limitations linked to ease of use, reliability, sensitivity and repertoires of analyses. This project will take into use recent developments within high sensitivity detection us ing high sensitivity fluorescence technology to detect a variety of analytes present in very low concentration in biological samples. This will be realized on the patent pending SpinChip platform which will perform these analyses reliably and easy using d isposable chips and a compact portable instrument. The pilot application of the high sensitivity system is for measuring cardiac Troponin I (cTnI) a sensitive and specific marker for acute myocardial infarction. cTnI can today not be measured on PoC IVD platforms with the required reliability, sensitivity and speed. The literature, workshops and interviews with physicians have confirmed a strong interest, socio-economic value and business potential for a PoC cTnI test with the characteristics of the tes t SpinChip Diagnostic AS aim at developing.