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1Stig Morten Borch, pHealth2009 ICT
In vitro diagnostic platforms of the future; technological possibilities and challenges
Stig Morten Borch and Liv Furuberg, Microsystems and Nanotechnology,
SINTEF ICT, Oslo, Norwaywww.sintef.no/microsystems
pHealth2009June 25. 2009, Session 1:
Medical sensors and sensor systems
2Stig Morten Borch, pHealth2009 ICT
In Vitro Diagnostics (IVD):Analysis of samples drawn from patients
Blood Whole Blood, Serum or PlasmaUrineStoolSecretion fluids
SalivaGastric juiceMucous secretion
Tissue samplesTissue fluids
Spinal fluidSynovial fluid
Mucous membranes
Microorganisms, Proteins, DNA/RNA, Lipids, Nutrients, Drugs, Hormones,…
3Stig Morten Borch, pHealth2009 ICT
Point of Care IVD platformsDoctors officesNursing homesRemote testing
In field / off shoreAmbulanceHome testingHospitals;
Children’s clinics BedsideEmergency wardsAcute careSurgery rooms
4Stig Morten Borch, pHealth2009 ICT
Clinical use of PoC IVD products:
Infections, Cancer,..Relapse
Anticoagulant therapy, Diabetes, Rheumatic disease, Cancer,..
Disease / treatment monitoring
Diabetes, Infections, Cardio vascular disease / AMI, Cancer,…
Specific diagnosis
Ongoing inflammations, Fibrinolysis,..Detection
Cancer, Cardio vascular disease,…Risk screening
ExamplesClinical use
5Stig Morten Borch, pHealth2009 ICT
Many POC IVD systems at the market CartridgeCartridge + Instrument+ Instrument
6Stig Morten Borch, pHealth2009 ICT
Critical features of PoC IVD platforms for the future:
Compactness (Cartridge + apparatus)
Minimal room for storage
Completely self-contained system
Ease of useIntegrated sample processingAutomated processing and measurements
Minimally invasive samples Fingerprick blood, saliva, urin
Simple three steps procedure; Add sample - Push button - Read result
Result < 5 minutes
Broad application platform – menu+ high sensitivity parameters Flexibility: Assay principles and sensitivity range.
RobustnessPhysicalChemical (e.g. room temp storage)
Reliability and safety: Performance = Ref-.lab. Assay
Low cost
Built in auto-calibration and fail safes
Safe and adequate read out, interfaces, communication, data storage and connectivity.
7Stig Morten Borch, pHealth2009 ICT
Detection systems
Chemistries
CartridgesSample + reagents
storage and processing
Instruments
Bioanalytical platforms.Integrated multi-disciplinary systems.
8Stig Morten Borch, pHealth2009 ICT
Lab-on-a-chipAllows for:
Completely self-contained system Disposable cassettes with all reagents included. Sealed compact format.
Micro-channels.High accuracy in liquid handling Operates small sample volumes Very little reagent necessary
Low cost productionFast assaysRobustness ..
Chemistries
Detectionsystems
Instruments
CartridgesSample +
assay processing
SINTEF equipment for polymer chip moldings (prototyping) SINTEF equipment for polymer chip moldings (prototyping)
9Stig Morten Borch, pHealth2009 ICT
Microfluidics allow for controlled liquid handling:
Filtering and active porous membranes
Exactmetering
Mixing
Splitting
ThinXXS design kit slides: microBUILDER
Microfluidic functionalities are readily combined with a variety of sensor and
actuator systems as well as a variety surface modifications (Bio-functional layers)
Silicon based microchips
Lysis buffer
Mixer 1
Mixer 2
Ethanol
Incubation chamber(21 µl)
Storage chamber(31µl)
Washing buffer 1
Waste
Product
Connections tosilicon chip
Washing buffer 2Elution buffer
Sample (blood)Sample storage loop(11µl)
Multifunctional slide for DNA extraction
www.microbuilder.orgwww.microbuilder.org
Reagent integrationExcellent, liquid and Excellent, liquid and gassgass barriersbarriers
OD- measurementsCuvette cavities
COC: excellent optical featuresCOC: excellent optical features
10Stig Morten Borch, pHealth2009 ICT
Detectionsystems
Chemistries
Instruments
Chemistries and reagents:Biotechnology,Nanotechnology,Surface modification:Small volumes and fast assays =>Very fast interaction between reactants:
Reagent stability:Room temperature storage
Liquid and dried reagents formulations
CartridgesSample + assay
processing
OC2H5
C2H5O
OC2H5
OC2H5
OC2H5
OH Si
Si OH
CO
C (C
yclic
Ole
fin
Cop
olym
er)
Methanol / Water , 18h
OH
CO
C (C
yclic
Ole
fin
Cop
olym
er)
Immobilized Immobilized biomoleculesbiomolecules::•• MicroMicro--cavity wallscavity walls•• BeadsBeads•• Porous membranePorous membrane•• Microchip surfacesMicrochip surfaces
11Stig Morten Borch, pHealth2009 ICT
Lab-on-a-chip cartridges may be operated by compact (handheld) instruments:
Signal read out:• Optics
• colours (OD), fluorescence, chemiluminescence
• Functionalized MEMS sensors• Electrochemical sensors• Integrated optical sensors• …….
Fluorescent readout of 10 chambers
Liquid processing:• Capillary forces• Pumps (Integrated or external) • Centrifugal forces• Electro-osmosis
Instruments
Detectionsystems
CartridgesSample +
assay processing
Chemistries
12Stig Morten Borch, pHealth2009 ICT
Detectionsystems
Chemistries
Cartridges
Instruments
Lab-on-a-chip / -disc• Microfluidics design• Prototype molding • High speed fluidic control • Sample + reagents processing
Micro-sensorsMicro-opticsHigh and low sensitivityWide range
• Integration• Automation• Miniaturation• Communication
• Assay design • Reagents preservation• Surface modification• Biotechnology
SINTEF; Cover all fields of competence necessary for developing reliable IVD platforms of the future:
SINTEF seek to utilize our broad and unique competences to further develop technologies in this field by direct collaboration with industry partners and
through international collaborative projects.
Through the microBUILDER consortium we have a network of volume production partners.