WO2005065157A2 - Point de plate-forme diagnostique de soins - Google Patents

Point de plate-forme diagnostique de soins Download PDF

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Publication number
WO2005065157A2
WO2005065157A2 PCT/US2004/041651 US2004041651W WO2005065157A2 WO 2005065157 A2 WO2005065157 A2 WO 2005065157A2 US 2004041651 W US2004041651 W US 2004041651W WO 2005065157 A2 WO2005065157 A2 WO 2005065157A2
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
modules
module
host computer
point
Prior art date
Application number
PCT/US2004/041651
Other languages
English (en)
Other versions
WO2005065157A3 (fr
Inventor
Thomas R. Witty
Robert Case
Original Assignee
Fastraq, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/746,127 external-priority patent/US20040228766A1/en
Priority claimed from US10/745,957 external-priority patent/US20040228765A1/en
Application filed by Fastraq, Inc. filed Critical Fastraq, Inc.
Priority to EP04813903A priority Critical patent/EP1702211A2/fr
Priority to CA002549367A priority patent/CA2549367A1/fr
Priority to JP2006547098A priority patent/JP2007516446A/ja
Publication of WO2005065157A2 publication Critical patent/WO2005065157A2/fr
Publication of WO2005065157A3 publication Critical patent/WO2005065157A3/fr

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N35/00069—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/492—Determining multiple analytes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G01N2035/00881—Communications between instruments or with remote terminals network configurations

Definitions

  • the present invention relates generally to a point of care diagnostic system that has a plurality of modules and associated cartridges, and more particularly, to a point of care diagnostic system that includes a plurality of modules that share common QC protocols.
  • Blood and other body fluid tests are important diagnostic methods in patient care and treatment. The reliability and the accuracy of the tests are critical in correctly diagnosing the patient and administrating proper treatment.
  • the Food and Drug Administration (FDA) has established numerous quality standards for the various blood or body fluid tests.
  • Monitoring the test process is beneficial in producing reliable and accurate test results.
  • One way of monitoring the test process is periodically performing the monitoring test on standard test samples. The monitoring test results are compared with expected results to verify the accuracy of the test processes or correct the test instrument or process when appropriate. In this approach, the test processes are assumed to generate consistent result between the monitoring tests.
  • Another way of monitoring the test process is including standard test samples in the test process. This approach is suitable for a test process that performs tests on multiple samples.
  • test results on the standard test samples are compared with expected results to verify the accuracy of the test processes.
  • the test processes on real samples are assumed to generate result consistent with those on standard test samples.
  • These monitoring processes are time and cost inefficient. They are deficient in meeting the needs of point of care, e.g., hospital emergency room/department, test processes.
  • an emergency room test process should be simple to operate and generate diversity of analytical results fast. Accordingly, there is a need for a point of care diagnostic platform that has a plurality of modules coupled to common host computer. There is another need for a point of care diagnostic platform with a plurality of modules that share common QC protocols.
  • a point of care diagnostic platform with a plurality of modules coupled to a host computer and an external communication system.
  • a point of care diagnostic platform with a plurality of modules, and a plurality of analytic cartridges, where each cartridge is associated with a module and is configured to directly accept a blood sample from a standard blood draw tube.
  • a point of care diagnostic platform that has a plurality of modules, a host computer coupled to the modules, a common external communication interface, with each module sharing the common external communication interface.
  • an object of the present invention is to provide a point of care diagnostic platform that includes a plurality of modules that share common QC protocols. Another object of the present invention is to provide a point of care diagnostic platform with a plurality of module coupled to a common host computer. Yet another object of the present invention is to provide a point of care diagnostic platform with a plurality of modules, a host computer coupled to the plurality of modules and an external communication system. Still another object of the present invention is to provide a point of care diagnostic platform with a plurality of modules, and a plurality of analytic cartridges, where each cartridge is associated with a module of the plurality of modules and is configured to directly accept a blood sample from a standard blood draw tube.
  • Another object of the present invention is to provide a point of care diagnostic platform with a plurality of modules; a host computer coupled to the plurality of modules and a common external communication interface, with each module sharing the common external communication interface.
  • a further object of the present invention is to provide a point of care diagnostic platform with a plurality of modules coupled to a common external communication interface such as a least one of WAN or a LAN.
  • Another object of the present invention is to provide a point of care diagnostic platform with a plurality of modules coupled to a common external communication interface that is coupled to a wireless network.
  • a further object of the present invention is to provide a point of care diagnostic platform with a plurality of modules coupled to a hospital information network or a laboratory information network.
  • a plurality of analytic cartridges are provided. Each cartridge is associated with a module and is configured to directly accept a blood sample from a standard blood draw tube.
  • a point of care diagnostic platform includes a plurality of modules.
  • a host computer is coupled to the plurality of modules and a common external communication interface. Each module shares the common external communication interface.
  • a point of care diagnostic platform includes a plurality of modules each sharing the same QC protocols.
  • a plurality of analytic cartridges are included.
  • a host computer is coupled to the plurality of modules. The host computer is coupled to an interface. Each module has a corresponding interface component.
  • a point of care diagnostic platform includes a plurality of modules.
  • a plurality of analytic cartridges are provided that each are bar-coded with information for test protocols, and lot expiration dates.
  • a point of care diagnostic platform includes a plurality of modules.
  • a plurality of analytic cartridges are provided that retain and seal fluids.
  • a point of care diagnostic platform includes a plurality of modules.
  • a plurality of analytic cartridges are provided. All fluids in the cartridges, including patient samples, remain within the cartridges.
  • a point of care diagnostic platform is provided that includes a plurality of modules.
  • a plurality of analytic cartridges are provided. Each cartridge has wet and dry chemistries and at least one substrate that carriers a chemistry.
  • Figure 1 (a) is a block diagram illustrating one embodiment of a point of care diagnostic platform of the present invention, with a user interface, host computer, multiple single-cartridge test processing modules and an external communication system.
  • Figure 1 (b) is a block diagram illustrating another embodiment of a point of care diagnostic platform of the present invention, with multiple multi-cartridge test processing modules.
  • Figure 1(c) is a block diagram illustrating another embodiment of a point of care diagnostic platform of the present invention, with the host computer being integrated with multiple, multi-cartridge modules.
  • Figure 1 (d) is a block diagram illustrating another embodiment of a point of care diagnostic platform of the present invention, with the host computer and user interface both integrated with multiple, multi-cartridge modules.
  • Figure 1(e) is a block diagram illustrating another embodiment of a point of care diagnostic platform of the present invention, with the host computer and user interface integrated with multiple, single-cartridge modules.
  • Figure 2 is a cross-sectional view of one embodiment of a cartridge that can be utilized with the point of care diagnostic platform of the present invention.
  • Figure 3 is a cross-sectional view of a sample tube that can be utilized with cartridges of the present invention.
  • Figure 4 is a schematic diagram illustrating one embodiment of the docking, and the relationship between a cartridge and a module of the present invention.
  • Figure 5 is a schematic diagram illustrating another embodiment of the docking, and the relationship between a cartridge and a module of the present invention.
  • Figure 6 is a schematic diagram illustrating another embodiment of the docking, and the relationship between a cartridge and a module of the present invention.
  • Figure 7 is a cross-sectional view of one embodiment of a cartridge utilized with the present invention, illustrating air, sample and reagent flow channels.
  • Figure 8 is a flow chart illustrating an overall methodology of the point of care diagnostic platform of the present invention.
  • Figure 9 is a flow chart illustrating one embodiment of a cartridge processing procedure implemented with the point of care diagnostic platform of the present invention.
  • Figure 10 is a flow chart illustrating one embodiment of an immunoassay operating procedure implemented with the point of care diagnostic platform of the present invention.
  • Figure 11 is a flow chart illustrating one embodiment of a hematology operating procedure implemented with the point of care diagnostic platform of the present invention.
  • Point of care diagnostic platform 10 includes a plurality of modules 12.
  • modules 12 can be included but not limited to, immunoassay, hematology, electrolyte, molecular diagnostic, coagulation, blood gas, chemistry and the like.
  • the modules 12 can share at least a portion of a common functionality of operation such as fluid movement, sample introduction, and the like.
  • each module 12 contains common functionalities, and unique technologies that correspond to one or more selected chemistries.
  • modules 12 are multiple single-cartridge test processing modules.
  • Platform 10 can deliver a multitude of discreet testing capabilities in a standardized manner.
  • Modules 12 can have common operation platforms. Examples of common operation systems are user interface, quality control, calibration, training, connection to various laboratory information systems, hospital information systems, emergency room information systems, wireless communication and the like.
  • a host computer 14 is coupled to the plurality of modules 12 and also to a user interface 16. Each module 12 is coupled to the user interface 16.
  • Host computer 14 has a variety of different capabilities, including but not limited to user interface, quality control, calibration, training, connection to various laboratory information systems, hospital information systems, emergency room information systems, wireless communication and the like.
  • User interface 16 is coupled to each module 12
  • User interface 16 provides uniform (automated and standardized) connectivity to the plurality of modules 12 as well as communication to other hospital and laboratory information systems.
  • User interface 16 establishes a database of analyzed samples and provides the operator with quality control options for the plurality of modules 12. This is achieved by centralizing and tracking the collective output of the plurality of modules 12.
  • user interface 16 includes capability for at least one of a cardiac , fertility, kidney, coagulation, electrolyte and hematology panel, molecular diagnostics and chemistry panels, and the like.
  • Each module 12 has a corresponding interface component for module control and sample results acquisition.
  • host computer 14 is also coupled to an external communication system 18.
  • a variety of different external communication systems are suitable including but not limited to a, WAN, LAN, wireless network, hospital information network, laboratory information network, and the like.
  • each module 12 shares common QC protocols.
  • the QC protocols include but are not limited to the following, module electronic verification, realtime process monitoring, patient record-keeping, periodic liquid control results monitoring, and the like.
  • the QC protocols are initiated in the same manner regardless of the module 12 that is tested.
  • Electronic monitoring of the process at each module 12 is continuous and transparent to the operator and do not require operator attention.
  • Results are stored in module specific databases.
  • Each module can utilize specific electronic and/or optical parameter monitoring. Changes in the electronic and optical parameters are tracked during the operation of the module 12 involved, and the outputs compared to expected thresholds/changes. These changes are indicative of correct internal operation during sample processing.
  • FIG. 1(b) In another embodiment, illustrated in Figure 1(b), multiple, multi-modules are provided, where a module 12 can be utilized with more than one cartridge.
  • host computer 14 is integrated with multiple, multi-cartridge modules 12.
  • host computer 14 and user interface 16 are both integrated with multiple, multi-cartridge modules 12.
  • host computer and user interface 16 are integrated with multiple, single-cartridge test processing modules 12.
  • Point of care diagnostic platform 10 includes a plurality of cartridges 20, illustrated in Figure 2.
  • Cartridges 20 include but are not limited to cardiac , fertility, kidney, coagulation, electrolyte and hematology panel, molecular diagnostics and chemistry panels, and the like.
  • Each cartridge 20 can include a dock 22 for receiving a sample tube, an air dock 24 that can be engaged by a module 12, a rotary valve 26, which can also be engaged by a module 12, a calibration chamber 28, waste chamber 30, sample/calibration flow path 32 which is coupled to a detector, sample out flow 34, sample pressure channel 36 and a flow cell 38 which is a detection chamber.
  • Cartridges 20 can have wet and dry chemistries and at least one substrate that carriers a chemistry. Examples of various wet and dry chemistries are listed in table 1.
  • Cartridges 20 are associated with a corresponding module 12.
  • cartridges 20 can directly accept a blood sample from a standard blood draw, sample tube 40 which can include a pressure needle 42 and a sampling needle 44, as shown in Figure 3. This can be achieved by, (i) piercing the cap of the standard blood draw tube 40 needles 42 and 44, which deliver low pressure air to force the sample through the other needle into the cartridge 20, penetrating the cap with a single needle and withdrawing fluid directly using a vacuum, and the like.
  • Cartridges 20 can be configured to retain and seal fluids. This can be achieved by using selective pressurization of reagent and sample reservoirs, which forces the fluids into cartridges 20 and through flow cell 38 into waste chamber 30, that can be an integral part of cartridges 20.
  • modules 12 can be configured to be engaged with the cartridges 20 to produce pneumatic movement of fluids in the cartridges 20.
  • the pneumatic pressure is applied by an external pump 46 through the dock 22 on cartridge 20, Figure 2, which is engaged by module 12.
  • Module 12 can include a valve, 48, a vent 50 to atmosphere and a channel 52 that is coupled to cartridge 20.
  • the pneumatic pressure is directed to specific reservoirs and samples in cartridge 20 using valve 48 mechanism to cause selective reagent flow.
  • Cartridge 20 includes a sample application area 54.
  • Optics 56 are included in module 12 and an optical window 57 is included in cartridge 20. At the cessation of reagent flow, excess pressure is vented through vent 50 to atmosphere to stop the flow.
  • Platform 10 can provide self-testing of modules 12, to provide for monitoring and detection of fluid flow.
  • Various electrical and optical properties of the samples and reagents allow continuous monitoring of flow cell contents and are compared to expected transition values, as illustrated in Figure 5.
  • Figure 6 illustrates a cross-sectional view of one embodiment of a cartridge 20.
  • Cartridge 20 can have a number of different flow channels, including but not limited to air, sample and reagent flow channels 58, 60 and 62.
  • Flow channels 58-62 can be created by depressions in both the top and bottom surfaces of the cartridge 20. Flow paths 58-62 can then be sealed with a vapor barrier 64.
  • pressurization of specific sample or reagent containers provided by pump 46 are selectively directed to sample and reagents containers in sequence, providing an outflow directed by a valve to detection chamber 38 or other location, as needed, in sequence and with precise timing.
  • the sample and reagents can flow through an area of controlled temperature to prepare them for precise analysis prior to or during introduction to detection chamber 38. After analysis the reagents and sample remain in the cartridge 20 in waste region 30, although the sample tube 40 can be removed by the operator for subsequent use if desired.
  • Each module 12 can include a processor 56 ( Figure 1(b). Host computer 16, in combination with a processor 56, determines a test protocol for a cartridge 20.
  • a fluid control mechanism in the cartridge 20 is then actuated that permits a flow of a patient sample with liquid chemistries and waste materials. This can occur without exposing an operator of platform 10 and the patient, to a transfer of a patient sample into the cartridge 20 without exposure to the chemistries.
  • Cartridges 20 are designed to isolate biohazards in a cartridge 20 from an operator of the cartridge 20 or the patient. Blood samples from patients are introduced to the cartridges 20 while isolating biohazards in the cartridge from an operator.
  • cartridges 20 are designed to work with whole blood. This eliminates the requirement of a secondary process to remove the cellular components which may interfere with the testing. This additional separation is both time consuming and error prone.
  • Cartridges 20 can include electronic identifiers, including but not limited to bar- coded identifiers, with information for test protocols, and lot expiration dates. Cartridges 20 can also include serialized identification. In one embodiment, placement of a cartridge 20 in a module 12 begins an initiation of the module 12. When a cartridge 20 is inserted into a module 12 it can be sensed automatically. The bar code of cartridge 20, with its unique sample, are read. This initiates the sequential operation of the fluid movement and detection. In another embodiment of the present invention, platform 10 includes a plurality of modules 12 each sharing common QC protocols. A list of possible QC protocols is found in table 2.
  • Figure 8 through 11 are flow charts illustrating point of care diagnostic platform 10 of the present invention.
  • Figure 8 is a flow chart illustrating an overall methodology of the point of care diagnostic platform of the present invention.
  • Figure 9 is a flow chart illustrating one embodiment of a cartridge processing procedure implemented with the point of care diagnostic platform of the present invention.
  • Figure 10 is a flow chart illustrating one embodiment of an immunoassay operating procedure implemented with the point of care diagnostic platform of the present invention.
  • Figure 11 is a flow chart illustrating one embodiment of a hematology operating procedure implemented with the point of care diagnostic platform of the present invention.
  • all reagents and waste are contained in cartridge 20. Fluids are moved in cartridge 20 via an external pump (in the module) coupled to cartridge 20 via an air dock.
  • Cartridge 20 contains the fluid flow, fluid distribution fluid segmentation and sample dilution.
  • a module 12 controls the fluid flow via a low pressure air connection and the fluid selection via one or more valve connections.
  • platform 10 provides real time QC monitoring, and real time test result threshold detection, as disclosed in U.S. Provisional Number 60/470,725, incorporated herein by reference. While embodiments of the invention have been illustrated and described, it is not intended that these embodiments illustrate and describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. What is claimed is:

Abstract

L'invention concerne un point d'une plate-forme diagnostique de soins pourvu d'une pluralité de modules, ainsi qu'une pluralité de cartouches analytiques. Chaque cartouche est associée à un module et conçue pour accepter directement un échantillon sanguin provenant d'un tube à tirage sanguin traditionnel.
PCT/US2004/041651 2003-12-23 2004-12-13 Point de plate-forme diagnostique de soins WO2005065157A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP04813903A EP1702211A2 (fr) 2003-12-23 2004-12-13 Point de plate-forme diagnostique de soins
CA002549367A CA2549367A1 (fr) 2003-12-23 2004-12-13 Point de plate-forme diagnostique de soins
JP2006547098A JP2007516446A (ja) 2003-12-23 2004-12-13 ポイントオブケア診断プラットフォーム

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10/746,127 US20040228766A1 (en) 2003-05-14 2003-12-23 Point of care diagnostic platform
US10/745,957 US20040228765A1 (en) 2003-05-14 2003-12-23 Point of care diagnostic platform
US10/746,127 2003-12-23
US10/745,957 2003-12-23

Publications (2)

Publication Number Publication Date
WO2005065157A2 true WO2005065157A2 (fr) 2005-07-21
WO2005065157A3 WO2005065157A3 (fr) 2005-10-20

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PCT/US2004/041651 WO2005065157A2 (fr) 2003-12-23 2004-12-13 Point de plate-forme diagnostique de soins

Country Status (4)

Country Link
EP (1) EP1702211A2 (fr)
JP (1) JP2007516446A (fr)
CA (1) CA2549367A1 (fr)
WO (1) WO2005065157A2 (fr)

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JP2009511869A (ja) * 2005-10-07 2009-03-19 ホリバ アベイクス エスアーエス 血液等の生体液を分析するモジュラー装置
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JP2009511869A (ja) * 2005-10-07 2009-03-19 ホリバ アベイクス エスアーエス 血液等の生体液を分析するモジュラー装置
US8741230B2 (en) 2006-03-24 2014-06-03 Theranos, Inc. Systems and methods of sample processing and fluid control in a fluidic system
US11287421B2 (en) 2006-03-24 2022-03-29 Labrador Diagnostics Llc Systems and methods of sample processing and fluid control in a fluidic system
US10533994B2 (en) 2006-03-24 2020-01-14 Theranos Ip Company, Llc Systems and methods of sample processing and fluid control in a fluidic system
US11162947B2 (en) 2006-05-10 2021-11-02 Labrador Diagnostics Llc Real-time detection of influenza virus
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EP1702211A2 (fr) 2006-09-20
CA2549367A1 (fr) 2005-07-21
WO2005065157A3 (fr) 2005-10-20

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