JP2007516446A - Point-of-care diagnostic platform - Google Patents

Abstract

One object of the present invention is to provide a point-of-care diagnostic platform that includes multiple modules that share a common QC protocol.
The objects and other objects of the present invention are achieved in a point-of-care diagnostic platform including a plurality of modules. A plurality of analysis cartridges are provided. Each cartridge is coupled to one module and is configured to receive a blood sample directly from a standardized blood draw tube.
[Selection] Figure 1A

Description

  The present invention relates generally to point-of-care diagnostic systems having multiple modules and associated cartridges, and more particularly to point-of-care diagnostic systems that include multiple modules that share a common QC protocol.

  Blood and other body fluid testing is an important diagnostic method in nursing and treating patients. The reliability and accuracy of these tests is very important in accurately diagnosing and properly treating patients. The Food and Drug Administration (FDA) has established a number of quality standards for testing various blood and body fluids. Monitoring the test process is beneficial for obtaining reliable and accurate test results.

  One way to monitor the test process is to periodically perform monitoring tests on standard test samples. In order to verify the accuracy of the test process or to adjust the test equipment or test process in a timely manner, the results of the monitoring test are compared with the expected results. In this way, the test process is considered to produce consistent results between monitoring tests.

  Another way to monitor the test process is to include a standardized test sample in the test process. This method is suitable for a test process in which a test is performed on a large number of samples. Test results for standardized test samples are compared with expected results to confirm the accuracy of the test process. In this way, the test process for the actual sample is considered to produce results that are consistent with the results for the standardized test sample.

  These monitoring processes are inefficient in terms of time and cost. These monitoring processes cannot meet the demands of point-of-care, eg, testing processes in hospital emergency rooms / departments. In addition to being reliable and accurate, the testing process in the emergency room should be simple so that various analytical results can be processed and generated at high speed.

  Therefore, there is a need for a point-of-care diagnostic platform having multiple modules coupled to a common host computer. There is also a need for a point-of-care diagnostic platform having multiple modules that share a common QC protocol. Furthermore, there is also a need for a point-of-care diagnostic platform having a plurality of modules coupled to a host computer and an external communication system. Furthermore, a point of care comprising a plurality of modules and a plurality of analysis cartridges, each cartridge coupled to one module and configured to receive a blood sample directly from a standardized blood draw tube. A diagnostic platform is also needed. Furthermore, there is a need for a point-of-care diagnostic platform having a plurality of modules, a host computer coupled to the modules, and a common external communication interface, each module sharing the common external communication interface. Yes.

  Accordingly, it is an object of the present invention to provide a point-of-care diagnostic platform that includes multiple modules that share a common QC protocol.

  Another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules coupled to a common host computer.

  Yet another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules and a host computer coupled to the plurality of modules and an external communication system.

  Yet another object of the present invention is to provide a plurality of modules, each coupled to one of the plurality of modules and configured to receive a blood sample directly from a standardized blood draw tube. A point of care diagnostic system having a plurality of analysis cartridges.

  Another object of the present invention includes a plurality of modules and a host computer coupled to the plurality of modules and a common external communication interface, and each of the plurality of modules shares the common external communication interface. To provide a point-of-care diagnostic system.

  Yet another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules coupled to a common external communication interface, such as at least one of a WAN or a LAN.

  Another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules coupled to a common external communication interface coupled to a wireless network.

  It is a further object of the present invention to provide a point-of-care diagnostic system having a plurality of modules coupled to a hospital information network or a laboratory information network.

  Yet another object of the present invention is a point-of-care diagnostic system having a plurality of modules and a plurality of analysis cartridges each labeled with information for the test protocol and a bar code using the lot life. Is to provide.

  Yet another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules and a plurality of analysis cartridges that retain and confine fluid.

  Yet another object of the present invention is to provide a point-of-care diagnostic system having a plurality of modules and a plurality of analysis cartridges, wherein all fluid in the cartridge, including patient samples, remains in the cartridge. It is.

  These and other objects of the present invention are achieved in a point-of-care diagnostic platform that includes a plurality of modules. A plurality of analysis cartridges are provided. Each cartridge is coupled to one module and is configured to receive a blood sample directly from a standardized blood draw tube.

  In another embodiment of the invention, the 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.

  In another embodiment of the invention, the point-of-care diagnostic platform includes multiple modules that each share the same QC protocol. A plurality of analysis cartridges are included. A host computer is coupled to the plurality of modules. The host computer is coupled to the interface. Each module has a corresponding interface component.

  In another embodiment of the invention, the point-of-care diagnostic platform includes a plurality of modules. A plurality of analysis cartridges are provided, each with a bar code using information for the test protocol and a lot life.

  In another embodiment of the invention, the point-of-care diagnostic platform includes a plurality of modules. A plurality of analysis cartridges are provided for holding and confining fluid.

  In another embodiment of the invention, the point-of-care diagnostic platform includes a plurality of modules. A plurality of analysis cartridges are provided. All fluid in the cartridge, including the patient sample, remains in the cartridge.

  In another embodiment of the invention, a point of care diagnostic platform is provided that includes a plurality of modules. A plurality of analysis cartridges are provided. Each cartridge has wet and dry chemistry and at least one substrate that performs one chemistry.

  As shown in FIG. 1A, one embodiment of the present invention is a point-of-care diagnostic platform generally designated 10 and a method of using this platform. The point-of-care diagnostic platform 10 includes a plurality of modules 12. Various different modules are available for immunoassay, hematology, electrolyte, molecular diagnostic, coagulation, blood gas, chemistry, etc. It may be included without being limited to these. Modules 12 can share at least some of the common operational functions such as liquid movement, sample introduction, and the like. In one embodiment, each module 12 includes a unique function corresponding to a common function and one or more selected chemistries. In the embodiment of FIG. 1A, the module 12 includes a number of single cartridge test processing modules.

  The platform 10 can achieve a number of discreet test capabilities in a standardized manner. Modules 12 can have a common operating platform. Examples of common operating systems are user interfaces, quality control, calibration, training, various laboratory information systems, hospital information systems, connections to emergency room information systems, wireless communications, and the like.

  Host computer 14 is coupled to a plurality of modules 12 and is also coupled to user interface 16. Each module 12 is coupled to a user interface 16. Host computer 14 has a variety of different capabilities including, but not limited to, user interface, quality control, calibration, training, various laboratory information systems, emergency room information system connections, wireless communications, and the like. Have A user interface 16 is coupled to each module 12. User interface 16 provides unified (automated and standardized) connectivity to multiple modules 12, along with communication to multiple modules 12 and other hospital and laboratory information systems. It should be understood that what has been standardized includes industry standards as documented by the Connectivity Industry Consortium. The user interface 16 establishes a database of analyzed samples and provides an operator with quality control options for the plurality of modules 12. This is achieved by centrally tracking the collective output of multiple modules 12. In one embodiment, the user interface 16 includes a cardiac panel, fertility panel, kidney panel, coagulation panel, electrolyte panel, hematology panel, molecular diagnostics. Includes capabilities for at least one of (molecular diagnostics) panels, chemistry panels, and the like.

  Each module 12 has corresponding interface components for module control and sample result acquisition, respectively. In one embodiment, host computer 14 is also coupled to external communication system 18. A variety of different external communication systems are suitable, including but not limited to WANs, LANs, wireless networks, hospital information networks, laboratory information networks, and the like. The platform 10 can be connected directly or indirectly to the emergency room / department patient management network.

  In one embodiment, each module 12 shares a common QC protocol. The QC protocol includes module electronic verification, real-time process monitoring, patient record-keeping, periodic liquid control results monitoring, etc. , Including but not limited to these. The QC protocol is started in the same way regardless of the module 12 to be tested. Electronic monitoring of processing in each of the modules 12 is continuous, transparent to the operator (operator) and does not require operator attention. Results are stored in the module's own database. Each module can utilize its own electronic and / or optical parameter monitoring. Changes in electronic and optical parameters are tracked while the relevant module 12 is operating, and the output is compared to the expected threshold / change. These changes are indicative of proper internal operation during sample processing.

  In another embodiment, as shown in FIG. 1B, a number of multi-modules are provided that allow one module 12 to be used with one or more cartridges. In FIG. 1C, the host computer 14 is integrated into a number of multi-cartridge modules 12. In the embodiment of FIG. 1D, both the host computer 14 and the user interface 16 are integrated into multiple multi-cartridge modules 12. In the embodiment of FIG. 1E, the host computer and user interface 16 are integrated into a number of single cartridge test processing modules 12.

  The point-of-care diagnostic platform 10 includes a plurality of cartridges 20 shown in FIG. The cartridge 20 includes, without limitation, a heart panel, a fertility panel, a kidney panel, a coagulation panel, an electrolyte panel, a hematology panel, a molecular diagnostic panel, a chemical panel, and the like.

  Each module 20 includes a dock 22 for receiving a sample tube, an air dock 24 that can engage the module 12, and a rotary valve 26 that can also engage the module 12. A calibration chamber 28, a waste chamber 30, a sample / calibration flow path 32 coupled to the detector, a sample output flow 34, a sample pressure channel 36, and a flow cell 38 which is a detection chamber. be able to.

The cartridge 20 can have wet and dry chemistries and at least one substrate that performs a chemistry. Various wet and dry chemistries are listed in Table 1 below.

  The cartridge 20 is coupled to one corresponding module 12. In one embodiment, the cartridge 20 can receive a blood sample directly from a standardized blood withdrawal sample tube 40 that can include a pressure needle 42 and a sampling needle 44 as shown in FIG. This punctures the cap of the standardized pull-in tube 40 needles 42 and 44 (the needles 42 and 44 carry low pressure air and suck the sample into the cartridge 20 through the other needle) This is achieved by, for example, letting one needle pass through the cap and drawing the fluid directly using a vacuum. The cartridge 20 can be configured to hold and confine fluid. This can be accomplished by selectively pressurizing the reactants and sample reservoirs so that fluid is moved into the cartridge 20 and is located within the cartridge 20. It is moved through a flow cell 38 into a waste chamber 30 which can be a part. All fluid in the cartridge 20 including the patient sample can be retained in the cartridge 20.

  As shown in FIG. 4, the module 12 is configured to engage with the cartridge 20, and can cause air movement of the fluid within the cartridge 20. Air pressure is provided by the external pump 46 through the dock 22 of the cartridge 20 in FIG. Module 12 can include a valve 48, a valve 50 to the atmosphere, and a channel 52 coupled to cartridge 20. Air pressure is directed to its own reservoir and sample within the cartridge 20 using the valve 48 mechanism to produce a selective reactant flow. The cartridge 20 includes a sample application area 54. An optics 56 is included in the module 12 and an optical window 57 is included in the cartridge 20. When the reactant flow is interrupted, excess pressure is released to the atmosphere by valve 50 and the flow is stopped. Platform 10 may perform self-testing of module 12 to perform fluid flow monitoring and detection. Various electrical and optical properties of the sample and reactant allow for continuous monitoring of the flow cell contents and are compared to the expected transition values as shown in FIG.

  FIG. 6 shows a cross-sectional view of one embodiment of the cartridge 20. The cartridge 20 can have a number of different flow channels including, but not limited to, air flow channel 58, sample flow channel 60, and reactant flow channel 62. The flow channels 58-62 can be formed by depressions in both the top and bottom surfaces of the cartridge 20. The flow paths 58-62 are then confined using the vapor barrier 64.

  Referring again to FIG. 4, the pressurization provided by the pump 46 to the unique sample or reactant container is selectively directed sequentially to the sample and reactant container to detect the detection chamber 38 or other location. The output flow that is directed by the valve to can be realized in sequence and with precise timing when needed. Samples and reactants can flow through a region of controlled temperature to achieve these accurate analyzes before and during introduction into the detection chamber 38. After analysis, these reactants and samples remain in the waste area 30 of the cartridge 20, but the sample tube 40 can be removed by an operator for later use if desired.

  Each module 12 may include a processor 56 (FIG. 1B). Host computer 16 cooperates with processor 56 to determine a test protocol for cartridge 20. After this, the fluid control mechanism in the cartridge 20 is activated that allows the flow of the patient sample using the liquid chemistry and the waste material. This can be done without showing the operator and patient of the platform 10 the transfer of the patient sample into the cartridge 20 without exposure to chemistry. The cartridge 20 is designed to isolate biological hazardous materials within the cartridge 20 from the operator or patient of the cartridge 20. A blood sample from the patient is directed to the cartridge 20 while isolating biological hazardous materials in the cartridge from the operator.

  In one embodiment, cartridge 20 is designed to work with whole blood. This reduces the need for secondary processes to remove cellular components that can interfere with the test. This additional separation is time consuming and error prone. In the cartridge, the separation of the cells provides a barrier through which the specimen to be measured by the exclusion of the cells from the analytical contact, except in the case of hematology, where the cells themselves are to be measured Automatically executed.

  The cartridge 20 can include an electronic identifier, including but not limited to a bar code identifier, along with information for the test protocol and lot life. The cartridge 20 can also include serialized identification.

  In one embodiment, placing the cartridge 20 in the module 12 initiates the operation of the module 12. The cartridge 20 can be automatically sensed when the cartridge 20 is inserted into the module 12. The barcode of the cartridge 20 with the unique sample is read. As a result, the movement and detection of the fluid are sequentially started.

In another embodiment of the present invention, platform 10 includes a plurality of modules 12 that each share a common QC protocol. A list of possible QC protocols is shown in Tables 2-5 below.

  8-11 are flow diagrams illustrating the point-of-care diagnostic platform 10 of the present invention. FIG. 8 is a flow diagram illustrating the overall method of the point-of-care diagnostic platform of the present invention. FIG. 9 is a flow diagram illustrating one embodiment of a cartridge processing procedure performed using the point-of-care diagnostic platform of the present invention. FIG. 10 is a flow diagram illustrating one embodiment of an immunoassay operation procedure performed using the point-of-care diagnostic platform of the present invention. FIG. 11 is a flow diagram illustrating one embodiment of a hematology operation procedure performed using the point-of-care diagnostic platform of the present invention.

  In the example described above, all reactants and waste are contained within the cartridge 20. Fluid in the cartridge 20 is removed by an external pump (within the module) coupled to the cartridge 20 via an air lock. Similarly, reactants and samples are sequentially guided in the cartridge by a valve (s) with-in the cartridge, but activated by a physical engagement with an external activator in the module. Is done. Cartridge 20 includes fluid flow, fluid distribution fluid segmentation, and sample dilution. Module 12 controls fluid flow through low pressure air connections and fluid selection through one or more valve connections.

  In another embodiment, platform 10 performs real-time QC monitoring and real-time test result threshold detection as disclosed by US Provisional Application No. 60 / 470,725, which is incorporated herein by reference.

  While various 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. Further, the terms used in the present specification are terms for explanation rather than limitation, and various modifications can be made without departing from the spirit and technical scope of the present invention. I want you to understand.

1 is a block diagram illustrating one embodiment of a point-of-care diagnostic platform of the present invention having a user interface, a host computer, multiple single cartridge test processing modules, and an external communication system. 4 is a block diagram illustrating another embodiment of the point-of-care diagnostic platform of the present invention having multiple multi-cartridge test processing modules. FIG. FIG. 4 is a block diagram illustrating another embodiment of the point-of-care diagnostic platform of the present invention having a host computer integrated into multiple multi-cartridge modules. FIG. 4 is a block diagram illustrating another embodiment of the point-of-care diagnostic platform of the present invention, having a host computer and user interface both integrated into multiple multi-cartridge modules. FIG. 4 is a block diagram illustrating another embodiment of the point-of-care diagnostic platform of the present invention having a host computer and user interface integrated into multiple single cartridge modules. 1 is a cross-sectional view illustrating one embodiment of a cartridge that can be used with the point-of-care diagnostic platform of the present invention. Sectional drawing which shows the sample tube which can be utilized using the cartridge of this invention. The schematic diagram which shows one Embodiment of the connection and relationship between the cartridge and module of this invention. The schematic diagram which shows another embodiment of the connection and relationship between the cartridge and module of this invention. The schematic diagram which shows another embodiment of the connection and relationship between the cartridge and module of this invention. 1 is a cross-sectional view of one embodiment of a cartridge utilized with the present invention showing an air flow channel, a sample flow channel, and a reactant flow channel. 1 is a flow diagram illustrating the overall method of the point-of-care diagnostic platform of the present invention. FIG. 3 is a flow diagram illustrating one embodiment of a cartridge processing procedure performed using the point-of-care diagnostic platform of the present invention. FIG. 5 is a flow diagram illustrating one embodiment of an immunoassay procedure performed using the point-of-care diagnostic platform of the present invention. FIG. 4 is a flow diagram illustrating one embodiment of a hematology operation procedure performed using the point-of-care diagnostic platform of the present invention.

Claims (35)

Multiple modules,
A plurality of analytical cartridges each coupled to one of the plurality of modules and configured to receive a blood sample directly from a standardized blood draw tube;
A point-of-care diagnostic system. Multiple modules,
A host computer coupled to the plurality of modules and a common external communication interface;
The point-of-care diagnostic system, wherein each of the plurality of modules shares the common external communication interface. A plurality of modules each sharing the same QC protocol;
Multiple analysis cartridges;
A host computer coupled to the plurality of modules and coupled to an interface;
Each of the plurality of modules has a corresponding interface component, the point-of-care diagnostic system. A plurality of modules, each sharing a common QC protocol;
Multiple analysis cartridges;
A host computer coupled to the plurality of modules and coupled to an interface;
Each of the plurality of modules has a corresponding interface component, the point-of-care diagnostic system.   The point-of-care diagnostic system according to any of claims 1 to 4, wherein each module includes a common function and a unique technique corresponding to one or more selected chemistries.   6. The point-of-care diagnostic system of claim 5, wherein each cartridge is labeled with information for the test protocol and a bar code using the lot life.   The point-of-care diagnostic system according to claim 1, 3 or 4, wherein fluid is held and confined in the plurality of analysis cartridges.   The point-of-care diagnostic system of claim 1, wherein a sample ID barcode is attached to the plurality of cartridges to automatically identify a patient.   The point-of-care diagnostic system according to any of claims 1 to 4, wherein all fluid in the cartridge, including a patient sample, remains in the cartridge.   The point-of-care of claim 1, claim 3 or claim 4, wherein each cartridge comprises wet and dry chemistry and at least one substrate that performs one chemistry. Diagnostic system.   The point-of-care diagnostic system according to any one of claims 1 to 4, wherein each module includes a processor.   Flow control in the cartridge, wherein the processor of the module, in cooperation with the host computer, determines the test protocol for the cartridge and allows the flow of the patient sample using the liquid chemistry and waste material The point-of-care diagnostic system of claim 11, wherein the mechanism is operated.   12. The point-of-care diagnostic system of claim 11, wherein a module processor operates in conjunction with the host computer to operate movement of a sample to the cartridge without exposing an operator to the chemistry.   The point-of-care diagnostic system according to claim 1, claim 3 or claim 4, wherein each cartridge is configured to isolate biological hazardous material in the cartridge from an operator of the cartridge.   5. Each cartridge is configured to introduce a blood sample into the cartridge while isolating biological hazardous materials in the cartridge from an operator. Point-of-care diagnostic system.   The point-of-care diagnosis system according to any one of claims 1 to 4, wherein each of the plurality of modules shares at least a part of a common operation function.   The point-of-care diagnostic system according to any of claims 1 to 4, wherein each module includes a common function and a unique technique corresponding to one or more selected chemistries.   The point-of-care diagnosis system according to claim 1, wherein each of the plurality of modules shares at least a part of a common operation function.   The point-of-care diagnostic system of claim 3, wherein the QC protocol includes at least one of modular electronic confirmation, real-time process monitoring, patient record keeping, and periodic fluid control result monitoring.   The point-of-care diagnostic system according to claim 3, wherein the QC protocol is initiated in the same way regardless of the module.   The point-of-care diagnosis system according to claim 1, wherein the plurality of modules have a common operation system.   The point-of-care diagnostic system according to any of claims 1 to 4, wherein at least a portion of the cartridge is configured to operate with whole blood.   The point-of-care diagnostic system according to any one of claims 1 to 4, which is connected to a laboratory information system.   The point-of-care diagnostic system according to any one of claims 1 to 4, which is directly connected to a laboratory information system.   The point-of-care diagnosis system according to any one of claims 1 to 4, which is connected to a hospital information system.   The point-of-care diagnostic system according to any one of claims 1 to 4, connected to an emergency room / department management network.   The point-of-care diagnostic system according to any of claims 1 to 4, wherein the host computer is coupled to at least one of a LAN, a WAN and a wireless network.   The point-of-care diagnostic system according to any one of claims 1 to 4, wherein a number of reliable test capabilities are realized by a standardized method.   The point-of-care diagnosis system according to any one of claims 1 to 4, wherein the plurality of modules have a common operation system.   The point-of-care diagnosis according to any one of claims 1 to 4, wherein the communication interface includes at least one of a heart panel, a fertility panel, a kidney panel, a coagulation panel, an electrolyte panel, and a hematology panel. system.   The point-of-care diagnostic system according to any one of claims 1 to 4, which performs real-time QC monitoring and real-time test result threshold detection.   The point-of-care diagnostic system according to any one of claims 1 to 4, wherein a self-test is performed to perform fluid flow monitoring and detection.   The point-of-care diagnosis system according to claim 1, wherein each of the plurality of modules shares at least a part of a common operation function.   The point-of-care diagnostic system according to any one of claims 1 to 4, wherein when the cartridge is arranged in the module, the operation of the module is started.   Flow control in the cartridge, wherein the processor of the module, in cooperation with the host computer, determines the test protocol for the cartridge and allows the flow of the patient sample using the liquid chemistry and waste material The point-of-care diagnostic system according to any one of claims 1 to 4, wherein the mechanism is operated.

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