US20040228766A1 - Point of care diagnostic platform - Google Patents

Abstract

A point of care diagnostic platform is provided that has a plurality of modules. 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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Ser. No. 60/470,725, and is related to co-pending application U.S. Ser. No. ______, (Attorney Docket No.: 40422-0004) filed the same day as the present application, all of which applications are fully incorporated herewith.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• 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.[0003]
• 2. Description of the Related Art[0004]
• 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.[0005]
• 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.[0006]
• 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. The test results on the standard test samples are compared with expected results to verify the accuracy of the test processes. In this approach, the test processes on real samples are assumed to generate result consistent with those on standard test samples.[0007]
• 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. In addition to being reliable and accurate, an emergency room test process should be simple to operate and generate diversity of analytical results fast.[0008]
• 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. Yet there is another need for a point of care diagnostic platform with a plurality of modules coupled to a host computer and an external communication system. There is still another need for 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. Yet there is a further need for 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.[0009]
SUMMARY OF THE INVENTION
• Accordingly, 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. (is the common operator interface another patent?)[0010]
• 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.[0011]
• 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.[0012]
• 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.[0013]
• 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.[0014]
• 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.[0015]
• 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.[0016]
• 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.[0017]
• Yet 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 that are each bar-coded with information for test protocols, and lot expiration dates.[0018]
• Still a further 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 that retain and seal fluids.[0019]
• Yet another object of the present invention is to provide a point of care diagnostic platform that has a plurality of modules and a plurality of analytic cartridges, where all fluids in a cartridge, including a patient sample, remain within the cartridge.[0020]
• These and other objects of the present invention are achieved in a point of care diagnostic platform includes a plurality of modules. 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.[0021]
• In another embodiment of the present invention, 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.[0022]
• In another embodiment of the present invention, 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.[0023]
• In another embodiment of the present invention, 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.[0024]
• In another embodiment of the present invention, a point of care diagnostic platform includes a plurality of modules. A plurality of analytic cartridges are provided that retain and seal fluids.[0025]
• In another embodiment of the present invention, 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.[0026]
• In another embodiment of the present invention, 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.[0027]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1([0028]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.
• FIG. 1([0029]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.
• FIG. 1([0030]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.
• FIG. 1([0031]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.
• FIG. 1([0032]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.
• FIG. 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.[0033]
• FIG. 3 is a cross-sectional view of a sample tube that can be utilized with cartridges of the present invention.[0034]
• FIG. 4 is a schematic diagram illustrating one embodiment of the docking, and the relationship between a cartridge and a module of the present invention.[0035]
• FIG. 5 is a schematic diagram illustrating another embodiment of the docking, and the relationship between a cartridge and a module of the present invention.[0036]
• FIG. 6 is a schematic diagram illustrating another embodiment of the docking, and the relationship between a cartridge and a module of the present invention.[0037]
• FIG. 7 is a cross-sectional view of one embodiment of a cartridge utilized with the present invention, illustrating air, sample and reagent flow channels.[0038]
• FIG. 8 is a flow chart illustrating an overall methodology of the point of care diagnostic platform of the present invention.[0039]
• FIG. 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.[0040]
• FIG. 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.[0041]
• FIG. 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.[0042]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• As illustrated in FIG. 1([0043]a), one embodiment of the present invention is a point of care diagnostic platform, denoted generally as10, and its method of use. Point of carediagnostic platform10 includes a plurality ofmodules12. A variety of different modules can be included but not limited to, immunoassay, hematology, electrolyte, molecular diagnostic, coagulation, blood gas, chemistry and the like. Themodules12 can share at least a portion of a common functionality of operation such as fluid movement, sample introduction, and the like. In one embodiment, eachmodule12 contains common functionalities, and unique technologies that correspond to one or more selected chemistries. In the FIG. 1(a) embodiment,modules12 are multiple single-cartridge test processing modules.
• [0044]Platform10 can deliver a multitude of discreet testing capabilities in a standardized manner.Modules12 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[0045]host computer14 is coupled to the plurality ofmodules12 and also to auser interface16. Eachmodule12 is coupled to theuser interface16.Host computer14 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 interface16 is coupled to eachmodule12User interface16 provides uniform (automated and standardized) connectivity to the plurality ofmodules12 as well as communication to other hospital and laboratory information systems. It will be appreciated that standardized includes industry standards as documented by the Connectivity Industry Consortium.User interface16 establishes a database of analyzed samples and provides the operator with quality control options for the plurality ofmodules12. This is achieved by centralizing and tracking the collective output of the plurality ofmodules12. In one embodiment,user interface16 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[0046]module12 has a corresponding interface component for module control and sample results acquisition. In one embodiment,host computer14 is also coupled to anexternal communication system18. 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.Platform10 can be connected directly or in-directly to a emergency room/department patient management network
• In one embodiment, each[0047]module12 shares common QC protocols. The QC protocols include but are not limited to the following, module electronic verification, real-time process monitoring, patient record-keeping, periodic liquid control results monitoring, and the like. The QC protocols are initiated in the same manner regardless of themodule12 that is tested. Electronic monitoring of the process at eachmodule12 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 themodule12 involved, and the outputs compared to expected thresholds/changes. These changes are indicative of correct internal operation during sample processing.
• In another embodiment, illustrated in FIG. 1([0048]b), multiple, multi-modules are provided, where amodule12 can be utilized with more than one cartridge. In FIG. 1(c)host computer14 is integrated with multiple,multi-cartridge modules12. In the FIG. 1(d) embodiment,host computer14 anduser interface16 are both integrated with multiple,multi-cartridge modules12. In the FIG. 1(e) embodiment, host computer anduser interface16 are integrated with multiple, single-cartridgetest processing modules12.
• Point of care[0049]diagnostic platform10 includes a plurality ofcartridges20, illustrated in FIG. 2.Cartridges20 include but are not limited to cardiac, fertility, kidney, coagulation, electrolyte and hematology panel, molecular diagnostics and chemistry panels, and the like.
• Each[0050]cartridge20 can include adock22 for receiving a sample tube, anair dock24 that can be engaged by amodule12, arotary valve26, which can also be engaged by amodule12, acalibration chamber28,waste chamber30, sample/calibration flow path32 which is coupled to a detector, sample outflow34,sample pressure channel36 and aflow cell38 which is a detection chamber.
• [0051]Cartridges20 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.

  TABLE 1
  cartridge	Wet Reagents	Dry Reagents
  electrolytes	calibration fluid	ion specific electrode
  immunology	—	Capture antibody
  		Conjugate antibody
  hemolotogy	Lysing solution/white blood cell	—
  	nuclear label
  	Hemoglobin dye
  Chemistry	Various	Various
  Coagulation	—	Initiator
  Blood gas	—	Electrode
  Molecular	Nucleic acid label	Nucleic acid capture
  		Amplification reagents

• [0052]Cartridges20 are associated with a correspondingmodule12. In one embodiment,cartridges20 can directly accept a blood sample from a standard blood draw,sample tube40 which can include apressure needle42 and asampling needle44, as shown in FIG. 3. This can be achieved by, (i) piercing the cap of the standardblood draw tube40needles42 and44, which deliver low pressure air to force the sample through the other needle into thecartridge20, penetrating the cap with a single needle and withdrawing fluid directly using a vacuum, and the like.Cartridges20 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 intocartridges20 and throughflow cell38 intowaste chamber30, that can be an integral part ofcartridges20. All fluids incartridges20, including patient samples, can remain within thecartridge20.
• As illustrated in FIG. 4,[0053]modules12 can be configured to be engaged with thecartridges20 to produce pneumatic movement of fluids in thecartridges20. The pneumatic pressure is applied by anexternal pump46 through thedock22 oncartridge20, FIG. 2, which is engaged bymodule12.Module12 can include a valve,48, avent50 to atmosphere and achannel52 that is coupled tocartridge20. The pneumatic pressure is directed to specific reservoirs and samples incartridge20 usingvalve48 mechanism to cause selective reagent flow.Cartridge20 includes asample application area54.Optics56 are included inmodule12 and anoptical window57 is included incartridge20. At the cessation of reagent flow, excess pressure is vented throughvent50 to atmosphere to stop the flow.Platform10 can provide self-testing ofmodules12, 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 FIG. 5.
• FIG. 6 illustrates a cross-sectional view of one embodiment of a[0054]cartridge20.Cartridge20 can have a number of different flow channels, including but not limited to air, sample andreagent flow channels58,60 and62. Flow channels58-62 can be created by depressions in both the top and bottom surfaces of thecartridge20. Flow paths58-62 can then be sealed with avapor barrier64.
• Referring again to FIG. 4, pressurization of specific sample or reagent containers provided by[0055]pump46 are selectively directed to sample and reagents containers in sequence, providing an outflow directed by a valve todetection chamber38 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 todetection chamber38. After analysis the reagents and sample remain in thecartridge20 inwaste region30, although thesample tube40 can be removed by the operator for subsequent use if desired.
• Each[0056]module12 can include a processor56 (FIG. 1(b).Host computer16, in combination with aprocessor56, determines a test protocol for acartridge20. A fluid control mechanism in thecartridge20 is then actuated that permits a flow of a patient sample with liquid chemistries and waste materials. This can occur without exposing an operator ofplatform10 and the patient, to a transfer of a patient sample into thecartridge20 without exposure to the chemistries.Cartridges20 are designed to isolate biohazards in acartridge20 from an operator of thecartridge20 or the patient. Blood samples from patients are introduced to thecartridges20 while isolating biohazards in the cartridge from an operator.
• In one embodiment,[0057]cartridges20 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. In the cartridge, the separation of cells is done automatically by providing a barrier which is penetrated by the analyte to be measured by excludes the cells from analytical contact, except in the case of hemotalogy, where the cells themselves are the subject of measurement.
• [0058]Cartridges20 can include electronic identifiers, including but not limited to bar-coded identifiers, with information for test protocols, and lot expiration dates.Cartridges20 can also include serialized identification.
• In one embodiment, placement of a[0059]cartridge20 in amodule12 begins an initiation of themodule12. When acartridge20 is inserted into amodule12 it can be sensed automatically. The bar code ofcartridge20, with its unique sample, are read. This initiates the sequential operation of the fluid movement and detection.
• In another embodiment of the present invention,[0060]platform10 includes a plurality ofmodules12 each sharing common QC protocols. A list of possible QC protocols is found in table 2.

  	TABLE 2
  	Responsibility	Comments

  Model POCT Platform Operating Procedure

  	Action (per cartridge)
  1.	Draw minimum of 1.5 ml whole blood	Operator	Exact volume
  	sample in appropriate 5 ml vacutainer-type		above minimum not
  	draw tube, using standard draw procedure		critical
  2.	Push sample tube into cartridge tube dock	Operator
  	and fully seat over needles
  3.	Place patient ID bar code label in	Operator	If ED bar code
  	designated target area on tube dock		system used
  4.	Push cartridge into module port until fully	Operator*	Platform in testing
  	seated over snap-type detents		mode
  5.	LED (blue) above port flashes to indicate	Platform	No LED, push
  	cartridge fully seated in port and cartridge		cartridge further
  	read in process		into port
  6.	LED steady illumination after 2 seconds if	Platform	No steady LED,
  	cartridge read OK (lot#, exp. Date, test		replace cartridge
  	type, patient ID) OPERATOR WALK AWAY		and reuse sample
  7.	Perform designated assay protocol	Platform	10-15 minutes
  8.	LED extinguishes, patient, test results,	Platform	Downloaded to LIS
  	reference range and QC data stored in		when connected
  	memory, displayed on screen and printed
  	on attached printer
  9.	Remove cartridge and discard in	Operator*
  	biohazardous solid waste (remove and sale
  	sample tube if required)

  Immunoassay

  1.	Action
  	Draw minimum of 1.5 ml whole blood	Operator	Exact volume
  	sample in appropriate 5 ml vacutainer-type		above minimum not
  	draw tube, using standard draw procedure		critical
  2.	Push sample tube into cartridge tube dock	Operator
  	and fully seat over needles
  3.	Place patient ID bar code label in	Operator	If ED bar code
  	designated target area on tube dock		system used
  4.	Push cartridge into module port until fully	Operator
  	seated over detents
  5.	Pressurize sample tube and flow sample:	Plafform	3X volumes for (3)
  	200 ul/test trip at 500 u./min.		strip cartridge
  6.	Stop flow by:	Platform	Test strip manifold
  	a. venting pressure to test strip manifold, or		is a porous
  	b. flow channel manifold if even distribution		membrane
  7.	Read reflectance change on strip reaction	Platform
  	areas at designatedintervals

  Hemotology

  1.	Draw minimum of 1.5 ml whole blood	Operator	Exact volume
  	sample in appropriate 5 ml vacutainer-		above minimum not
  	type draw tube, using standard draw		critical
  	procedure
  2.	Push sample tube into cartridge tube	Operator
  	dock and fully seat over needles
  3.	Place patient ID bar code label in	Operator	If ED bar code
  	designated target area on tube dock		system used
  4.	Push cartridge into module port until fully	Operator	LED illuminates
  	seated over detents		above port
  5.	Pressurize sample tube and flow sample	Platform
  	to segment at 200 ul sample
  6.	Stop flow by venting pressure to sample	Platform
  	tube
  7.	Pressurize diluent and flow to wash	Platform
  	sample segment into mixing chamber
  8.	Stop flow by venting pressure	Platform
  9.	Mix sample and diluent	Platform	How mix?
  10.	Pressurize mixed sample and flow to	Platform
  	flowcell.
  11.	Stop flow by ventingpressure	Platform
  12.	Repeat steps 10 and 11 (4) times	Platform
  13.	Segment 50 ul ofsample	Platform
  14.	Mix with 500 ul of Hb reagent	Platform
  15.	Flow mixed sample into flowcell: 100 ul at	Platform
  	1 ml/min

  Electrolytes

  1.	Draw minimum of 1.5 ml whole blood	Operator	Exact volume
  	sample in appropriate 5 ml vacutainer-		above minimum not
  	type draw tube, using standard draw		critical
  	procedure
  2.	Push sample tube into cartridge tube dock	Operator
  	and fully seat over needles
  3.	Place patient ID bar code label in	Operator	If ED bar code
  	designated target area on tube dock		system used
  4.	Push cartridge into module port until fully	Operator
  	seated over detents
  5.	Pressurize sample tube and flow sample	Platform
  	to segment: 300 ul at 2 ml/min.
  6.	Stop flow by venting pressure	Platform
  7.	Pressurize sample tube and flow sample	Platform
  	through cartridge: 400 ul at 3 ml/min.
  8.	Stop flow by venting pressure	Platform

• FIG. 8 through[0061]11 are flow charts illustrating point of carediagnostic platform10 of the present invention. FIG. 8 is a flow chart illustrating an overall methodology of the point of care diagnostic platform of the present invention. FIG. 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. FIG. 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. FIG. 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.
• In the preceding example, all reagents and waste are contained in[0062]cartridge20. Fluids are moved incartridge20 via an external pump (in the module) coupled tocartridge20 via an air dock. Likewise the reagents and sample are directed sequentially by valve(s) with-in the cartridge but activated through physical engagement to an external activator in the module.Cartridge20 contains the fluid flow, fluid distribution fluid segmentation and sample dilution. Amodule12 controls the fluid flow via a low pressure air connection and the fluid selection via one or more valve connections.
• In another embodiment,[0063]platform10 provides real time QC monitoring, and real time test result threshold detection, as disclosed in U.S. Provisional No. 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.[0064]

Claims (52)

What is claimed is:

1. A point of care diagnostic system, comprising:

a plurality of modules;

a plurality of analytic cartridges, each of a cartridge associated with a module of the plurality of modules and configured to directly accept a blood sample from a standard blood draw tube.

2. The system ofclaim 1, wherein the system includes immunoassay, hematology, electrolyte, general chemistry and molecular diagnostic modules.

3. The system ofclaim 1, wherein the plurality of modules are coupled to an external communication link.

4. The system ofclaim 3, wherein the external communication link is a WAN or a LAN.

5. The system ofclaim 3, wherein the external communication link is a wireless network.

6. The system ofclaim 3, wherein the external communication link is a hospital information network or a laboratory information network.

7. The system ofclaim 1, wherein each of the modules share at least a portion of a common functionality of operation.

8. The system ofclaim 7, wherein placement of a cartridge in a module begins an initiation of the module.

9. The system ofclaim 1, wherein each module contains common functionalities, and unique technologies that correspond to one or more selected chemistries.

10. The system ofclaim 8, wherein each cartridge is bar-coded.

11. The system ofclaim 10, wherein each cartridge is bar-coded with information for test protocols, and lot expiration dates.

12. The system ofclaim 8, wherein fluids are retained and sealed in the cartridges.

13. The system ofclaim 8, wherein the cartridges include serialized identification.

14. The system ofclaim 12, wherein a sample ID barcode is attached to the cartridge for automatic patient identification.

15. The system ofclaim 12, wherein a sample contained in a sample tube is removable after analysis.

16. The system ofclaim 12, wherein all fluids in a cartridge remain within the cartridge including a patient sample.

17. The system ofclaim 8, wherein each cartridge includes wet and dry chemistries and at least one substrate that carriers a chemistry.

18. The system ofclaim 8, wherein the modules are configured to be engaged with cartridges to produce pneumatic movement of fluids in the cartridges.

19. The system ofclaim 1, wherein each module includes a processor.

20. The system ofclaim 19, wherein a processor of a module in combination with the host computer determines a test protocol for a cartridge and actuates a flow control mechanism in the cartridge that permits a flow of a patient sample with liquid chemistries and waste materials.

21. The system ofclaim 19, wherein a processor of a module in combination with the host computer activates a transfer of a sample into the cartridge without exposing an operator to the chemistry.

22. The system ofclaim 8, wherein each cartridge is configured to isolate biohazards in the cartridge from an operator of the cartridge.

23. The system ofclaim 8, wherein each cartridge is configured to provide introduction of a blood sample to the cartridge while isolating biohazards in the cartridge from an operator.

24. The system ofclaim 8, wherein each cartridge is configured to provide introduction of a blood sample to the cartridge without exposing an operator to patient material in the cartridge.

25. The system ofclaim 8, wherein each cartridge is configured to provide removal of a blood sample from a vial and introduction of the blood sample to the cartridge without exposing the patient or an operator to the blood sample.

26. The system ofclaim 8, wherein each cartridge is configured to provide that an operator is not exposed to contents in the cartridge.

27. The system ofclaim 8, wherein the cartridge is configured to work with whole blood.

28. The system ofclaim 1, wherein the system is connected to a laboratory information system.

29. The system ofclaim 1, wherein the system is directly connected to a laboratory information system.

30. The system ofclaim 1, wherein the system is connected to a hospital information system.

31. The system ofclaim 1, wherein the system is directly connected to a hospital information system.

32. The system ofclaim 1, wherein the system is connected to a emergency room/department patient management network.

33. The system ofclaim 1, wherein the system is directly connected to a emergency department patient management network.

34. The system ofclaim 1, wherein the host computer is coupled to at least one of a LAN, a WAN and a wireless network.

35. The system ofclaim 1, wherein the system delivers a multitude of discreet testing capabilities in a standardized manner.

36. The system ofclaim 1, wherein the modules have common operation systems.

37. The system ofclaim 1, wherein the communication interface includes at least one of a cardiac , fertility, kidney, coagulation, electrolyte and hematology panel.

38. The system ofclaim 8, wherein each cartridge is configured to directly accept directly a blood sample from a standard blood draw tube.

39. The system ofclaim 8, wherein each cartridge is configured to provide direct sampling that uses a primary tube direct sampling that is directly introduced to the cartridge.

40. The system ofclaim 1, further comprising:

a coagulation module; and

a coagulation cartridge.

41. The system ofclaim 1, wherein the system provides real time QC monitoring, and real time test result threshold detection.

42. The system ofclaim 1, wherein the cartridges include electronic identifiers

43. The system ofclaim 1, wherein the system provides self-testing of the modules, to provide for monitoring and detection of fluid flow.

44. A point of care diagnostic system, comprising:

a plurality of modules; and

a host computer coupled to the plurality of modules and a common external communication interface, each of a module of the plurality of modules sharing the common external communication interface.

45. The system ofclaim 44, wherein the common external communication interface is coupled to at least one of WAN or a LAN.

46. The system ofclaim 44, wherein the common external communication interface is coupled to a wireless network.

47. The system ofclaim 44, wherein the common external communication interface is a hospital information network or a laboratory information network.

48. A point of care diagnostic system, comprising:

a plurality of modules each sharing the same QC protocols;

a plurality of analytic cartridges, and

a host computer coupled to the plurality of modules, the host computer being coupled to an interface, each of a module having a corresponding interface component.

49. A point of care diagnostic system, comprising:

a plurality of modules; and

a plurality of analytic cartridges each being bar-coded with information for test protocols, and lot expiration dates.

50. A point of care diagnostic system, comprising:

a plurality of modules; and

a plurality of analytic cartridges that retain and seal fluids.

51. A point of care diagnostic system, comprising:

a plurality of modules; and

a plurality of analytic cartridges, wherein all fluids in a cartridge remain within the cartridge including a patient sample.

52. A point of care diagnostic system, comprising:

a plurality of modules; and

a plurality of analytic cartridges, each cartridge includes wet and dry chemistries and at least one substrate that carriers a chemistry.

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