Diagnostic device with selection capability and selection method therefor

Abstract

A diagnostic device and a method of operating a diagnostic device are provided. The method of operating a diagnostic device includes providing a diagnostic device having one or more modules, the one or more modules configured to analyze samples; providing a sample sorter coupled to the diagnostic device; and sorting the samples into at least a first group and a second group, where the samples in the first group are analyzed by at least one of the one or more modules and the samples in the second group are not analyzed by any of the one or more modules. Other sorting methods and diagnostic devices are provided.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 169,372, filed April 1, 2021, entitled "DIAGNOSTIC INSTRUMENTS HAVING SORTING CAPABILITY AND SORTING METHODS THEREOF," the disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0002] SUMMARY OF THE INVENTION Embodiments of the present disclosure relate to diagnostic instruments and methods of operation thereof. [Background technology]

[0003] Diagnostic laboratory systems analyze biological specimens, such as whole blood, serum, plasma, urine, interstitial fluid, and cerebrospinal fluid, to identify analytes or other components in the specimen. Some diagnostic laboratory systems may contain multiple modules and instruments that perform specimen prescreening and analysis. Some diagnostic laboratory systems may contain hundreds of modules and instruments and perform thousands of analyses per day.

[0004] Specimens are typically contained in specimen containers (e.g., specimen collection tubes). The specimen containers are sent to a diagnostic laboratory system and then sorted according to the tests to be performed on the specimen. The specimen containers and / or specimens are then transported to the appropriate modules and / or equipment for pre-screening and testing. For example, specimen containers can be transported via an automated tracking system to one or more pre-processing modules, pre-screening modules, and analyzers (e.g., immunoassay and / or clinical chemistry) within the diagnostic laboratory system. Summary of the Invention [Problem to be solved by the invention]

[0005] One of the time-consuming processes that occurs within a diagnostic laboratory system is the sorting process. The sorting process may be performed manually by an operator or by a designated sorter. In some embodiments, the sorting process may select specimen containers based on the specific analysis to be performed on the specimens, which can take a significant amount of time. Additionally, if the sorter malfunctions, the diagnostic laboratory analyzer may be unable to perform the analysis or the efficiency of the laboratory analyzer may be reduced.

[0006] Based on the foregoing, there is a need for improvements in specimen and specimen container sorting in diagnostic laboratory systems. [Means for solving the problem]

[0007] According to a first aspect, there is provided a method of operating a diagnostic device, the method comprising: providing a diagnostic device having one or more modules, the one or more modules configured to analyze samples; providing a sample sorter coupled to the diagnostic device; and sorting the samples using the sample sorter into at least a first group and a second group, wherein the samples in the first group are analyzed by at least one of the one or more modules and the samples in the second group are not analyzed by any of the one or more modules.

[0008] In another aspect, a method of operating a diagnostic device is provided that includes providing a diagnostic device having one or more modules configured to analyze and / or process specimen containers and / or specimens contained in the specimen containers; providing a specimen sorter coupled to the diagnostic device; and sorting the specimen containers into at least a first group and a second group, wherein the specimen containers or specimens in the first group are analyzed or processed by at least one of the one or more modules and the specimen containers or specimens in the second group are not analyzed or processed by any of the one or more modules.

[0009] In another aspect, a diagnostic device is provided that includes one or more modules; a specimen sorter configured to sort specimens into at least a first group and a second group, where specimens in the first group are analyzed by at least one of the one or more modules and specimens in the second group are not analyzed by any of the one or more modules; and a transport system interconnecting the specimen sorter and at least one of the one or more modules, the transport system configured to move specimens in the first group to at least one of the one or more modules.

[0010] Further aspects, configurations, and advantages of the present disclosure will become readily apparent from the following description and illustration of numerous example embodiments, including the best mode contemplated for carrying out the present disclosure. The present disclosure is also capable of other and different embodiments, and its several details can be modified in various respects, all without departing from the scope of the present disclosure. The present disclosure is intended to cover all modifications, equivalents, and alternatives that are within the scope of the claims.

[0011] The drawings described below are for illustrative purposes and are not necessarily drawn to scale. Accordingly, the drawings and descriptions should be regarded as illustrative in nature, and not as restrictive. The drawings are not intended to limit the scope of the present disclosure in any way. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic block diagram of a diagnostic laboratory system including multiple modules and diagnostic instruments, in accordance with one or more embodiments of the present disclosure, wherein at least one diagnostic instrument is configured to sort specimen containers. [Figure 2A] FIG. 1 is a side elevation view of a specimen container positioned within a carrier, the specimen container containing a specimen separated into at least a serum or plasma portion and a sedimented blood portion, in accordance with one or more embodiments of the present disclosure. [Figure 2B] 1 is a side elevational view of a specimen container positioned within a carrier, the specimen container containing an unseparated specimen, in accordance with one or more embodiments of the present disclosure. [Figure 2C] 1 is a side elevation view of a specimen container removed from a carrier, the specimen container containing an unseparated specimen, according to one or more embodiments. [Figure 3] FIG. 1 is a schematic diagram of equipment for a diagnostic laboratory system including a specimen sorter, in accordance with one or more embodiments of the present disclosure. [Figure 4A] 1 is a flowchart illustrating a method of operating a diagnostic laboratory system including an instrument that includes a specimen sorter, in accordance with one or more embodiments of the present disclosure. [Figure 4B] 1 is a flowchart illustrating a method of operating a diagnostic laboratory system including an instrument that includes a specimen sorter, in accordance with one or more embodiments of the present disclosure. [Figure 5] 1 is a flowchart illustrating a method of operating a diagnostic device according to one or more embodiments. [Figure 6]10 is a flowchart illustrating another method of operating a diagnostic device according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0013] A diagnostic laboratory system may include one or more modules and / or diagnostic instruments that process, prescreen, and / or analyze specimen containers and / or specimens located within the specimen containers. Examples of individual modules and / or modules within a diagnostic instrument configured to process specimen containers include input / output (I / O) loaders and decappers. Other specimen container processing modules may also be used. Examples of individual modules and / or modules within a diagnostic instrument configured to process or prescreen specimens prior to testing include centrifuges, quality control modules, and aliquoters. Examples of modules and / or modules within a diagnostic instrument configured to analyze specimens include diagnostic analyzers (sometimes simply referred to herein as "analyzers") that identify and / or analyze one or more analytes within a specimen. For example, some diagnostic analyzers may perform one or more clinical chemistry analyses, others may perform one or more immunoassays, and others may perform one or more other functions, such as genetic or drug analyses.

[0014] The diagnostic laboratory system may include a transport system, such as a truck, that transports specimen containers between different modules and / or instruments. Thus, a diagnostic laboratory system may include multiple modules and / or instruments and have tracks extending between the modules and instruments.

[0015] A medical professional may order a specific analysis (e.g., a test order) to be performed on a specific specimen (e.g., fluid) collected from a patient. These test orders may be entered into a program or server, such as a Hospital Information System (HIS). The test orders may then be sent from the HIS to a Laboratory Information System (LIS), which receives multiple test orders and, possibly using I / O loader logic, generates test protocols and / or scheduling for diagnostic laboratory systems to complete the test orders. Test orders may also come from sources other than the HIS in some cases.

[0016] Specimen containers containing specimens can be physically sent to a diagnostic laboratory system, and test orders can be electronically sent to a diagnostic laboratory system. Several medical professionals can simultaneously create test orders to be performed using the diagnostic laboratory system. Thus, many specimen containers and test orders may be received by the diagnostic laboratory system. One of the first steps performed by a diagnostic laboratory system is sorting specimen containers. Considering the large number of test orders that a diagnostic laboratory system may receive, sorting can be very time-consuming and costly. Sorting may be performed manually by an operator (user) or by an automated sorting system. In some diagnostic laboratory systems, a single module is dedicated solely to sorting specimen containers. This single module may place specimen containers requiring similar analysis in the same rack during the sorting process.

[0017] Sorting can be very time-consuming and very expensive. For example, modules that can be very expensive may be dedicated solely to sorting specimen containers, or employees may be paid to sort specimen containers. Modules can malfunction, which can reduce the number of specimens that the diagnostic laboratory system can analyze. Manual sorting is subject to human error.

[0018] The methods and devices described herein provide a diagnostic device having one or more specimen sorters coupled to the diagnostic device. The diagnostic device also includes one or more modules configured to analyze and / or process specimens and / or specimen containers. In some embodiments, the specimen sorter may be a module of the diagnostic device. In some embodiments, the specimen sorter may be implemented in another module, such as a specimen handling module of the diagnostic device. The specimen sorter or a component of the diagnostic device can identify the specimen container, such as by reading information or indicia located on the specimen container. The diagnostic device can then request information regarding the specimen's status, which may include tests (e.g., analyses) and / or processes to be performed on the specimen. In some embodiments, the diagnostic device may also request the status of the specimen's testing from an LIS or the like.

[0019] In some embodiments, the specimen sorter can sort specimen containers or specimens into at least a first group and a second group. The first group can include specimens that will be analyzed or processed by at least one of the one or more modules of the diagnostic device. The second group can include specimens that will not be analyzed or processed by at least one of the one or more modules of the diagnostic device. In some embodiments, the first group can include specimen containers that will be processed or analyzed by at least one of the one or more modules in the diagnostic device. In such embodiments, the second group can include specimen containers that will not be processed or analyzed by at least one of the one or more modules in the diagnostic device.

[0020] In some embodiments, specimen containers may be sorted such that specimen containers containing specimens for which additional testing is to be performed by other diagnostic devices may be grouped together. Specimen containers containing specimens for which testing has been completed may be grouped together. Specimen containers containing specimens that do not have any testing status may be grouped together. Other sorting configurations may be used.

[0021] These and other devices, diagnostic laboratory systems, instruments, and methods are described in more detail with reference to Figures 1-6 herein.

[0022] Reference is now made to Figure 1, which illustrates an example embodiment of an automated diagnostic analyzer system 100 configured to process and / or analyze biological specimens contained in specimen containers 102. The specimen containers 102 may be received in the system 100 in one or more racks 104 located in a loading area 106. The specimen containers 102 may be transported throughout the system 100, such as through tracks 112 to and from modules 108 and instruments 110, by carriers 114. The carriers 114 may be configured to transport the specimen containers 102 in a vertical orientation throughout the system 100 (see Figures 2A and 2B).

[0023] The diagnostic laboratory system 100 can include a computer 118 or can be configured to communicate with an external computer. The computer 118 can be a microprocessor-based central processing unit (CPU) with suitable memory, software, and coordinating electronics and drivers for operating the various components of the system 100, the modules 108, and the instrument 110. The computer 118 can include a processor 118A and a memory 118B, where the processor 118A is configured to execute a program 118C stored in the memory 118B. The computer 118 can be housed as part of the system 100 or can be housed separately from the system 100. The program 118C can operate the components of the system 100, as well as the modules 108 and / or the instrument 110, as described herein.

[0024] The computer 118, through program 118C, can control the movement of the carrier 114 to and from the loading area 106, around the system track 112, between the module 108 and the equipment 110, and between the other modules and components of the system 100. The operation of each of the module 108, the equipment 110, and the other components and modules may be performed by the computer 118. In some embodiments, the operation of each of the module 108, the equipment 110, and the other components and modules may be performed at least in part by a local workstation computer (not shown) in one or more of the modules 108 and / or the equipment 110. One or more of the workstations can communicate with the computer 118 via a network, such as a local area network (LAN), a wide area network (WAN), or other suitable communications network, including wired and wireless networks.

[0025] In some embodiments, the computer 118 can be coupled to a computer interface module (CIM) 120. The CIM 120 and / or the computer 118 can be coupled to a display 122. The CIM 120, in conjunction with the display 122, allows a user to access various control and status display screens and input data into the computer 118. These control and status display screens can display and enable control of some or all aspects of the modules 108 and / or instruments 110 used in the preparation, pre-screening, and analysis of the specimen containers 102 and / or specimens located therein. Thus, the CIM 120 can be adapted to facilitate interaction between a user and the system 100. In some embodiments, the display 122 can be configured to display menus including icons, scroll bars, boxes, and buttons through which a user can interface with the diagnostic laboratory system 100. The menus can include a number of functional elements programmed to display and / or operate functional aspects of the diagnostic laboratory system 100.

[0026] The diagnostic laboratory system 100 may include a laboratory information system (LIS) 124 configured to schedule tests for the modules 108, the equipment 110, and / or other components. In some embodiments, the LIS 124 may be implemented on the computer 118. In some embodiments, the LIS 124 may be located and operated separately from the diagnostic laboratory system 100. The LIS 124 may communicate with a hospital information system (HIS) 126, which may be configured to receive test orders from healthcare providers and the like. In some embodiments, the HIS 126 may be implemented on the computer 118, the LIS 124, and / or a separate computer.

[0027] In the embodiment of FIG. 1, diagnostic laboratory system 100 includes a first instrument 131, a second instrument 133, and a third instrument 134, each of which may include multiple modules therein. First instrument 131 may include three modules 130A-130C, one or more of which may perform a similar or identical function to module 108 as described herein. Second instrument 133 may include four modules 132A-132D, one or more of which may perform a similar or identical function to module 108 as described herein. Third instrument 134 may include multiple modules 136, individually referred to as first module 136A, second module 136B, and third module 136C. Third instrument 134 may also include a specimen sorter 138 as described herein. In some embodiments, the specimen sorter 138 may be one of the modules 136. A specimen sorter, as described herein, is a device configured to sort specimens and / or specimen containers 102 into two or more preselected groups.

[0028] In some embodiments, first module 130A of first instrument 131 and first module 132A of second instrument 133 may be or include a specimen sorter. The remaining modules 130B and 130C of first instrument 131 and the remaining modules 132B-132D of second instrument 133 may be pre-processing modules, analyzers, and / or other modules configured to analyze or process specimens and / or specimen containers 102. Others of modules 130 and 132 may be specimen sorters.

[0029] In the embodiment of FIG. 1 , diagnostic laboratory system 100 includes four modules 108, individually referred to as first module 108A, second module 108B, third module 108C, and fourth module 108D. Diagnostic laboratory system 100 may include other modules and components (not shown) that perform specific functions and / or processes. At least one of modules 108 may perform pre-processing functions and may include, for example, a decapper and / or a centrifuge. In some embodiments, one or more of modules 108 may be one or more clinical chemistry analyzers and / or one or more assay instruments, or the like, or a combination thereof. Some of modules 130, 132, 136 of instrument 110 may perform the same or similar functions as module 108.

[0030] The modules 108 can include machinery configured to prepare and / or process the specimen containers 102 and / or specimens located therein for testing by one or more instruments 110. In some embodiments, the modules 108 can prepare the specimen containers 102 and / or specimens to be received and / or tested by an analyzer module. In the embodiment of FIG. 1, the modules 108 can include machinery such as an input / output (I / O) loader, a desealer, a centrifuge, and a quality control (QC) station. The diagnostic laboratory system 100 may include other or fewer modules. In the embodiment of FIG. 1, the diagnostic laboratory system 100 can have redundant modules to handle high test volumes and to enable testing if one or more of the modules 108 or instruments 110 fail or become unavailable.

[0031] Diagnostic tests performed by one or more of the modules 108 configured as analyzers can include, but are not limited to, immunoassay tests (e.g., chemiluminescent immunoassay (CLIA), radioimmunoassay (RIA), counting immunoassay (CIA), fluorescent immunoassay (FIA), and enzyme immunoassays (EIA, enzyme-linked immunosorbent assay (ELISA)) targeting specific target biomolecules. In addition, some of the modules 108 can measure the concentration of substances or analytes in a sample, such as glucose, hemoglobin A1C, lipids (fats), triglycerides, blood gases (e.g., carbon dioxide), enzymes, electrolytes (e.g., sodium, potassium, chloride, and bicarbonate), lipase, bilirubin, creatinine, blood urea nitrogen (BUN), hormones (e.g., thyroid-stimulating hormone), hepatitis, minerals (e.g., iron, calcium, magnesium), proteins, and other metabolites. Other tests may also be performed on a sample by the modules 108. The specimen may include whole blood, serum, plasma, urine, cerebrospinal fluid, interstitial fluid, saliva, feces, etc. Modules 130, 132, 136 of device 110 may perform the same or similar functions as module 108 described herein.

[0032] In some embodiments, two or more of the modules 108, including modules 130, 132, 136, may be capable of performing the same tests (i.e., they have the same or overlapping test menus), while others of the modules 108 may be capable of performing only a limited number of tests or only specific individual tests. Thus, in some embodiments, modules 108, 130, 132, 136 may be configured to perform the same or overlapping tests, allowing the diagnostic laboratory system 100 to handle large volumes of tests, perform redundant tests, and continue testing if a module fails or becomes disabled.

[0033] 2A-2C, which illustrate an embodiment of a specimen container 202 having a specimen 216 located therein. The specimen container 202 may be representative of the specimen container 102 (FIG. 1). The specimen 216 may be representative of a specimen located in the specimen container 102. The specimen container 202 may include a tube 218 and may be capped with a cap 220. The caps 220 of different specimen containers may be of different types and / or colors (e.g., red, royal blue, light blue, green, gray, tan, yellow, or color combinations), which may have significance regarding the test for which the specimen container 202 is used, the type of additive contained within the specimen container 202, whether the container includes a gel separator 216G, etc. Other colors may be used to indicate other functionality.

[0034] The specimen container 202 may be provided with at least one label 222, which may include identifying information 222I (i.e., indicia), such as a bar code, alphanumeric characters, or a combination thereof, thereon. The identifying information 222I may include or be associated with data stored in or accessible by the LIS 124, such as a database within the LIS 124. The database may include patient information such as name, date of birth, address, and / or other personal information. The database may also include tests to be performed, the date and time the specimen 216 was collected, and / or medical facility information. The database may also include tracking and routing information, including what tests have been performed on the specimen 216 and what tests need to be performed on the specimen 216. Other relevant information may also be included.

[0035] The identifying information 222I may be machine-readable at various locations throughout the diagnostic laboratory system 100. The machine-readable information may be a darker color (e.g., black) than the label material (e.g., white paper) so that the identifying information 222I can be easily imaged (e.g., read). The identifying information 222I may indicate or otherwise associate, via the LIS 124 or other test ordering system, the patient's identity with the test to be performed on the specimen 216. The identifying information 222I may be provided on a label 222 that may be adhered or otherwise provided to the exterior surface of the tube 218.

[0036] 2A has undergone a centrifugation process, such as in one of modules 108, and may include a serum or plasma portion 216SP and a sedimented blood portion 216SB contained within a tube 218. A gel separator 216G may be located between the serum or plasma portion 216SP and the sedimented blood portion 216SB. Air 224 may be located above the serum and plasma portion 216SP.

[0037] The embodiment of Figures 2A and 2B shows a side elevation view of a specimen container 202 positioned in a carrier 214. The carrier 214 may be representative of the carrier 114 (Figure 1). The carrier 214 may include a holder 214H configured to hold the specimen container 202 in a defined upright position. The holder 214H may include multiple fingers or leaf springs that secure the specimen container 202 within the carrier 214. Some of the fingers or leaf springs may be movable or flexible to accommodate specimen containers 202 of different sizes (widths). In some embodiments, the carrier 214 may move away from the loading area 106 (Figure 1) after the specimen container 202 has been loaded. Figure 2C shows the specimen container 202 removed from the carrier 214.

[0038] 1 , the computer 118 can be in communication with a communication device 129 that enables communication between the computer 118 and the modules 108 and instruments 110. The communication device 129 can provide wireless (e.g., radio frequency (RF) or optical) and / or wired communication between the computer 118, the modules 108, the instruments 110, and other components of the diagnostic laboratory system 100. The communication device 129 can enable data measured by the modules 108 and the instruments 110 to be transmitted to the computer 118. The communication device 129 can also enable the computer 118 to transmit instructions, such as operation instructions, to the modules 108 and the instruments 110.

[0039] In some embodiments, the diagnostic laboratory system 100 can include an I / O loader 140 located proximate the track 112 and the loading area 106. The I / O loader 140 can include a robot 144 configured to load specimen containers 102 onto the track 112 and remove the specimen containers 102 from the track 112. For example, the robot 144 can place specimen containers 102 into carriers 114 and remove the specimen containers 102 from the carriers 114. The robot 144 or other device can also sort specimen containers 102 into particular ones of the racks 104 as described herein. The I / O loader 140 and components therein, including the robot 144, can communicate with the computer 118, such as via a communication device 129.

[0040] In some embodiments, the I / O loader 140 may include a component 142 configured to read a label (e.g., label 222—FIGS. 2A and 2B), such as identifying information (e.g., identification information 222I—FIGS. 2A and 2B) on the specimen container 102. In some embodiments, the identifying information 222I may be a barcode, and the component 142 may include a barcode reader configured to read the barcode. In some embodiments, the label 222 may include identifying information thereon, such as a time and / or date stamp, a requested test, a patient identification, etc.

[0041] Once the identification information 222I is read, such as by one or more of the components 142, data representing the identification information 222I can be transmitted to the computer 118, such as via the communication device 129. One or more of the programs 118C executable by the computer 118 can receive the information read from the label 222 and, based on the information and internal logic, determine the tests to be performed on the specimen 216. For example, the HIS 126 can transmit a test order to the LIS 124. The LIS 124 can provide the test order to one or more programs 118C in response to the test order received from the HIS 126. In some embodiments, the LIS 124, or logic in the I / O loader 140, can determine the processes and tests that need to be performed on the specimen container 102 and / or specimen located therein (e.g., specimen 216), and can determine the modules 108 and / or instruments 110 to use to perform the processes and tests.

[0042] The program 118C can send commands to the robot 144 instructing the robot 144 to place a particular one of the specimen containers 102 in a particular one of the racks 104 or at a particular location within the rack 104. In some embodiments, placing the specimen containers 102 in the rack 104 can serve to physically sort the specimen containers 102 according to a pre-established sorting pattern. In some embodiments, the sorting may be to place similar specimen containers together. In some embodiments, the sorting may be to place specimen containers containing specimens undergoing similar tests together. In some embodiments, the sorting may be performed via software, where one or more of the programs 118C knows the locations within the rack 104 of similar specimen containers 102 and / or specimen containers 102 containing specimens undergoing similar tests.

[0043] The LIS 124 will know the locations of the specimen containers 102 and can instruct the laboratory diagnostic system 100 to transport particular ones of the specimen containers 102 to particular modules and / or instruments based on the tests to be performed on the specimen containers 102. Determining which specimen containers 102 to transport to particular modules 108 and / or instruments 110 can include determining which modules 108, including modules within the instrument 110, are available to perform the ordered tests.

[0044] If an error occurs in the I / O loader 140, the robot 144, and / or a component 142 (e.g., a barcode reader), the laboratory diagnostic system 100 may not operate efficiently or may be forced to shut down. For example, if the specimen containers 102 cannot be sorted or if the labels 222 on the specimen containers 102, 202 cannot be read, the LIS 124 may not be able to generate instructions that cause the modules 108 and / or instruments 110 to perform the tests described herein. In other situations, if the I / O loader 140 becomes overloaded, such as with a large number of specimen containers 102, testing may be delayed while the specimen containers 102 are sorted as described herein.

[0045] Some of the modules 108, including modules within the instrument 110, will now be described. In some embodiments, one or more of the modules 108, 130, 132, 136 may be or include a desealer configured to deseal specimen containers 102. The desealer can remove caps (e.g., caps 220) from specimen containers 102 to provide access to the specimens 216. In some embodiments, a component within the desealer (e.g., an imaging device) can read the identification information 222I and provide an update to the program 118C and / or the LIS 124 indicating the location and / or status of specimen containers 102 undergoing a seal removal operation. Thus, the LIS 124 and / or the program 118C know which specimen containers 102 have had their seals removed and which specimen containers 102 are within the desealer.

[0046] In some embodiments, one or more of the modules 108, 130, 132, 136 may be a centrifuge configured to separate portions of the specimen 216 (FIGS. 2A-2C) by fractionation. In embodiments in which the specimen is blood, the centrifuge separates the sedimented blood portion 216SB from the serum or plasma portion 216SP, as shown in FIG. 2A. In some embodiments, one or more of the modules 108, 130, 132, 136 may be or include a quality control module that tests the specimen and / or specimen container 102 prior to analysis. In some embodiments, the quality control module may test the specimen 216 for interferents such as hemolysis, icterus, or lipemia (HIL), blood clots, air bubbles, or foam.

[0047] As discussed above, if the sorting capacity of the I / O loader 140 is reduced or if the I / O loader 140 is overloaded, the system 100 may not function to its capacity or may not function at all. For example, the sorting function of the I / O loader 140 may not function properly. In the embodiments described herein, one or more of the instruments 110 are configured to sort specimen containers 102 to perform some of the sorting functions that would otherwise be performed in the I / O loader 140. Thus, the system 100 can function when the I / O loader 140 is unable to sort specimen containers 102. Additionally or alternatively, the performance of the system 100 can be improved by using one or more of the instruments 110 to perform secondary sorting.

[0048] Referring further to FIG. 3, FIG. 3 illustrates a third instrument 134, which may be the same as or similar to one or more of the instruments 110 (FIG. 1). In the embodiment of FIG. 3, the third instrument 134 includes three modules 136, individually referred to as a first module 136A, a second module 136B, and a third module 136C, and a specimen sorter 138. The modules 136 may include one or more analyzers 342 as described herein. For example, the first module 136A may include a first analyzer 342A that performs one or more first analyses on specimens (e.g., specimen 216—FIGS. 2A and 2B), the second module 136B may include a second analyzer 342B, and the third module 136C may include a third analyzer 342C. In some embodiments, one or more of the analyzers 342 may be devices that process specimens and / or specimen containers 102. Examples of devices that process specimens and / or specimen containers 102 include quality control modules, centrifuges, decappers, aliquoters, and other devices described herein.

[0049] The third instrument 134 includes a specimen sorter 138 coupled to or otherwise incorporated within the third instrument 134. For example, in some embodiments, the specimen sorter 138 may be one of the modules 136 of the third instrument 134. In some embodiments, the specimen sorter 138 may be a separate module or device located directly adjacent to the third instrument 134. The specimen sorter 138 may enable transport of specimen containers 102 and / or specimens (e.g., specimen 216—FIGS. 2A and 2B) to one or more of the modules 136 within the third instrument 134. As described herein, the specimen sorter 138 may sort the specimens into at least a first group and a second group. In some embodiments, the first group of specimens is analyzed by at least one of the one or more modules 136, and the second group of specimens is not analyzed by any of the modules 136.

[0050] The specimen selector 138 can include multiple racks 348 into which specimen containers 102, and therefore specimens, can be selected. In some embodiments, the racks 348 are located within the specimen selector 138. In other embodiments, the racks 348 may be external to the specimen selector 138 but within the range of motion of the specimen selector 138's robot. In the embodiment of FIG. 3, the specimen selector 138 includes four racks 348, individually designated a first rack 348A, a second rack 348B, a third rack 348C, and a fourth rack 348D. Each of the racks 348 can include multiple holders 350 (several of which are labeled) configured to hold specimen containers 102. For example, each of the holders 350 can hold a single specimen container (e.g., specimen container 202—FIGS. 2A-2C). The holders 350 may include one or more springs to securely hold the specimen containers 102 in a defined upright orientation and position. In some embodiments, the specimen selector 138 may include a robot 352 configured to move specimen containers 102 into and out of particular ones of the holders 350. In some embodiments, the robot 352 may be a gantry robot that may be configured to move in at least the X and Y directions to access the holders 350. The robot 352 may also be configured to move toward and away from the holders 350 in the Z direction to access and place specimen containers in the holders 350.

[0051] The third instrument 134 may be directly adjacent to the system track 112, or the third instrument 134 may have access to the system track 112 via a robot 352 or other means. In some embodiments, a diverter device 356, which may be a movable member, may be coupled to the third instrument 134 or the specimen selector 138 and may redirect specimen containers 102 into and / or out of the third instrument 134 or the specimen selector 138 as commanded. The diverter device 356 may be coupled to a transport system 312 configured to transport specimen containers 102 throughout the third instrument 134. In some embodiments, the transport system 312 may be or may include a track. The robot 352 may be configured to move specimen containers 102 from the transport system 312 to the racks 348 and to move specimen containers 102 from the racks 348 to the transport system 312. In some embodiments, the robot 352 may remove the specimen container 102 from the carrier 114 on the track such that only the specimen container 102 is moved to the holder 350 .

[0052] In some embodiments, the specimen selector 138 may include a reader 358, such as a barcode reader or an imaging device, configured to read identifying information (e.g., identifying information 222I—FIGS. 2A and 2B) on a label (e.g., label 222—FIGS. 2A and 2B) on the specimen container 102. In some embodiments, the reader 358 may be configured to read the label as the specimen container 102 is transported on the transport system 312. For example, the reader 358 may be located proximate to the transport system 312. In some embodiments, the robot 352 may be configured to move the specimen container 102 proximate to the reader 358, where the reader 358 is configured to read the label in response to the specimen container 102 being proximate to the reader 358.

[0053] Both the reader 358 and the robot 352 can communicate with the computer 118 and / or the LIS 124. Thus, data generated by the reader 358 can be sent to the computer 118 and / or the LIS 124. Instructions to move the robot 352 can be generated by one or more programs 118C and sent to the robot 352 to move the specimen container 102 to a particular location, such as a particular one of the holders 350 and / or the transport system 312. One or more of the programs 118C or the LIS 124 can process the data generated by the reader 358. Thus, the programs 118C and / or the LIS 124 will know which specimens and / or specimen containers 102 are located in the specimen sorter 138. In some embodiments, the programs 118C and / or the LIS 124 will know which one of the holders 350 and racks 348 a particular specimen container 102 is located in.

[0054] As described above, the specimen selector 138 can sort specimens (e.g., specimen containers 102) into particular groups as described herein. In some embodiments, specimens may be physically sorted (e.g., grouped) into individual racks 348. For example, specimens of a first type may be placed in a first rack 348A, and specimens of a second type may be placed in a second rack 348B. In some embodiments, specimens may be sorted electronically. For example, the LIS 124 and / or one or more of the programs 118C can identify the locations within the holders 350 of at least the first and second groups of specimens.

[0055] As shown in FIG. 3 , the transport system 312 can enable transport of specimen containers 102 to at least one of the modules 136. In some embodiments, a diverter can redirect particular ones of the specimen containers 102 and / or specimens to particular ones of the analyzers 342 for analysis (e.g., testing). In the embodiment of FIG. 3 , a first diverter 360A in or associated with the first module 136A can redirect specimen containers 102 into or out of the first analyzer 342A. A second diverter 360B in or associated with the second module 136B can redirect specimen containers 102 into or out of the second analyzer 342B. A third diverter 360C within or associated with the third module 136C can redirect the specimen container 102 into or out of the third analyzer 342C.

[0056] To explain the method of operation of the system 100, further reference is made to Figure 1 and Figures 4A and 4B. Figures 4A and 4B are a flow chart illustrating a method 400 of operating the system 100 with respect to the third instrument 134. In block 402 of the method 400, specimen containers 102 are loaded into the system 100. For example, the specimen containers 102 may be loaded into the I / O loader 140. Some or all of the specimen containers 102 may then be placed on the system track 112. For example, the robot 144 may move the specimen containers 102 onto the system track 112.

[0057] At block 404 of the method 400, a test order is received at the LIS 124. In some embodiments, the LIS 124 may be integral with the computer 118, such that the test order is received at the computer 118. The test order indicates a test to be performed on the specimen in the specimen container 102. The LIS 124 and / or program 118C may generate instructions to route a particular specimen container to a particular one of the modules 108 and / or instruments 110 depending on the particular test to be performed. In some cases, logic in the I / O loader 140 may generate the instructions to route a particular specimen container 102.

[0058] The method 400 includes, at block 406, transferring at least one of the specimen containers 102 to a third instrument 134. In some embodiments, the specimen in the specimen container 102 transferred to the third instrument 134 may have undergone at least one test in one or more of the instruments 110 and / or one or more of the modules 108 before being transferred to the third instrument 134. In some embodiments, the specimen and / or one or more of the specimen containers 102 transferred to the third instrument 134 have undergone processes such as decapping, quality control, and / or centrifugation before being received by the third instrument 134.

[0059] The method 400 includes, at block 408, reading a label (e.g., label 222—FIGS. 2A and 2B) on the specimen container 102 and transmitting data generated by the reading to the LIS 124. As described above, the LIS 124 may be implemented in the computer 118 and may therefore transmit data generated by the reading to the computer 118. For example, the robot 352 may move the specimen container 102 into proximity with a reader 358, which may cause the reader 358 to read the label or indicia on the specimen container 102 and transmit data generated by the reading to the LIS 124 and / or the computer 118.

[0060] Processing continues to decision block 410, where it is determined whether a test order exists for the specimen whose label was read. For example, software in the LIS 124 and / or program 118C determines whether a test order exists for the specimen located in the specimen container 102. If a test order does not exist, processing continues to decision block 412, where the specimen container may be moved to a first rack 348A. In the embodiment of FIG. 3, all specimen containers 102 containing specimens without test orders may be grouped in the first rack 348A. When a test order is received for the specimen in the first rack 348A, the corresponding specimen container may be moved to a particular instrument and / or module designated for testing. If a test order is not received for the specimen container in the first rack 348A after a preselected period of time, the specimen container may be removed from the system 100.

[0061] If a test order exists, as determined at decision block 410, processing proceeds to decision block 414, where it is determined whether testing on the specimen is complete. If testing on the specimen is complete, as determined at decision block 414, the specimen container 102 may be moved to a second rack 348B, as shown at 415, or the specimen container 102 may be removed from the system 100. For example, the specimen container 102 and other specimen containers 102 having specimens for which testing has been completed may be grouped in the second rack 348B, where they will await removal from the system 100. In some embodiments, the LIS 124 or program 118C may cause the specimen container 102 to be stored in the second rack 348B until there is space on the system track 112 for the specimen container 102 to be moved to the I / O loader 140, which can remove the specimen container 102 from the system 100. In some embodiments, the specimen containers stored or grouped in the second rack 348B can be removed from the third instrument 134 and / or the system 100.

[0062] If the determination at decision block 414 determines that testing on the specimen in the specimen container 102 is not complete, processing proceeds to decision block 416, where a determination is made as to whether testing is required in the third instrument 134. For example, the LIS 124 or program 118C may determine whether testing is to be performed by one or more of the modules 136 in the third instrument 134. In some embodiments, the inquiry at decision block 416 may determine whether any processes, such as a process on the specimen container (e.g., decapping) or a treatment on the specimen (e.g., centrifugation), are to be performed by any of the modules 136 in the third instrument 134.

[0063] If the outcome of decision block 416 is positive, processing continues to 418, where the specimen container is moved to the third rack 348C. For example, the LIS 124 and / or program 118C can generate instructions to the robot 352 to move the specimen container 102 to the third rack 348C. In this embodiment, the third rack 348C holds specimen containers of specimens that require testing and / or processing in one or more of the modules 136 in the third instrument 134. The LIS 124 and / or program 118C can generate instructions to move the specimen container 102 to one or more of the modules 136 for testing and / or processing, if such modules are available.

[0064] If the outcome of decision block 416 is negative, processing proceeds to block 420, where the specimen container is moved to the fourth rack 348D. For example, the LIS 124 and / or program 118C can generate instructions to the robot 352 to move the specimen container 102 to the fourth rack 348D. The fourth rack 348D can be configured to hold specimen containers requiring testing by one or more of the modules 108 and / or other of the instruments 110. The specimen containers in the fourth rack 348D can be held in the fourth rack 348D until other of the modules 108 and / or instruments 110 are available to perform the testing. The LIS 124 and / or program 118C can generate instructions to the robot 352 to move the specimen container 102 from the fourth rack 348D once such other modules 108 and / or other instruments 110 are available.

[0065] System 100 may use sorting schemes other than the sorting scheme described in method 400. In some embodiments, other of the instruments 110 may include specimen sorters, and thus the sorting schemes described herein and other sorting schemes may be used in combination with the other instruments. In some embodiments, system 100 may have 20 or more, 30 or more, 40 or more, or even 50 or more modules 108 and / or instruments 110. Multiple instruments in system 100 may include specimen sorters that are the same as or similar to specimen sorter 138. Thus, system 100 may provide multiple redundant specimen sorting modules.

[0066] In some embodiments, the instruments comprising or associated with the specimen sorter may be individual or stand-alone devices. Such instruments may not be coupled to other modules or devices by a system track. In such embodiments, sorting, such as that described above with respect to the third instrument 134, may be performed using the stand-alone instruments. In such embodiments, racks, such as rack 348, may be removable after the specimen containers 102 have been sorted into rack 348. Rack 348 may be moved to another location for processing and / or testing of the specimen containers 102 therein.

[0067] Reference is now made to FIG. 5, which is a flowchart illustrating a method 500 of operating a diagnostic instrument (e.g., instrument 110). Method 500 includes, at block 502, providing a diagnostic instrument (e.g., third instrument 134) having one or more modules (e.g., module 136), where the one or more modules are configured to analyze analytes (e.g., analytes 216). Method 500 includes, at block 504, providing a specimen sorter (e.g., specimen sorter 138) coupled to the diagnostic instrument (e.g., third instrument 134). Method 500 includes, at block 506, sorting the specimens into at least a first group and a second group using the specimen sorter, where the specimens in the first group are analyzed in at least one of the one or more modules and the specimens in the second group are not analyzed in any of the one or more modules.

[0068] Reference is now made to FIG. 6, which is a flowchart illustrating a method 600 of operating a diagnostic instrument (e.g., instrument 110). Method 600 includes, at block 602, providing a diagnostic instrument (e.g., third instrument 134) having one or more modules (e.g., module 136), where the one or more modules are configured to analyze and / or process specimen containers (e.g., specimen container 102) and / or specimens contained in the specimen containers (e.g., specimen 216). Method 600 includes, at block 604, providing a specimen sorter (e.g., specimen sorter 138) coupled to the diagnostic instrument. Method 600 includes, at block 606, sorting the specimen containers into at least a first group and a second group, where specimen containers or specimens in the first group are analyzed or processed by at least one of the one or more modules and specimen containers or specimens in the second group are not analyzed or processed by any of the one or more modules.

[0069] While the disclosure is susceptible to various modifications and alternative forms, specific method and apparatus embodiments have been shown by way of example in the drawings and are herein described in detail. It is to be understood, however, that the specific methods and apparatus disclosed herein are not intended to limit the disclosure, but on the contrary, are intended to cover all modifications, equivalents, and alternatives falling within the scope of the claims.

Claims

1. A method of operating a diagnostic system including one or more I / O loaders with screening capabilities and one or more diagnostic instruments, comprising: providing a diagnostic instrument having one or more modules, the one or more modules configured to analyze specimens in respective specimen containers; providing a specimen container sorter coupled to the diagnostic device that functions when the sorting function of the I / O loader fails or that performs secondary sorting; sorting the specimen containers into at least a first group and a second group using a specimen container sorter, wherein each specimen in each specimen container of the first group is analyzed in at least one of the one or more modules, and each specimen in each specimen container of the second group is not analyzed in any of the one or more modules until a test order is received within a preselected time for the specimen in each specimen container of the second group; The method comprising:

2. 10. The method of claim 1, comprising moving a first group of specimen containers to at least a first rack.

3. 10. The method of claim 1, further comprising moving a second group of specimen containers to at least a second rack.

4. 10. The method of claim 1, comprising moving a first group of specimen containers to at least a first rack in a specimen container selector.

5. 10. The method of claim 1, further comprising moving a second group of specimen containers to at least a second rack in a specimen container selector.

6. The provision of a specimen container sorter may be implemented as one of one or more modules.

10. The method of claim 1, further comprising providing a specimen container selector configured as follows:

7. 10. The method of claim 1, further comprising receiving data from a location external to the diagnostic device, the data indicating whether at least one of the specimen containers is to be sorted into the first group or the second group, and the sorting being performed in response to the data.

8. 10. The method of claim 1, further comprising receiving data from a laboratory information system, the data indicating whether at least one of the specimen containers is to be sorted into the first group or the second group, and wherein sorting is performed in response to the data.

9. 10. The method of claim 1, further comprising sorting the specimen containers into a third group, wherein each specimen in each specimen container of the third group is analyzed by one or more modules external to the diagnostic instrument.

10. 10. The method of claim 1, further comprising sorting the specimen containers into a fourth group, wherein each specimen in each specimen container of the fourth group does not require further analysis and awaits removal from the diagnostic instrument.

11. providing a reader coupled to a specimen container selector; reading information from a label on a specimen container containing the specimen; The method of claim 1 , comprising:

12. The method of claim 11 , wherein the sorting is performed at least in part in response to the reading.

13. providing a transport system interconnecting the specimen container selector and at least one of the one or more modules; moving a first group of specimen containers with the transport system; The method of claim 1 , comprising:

14. The method of claim 1 , wherein the one or more modules are configured to determine the concentration of at least one analyte in the sample.

15. The method of claim 1 , wherein the one or more modules are configured to determine the presence of at least one analyte in the sample.

16. A method of operating a diagnostic system including one or more selective I / O loaders and one or more diagnostic instruments, comprising: providing a diagnostic instrument having one or more modules, the one or more modules configured to analyze and / or process the specimen container and / or each specimen contained in each specimen container; providing a specimen container sorter coupled to the diagnostic device that functions when the sorting function of the I / O loader fails or that performs secondary sorting; sorting the specimen containers into at least a first group and a second group, wherein the specimen containers or specimens in the first group are analyzed or processed by at least one of the one or more modules, and the specimen containers or specimens in the second group are not analyzed or processed by any of the one or more modules until a test order is received within a preselected time for the specimen containers or specimens in the second group; And, The method comprising:

17. 17. The method of claim 16, wherein the one or more modules are configured to determine the concentration of at least one analyte in the sample.

18. 17. The method of claim 16, wherein the one or more modules are configured to determine the presence of at least one analyte in the sample.

19. A diagnostic system including one or more selective I / O loaders and one or more diagnostic instruments, comprising: The diagnostic device comprises one or more modules; a specimen container sorter configured to function when the sorting function of the I / O loader fails or to perform secondary sorting, and to sort specimens in each specimen container into at least a first group and a second group, wherein specimens or specimen containers in the first group are analyzed by at least one of the one or more modules, and specimens or specimen containers in the second group are not analyzed by any of the one or more modules until a test order is received within a preselected time for the specimen containers or specimens in the second group; a transport system interconnecting the specimen container sorter and at least one of the one or more modules, the transport system configured to move a first group of specimen containers to at least one of the one or more modules; The diagnostic device comprising:

20. 20. The diagnostic instrument of claim 19, wherein the transport system is configured to remove the second group of specimen containers from the specimen selector after a preselected period of time has elapsed without receiving a test order.

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