System and method for reading machine-readable marks on racks and receptacles

Abstract

To provide a sample processing device and a sample assay device.SOLUTION: A sample processing device or a sample assay device includes a moveable support. The moveable support defines a first pocket configured so as to store a first object having a first machine-readable mark. The moveable support defines a second pocket configured so as to store a second object having a second machine-readable mark. The moveable support also includes a first fiducial machine-readable mark and a second fiducial machine-readable mark. The device also includes an image capture device that captures a first image including the first fiducial machine-readable mark and the first machine-readable mark of the first object. The image capture device captures a second image that includes the second fiducial machine-readable mark and the second machine-readable mark of the second object. The device also includes a processor configured so as to associate information decoded from the first and second machine-readable marks with first and second positions on the moveable support.SELECTED DRAWING: None

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 245,930, filed October 23, 2015, the entire contents of which are incorporated herein by reference.

[0002] Embodiments of the present disclosure relate to systems and methods for reading machine-readable marks on sample racks and receptacles, such as racks and receptacles used to perform molecular assays. [Background technology]

[0003] The assay device performs an assay on a fluid sample material. For example, in a clinical laboratory setting, an analytical system can be configured to perform a multi-step analytical process (e.g., a nucleic acid test (NAT) designed to detect microorganisms such as viruses or bacteria). A multi-step analytical process can include placing and / or removing a substance (e.g., a fluid) such as a sample, solid support, buffer, oil, primer, polymerase, nucleotide, label, probe, or other reaction fluid into a receptacle, agitating the receptacle to mix its contents, maintaining and / or altering the temperature of the receptacle's contents, heating or cooling the receptacle's contents, altering the concentration of one or more components of the receptacle's contents, separating or isolating components of the receptacle's contents, detecting electromagnetic signal radiation (e.g., light) from the receptacle's contents, inactivating or stopping an ongoing reaction, or any combination of two or more of such processes.

[0004] Assay devices can be automated to perform a desired analytical process. In such applications, it is necessary to reliably match the results of the analytical process to a specific sample. To do this, the assay device must know the location of sample containers placed on the device. It is also desirable to similarly track the reagents and consumables used to obtain the results. This disclosure describes methods for tracking samples, reagents, and consumables using a handheld or automated image-based barcode reader or similar imaging system. In a typical method of sample tracking, sample containers are labeled with a machine-readable label, e.g., a barcode. Sample containers are placed in a holder or rack on the device, and the device either automatically moves the containers or manually monitors the location of moved containers. The device or an operator moves the samples to a location where an integrated barcode reader reads the label on the sample container. Because the device actively moves or monitors the location of a particular sample, it "knows" the location of the sample. The device can associate a sample in a specific position or slot in a holder with its barcode, and all processing of a particular sample can be reliably tracked by that sample's barcode.

[0005] An attached barcode reader or an actuator that moves the sample in front of the machine so that an operator can move the sample to the reader while the device monitors the position can increase the implementation cost and size of the device and can certainly have a negative impact on the reliability of the device. The methods described in this disclosure show an alternative method where a handheld barcode reader and specially labeled racks or labeled positions within the device allow for reliable association of a sample with a position within the rack, or reliable association of a reagent or other consumable with a position within the device. Summary of the Invention [Means for solving the problem]

[0006] A method for reading machine-readable marks on a movable support and on an object of a sample apparatus includes capturing a first image of the movable support using an image capturing device as the movable support moves from a first position to a second position. The method also includes determining whether a first reference machine-readable mark on the movable support is present in the first image. If the first reference machine-readable mark is present in the first image, the method also includes determining whether a first machine-readable mark on the object coupled to the movable support is at a predetermined position in the first image relative to the first reference machine-readable mark. If the first machine-readable mark on the object is present in the first image, the method further includes decoding the first machine-readable mark in the first image. The method also includes associating information decoded from the first machine-readable mark on the object with a first position on the movable support associated with the first reference machine-readable mark.

[0007] The sample apparatus includes a movable support configured to move from a first position to a second position. The movable support defines a first pocket configured to accommodate a first object having a first machine-readable mark. The movable support also defines a second pocket configured to accommodate a second object having a second machine-readable mark. The movable support includes a first reference machine-readable mark including information identifying the location of the first reference machine-readable mark and a second reference machine-readable mark including information identifying the location of the second reference machine-readable mark. The apparatus also includes an image capture device having a field of view that captures a first image. The first image includes the first reference machine-readable mark and the first machine-readable mark of the first object when the first object is accommodated in the first pocket. The image capture device also captures a second image when the movable support moves from the first position to the second position. The second image includes a second reference machine-readable mark and, if the second object is contained in the second pocket, a second machine-readable mark on the second object. The apparatus also includes a processor configured to decode the first machine-readable mark and the first reference machine-readable mark in the first image. The processor is configured to associate information decoded from the first machine-readable mark with a first position on the movable support that was previously associated with the first reference machine-readable mark. The processor can also decode the second machine-readable mark and the second reference machine-readable mark in the second image. The processor is configured to associate information decoded from the second machine-readable mark with a second position on the movable support that was previously associated with the second reference machine-readable mark. The present invention provides, for example, the following. (Item 1) A sample device, comprising: a movable support configured to move from a first position to a second position, the movable support defining a first pocket configured to accommodate a first object having a first machine-readable mark and a second pocket configured to accommodate a second object having a second machine-readable mark, the movable support including the first reference machine-readable mark including information identifying a position of the first reference machine-readable mark and the second reference machine-readable mark including information identifying a position of the second reference machine-readable mark; an image capturing device having a field of view that captures a first image including the first reference machine-readable mark and the first machine-readable mark of the first object when the first object is contained within the first pocket, and captures a second image including the second reference machine-readable mark and the second machine-readable mark of the second object when the second object is contained within the second pocket when the movable support moves from the first position to the second position; 1. A processor, comprising: decoding the first machine-readable mark and the first reference machine-readable mark in the first image; associating information decoded from the first machine-readable mark with a first position on the movable support that is pre-associated with the first reference machine-readable mark; decoding the second machine-readable mark and the second reference machine-readable mark in the second image; a processor configured to associate information decoded from the second machine-readable mark with a second position on the movable support that is pre-associated with the second reference machine-readable mark; and A sample device comprising: (Item 2) Item 10. The sample device of item 1, wherein the first object has different dimensions than the second object. (Item 3) 3. The sampling device according to claim 1 or 2, wherein the movable support is a sample rack, the first object is a first sample receptacle, and the second object is a second sample receptacle. (Item 4) 3. The sample device according to claim 1 or 2, wherein the movable support is a reagent drawer, the first object is a first reagent container, and the second object is a second reagent container. (Item 5) 3. The sampling device of claim 1 or 2, wherein the movable support is a consumable drawer, the first object is a first consumable, and the second object is a second consumable. (Item 6) The sample device according to any one of items 1 to 5, wherein the sample device is a sample assay device. (Item 7) 6. The sample device according to items 1 to 5, wherein the sample device is a sample processing device. (Item 8) 8. The sample device according to items 1 to 7, wherein the first reference machine-readable mark is a first two-dimensional barcode, and the second reference machine-readable mark is a second two-dimensional barcode. (Item 9) 9. The sample device of item 8, wherein the first reference machine-readable mark is different from the second reference machine-readable mark. (Item 10) 10. The sample device according to items 1 to 9, wherein the first reference machine-readable mark is located below the first pocket, and the second reference machine-readable mark is located below the second pocket. (Item 11) 10. The sample device according to items 1 to 9, wherein the first reference machine-readable mark is located above the first pocket, and the second reference machine-readable mark is located above the second pocket. (Item 12) 10. The sample device according to any one of items 1 to 9, wherein the first reference machine-readable mark is disposed on a side surface of the first pocket, and the second reference machine-readable mark is disposed on a side surface of the second pocket. (Item 13) 13. The sample device according to items 1 to 12, wherein the first machine-readable mark is a first one-dimensional barcode, and the second machine-readable mark is a second one-dimensional barcode. (Item 14) Item 14. The sample device of item 13, wherein the first machine-readable mark is different from the second machine-readable mark. (Item 15) The processor further comprises: identifying the first machine-readable mark in the first image based on a predetermined position of the first machine-readable mark in the first image relative to the position of the first reference machine-readable mark in the first image; 15. The sample device of claim 1, configured to identify the second machine-readable mark in the second image based on a predetermined position of the second machine-readable mark in the second image relative to the position of the second reference machine-readable mark in the second image. (Item 16) The processor further comprises: identifying the first machine-readable mark in the first image by processing only a portion of the first image that includes the predetermined position of the first machine-readable mark in the first image relative to the position of the first reference machine-readable mark in the first image; Item 16. The sample device of item 15, configured to identify the second machine-readable mark in the second image by processing only a portion of the second image that includes the predetermined position of the second machine-readable mark in the second image relative to the position of the second reference machine-readable mark in the first image. (Item 17) The processor further comprises: identifying the first machine-readable mark in the first image by processing the entire first image; Item 16. The sample device of item 15, configured to identify the second machine-readable mark in the second image by processing the entire first image. (Item 18) The processor further comprises: processing only a predetermined portion of the first image to identify the first reference machine-readable mark within the first image; 18. The sample device of items 1 to 17, configured to process only a predetermined portion of the second image to identify the second reference machine-readable mark in the second image. (Item 19) The processor further comprises: processing the entire first image to identify the first reference machine-readable mark within the first image; 18. The sample device of items 1 to 17, configured to process the entire second image to identify the second reference machine-readable mark within the second image. (Item 20) 20. The sampling device according to items 1 to 19, wherein the movable support is manually moved from the first position to the second position. (Item 21) 21. The sample apparatus according to items 1 to 20, wherein the image capture device is a camera. (Item 22) 1. A method for reading machine-readable marks on a movable support and an object of a sample device, comprising: capturing a first image of the movable support with an image capture device as the movable support moves from a first position to a second position; determining whether a first reference machine-readable mark on the movable support is within the first image; If the first reference machine-readable mark is in the first image, determining whether a first machine-readable mark on an object coupled to the movable support is at a predetermined position in the first image relative to the first reference machine-readable mark; associating information decoded from the first machine-readable mark on the object with a first position on the movable support associated with the first reference machine-readable mark; A method comprising: (Item 23) capturing a second image of the movable support with the image capture device as the movable support moves from the first position to the second position; determining whether a second reference machine-readable mark on the movable support is within the second image; If the second reference machine-readable mark is present in the first image, determining whether a second machine-readable mark on a second object coupled to the movable support is at a predetermined position in the second image relative to the second reference machine-readable mark; associating information decoded from the second machine-readable mark on the second object with a second position on the movable support associated with the second reference machine-readable mark; and 23. The method of claim 22, further comprising: (Item 24) 24. The method according to item 22 or 23, wherein the movable support is a sample rack and the object is a sample receptacle. (Item 25) 24. A sample device according to item 22 or 23, wherein the movable support is a reagent drawer and the object is a reagent container. (Item 26) 24. The sampling device according to item 22 or 23, wherein the movable support is a consumable drawer and the object is a consumable item. (Item 27) 27. The method according to any one of items 22 to 26, wherein the sample device is a sample assay device. (Item 28) 27. The method according to any one of items 22 to 26, wherein the sample device is a sample processing device. (Item 29) 29. The method according to any one of items 22 to 28, wherein the first reference machine-readable mark is a two-dimensional barcode. (Item 30) 30. The method according to any one of items 22 to 29, wherein determining whether the first reference machine-readable mark on the movable support is within the first image includes processing only a portion of the first image. (Item 31) 30. The method according to any one of items 22 to 29, wherein determining whether the first reference machine-readable mark on the movable support is within the first image includes processing the entire first image. (Item 32) 32. The method according to claim 22, wherein determining whether the first machine-readable mark on the object coupled to the movable support is at the predetermined position relative to the first reference machine-readable mark in the first image comprises processing only a portion of the first image that includes the predetermined position. (Item 33) 32. The method according to claim 22, wherein determining whether the first machine-readable mark on the object coupled to the movable support is at the predetermined position relative to the first reference machine-readable mark in the first image comprises processing the entire first image. (Item 34) 23. The method of claim 22, further comprising decoding the first reference machine-readable mark present in the first image. (Item 35) Item 35. The method of item 34, wherein the first position on the movable support associated with the first reference machine-readable mark is determined based on decoded information from the first reference machine-readable mark present in the first image. (Item 36) Item 35. The method of item 34, wherein the predetermined position relative to the first reference machine-readable mark is identified based on information decoded from the first reference machine-readable mark present in the first image. (Item 37) Item 35. The method of item 34, wherein the decoded information from the first reference machine-readable mark includes unique information associated with a pocket defined by the movable support that is configured to accommodate the object. (Item 38) 23. The method of claim 22, further comprising determining whether a second machine-readable mark in a pocket defined by the movable support and configured to accommodate the object is at a second predetermined position relative to the first reference machine-readable mark in the first image if the first reference machine-readable mark is not present in the first image. [Brief explanation of the drawings]

[0008] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments and, together with the description, further explain the principles of the embodiments and assist those skilled in the relevant art in making and using the embodiments. [Figure 1] FIG. 1 is a partial perspective view of an analyzer system including a sample bay according to one embodiment. [Figure 2] FIG. 2 is a cross-sectional plan view of the analyzer system of FIG. 1 according to one embodiment. [Figure 3] FIG. 3 is a front perspective view of a sample bay according to one embodiment. [Figure 4] FIG. 4 is a partial side view of a sample rack supporting sample receptacles according to one embodiment. [Figure 5] FIG. 5 is a partial side view of a sample rack supporting sample receptacles according to another embodiment. [Figure 6] FIG. 6 is a partial side view of a sample rack supporting sample receptacles according to yet another embodiment. [Figure 7] FIG. 7 is a partial side view of a sample rack supporting sample receptacles according to another embodiment. [Figure 8] FIG. 8 is a partial side view of a sample rack supporting sample receptacles according to yet another embodiment. [Figure 9] FIG. 9 is a front perspective view of a sample bay with a rack partially inserted into the sample bay housing according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] Features and advantages of the embodiments will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings, in which like reference numbers identify corresponding elements throughout and indicate generally identical, functionally similar, and / or structurally similar elements.

[0010] Reference will now be made in detail to embodiments of the present invention as illustrated in the accompanying drawings. References to "one embodiment," "an embodiment," "some embodiments," "another embodiment," "exemplary embodiment," "for example," "an example," etc., may indicate that the described embodiment includes a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is believed to be within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in relation to another embodiment, whether or not explicitly stated.

[0011]

[0003] Embodiments described herein provide systems and methods for reading machine-readable marks (e.g., one-dimensional barcodes, two-dimensional barcodes, alphanumeric characters, symbols, or any other suitable machine-readable mark) on movable supports (e.g., sample racks, reagent drawers, or consumable drawers) used in a sample device, e.g., a sample processing device or a sample assay device, and objects (e.g., sample receptacles, reagent containers, and consumables) removably coupled to the movable supports. For example, an assay device can be configured to accommodate one or more movable supports that removably hold multiple objects, each having a machine-readable mark, e.g., a one-dimensional or two-dimensional barcode. The movable support defines multiple pockets for accommodating the multiple objects and has at least one machine-readable reference mark corresponding to each pocket defined by the movable support. The position of each of the at least one machine-readable reference mark on the movable support is predetermined (i.e., preset). The assay device can include an image capture device, e.g., a camera, configured to capture an image including the machine-readable marks on the sample rack and sample receptacles. The system also includes a processor that processes the captured image to identify and decode machine-readable marks in the captured image. The processor can also associate information from identified and decoded machine-readable marks on the sample rack with information from corresponding identified and decoded machine-readable marks on the sample receptacle. Such systems and methods for reading machine-readable marks on the sample rack and sample receptacle can be used to perform assays on fluid sample materials and to identify the contents of the sample receptacle, such as patient information (e.g., patient identification number).

[0012] In this application, a "sample device" refers to a sample processing device or a sample assay device. In this application, a "sample assay device" refers to any device capable of analyzing a sample and displaying a result. For example, any device capable of performing a hybridization assay, amplification assay, sequencing assay, or immunoassay on a sample is an assay device. An assay device can perform an assay directly on a sample without sample processing, or the assay device can further process the sample before performing the assay. In some embodiments, samples that require some form of sample processing before undergoing an assay process include cell samples, tissue samples, stool samples, mucus samples, semen samples, cerebrospinal fluid samples, blood samples, bone marrow samples, serum samples, urine samples, bile samples, respiratory samples, sputum samples, and exosome samples. Exemplary assay devices include the Tigris® and Panther® systems (Hologic, Inc., San Diego, CA). In this disclosure, a "sample processing device" is any device that can perform processing steps on a sample contained in a receptacle before assaying the sample, but is not capable of analyzing the sample and displaying the results. Exemplary sample processing devices include the Tomcat® device (Hologic, Inc., San Diego, CA). In this disclosure, a "sample" is any substance to be analyzed, regardless of source. The substance may be in its native form or at any stage of processing (e.g., the substance may be chemically altered or one or more components of the sample that have been separated and / or purified from one or more other components of the sample). Samples can be obtained from any source, including, but not limited to, animal, environmental, food, industrial, or water sources. Animal samples include, but are not limited to, peripheral blood, plasma, serum, bone marrow, urine, bile, mucus, sputum, saliva, cerebrospinal fluid, stool, biopsy tissue including lymph nodes, respiratory tissue or exudates, gastrointestinal tissue, cervical swab samples, semen, or other bodily or cellular fluids, tissues, or secretions. A sample can be diluted or contained in a receptacle containing a diluent, transport medium, preservative solution, or other liquid. Thus, the term "sample" is intended to encompass a sample contained within a diluent, transport medium, and / or preservative or other fluid intended to hold the sample.

[0013] 1 and 2 illustrate a perspective view and a plan cross-sectional view, respectively, of an exemplary sample device 100, i.e., a sample assay device for performing an assay on a sample. In some embodiments, the sample assay device 100 is configured to perform a multi-step analytical process (e.g., a nucleic acid test (NAT) designed to detect microorganisms such as viruses or bacteria), or other chemical, biochemical, or biological process. Exemplary process steps include, for example, placing and / or removing substances (e.g., fluids) such as a sample, solid support, buffer, oil, primer, polymerase, nucleotides, labels, probes, or other reaction fluids into and / or from a receptacle; agitating a receptacle to mix its contents; maintaining and / or altering the temperature of the contents of a receptacle (e.g., using a heated incubator configured to house multiple reaction receptacles and maintain the receptacles in an elevated temperature environment); maintaining and / or altering the temperature of the contents of a receptacle (e.g., using a temperature gradient station configured to increase the temperature of the contents of a reaction receptacle or a cooling station configured to decrease the temperature of the contents of a receptacle); The process may include heating or cooling the contents of the receptacle (e.g., using a magnetic separation and washing station configured to isolate target nucleic acids immobilized on a magnetically responsive solid support from the contents of the receptacle), separating or isolating components of the contents of the receptacle (e.g., using a magnetic separation and washing station configured to isolate target nucleic acids immobilized on a magnetically responsive solid support from the contents of the receptacle), detecting electromagnetic signal emissions (e.g., light) from the contents of the receptacle (e.g., using a detector configured to detect a signal (e.g., an optical signal) emitted by the contents of the reaction receptacle), inactivating or stopping an ongoing reaction, or any combination of two or more of such processes. Fluid sample materials include, for example, urine, blood, plasma, sputum, saliva, mucus, pus, semen, amniotic fluid, cerebrospinal fluid, synovial fluid, and culture medium.

[0014] In some embodiments, a sample is introduced into the sample assay device 100 via a sample bay 102. FIG. 2 illustrates a cross-sectional plan view of the sample assay device 100 according to one embodiment. As shown in FIG. 2, the sample assay device 100 includes a sample bay 102 configured to accommodate multiple sample racks, which are described further below. In some embodiments, the sample assay device 100 also includes a reagent bay 104. The reagent bay 104 is configured to store one or more containers of reagents used during a multi-step analytical process. In some embodiments, the sample assay device 100 includes a reader 105, such as an image capture device or a laser barcode reader, configured to read machine-readable marks, such as one-dimensional or two-dimensional barcodes, on reagent containers stored on a movable drawer within the reagent bay 104. In some embodiments, the sample assay device 100 includes one or more movable tip drawers 106 configured to store multiple tips for use by a fluid transfer device (not shown in FIG. 2) of the sample assay device 100. In some embodiments, the sample assay device 100 comprises a target capture reagent carousel 108 configured to support and rotate one or more containers of target capture reagent (TCR). In some embodiments, the sample assay device 100 comprises a reader 110, such as an image capture device or a laser barcode reader, configured to read machine-readable marks, such as one-dimensional or two-dimensional barcodes, on the TCR containers on the TCR carousel 108.

[0015] FIG. 3 illustrates a front perspective view of a sample bay 102 according to one embodiment. The sample bay 102 is configured to accommodate a plurality of sample racks 112 along defined lanes within the sample bay 102. Each of the sample racks 112 supports a plurality of sample receptacles (not shown in FIG. 3), each containing a sample. For example, as shown in FIG. 3, the sample bay 102 is configured to accommodate eight sample racks 112 that move along defined lanes within the sample bay 102. In other embodiments, the sample bay 102 is configured to accommodate fewer or more than eight sample racks 112.

[0016] The sample bay 102 includes a housing 114 that defines an interior compartment that accommodates the sample rack 112. The housing 114 can be rectangular, as shown in FIG. 3, or any other suitable shape. In some embodiments, the housing 114 includes a base 116 that is, for example, planar and rectangular. The housing 114 also includes a first sidewall 118 and a second sidewall 120 extending from opposite sides of the base 116, and a rear wall (not shown in FIG. 3) extending from the back side of the base 116 between the first sidewall 118 and the second sidewall 120. The housing 114 has an opening 122 at its front end that allows the sample rack 112 to be inserted into and removed from the compartment defined by the housing 114.

[0017] The housing 114 defines multiple lanes along which the sample racks 112 move, e.g., eight lanes as shown in FIG. 3 . In some embodiments, the base 116 includes multiple guides 123 that define the lanes of the housing 114. The guides 123 can be protrusions extending from the base 116 and configured to operably mate with corresponding recesses in the sample racks 112. The guides 123 ensure that the sample racks 112 are accurately and repeatably positioned within the defined lanes of the housing 114 as the sample racks 112 move within the compartment defined by the sample bay 102. As shown in FIG. 3 , the lanes are linear and extend from the front end of the housing 114 to the rear end of the housing 114.

[0018] In some embodiments, the housing 114 also includes a top plate 124. In some embodiments, the top plate 124 includes a plurality of guides 126 that, together with the guides 123, define lanes along which the sample racks 112 move. The guides 126 can be protrusions that extend from the top plate 124 toward the base 116 and are configured to operably mate with corresponding recesses on the sample racks 112. In some embodiments, the top plate 124 defines a plurality of sample receptacle access openings 127 arranged in a rectangular array of rows and columns, in some embodiments as shown in FIG. 3 . For example, each row of openings 126 is aligned with a respective sample rack 112 so that the assay device 101 can easily access the receptacles held by the sample racks 112.

[0019] The sample bay 102 also includes an image capture device 128 configured to capture images of machine-readable marks (e.g., one-dimensional barcodes, two-dimensional barcodes, alphanumeric characters, symbols, and any other suitable machine-readable marks) on the sample rack 112 and to capture images of machine-readable marks (e.g., one-dimensional barcodes, two-dimensional barcodes, alphanumeric characters, symbols, and any other suitable machine-readable marks) on the sample receptacles supported by the sample rack 112. In some embodiments, as shown in FIG. 3 , the sample bay 102 includes an image capture device support 130 configured to support the image capture device 128 and fixedly coupled to the housing 114. The image capture device 128 is coupled to the image capture device support 130 and is thus fixedly coupled to the housing 114. As shown in FIG. 3 , the image capture device support 130 is coupled to the housing 114, for example, fixedly coupled to the sidewall 120. In some embodiments, when viewed from above, image capture device support 130 is substantially U-shaped and forms a compartment sized to house and support image capture device 128. Image capture device 128 is also coupled to image capture device support 130, which in some embodiments fixes the position of image capture device 128 relative to housing 114.

[0020] The sidewall 120 can define an opening 132 that extends into an interior compartment defined by the housing 114 such that the image capture device 128 can read labels on the sample racks 112 within the housing 114 through the opening 132. In some embodiments, the image capture device 128 is configured to read the machine-readable marks when the sample racks 112 are inserted into or removed from the housing 114. In another embodiment, the image capture device 128 is configured to read the machine-readable marks after the sample racks 112 are fully inserted into the housing 114.

[0021] 3, the image capture device 128 is located outside the housing 114 and spaced from the opening 132. In another embodiment (not shown), the image capture device 128 is located outside the housing 114 directly adjacent to the opening 132, or the image capture device 128 is located within the housing 114. In yet another embodiment, the image capture device 128 is a handheld device separate from the housing 114 that is manually operated by a user to read machine-readable markings on the sample rack 112 and on the receptacles held by the rack 112 before the sample rack is inserted into the sample bay 102.

[0022] In some embodiments, as shown in FIG. 3 , the sample bay 102 includes a light source, e.g., a strobe light, configured to illuminate the interior of the housing 114. For example, the light source can illuminate machine-readable markings on the sample rack 112 within the housing 114 and on the sample receptacles held by the sample rack 112. As shown in FIG. 3 , for example, the light source is proximate the image capture device 128 and coupled to the image capture device support 130. In some embodiments, the light source includes an array of LEDs. In some embodiments (not shown), the light source is located inside the housing 114 or in any other suitable location. In some embodiments, the light source is embodied within the image capture device 128.

[0023] 3 and 9, in some embodiments, each sample rack 112 may include a handle 144 configured to allow a user to grasp and manually move the sample rack 112. For example, a user can grasp the handle 144 to insert or remove the sample rack 112 from the housing 114 of the sample bay 102. In some embodiments, as best shown in FIG. 9, the handle 144 defines an opening 146 configured to allow a user's finger to pass through. In some embodiments, the opening 146 allows the optical path through which the image capture device 128 captures an image to pass through one sample rack 112 to allow the image capture device 128 to read machine-readable marks on another sample rack 112 located on the opposite side of the opening 146.

[0024] In some embodiments, as shown in FIG. 9 , the sample rack 112 includes a rack identifier that provides unique rack identification information, e.g., a rack identification number. In some embodiments (not shown), the rack identifier is an RFID tag. In such RFID embodiments, the sample bay 102 includes an RFID reader configured to obtain data from the RFID tag when the sample rack 112 is within the sample bay 102. In another embodiment (as shown in FIG. 9 ), the rack identifier is a machine-readable mark 148, such as a one-dimensional barcode or a two-dimensional barcode (as shown in FIG. 9 ). The image capture device 128 can be configured to capture an image that includes the rack identification machine-readable mark 148. In some embodiments, as shown in FIG. 9 , the rack identification machine-readable mark 148 can be located near the handle 144 of the sample rack 112.

[0025] 4-8 illustrate various embodiments of the sample rack 112, the sample receptacle 136, and the field of view of the image capture device 128. FIG.

[0026] Referring to FIG. 4 , the sample rack 112 is configured to hold a plurality of sample receptacles 136. For example, the sample rack 112 may be configured to hold 15 sample receptacles 136. The sample receptacles 136 may be any type of fluid container, including, for example, tubes, vials, cuvettes, cartridges, microtiter plates, etc., configured to accommodate a sample at any point during sample processing. In some embodiments, each sample receptacle 136 supported by the sample rack 112 includes at least one machine-readable mark 147. The machine-readable mark 147 may be a one-dimensional barcode (e.g., as shown in FIGS. 4 , 5 , and 6 ), a two-dimensional barcode (e.g., as shown in FIGS. 7 and 8 ), alphanumeric characters, symbols, and any other suitable machine-readable mark. A one-dimensional barcode represents information in one direction, e.g., either horizontally or vertically. Examples of one-dimensional barcodes include Code 39, Code 128, ITF (Interleaved 2 of 5), and Codabar. Two-dimensional barcodes represent information in two directions, e.g., horizontally and vertically, and include stacked and matrix barcodes. Examples of two-dimensional barcodes include Aztec, PDF417, MaxiCode, Codablock, Data Matrix, and QR Code. Two-dimensional barcodes can improve decoding accuracy and increase the amount of information contained within a barcode compared to one-dimensional barcodes. In some embodiments, the machine-readable mark 147 of each receptacle 136 includes one or more of the following items of information: Patient information such as a unique patient identifier (e.g., patient name or patient identification number), patient metadata (e.g., date of birth, age, sex, height, or weight), medical history, or any other desired patient information, and sample information such as the healthcare provider requesting the assay, the sample type, the date the sample was collected, the collection location, the type of assay performed, the test results of the assay, and other appropriate information.

[0027] 4, the sample rack 112 includes a base 138 that defines a plurality of pockets 140 for snugly receiving sample receptacles 136. In some embodiments, the pockets 140 can be separated from one another by vertical partitions 142. As shown in FIG. 4, when the receptacles 136 are placed in the pockets 140, the vertical partitions 142 are configured to form gaps therebetween such that machine-readable marks 147 on the sample receptacles 136 are visible to the image capture device 128.

[0028] The sample rack 112 includes at least one reference machine-readable mark 150, and in some embodiments, at least one reference machine-readable mark for each pocket 140 of the sample rack 112. The reference machine-readable marks 150 can be, for example, one-dimensional barcodes, two-dimensional barcodes (as shown in FIGS. 4-8), alphanumeric characters, symbols, and any other suitable machine-readable mark. Two-dimensional barcodes can improve decoding accuracy and increase the amount of information contained within the reference machine-readable marks 150. In some embodiments, each reference machine-readable mark 150 includes information that can be used to identify the location of the reference machine-readable mark 150 on the sample rack 112. For example, each reference machine-readable mark 150 can include unique information, such as a unique identification number, value, or character, that has a predefined association with a particular location on the sample rack 112. In some embodiments, the association between the reference machine-readable mark 150, including the unique information contained in the reference machine-readable mark 150, and a particular location on the sample rack 112 can be stored in memory of the sample assay device 100.

[0029] In some embodiments, the reference machine-readable mark 150 is located on an outer surface of a partition 142 that separates adjacent pockets 140 from one another. In other embodiments (described further below), the reference machine-readable mark 150 is located on a cover configured to fit over a sample receptacle 136 held in a pocket 140 of the sample rack 112. In other embodiments (described further below), the reference machine-readable mark 150 is located on a portion of the base 138 of the sample rack 112 that is below the pocket 140 of the sample rack 112.

[0030] In some embodiments, as shown in Figures 4 and 5, the sample rack 112 may include one reference machine-readable mark 150 on the left and right sides of each pocket 140. And, in some embodiments, as shown in Figures 4 and 5, the reference machine-readable marks 150 are aligned in a straight line (e.g., horizontally). In some embodiments, as shown in Figure 6, the sample rack 112 may include two vertically aligned reference machine-readable marks 150 on the left and right sides of each pocket 140. In some embodiments, as shown in Figure 7, the sample rack 112 may include one reference machine-readable mark 150 on each top and bottom side of each pocket 140. And, in some embodiments, as shown in Figure 8, the sample rack 112 may include one vertically aligned reference machine-readable mark 150 below each pocket 140.

[0031] The sample rack 112, in some embodiments, can also include machine-readable marks 158 in each pocket 140 of the sample rack 112. The reference machine-readable marks 158 can be, for example, a one-dimensional barcode (as shown in FIGS. 4-8 ), a two-dimensional barcode, alphanumeric characters, symbols, and any other suitable machine-readable mark. The machine-readable marks 158 are positioned in each pocket 140 so that they are visible to the image capture device 128 when a sample receptacle 136 is not received in the corresponding pocket 140. For example, as shown in FIG. 4 , empty-pocket identifying machine-readable marks 158 are shown in pockets 140D and 140E of the sample rack 112 because these two pockets 140D and 140E do not hold sample receptacles 136.

[0032] When a sample receptacle 136 is placed in a pocket 140, the position of the machine-readable mark 147 on the sample receptacle 136 relative to each reference machine-readable mark 150 is predetermined, and the position of the empty-pocket identifying machine-readable mark 158 on the sample rack 112 is predetermined relative to each reference machine-readable mark 150. These predetermined relative positions can be stored in the memory of the sample assay device 100.

[0033] 4, image capture device 128 has a field of view sufficient to capture an image that includes (1) at least one reference machine-readable mark 150 and (2) at least one of (a) at least one machine-readable mark 147 on at least one sample receptacle 136 contained in each pocket 140, and (b) at least one empty-pocket-identifying machine-readable mark 158 in each pocket 140. For example, as shown in FIG. 4, image capture device 128 has a field of view sufficient to capture an image that includes (1) a set of reference machine-readable marks 150 (one mark 150 on the left side of each pocket 140 and one mark 150 on the right side of each pocket 140), and (2) either the machine-readable marks 147 on the sample receptacles 136 contained in each pocket or, if each pocket 140 is empty, the empty-pocket-identifying machine-readable mark 158 in each pocket 140. 4, image capture device 128 has a field of view sufficient to capture image 152A that includes (1) reference machine-readable mark 150A on the left side of pocket 140A, (2) reference machine-readable mark 150B on the right side of pocket 140A, and (3) machine-readable mark 147 on sample receptacle 136 within pocket 140A. Image capture device 128 then (when sample rack 112 is inserted into sample bay 102) has a field of view sufficient to capture image 152B that includes (1) reference machine-readable mark 150B on the left side of pocket 140B, (2) reference machine-readable mark 150C on the right side of pocket 140B, and (3) machine-readable mark 147 on sample receptacle 136 within pocket 140B. Image capture device 128 may then capture similar images of reference machine-readable marks 150C, 150D, 150E, etc., and machine-readable marks 147 on sample receptacles 136 within pockets 140C, 140D, 140E, etc.

[0034] 5, image capture device 128 has a field of view sufficient to capture an image 152A that includes (1) only one reference machine-readable mark 150 (e.g., mark 150 on the left side of each pocket 140) and (2) either machine-readable mark 147 on a sample receptacle 136 contained within each pocket 140 or, if the respective pocket 140 is empty, empty-pocket identifying machine-readable mark 158 within each pocket 140. As shown in FIG. 5, image capture device 128 has a field of view sufficient to capture an image 152A that includes (1) reference machine-readable mark 150A on the left side of pocket 140A and (2) machine-readable mark 147 on a sample receptacle 136 within pocket 140A (or machine-readable mark 158 if a sample receptacle 136 is not within pocket 140A). Image capture device 128 then has a field of view sufficient to capture image 152B (if sample rack 112 is inserted into sample bay 102) that includes (1) reference machine-readable mark 150B on the left side of pocket 140B, and (2) machine-readable mark 147 on sample receptacle 136 in pocket 140B (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140B). Image capture device 128 then has a field of view sufficient to capture image 152C (if sample rack 112 is further inserted into sample bay 102) that includes (1) reference machine-readable mark 150C on the left side of pocket 140C, and (2) machine-readable mark 147 on sample receptacle 136 in pocket 140C (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140C). The image capture device 128 can then capture similar images of the reference machine-readable marks 150D, 150E, etc. and the machine-readable marks 147 on the sample receptacles 136 in the pockets 140D, 140E, etc. (or machine-readable marks 158 if there are no sample receptacles 136 in the pockets 140D, 140E, etc.).

[0035] 6, image capture device 128 has a field of view sufficient to capture an image that includes (1) a pair of reference machine-readable marks 150 on the left side of each pocket 140 and a pair of reference machine-readable marks 150 on the right side of each pocket 140, and (2) either machine-readable marks 147 on the sample receptacles 136 contained within each pocket, or, if the respective pocket 140 is empty, an empty-pocket identifying machine-readable mark 158 within each pocket 140. As shown in FIG. 6, image capture device 128 has a field of view sufficient to capture image 152A that includes (1) reference machine-readable marks 150A and 150A' on the left side of pocket 140A, (2) reference machine-readable marks 150B and 150B' on the right side of pocket 140A, and (3) machine-readable marks 147 on the sample receptacles 136 within pocket 140A. The image capture device 128 then has a field of view sufficient to capture an image 152B that includes (1) the reference machine-readable marks 150B and 150B' on the left side of pocket 140B, (2) the reference machine-readable marks 150C and 150C' on the right side of pocket 140B, and (3) the machine-readable mark 147 on the sample receptacle 136 in pocket 140B (when the sample rack 112 is inserted into the sample bay 102). The image capture device 128 can then capture similar images of the reference machine-readable marks 150C, 150C', 150D, 150D', 150E, 150E', etc., and the machine-readable marks 147 on the sample receptacles 136 in the pockets 140C, 140D, 140E, etc. (or machine-readable marks 158 if there are no sample receptacles 136 in the pockets 140C, 140D, 140E, etc.).

[0036] 7, image capture devices 128 have a field of view sufficient to capture images 152A that each include (1) a set of reference machine-readable marks 150 (one mark 150 on the top side of each pocket 140 and one mark 150 on the bottom side of each pocket 140), and (2) either a machine-readable mark 147 on a sample receptacle 136 contained within each pocket, or, if the respective pocket 140 is empty, an empty-pocket identifying machine-readable mark 158 within the respective pocket 140. As shown in FIG. 7, image capture device 128 has a field of view sufficient to capture images 152A that include (1) a reference machine-readable mark 150A on the top side of pocket 140A, (2) a reference machine-readable mark 150A' on the bottom side of pocket 140A, and (3) a machine-readable mark 147 on a sample receptacle 136 within pocket 140A. The image capture device 128 then has a field of view sufficient to capture an image 152B that includes (1) the reference machine-readable mark 150B on the top side of the pocket 140B, (2) the reference machine-readable mark 150B' on the bottom side of the pocket 140B, and (3) the machine-readable mark 147 on the sample receptacle 136 within the pocket 140B (when the sample rack 112 is inserted into the sample bay 102). The image capture device 128 then has a field of view sufficient to capture an image 152C (if the sample rack 112 is further inserted into the sample bay 102) that includes (1) the reference machine-readable mark 150C on the top side of the pocket 140C, (2) the reference machine-readable mark 150C' on the bottom side of the pocket 140C, and (3) the machine-readable mark 147 on the sample receptacle 136 in the pocket 140C (or the machine-readable mark 158 if the sample receptacle 136 is not in the pocket 140C). The image capture device 128 can then capture similar images of the reference machine-readable marks 150D, 150D', 150E, 150E', etc., and the machine-readable marks 147 on the sample receptacles 136 in the pockets 140D, 140E, etc. (or machine-readable marks 158 if there are no sample receptacles 136 in the pockets 140D, 140E, etc.).

[0037] 7, in some embodiments, the sample rack 112 includes a cover 151 configured to be releasably secured to the base 138 of the sample rack 112. In some embodiments, reference machine-readable marks 150A-150E are disposed on the cover 151, and reference machine-readable marks 150A'-150E' are disposed on a portion 154 of the base 138 of the sample rack 112 below the pocket 140. In some embodiments, the cover 151 also includes a machine-readable mark 156, such as a one-dimensional barcode or a two-dimensional barcode (as shown in FIG. 9). The label 156 is configured to be used to determine whether the cover 151 is coupled to and / or properly positioned relative to the base 138.

[0038] 8, image capture device 128 has a field of view sufficient to capture image 152A that includes (1) reference machine-readable mark 150A on the bottom side of pocket 140A, and (2) machine-readable mark 147 on sample receptacle 136 in pocket 140A (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140A). Image capture device 128 then has a field of view sufficient to capture image 152B that includes (when sample rack 112 is inserted into sample bay 102) (1) reference machine-readable mark 150B on the bottom side of pocket 140B, and (2) machine-readable mark 147 on sample receptacle 136 in pocket 140B (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140B). Image capture device 128 then has a field of view sufficient to capture image 152C (if sample rack 112 is further inserted into sample bay 102) that includes (1) reference machine-readable mark 150C on the bottom side of pocket 140C, and (2) machine-readable mark 147 on sample receptacle 136 in pocket 140C (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140C). Image capture device 128 can then capture similar images of reference machine-readable marks 150D, 150E, etc., and machine-readable mark 147 on sample receptacle 136 in pocket 140D, 140E, etc. (or machine-readable mark 158 if sample receptacle 136 is not in pocket 140D, 140E, etc.).

[0039] The image capture device 128 can be configured to have a working distance range that includes each lane defined by the sample bays 102 within the housing 114 along which the sample rack 112 moves.

[0040] The sample assay apparatus 100 can include a processor configured to process the image captured by the image capture device 128 to associate information contained in the machine-readable mark 147 on each sample receptacle 136 on the sample rack 112 with a particular location, such as a particular pocket 140 on the sample rack 112. For example, the processor can process the captured image to identify at least one reference machine-readable mark 150 within the image. Based on the predetermined, pre-defined position of each machine-readable mark 147 on the sample receptacle 136 relative to the identified reference machine-readable mark 150, the processor can identify and decode each machine-readable mark 147 on each sample receptacle 136. The processor can then associate the information decoded from each machine-readable mark 147 with a particular location or pocket on the sample rack 112 that is pre-defined to be associated with the identified reference machine-readable mark 150 in the image. In some embodiments, the processor can also store this association of the information decoded from each machine-readable mark 147 with a particular location or pocket on the sample rack 112 in the memory of the sample assay device 100.

[0041] In some embodiments, for example, the processor determines whether an image captured by image capture device 128 includes reference machine-readable mark 150. In some embodiments, the processor processes the entire captured image to determine the presence of reference machine-readable mark 150. In other embodiments, the processor processes only a portion of the captured image that is known to include reference machine-readable mark 150 to determine the presence of reference machine-readable mark 150 in the captured image.

[0042] If the captured image does not contain the reference machine-readable mark 150, the processor begins processing the next captured image.

[0043] If the captured image includes the reference machine-readable mark 150, the processor determines whether the captured image includes a machine-readable mark at a predetermined position relative to the identified reference machine-readable mark 150 in the captured image, corresponding to the position where the machine-readable mark 147 on the sample receptacle 136 would be if the sample receptacle 136 were in the pocket 140 associated with the identified reference machine-readable mark 150. In some embodiments, the processor processes the entire captured image to determine whether the machine-readable mark is at the predetermined relative position. In other embodiments, the processor processes only the portion of the captured image that includes the predetermined relative position to determine whether the machine-readable mark is at the predetermined relative position. If the captured image includes the machine-readable mark 147 at the predetermined relative position, the processor decodes the machine-readable mark 147 and associates the decoded information with a particular position or pocket on the sample rack 112 that is predetermined to be associated with the identified reference machine-readable mark 150 in the captured image. The processor can then store this association in memory of the sample assay device 100. The processor can then begin processing the next captured image and repeat the steps above.

[0044] If the captured image does not include the machine-readable mark 147 at the predetermined position, the processor determines whether the captured image includes a machine-readable mark at a predetermined position relative to the identified reference machine-readable mark 150 in the captured image, corresponding to the position where the machine-readable mark 158 would be if the receptacle 136 were not in the pocket 140 associated with the identified reference machine-readable mark 150. If the captured image includes the machine-readable mark 158, the processor begins processing the next captured image and repeats the above steps. In some embodiments, the processor processes the entire captured image to determine whether the machine-readable mark 158 is in the predetermined relative position. In other embodiments, the processor processes only the portion of the captured image that includes the predetermined relative position to determine whether the machine-readable mark 158 is in the predetermined relative position.

[0045] 5 or 8, a processor processes captured image 152A and determines that image 152A includes reference machine-readable mark 150A, e.g., by processing a portion of image 152A or the entire image 152A. The processor then determines, e.g., by processing the entire image 152A or the portion of image 152A, that captured image 152A includes machine-readable mark 147 at a predetermined location relative to the identified reference machine-readable mark 150A in captured image 152A, corresponding to the location where machine-readable mark 147 would be on sample receptacle 136 if receptacle 136 were within pocket 140A associated with the identified reference machine-readable mark 150A. The processor then decodes machine-readable mark 147 in image 152A and associates the decoded information with a particular location or pocket on sample rack 112 that is predetermined to be associated with the identified reference machine-readable mark 150A in captured image 152A. The processor can then store this association in the memory of the sample assay device 100. The processor can then begin processing the next captured image 152B and repeat the steps above.

[0046] In another processing embodiment, a processor processes each image captured by image capture device 128 to identify each machine-readable mark in the captured image 152. The processor then determines whether any one of the identified machine-readable marks in the captured image is a reference machine-readable mark 150 on sample rack 112. If the identified machine-readable marks in the captured image include a reference machine-readable mark 150, the processor then determines whether any of the identified machine-readable marks in the captured image are located in a predetermined position relative to the identified machine-readable mark 150 in the captured image, corresponding to the position where machine-readable mark 147 on receptacle 136 would be if receptacle 136 were within the corresponding pocket 140 associated with the identified reference machine-readable mark 150. If the identified machine-readable mark in the captured image 152 includes a machine-readable mark 147 in a predetermined location relative to the identified machine-readable mark 150 in the captured image, the processor decodes the machine-readable mark 147 and associates the decoded information in the machine-readable mark 147 with the particular location or pocket 140 that corresponds to the identified machine-readable mark 150. The processor can then store this association in memory of the sample assay device 100. If the identified machine-readable marks in the captured image do not include machine-readable marks 158 at a predetermined position relative to the identified machine-readable marks 150 in the captured image 152 corresponding to the position where any machine-readable marks 147 on the receptacle 136 would be present if the receptacle 136 were in the corresponding pocket 140, the processor determines whether any of the identified machine-readable marks in the captured image are located at a predetermined position relative to the identified machine-readable marks 150 in the captured image corresponding to the position associated with the identified reference machine-readable marks 150 where the machine-readable marks 158 corresponding to the empty pocket 140 are located.If the identified machine-readable mark in the captured image 152 includes a machine-readable mark 158 in a predetermined location relative to the identified machine-readable mark(s) 150 in the captured image, the processor decodes the machine-readable mark 158 and associates an empty state with the particular location or pocket 140 that corresponds to the identified machine-readable mark 150. The processor can then store this association in memory of the sample assay device 100. The processor can repeat these steps for each captured image 152.

[0047] In some embodiments, the sample bay 102 is configured so that the sample rack 112 is manually inserted into the housing 114 of the sample bay 102. In this disclosure, "manually inserted," "manually moved," or similar phrases mean that the sample rack 112 is inserted or moved without the use of automated or electrical device components. That is, using only a user's hands, the sample rack 112 is inserted or moved into the housing 114 along a defined lane. In some embodiments, when the sample rack 112 is manually moved, the sample rack 112 can be moved at a high speed of more than 100 mm / sec, such as 300 mm / sec, 500 mm / sec, 600 mm / sec, or 1000 mm / sec.

[0048] In another embodiment, the sample bay 102 is configured to automatically move the sample rack 112 within the housing 114 of the sample bay 102. For example, the sample bay 102 may include an automated actuator that moves the sample rack 112 to a fully inserted position within the housing 114 of the sample bay 102. In some embodiments, the sample rack 112 is automatically moved within the housing 114 at a predetermined constant speed.

[0049] 9 , to insert the sample rack 112 into the housing 114 of the sample bay 102, a user aligns the sample rack 112 with the guides 123 on the base 116. The user then moves the sample rack 112 in a direction 158 (as shown in FIG. 9 ) along the lane defined by the guides 123 from a first, initial position within the housing 114 of the sample bay 102 to a second, fully inserted position. As shown in FIG. 9 , the sample receptacles 136 are positioned within the sample rack 112 such that the machine-readable marks 147 align with openings defined by the partitions 142 that separate adjacent pockets 140 from one another. Thus, the machine-readable marks 147 are visible to the image capture device 128 through the openings 132 defined in the sidewalls 120 of the housing 114. Thus, as the sample rack 112 moves from the initial position to the fully inserted position, the image capture device 128 can read the pocket identification reference machine-readable mark 150, the rack identification machine-readable mark 148, the cover identification machine-readable mark 156, and the empty pocket identification machine-readable mark 158, as well as the machine-readable mark 147 on each sample receptacle 136 on the sample rack 112.

[0050] In some embodiments, the image capture device 128 has a field of view configured to capture the image 152. In some embodiments, the image capture device 128 can have a working distance range large enough to include each lane defined within the housing 114 along which the sample rack 112 moves.

[0051] In some embodiments, image capture device 128 has sufficient depth of field so that reference machine-readable mark 150, machine-readable mark 147 on each sample receptacle 136, rack-identifying machine-readable mark 148, cover-identifying machine-readable mark 156, and empty-pocket-identifying machine-readable mark 158 are each sufficiently focused in the captured image to allow a processor to process the captured image as described above. For example, while reference machine-readable mark 150, rack-identifying machine-readable mark 148, and cover-identifying machine-readable mark 156 are positioned substantially coplanar as shown in FIG. 9 , in some embodiments, machine-readable mark 147 on each sample receptacle 136 and empty-pocket-identifying machine-readable mark 158 can be positioned out of plane, away from image capture device 128, due to their location on receptacle 136 and the walls of pocket 140 in which machine-readable mark 147 and empty-pocket-identifying machine-readable mark 158, respectively, are positioned. In some embodiments, image capture device 128 may have sufficient depth of field, e.g., each of these machine-readable marks may be in sufficient focus in the captured image to undergo the processes described above. In some embodiments, the depth of field may be approximately 1 inch, and in some embodiments, the depth of field may be approximately the diameter of pocket 140.

[0052] In some embodiments, the image capture device 128 is a camera. Exemplary cameras include a charge-coupled device (CCD) camera or a complementary metal-oxide semiconductor (CMOS) camera. In some embodiments, the image capture device 128 captures multiple images 152 at a rate sufficient to obtain images of the machine-readable mark 147, the reference machine-readable mark 150, the rack identification machine-readable mark 148, the cover identification machine-readable mark 156, and the empty-pocket identification machine-readable mark 158 on each sample receptacle 136 when the sample rack 112 moves at a speed of at least 1000 mm / sec, including, for example, 100 mm / sec, 300 mm / sec, 500 mm / sec, and 600 mm / sec. For example, in some embodiments, the image capture device 128 captures images 152 at a rate of at least 20 Hz, e.g., 25 Hz, 35 Hz, 50 Hz, or 60 Hz.

[0053] 9 , as the sample rack 112 is inserted into the sample bay 102 along the lane defined by the guide 123 (and in the direction 158), the image capture device 128 captures multiple images of the sample rack 112 and its contained receptacles 136 as it passes through the field of view of the image capture device 128. For example, the captured images 152 include the machine-readable mark 147, the reference machine-readable mark 150, the rack-identifying machine-readable mark 148, the cover-identifying machine-readable mark 156, and the empty-pocket-identifying machine-readable mark 158 on each sample receptacle 136. In some embodiments, the captured images 152 are transmitted to a processor configured to process the captured images as described above. In some embodiments, the processor is coupled to or located within the housing 114. In some embodiments, this image processing by the processor occurs while the sample rack is inserted into the housing 114. In another embodiment, this image processing by the processor occurs after the sample rack 112 is fully inserted into the housing 114 of the sample bay 102 .

[0054] In some embodiments, the processor is also configured to activate the light source each time an image 152 is captured at the sample rack 112. The use of a light source when acquiring an image 152 can further reduce the necessary performance requirements of the image capture device 128.

[0055] Although the above-described embodiments include sample racks 112 and sample receptacles 136, the embodiments are not limited to sample racks 112 and sample receptacles 136. For example, the embodiments may be applied to other racks and fixtures of the sample assay device 100 that hold reagent containers or other consumables used in processing. Thus, the above-described embodiments may be used to determine the location of a reagent container or other processing consumable relative to the rack or fixture on which the respective reagent container or other processing consumable is located.

[0056] While the above-described embodiments include an image capture device 128 fixedly coupled to the sample bay 102, the disclosed embodiments are not limited to fixed readers 128. For example, these embodiments may be applicable when using a portable reader that is manually operated by a user. Such portable embodiments may help accommodate user variability, which may result in scanning the receptacles 136 in a non-sequential order.

[0057] Some embodiments are implemented via control and computation hardware components, user-written software, data input components, and data output components. Hardware components include, for example, a processor, such as a microprocessor or computer, configured to perform computational and / or control steps by executing one or more algorithms stored on a non-transitory, machine-readable medium (e.g., software) that receives one or more input values, provides instructions for manipulating or otherwise acting on the input values, and outputs one or more output values. Such output may be displayed or indicated to an operator to provide information to the operator, such as information regarding the status of the device or the process being performed thereby, or such output may include input for another process and / or control algorithm. Data input components include elements that input data for use by the control and computation hardware components. Such data input includes manual input elements, such as graphic user interfaces, keyboards, touchscreens, microphones, switches, manually operated scanners, voice-activated inputs, etc., as well as image capture devices, position sensors, and motor encoders. Data output components may include a hard drive or other storage medium, a graphic user interface, a monitor, a printer, indicator lights, or an audible signaling element (e.g., a buzzer, horn, bell, etc.). In some embodiments, the processor may comprise a single module that performs image processing and system control. In other embodiments, the processor comprises multiple modules that perform separate processing and control steps. In some embodiments, the processor may be a component of image capture device 128 that processes (e.g., post-processes) images stored in a buffer of image capture device 128.

[0058] The software includes instructions stored on a non-transitory computer-readable medium that, when executed by the control hardware and computer hardware, cause the control hardware and computer hardware to perform one or more automated or semi-automated processes. In some embodiments, the software for image processing is stored in memory on the image capture device 128, for example. In some embodiments, the software for image processing is stored in external memory in communication with the processor.

[0059] It is understood that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections present one or more, but not all, exemplary embodiments of the invention contemplated by the inventors, and therefore do not limit the scope of the invention and the appended claims in any way.

[0060] The present invention has been described above using functional components that illustrate the performance of certain functions and their relationships. The boundaries of these functional components have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and their relationships are appropriately performed.

[0061] The foregoing descriptions of specific embodiments will make fully apparent the general nature of the present invention, such that others may readily modify and / or adapt such specific embodiments to various applications within the skill of those skilled in the art without undue experimentation and without departing from the general concept of the invention. Such adaptations and modifications are therefore intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phrases or terminology herein are for the purpose of description and not of limitation, as the terms or phrases herein would be interpreted by one of ordinary skill in the art in light of the teaching and guidance.

[0062] The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. 1. A method for reading machine-readable marks on a movable support and an object of a sample device, comprising: (A) capturing a first image of the movable support with an image capture device as the movable support moves from a first position to a second position; (B) determining whether a first reference machine-readable mark on the movable support and a second reference machine-readable mark on the movable support are within the first image, wherein the first reference machine-readable mark is positioned on a first side of a first pocket defined in the movable support, and the second reference machine-readable mark is positioned on a second side of the first pocket opposite the first side of the first pocket and is laterally aligned with the first reference machine-readable mark; (C) when the first reference machine-readable mark and the second reference machine-readable mark are present in the first image, determining whether a first machine-readable mark on the object coupled to the movable support or a first empty-pocket identifying machine-readable mark disposed in the first pocket is at a predetermined position relative to the first reference machine-readable mark and the second reference machine-readable mark in the first image; (D) associating information decoded from the first machine-readable mark on the object or from the first empty-pocket identifying machine-readable mark with a third location on the movable support associated with the first reference machine-readable mark and the second reference machine-readable mark; A method comprising:

2. (B) The method of claim 1, including processing either the entire first image or only a portion of the first image.

3. The method of claim 2, wherein (C) includes processing either the entire first image or only a portion of the first image that includes the predetermined location. (E) capturing a second image of the movable support using the image capture device as the movable support moves from the first position to the second position; and (F) determining whether the second reference machine-readable mark and a third reference machine-readable mark on the movable support are within the second image, wherein the second reference machine-readable mark is positioned on a first side of a second pocket defined in the movable support, and the third reference machine-readable mark is positioned on a second side of the second pocket opposite the first side of the second pocket and is laterally aligned with the second reference machine-readable mark; (G) when the second reference machine-readable mark and the third reference machine-readable mark are present in the second image, determining whether a second machine-readable mark on a second object coupled to the movable support or a second empty-pocket identifying machine-readable mark disposed in the second pocket is at a predetermined position relative to the second reference machine-readable mark and the third reference machine-readable mark in the second image; (H) associating information decoded from the second machine-readable mark on the second object or from the second empty-pocket identifying machine-readable mark with a fourth location on the movable support associated with the second reference machine-readable mark and the third reference machine-readable mark; The method of claim 1 further comprising:

5. The method of claim 4 , wherein the object has different dimensions than the second object.

6. The method of claim 1 , wherein the movable support is a sample rack and the object is a sample receptacle.

7. The method of claim 1 , wherein the movable support is a reagent drawer and the object is a reagent container.

8. The method of claim 1 , wherein the movable support is a consumable drawer and the object is a consumable item.

9. The method of claim 1 , wherein the sample device is a sample assay device or a sample processing device.

10. The method of claim 1 , wherein the first reference machine-readable mark is a first two-dimensional barcode and the second reference machine-readable mark is a second two-dimensional barcode.

11. The method of any one of claims 1 to 10, wherein the first reference machine-readable mark is different from the second reference machine-readable mark.

12. The method of claim 1 , wherein the image capture device is a camera.

13. 1. A method for reading machine-readable marks on a movable support and an object of a sample device, comprising: (A) capturing a first image of the movable support with an image capture device as the movable support moves from a first position to a second position; (B) determining whether a first pair of vertically aligned reference machine-readable marks on the movable support and a second pair of vertically aligned reference machine-readable marks on the movable support are present in the first image, wherein the first pair of vertically aligned reference machine-readable marks are on a first side of a first pocket defined in the movable support and the second pair of vertically aligned reference machine-readable marks are on a second side of the first pocket opposite the first side of the first pocket; (C) when the first pair of vertically aligned reference machine-readable marks and the second pair of vertically aligned reference machine-readable marks are present in the first image, determining whether a first machine-readable mark on the object coupled to the movable support or a first empty-pocket identifying machine-readable mark disposed in the first pocket is at a predetermined position relative to the first pair of vertically aligned reference machine-readable marks and the second pair of vertically aligned reference machine-readable marks in the first image; (D) associating information decoded from the first machine-readable mark on the object or from the first empty-pocket identifying machine-readable mark with a third location on the movable support associated with the first pair of vertically aligned reference machine-readable marks and the second pair of vertically aligned reference machine-readable marks; A method comprising: (E) capturing a second image of the movable support using the image capture device as the movable support moves from the first position to the second position; (F) determining whether a second pair of vertically aligned reference machine-readable marks on the movable support and a third pair of vertically aligned reference machine-readable marks on the movable support are within the second image, wherein the second pair of vertically aligned reference machine-readable marks are positioned on a first side of a second pocket defined in the movable support, and the third pair of vertically aligned reference machine-readable marks are positioned on a second side of the second pocket opposite the first side of the second pocket; (G) when the second pair of vertically aligned reference machine-readable marks and the third pair of vertically aligned reference machine-readable marks are present in the second image, determining whether a second machine-readable mark on a second object coupled to the movable support or a second empty-pocket identifying machine-readable mark disposed in the second pocket is at a predetermined position in the second image relative to the second pair of vertically aligned reference machine-readable marks and the third pair of vertically aligned reference machine-readable marks; (H) associating information decoded from the second machine-readable mark on the second object or from the second empty-pocket identifying machine-readable mark with a fourth location on the movable support associated with the second pair of vertically aligned reference machine-readable marks and the third pair of vertically aligned reference machine-readable marks; 14. The method of claim 13, further comprising:

15. A method as described in claim 13 or 14, wherein (B) includes processing either the entire first image or only a portion of the first image.

16. The method of claim 15, wherein (C) includes processing either the entire first image or only a portion of the first image that includes the predetermined location.

17. The method of claim 13 , wherein the image capture device is a camera.

18. The method of claim 13 , wherein the movable support is a sample rack and the object is a sample receptacle.

19. 14. The method of claim 13, wherein the movable support is a reagent drawer and the object is a reagent container.

20. 14. The method of claim 13, wherein each reference machine-readable mark of the first and second pair of vertically aligned reference machine-readable marks is a two-dimensional bar code.

Images