Methods and apparatus for inspecting a sample within a sample container

Abstract

In some embodiments, an optical inspection system includes a sample container location configured to receive a sample container having a sample, a label and a label opening through which the sample can be optically probed and a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location. A light source is configured to output a light beam through the first lens along a light path that is offset from the optical axis of the first lens, the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container. A detector is configured to detect at least a portion of the light beam scattered by the sample within the sample container. Numerous other embodiments are provided.

Description

METHODS AND APPARATUS FOR INSPECTING A SAMPLE WITHIN A SAMPLE CONTAINERCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 651,234 entitled "METHODS AND APPARATUS FOR INSPECTING A SAMPLE WITHIN A SAMPLE CONTAINER" filed on May 23, 2024, the disclosure of which is hereby incorporated by reference in its entirety for all purposes .FIELD

[0002] The present disclosure relates to methods and apparatus for inspecting a sample within a sample container.BACKGROUND

[0003] Diagnostic laboratory systems conduct clinical chemistry or assays to identify analytes or other constituents in biological samples such as blood serum, blood plasma, urine, interstitial liquid, cerebrospinal liquids, and the like. The samples may be collected in sample containers, such as test tubes, by a medical technician. The test tubes may include labels which include patient information, sample information, or the like.

[0004] When the sample containers arrive at a diagnostic laboratory system, an initial quality assessment of the sample containers and / or the samples stored therein may be performed by noninvasive optical techniques. For example, an image of a sample container and / or the sample may be captured and / or the spectral characteristics of the sample may be determined. To access a sample within a sample container, optical techniques require a clear field of view of the sample. In some situations, a label may partially block the sample, such as when the label is not applied correctly, and the sample may need to be manually inspected.

[0005] Accordingly, improved methods and apparatus for inspecting a sample within a sample container are desired .SUMMARY

[0006] In some embodiments , an optical inspection system is provided that includes a sample container location conf igured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed . The optical inspection system further includes a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location . The optical inspection system al so includes a light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at lea st a portion of the light beam contacts the sample through the label opening of the sample container . A detector i s provided that is configured to detect at least a portion of the light beam scattered by the sample within the sample container .

[0007] In some embodiments , a method of inspecting a sample is provided that includes receiving a sample container containing a sample , the sample container having a label and a label opening through which the sample can be optically probed . The method also includes positioning the sample container at a sample container location and aligning the label opening of the sample container with an optical axis of a first lens . The method further includes employing a light source to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container . The method al so includes employing adetector to detect at least a portion of the light beam scattered by the sample within the sample container .

[0008] In some embodiments , an optical inspection system includes a sample container location configured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed . A first lens is provided having an optical axis configured to align with the label opening of the sample container at the sample container location . The optical inspection system further includes a plurality of light sources , each light source configured to output a light beam through the f irst lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container . A detector is configured to detect at least a portion of light scattered by the sample within the sample container .

[0009] Still other aspects , features , and advantages of this disclosure may be readily apparent from the following description and illustration of a number of example embodiments , including the best mode contemplated for carrying out the disclosure . This disclosure may al so be capable of other and different embodiments , and its several detail s may be modified in various respects , all without departing from the scope of the disclosure .BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The drawings described below are provided for illustrative purposes and are not nece s sarily drawn to scale . Accordingly, the drawings and descriptions are to be regarded as illustrative in nature , and not as restrictive . The drawings are not intended to limit the scope of the dis closure m any way .

[0011] FIGS. 1A and IB illustrate side views of an example optical inspection system in accordance with embodiments provided herein.

[0012] FIG. 1C illustrates an additional example embodiment in which a plurality of light sources are evenly spaced near an outer edge of a lens as provided herein.

[0013] FIG. ID illustrates an example spectrometer embodiment of a detector having a dispersion element and a detection device as provided herein.

[0014] FIG. IE illustrates an alternative embodiment of an optical inspection system in which a single light source is employed as provided herein.

[0015] FIG. IF illustrates an alternative embodiment of an optical inspection system in which a detector is positioned farther from a lens than the light sources as provided herein.

[0016] FIG. 1G illustrates an alternative embodiment of an optical inspection system in which a second lens having an optical axis positioned along the optical axis of a first lens as provided herein.

[0017] FIG. 1H illustrates a laterally compact optical inspection system based on the embodiment of FIG. IB as provided herein.

[0018] FIG. II illustrates a laterally compact optical inspection system based on the embodiment of FIG. IF as provided herein.

[0019] FIG. 1J illustrates a laterally compact optical inspection system based on the embodiment of FIG. 1G as provided herein.

[0020] FIG. IK illustrates an alternative embodiment of an optical inspection system in which light sources arepositioned to focus light beams within a sample container as provided herein.

[0021] FIG. IL illustrates an alternative embodiment of an optical inspection system in which light sources are positioned to focus light beams at a front surface of a sample container as provided herein.

[0022] FIG. 2 illustrates a diagnostic laboratory system employing an optical inspection system as part of a sample quality check module in accordance with embodiments provided herein .

[0023] FIG. 3 illustrates a flowchart of a method of optically inspecting a sample within a sample container in accordance with embodiments provided herein.DETAILED DESCRIPTION

[0024] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0025] As discussed above, labels placed on sample containers (e.g. , to provide patient and / or sample information) may be placed in a way that hinders a clear view of the samples stored therein. This may prevent the sample containers from being automatically processed and / or quality- checked. Such samples may require time-intensive manual inspection which reduces the efficiency of the diagnostic laboratory system processing the samples.

[0026] In accordance with embodiments provided herein, an optical inspection system is provided that allows optical probing of a sample within a sample container despite limited view of the sample (e.g. , due to poorly placed labels) . In one or more embodiments, such an optical inspection system may be employed within a sample quality check module of a diagnostic laboratory system to perform sample quality checks. Samplequality checks may be employed within diagnostic laboratory systems to identify problematic samples before they are processed. This improves system efficiency by preventing system resources (e.g., analyzer time, reagents, etc.) from being used on samples that are not suitable for testing and that may produce unusable results.

[0027] Conventional optical inspection systems require a large field of view during inspection of samples stored within sample containers. For example, optical inspection systems for test tubes generally require label placement that offers an unobstructed horizontal opening over an entire height of a label. Such an opening may be located between edges of a label that partially surrounds a sample container. Labels that are applied incorrectly may not provide a large enough field of view to obtain a sufficiently large image patch or to allow sufficient light to reach samples for imaging or spectral analysis .

[0028] The systems and methods disclosed herein may enable optical inspection of sample containers and / or samples stored therein even when labels are improperly applied to the sample containers. For example, optical inspection systems provided herein are able to focus light on small areas of the sample containers that are not occluded by labels. Light scattered from the samples may then be collected for assessment (e.g., within a sample quality check module) .

[0029] In one or more embodiments disclosed herein, an off- axis optical arrangement is employed for the light source or detector. For example, a first lens may be positioned so that its optical axis aligns with a label opening of a sample container. In some embodiments, a light source may be placed in front of the first lens (e.g. , at a front focal plane of the lens) but offset from the lens' optical axis. Placing the light source offset from the optical axis but in the focal plane of the lens causes a light beam from the light source tobe collimated by the lens at an angle relative to the optical axis. At a back focal plane of the lens, the light beam will intersect the optical axis of the lens at which the sample container to be inspected is positioned. If the detector is positioned along the optical axis of the lens (or offset from the optical axis by an amount smaller than the offset of the light source) , any light reflected from the surface of the sample container will reflect at an angle away from the detector .

[0030] In some embodiments, the detector may be located in the front focal plane of the first lens, such that it is focused at infinity (e.g. , backscattered light from the sample within a near-parallel cone of observation will be focused on the detector) . In other embodiments, the detector may be placed farther in front of the focal plane of the first lens so that it focusses to a point within the sample container. That is, the detector may be positioned farther in front of the lens than the front focal plane of the lens such that scattered light from within a cone of observation whose focus lies within the sample container is focused on the detector.

[0031] In yet other embodiments, a second (additional) lens may be employed so that the detector is focused at the plane of the label opening. (That is, the detector may be positioned at the focal point of the second lens such that scattered light from within a cone of observation whose focus lies at the plane of the label opening is focused on the detector.) In such cases, the minimum tolerable label opening may be defined by the respective focal lengths of the first and second lenses .

[0032] Similarly, in some embodiments, the light source may be positioned such that the focal point of the light beam from the light source either lies at infinity, inside the sample container, or on a front surface of the sample container. Focusing the light beam from the source within the samplecontainer or at the front surface of the sample container may allow optical probing through a smaller label opening (e.g., allowing the light beam to enter the sample container without a portion of the light beam scattering off of a label) .

[0033] In one or more embodiments, compact variants of the above-described optical inspection systems may be provided (e.g. , by employing a deflecting mirror, a right-angle prism, etc. ) . This may allow for integration of the optical inspection system in a (laterally) confined space. The same degrees of freedom in terms of focusing of light detected by the detector and / or provided by the light source are possible in the compact variants (e.g. , focusing at infinity, within the sample container, or at the front surface of the sample container) .

[0034] These and other embodiments of the invention are described below with reference to FIGS. 1A-3.

[0035] FIGS. 1A and IB illustrate side views of an example optical inspection system 100 in accordance with embodiments provided herein. With reference to FIGS. 1A and IB, optical inspection system 100 includes a sample container location 102 at which a sample container 104 is positioned during optical probing. In the embodiment of FIGS. 1A and IB, sample container 104 has a tube-shape. Other sample container shapes may be employed. Note that in FIGS. 1A-1B and 1E-1L, for clarity, optical components and beam widths are enlarged relative to the sample container 104. As stated above, the drawings are for illustrative purposes and are not necessarily drawn to scale.

[0036] FIGS. 1A and IB illustrate sample container 104 supported by a sample carrier 106 and including a cap 108. Cap 108 may be of different types and / or colors (e.g., red, royal blue, light blue, green, grey, tan, yellow, or color combinations) , which may indicate what test the sample container 104 is used for, the type of additive includedtherein (e.g., for preventing clot formation) , whether the container includes a gel separator, whether the sample is provided under a vacuum, or the like. Other colors may be used .

[0037] The sample container 104 may be provided with one or more labels 110 that may include identification information thereon (not shown) , such as a barcode, alphabetic characters, numeric characters, or combinations thereof. Sample identification information may include or be associated with patient information (e.g. , name, date of birth, address, and / or other personal information) , tests to be performed, time and date the sample was obtained, medical facility information, tracking and routing information, etc. Other information may also be included. As shown in FIG. 1A, the label 110 may not extend all the way around the sample container 104 or all along a length of the sample container 104 such that from the particular lateral front viewpoint shown, some part of a sample 112 stored within sample container 104 is viewable and unobstructed by the label 110. This viewable window through which the sample 112 may be observed is referred to as label opening 114.

[0038] In many cases, one or more labels may allow only a small part of the sample to be viewable. For example, a label may partially block the sample, such as when the label is not applied correctly. The optical inspection system 100 allows optical probing of the sample 112 within sample container 104 even if the label opening 114 does not extend over an entire height of the label 110 and / or for a narrower label opening 114 (between ends of label 110) than may be acceptable for conventional optical inspection systems .

[0039] The sample 112 may include any fluid to be tested and / or analyzed (e.g. , blood serum, blood plasma, urine, interstitial fluid, cerebrospinal fluid, or the like) . In some embodiments, the sample 112 may include a serum or plasmaportion (light shading) and a settled blood portion (dark shading) contained within sample container 104. Air may be provided above the serum and plasma portion, for example.

[0040] In some embodiments, optical inspection system 100 may include a first lens 116 having an optical axis 118 configured to align with the label opening of each sample container at the sample container location 102. For example, the optical axis 118 of the first lens 116 is shown being aligned with the label opening 114 of sample container 104 in FIGS. 1A and IB.

[0041] The optical axis 118 of the first lens 116 may be aligned with the label opening 114 of sample container 104 by positioning the sample container 104 at the sample container location 102 (e.g., via a robot (not shown) , a conveyor system (not shown) , by rotating the sample container 104, etc. ) .Alternatively, one or more optical components of the optical system 100, such as the first lens 116, one or more light sources or detectors (described below) , or the like, may be moved to align the optical axis 118 of the first lens 116 with the label opening 114 of the sample container 104. For example, the first lens 116 ) nd / or one or more optical components of optical system 100 may be movable via one or more motors, a robot (e.g. , such as by being coupled to a gripper of a robot used to grasp the sample container 104) , etc. In yet other embodiments, both optical components of optical inspection system 100 and the sample container 104 may be moved, rotated or otherwise adjusted to align the optical axis 118 of the first lens 116 with the label opening 114 of sample container 104.

[0042] The first lens 116 may be formed from any suitable material or materials such as glass (e.g., BK7 glass) , plastic (e.g. , polyethylene, polycarbonate, a polymer, etc. ) , or the like. Example indices of refraction may range from about 1.3 to 1.5. Example focal lengths range from about 2 to 50 mm,depending on the distance between the first lens 116 and the sample container 104. For example, in embodiments in which the first lens 116 is close to the sample container 104 being analyzed, such as when the first lens 116 is coupled to a robot arm (e.g., a gripper) that positions the sample container 104, the focal length of the first lens 116 may range from about 2-10 mm, in some embodiments, about 4-6 mm. Other lens materials, indices of refraction, focal lengths or other lens properties may be employed. In the embodiment shown, the first lens 116 is a spherical lens. Other lens shapes may be employed, such as aspherical.

[0043] Optical inspection system 100 further includes a first light source 120a configured to output a light beam 122a through the first lens 116 along a light path 124a (FIG. 1A) that is offset from the optical axis 118 of the first lens 116. As shown in FIG. 1A, the light path 124a extends between the light source 120a and the sample container location 102 so that at least a portion of the light beam 122a contacts the sample 112 through the label opening 114 of the sample container 10 .

[0044] Optical inspection system 100 may include a single light source 120a or one or more additional light sources, such as light source 120b. FIG. 1C illustrates an additional example embodiment of the optical inspection system 100 in which a plurality of light sources 120a-120h are evenly spaced near an outer edge of the first lens 116. Other numbers and / or arrangements of light sources may be employed. As with light source 120a, light source 120b may be similarly offset from the optical axis 118 (as shown by light path 124b in FIGS. 1A) . Light sources 120c-h of FIG. 1C may be similarly offset. Example offsets for the light sources range from about 2 to 10 mm, depending on the size of the first lens 120 (e.g., offsets are limited by the size of the lens employed) . Example lens diameters may range from about 5 to 20 mm, depending on lightsource and detector diameters and / or other tradeoffs or factors. Other offsets and / or lens diameters may be employed.

[0045] In some embodiments, the light sources may include a laser, an LED, a broad-band white light source (e.g. , a broadband LED) , a halogen bulb, a visible light source, an infrared light source, etc. Other light source types and / or wavelength ranges may be employed including narrowband light sources .

[0046] Optical inspection system 100 also includes a detector 126 configured to input at least a portion of the light beam scattered by the sample 112 within the sample container 104. For example, light beam 122a from light source 120a and / or light beam 122b from light source 120b may reach sample 112 through label opening 114 and scatter (e.g., backscatter) off of sample 112. A portion of this scattered light, referred to as scattered light beam 128 in FIG. 1A and IB, will travel through the first lens 116 and reach detector 126.

[0047] If the detector 126 is positioned along the optical axis 118 of the first lens 116 as shown in FIGS. 1A and IB (or offset from the optical axis 118 by an amount smaller than the offset of the light source 120a or 120b) , any light reflected from the surface of the sample container 104 will reflect at an angle away from the detector 126 (and thus not interfere with the measurement of properties of the sample 112) . In some embodiments, the detector 126 may be offset from the optical axis 118 of the first lens 116 by less than about half the offset of the light source (s) . Other detector offsets may be employed (e.g. , depending on factors such as alignment tolerances, sample container tilt, light source and detector sizes, or the like) .

[0048] In one or more embodiments, the detector 126 may include a spectrometer. For example, FIG. ID illustrates an example spectrometer embodiment of the detector 126 that may include a dispersion element 130 such as a prism or gratingand a detection device 132 such as a photomultiplier tube, CCD camera, a CMOS camera, or the like that allows intensity measurements of scattered light from the sample at different wavelengths or wavelength ranges. Other detector types may be employed .

[0049] With reference to FIGS. 1A and IB, the optical inspection system 100 may include a processor 134 (FIG. 1A) coupled to the light source 120a, light source 120b, and / or detector 126. The processor 134 may be configured to analyze optical intensity data, spectral data, or the like, generated by the detector 126 in response to the scattered light beam 128 being detected by the detector 126. For example, the detector 126 may generate electrical signals representative of the intensity or other property of different wavelengths or wavelength ranges within the scattered light beam 128 (e.g., different wavelengths of light spatially separated by dispersion element 130 and detected by detection device 132 of FIG. ID) . In one or more embodiments, the processor 134 may be configured to determine a presence and / or a concentration of one or more interferents within the sample such as the presence of hemolysis, icterus, and lipemia, interferent concentration (e.g. , concentration of hemoglobin, bilirubin, and lipid emulsion / intralipid) , level of interference (e.g., Hl, H2, etc. ) or the like. Other sample properties may be determined .

[0050] In some embodiments, the processor 134 may be coupled to a memory 136 (FIG. 1A) . The memory 136 may include one or more programs 138 for carrying out the methods described herein when executed by the processor 134, such as measuring one or more properties of the sample 112 held within sample container 104 by employing light source 120a and / or 120b to transmit an optical beam at sample 112 (through label opening 114) and detector 126 to measure scattered light from sample 112 as described above. The memory 136 may includemultiple memory units and / or types of memory. In some embodiments, all or a portion of the memory 136 may be external to and / or remote from the processor 134. Additionally, in some embodiments, multiple processors may be employed .

[0051] In the embodiment of FIGS. 1A and IB, the light source 120a, light source 120b, and detector 126 are positioned at a front (left-side in FIG. IB) focal position FP1 of the first lens 116 (as defined by focal length Fl in FIG. IB) . In this position, light beams emitted from light source 120a and light source 120b are collimated as shown by light beams 140a and 140b.

[0052] In the embodiment of FIGS. 1A and IB, the detector 126 is located in the front focal plane FP1 (at the front focal point) of the first lens 116, such that it is focused at infinity (e.g. , backscattered light from the sample 112 within a near-parallel cone of observation will be focused on the detector 126) . That is, the detector 126 "gazes" at infinity. If the sample container 104 is placed at the back focal position FP1' (right-side in FIG. IB) of the lens 116 (as defined by focal length Fl' in FIG. IB) , the label opening 114 may appear blurred to the detector 126.

[0053] FIG. IE illustrates an alternative embodiment of the optical system 100 in which a single light source 120a is employed. Note that the light source 120a may be located at other positions (e.g. , below the detector, above the detector, etc. ) . Use of a single light source 120a reduces cost of the optical inspection system 100 but may make it more difficult to provide sufficient light to the sample 112 during inspection. Also, using a single light source to illuminate the sample may result in less uniform illumination than the embodiments of FIG. 1A, IB and 1C.

[0054] FIG. IF illustrates an alternative embodiment of the optical inspection system 100 in which the detector 126 ispositioned farther from the first lens 116 than the light sources 120a and 120b. That is, the detector 126 may be positioned farther in front of the first lens 116 than the front focal plane FP1 of the first lens 116 such that light scattered (from the sample 112) within a cone of observation whose focus lies within the sample container 104 is focused on the detector 126. (Viewed from the detector 126, the detector 126 is focused on the sample 112 within the sample container 104. )

[0055] In some embodiments, the detector 126 may be positioned approximately 1 to 50 mm in front of the focal point of the first lens 116, depending on the focal length and size of the first lens 116. More generally, the detector 126 may be positioned anywhere between close to the focal point Fl of the first lens 116 to several focal lengths away (e.g. , depending on engineering tradeoffs) . Other detector positions may be employed.

[0056] FIG. 1G illustrates an alternative embodiment of the optical inspection system 100 in which a second lens 142 has an optical axis 144 positioned along the optical axis 118 of the first lens 116. The second (additional) lens 142 may be employed so that the detector 126 is focused at the plane of the label opening 114 of the sample container 104. That is, the detector 126 may be positioned at the focal point (defined by focal length F2) of the second lens 142 such that scattered light from within a cone of observation whose focus lies at the plane of the label opening 114 is focused on the detector 126. In such cases, the minimum label opening may be defined by the respective focal lengths of the first lens 116 and second lens 142.

[0057] As with the first lens 116, the second lens may be formed from any suitable material or materials such as glass (e.g. , BK7 glass) , plastic (e.g. , polyethylene, polycarbonate, a polymer, etc.) , or the like. Example indices of refractionmay range from about 1.3 to 1.5. Example focal lengths may range from about 2-50 mm, depending on the distance between the second lens 142 and the detector 126. In some embodiments, the second lens 142 may be a spherical lens. Other lens types and / or lens properties may be employed.

[0058] As described in FIGS. 1A-1G, the first lens 116 has a front focal plane FP1 (defined by the focal length Fl) and a back focal plane FP1' (defined by the focal length Fl' ) . In some embodiments, the sample container location 102 may be configured to position sample containers at the back focal plane FP1' of the first lens 116. Other sample container locations may be employed. In the embodiments of FIGS. 1A-1C, the detector 126 and the light source (s) are positioned the same distance from the first lens 116 (e.g. , at the front focal plane FP1 of the first lens 116) , whereas in the embodiments of FIGS. IF and 1G, the detector 126 is positioned a further distance from the first lens 116 than the light sources 120a and 120b.

[0059] FIG. 1H illustrates a laterally compact optical inspection system 100 based on the embodiment of FIG. IB as provided herein. With reference to FIG. 1H, a redirection device 146 (e.g. , a mirror or prism) is employed to redirect the light beam 122a from light source 120a and the light beam 122b from light source 120b toward label opening 114 of the sample container 104. The redirection device 146 also redirects the scattered light beam 128 from the sample container 104 toward the detector 126. FIG. II illustrates a laterally compact optical inspection system 100 based on the embodiment of FIG. IF (wherein the detector 126 is moved back from the light sources 120a and 120b) as provided herein. Likewise, FIG. 1J illustrates a laterally compact optical inspection system 100 based on the embodiment of FIG. 1G (wherein the second lens 142 is employed to focus scattered light on the detector 126) as provided herein.

[0060] Other off-axis arrangements may be employed. For example, as shown in FIG. IK, in some embodiments, a light source (e.g. , one or more of light sources 120a-b in FIG. IK) may be moved farther from the first lens 116 so that the light beam from each light source is focused within the sample 112 (similar to the detector 126 in the embodiments of FIGS. IF and II) . In the embodiment of FIG. IK, the focal point of the light source 120a lies below the optical axis 118 and the focal point of the light source 120b lies above the optical axis 118. In other embodiments, an additional lens may be employed for each light source to produce light beams that are focused at the surface of the sample container 104 at label opening 114 (e.g. , which is positioned at the back focal plane FP1' of the first lens 116) similar to the detector 126 in the embodiments of FIG. 1G and 1J. An example of such an embodiment is shown in FIG. IL, in which additional lenses 148a and 148b are employed with light sources 120a and 120b, respectively. Laterally compact arrangements based on the embodiments of FIG. IK and IL, employing a redirection device (e.g. , redirection device 146) , also may be employed. Other light source and / or detector arrangements may be used.

[0061] FIG. 2 illustrates a diagnostic laboratory system 200 employing the optical inspection system 100 as part of a sample quality check module 202 in accordance with embodiments provided herein. With reference to FIG. 2, the diagnostic laboratory system 200 may be configured to perform a plurality of analyses or tests on a plurality of different biological samples. For example, the tests may determine levels of constituents or chemicals present in biological samples such as blood, urine, cerebral fluid, and the like. The diagnostic laboratory system 200 may include a plurality of diagnostic instruments 204a-c (e.g. , analyzers) that are configured to perform the same or different tests on the biological samples. Fewer or more diagnostic instruments may be employed.

[0062] In some embodiments, the diagnostic instruments 204a-c may be interconnected by a transport system (e.g. , transport system 206) . The transport system may be configured to transport the biological samples between the diagnostic instruments 204a-c and / or other devices in the diagnostic laboratory system 200, such as an input module 208 for loading sample carriers into or out of the diagnostic laboratory system 200, a sample prep module 210 (e.g. , centrifuges, decappers, etc.) , the sample quality check module 202, etc. The diagnostic laboratory system 200 may include other configurations .

[0063] The diagnostic laboratory system 200 may be coupled to a computer 212 that may be located within the diagnostic laboratory system 200 or external to the diagnostic laboratory system 200. In some embodiments, portions of the computer 212 may be located within the diagnostic laboratory system 200 and other portions of the computer 212 may be located external to the diagnostic laboratory system 200. The computer 212 may include a processor 214 and a memory 216, wherein the memory 216 stores one or more programs 218 configured to be executed or run on the processor 214. In some embodiments, the memory 216 and / or the program(s) 218 may be located external to the computer 212. For example, the computer 212 may be connected to the Internet or an intranet to access external data and the like .

[0064] In some embodiments, the program (s) 218 may operate the diagnostic instruments 204a-c and process data generated by the diagnostic instruments 204a-c. For example, under the direction of processor 214 executing one or more programs 218, sample containers 104 (two sample containers 104a and 104b are shown in FIG. 2) may be loaded into input module 208, prepped in sample prep module 210, quality checked in sample quality check module 202 (e.g., using optical inspection system 100) , and processed in one or more of diagnostic instruments 204a-c.

[0065] In some embodiments, sample quality check module 202 and / or optical inspection system 100 may include a separate processor, memory and program(s) , such as the processor 134, memory 136 and program(s) 138 of FIG. 1A for controlling operation of optical inspection system 100. Alternatively, processor 214, memory 216 and / or one or more programs 218 may operate the sample quality check module 202 and / or optical inspection system 100.

[0066] FIG. 3 illustrates a flowchart of a method 300 of optically inspecting a sample within a sample container in accordance with embodiments provided herein. With reference to FIG. 3, method 300 begins in block 302 wherein a sample container containing a sample is received, the sample container having a label and a label opening through which the sample can be optically probed. For example, sample container 104 having sample 112 therein, such as blood plasma or another biological sample, may be received. Sample container 104 has label 110 with label opening 114 through which sample 112 may be optically probed.

[0067] In block 304, method 300 includes positioning the sample container at a sample container location. In some embodiments, a robot or conveyor system (not shown) may deliver the sample container 104 to the sample container location 102.

[0068] In block 306, method 300 includes aligning the label opening of the sample container with an optical axis of a first lens. In one or more embodiments, a robot (not shown) may move and / or rotate the sample container 104 so that the label opening 114 of the sample container 104 is aligned with the optical axis 118 of the first lens 116. In other embodiments, the first lens 116 (and / or other optical components) may be coupled to a robot, motor, etc., that moves the first lens 116 so that the optical axis 118 of the first lens 116 is aligned with the label opening 114 of the samplecontainer 104 at the sample container location 102. For example, the first lens 116 may be coupled to a robot gripper that grasps and positions the sample container 102. In yet other embodiments, both the first lens 116 and the sample container 104 may be moved so as to align the optical axis 118 of the first lens 116 with the label opening 114 of the sample container 102.

[0069] In Block 308, method 300 includes employing a light source to output a light beam through the first lens along a light path that is offset from the optical axis of the first lens, the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container. As shown in FIG. 1A-1L, a light source (e.g. , one or more of light sources 120a-h) may be offset from the optical axis 118 of the first lens 116 and employed to direct a light beam along light path that is offset from the optical axis 118. For example, light path 124a (FIG. 1A) is offset from the optical axis 118 of the first lens 116 and extends between the light source 120a and the sample container location 102 so that at least a portion of the light beam 140a contacts the sample 112 through the label opening 114 of the sample container 104.

[0070] Method 300 further includes, in block 310, employing a detector to detect at least a portion of the light beam scattered by the sample within the sample container. For example, as shown in FIG. 1A, the detector 126 may be employed to detect a least a portion of the light beam 140a (and / or 140b) scattered by the sample 112 within the sample container 102. As stated, in some embodiments, the detector 126 may be positioned along the optical axis 118 of the first lens 116 while in other embodiments the detector 126 may be slightly offset from the optical axis 118 (e.g. , significantly less offset than the light sources) . In yet other embodiments, thepositions of the detector 126 and light source (s) may be reversed, with the light source (s) positioned along (or near) the optical axis 118 of the first lens 116 and the detector being more offset.

[0071] In some embodiments, the processor 134 may analyze response data generated by the detector 126 and determine at least one sample characteristic based on the response data. For example, based on the intensity of light at one or more wavelengths as measured by the detector 126, the processor 134 may determine a presence and / or concentration of one or more interferents within the sample. Further, based on such a determination, the processor 134 may perform a sample quality check (e.g. , approve or reject samples based on the presence of hemolysis, icterus, and lipemia or another interferent) .

[0072] The off-axis optical arrangements described herein may be employed to detect transmitted and ref lected / backscattered light from a sample within a sample container without light reflected from sample container surfaces inadvertently being detected by the detector. Because the optical inspections systems provided herein allow inspection of small label openings, without the risk of capturing surface reflections by the detector, they may reduce the number of sample containers that are rejected for processing and directed to manual inspection. In some embodiments, the off-axis optical arrangements described herein may be employed in instances in which a label opening does not extend over the entire label height (e.g., such as where two or more skewed labels form only a "pinhole" size opening of a few millimeters in diameter) .

[0073] The foregoing description discloses only example embodiments of the invention; modifications of the above disclosed apparatus and methods which fall within the scope of the invention will be readily apparent to those of ordinary skill in the art. Accordingly, while the present inventionhas been disclosed in connection with the example embodiment s thereof , it should be understood that other embodiments may fall within the spirit and scope of the invention , as defined by the following claims .Non-Limiting Illustrative Embodiments

[0074] Ill ustrative embodiment 1 . An optical inspection system, comprising :

[0075] a sample container location configured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed;

[0076] a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location ;

[0077] a light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container ; and

[0078] a detector configured to detect at least a portion of the light beam scattered by the sample within the sample container .

[0079] Illustrative embodiment 2 . The optical inspection system of illustrative embodiment 1 wherein the detector is positioned along the optical axis of the f irst lens .

[0080] Ill ustrative embodiment 3 . The optical inspection system of one of the preceding embodiments wherein the first lens comprises a spherical lens .

[0081] Ill ustrative embodiment 4 . The optical inspection system of one of the preceding embodiments wherein the light source comprises a broadband light source and the detector comprises a spectrometer .

[0082] Ill ustrative embodiment 5 . The optical inspection system of one of the preceding embodiments further comprising a plurality of light sources , each light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens .

[0083] Illustrative embodiment 6 . The optical inspection system of one of the preceding embodiments wherein the first lens is configured to move so that the optical axis aligns with the label opening of the sample container at the sample container location .

[0084] Ill ustrative embodiment 7 . The optical inspection system of one of the preceding embodiments further comprising a second lens having an optical axis positioned along the optical axis of the first lens .

[0085] Illustrative embodiment 8 . The optical inspection system of one of the preceding embodiments wherein the second lens focuses scattered light from the sample onto the detector .

[0086] Illustrative embodiment 9 . The optical inspection system of one of the preceding embodiments wherein the first lens has a focal plane and wherein the sample container location is configured to position sample containers at the focal plane .

[0087] Illustrative embodiment 10 . The optical inspection system of one of the preceding embodiments wherein the light source and detector are positioned a same distance from the first lens .

[0088] Illustrative embodiment 11 . The optical inspection system of one of the preceding embodiments wherein the detector is positioned a further distance from the first lens than the light source .

[0089] Illustrative embodiment 12 . The optical inspection system of one of the preceding embodiments further comprising a proces sor coupled to the detector , the proces sor conf iguredto analyze response data generated by the detector and determine at least one sample characteristic ba sed on the response data .

[0090] Ill ustrative embodiment 13 . The optical inspection system of one of the preceding embodiments wherein the processor is configured to determine a pre sence of one or more interf erents within the sample .

[0091] Illustrative embodiment 14 . The optical inspection system of one of the preceding embodiments wherein the processor is configured to determine a concentration of one or more interf erents within the sample .

[0092] Ill ustrative embodiment 15 . A sample quality check module comprising the optical inspection system of one of the preceding embodiments .

[0093] Illustrative embodiment 16 . A method of inspecting a sample comprising :

[0094] receiving a sample container containing a sample , the sample container having a label and a label opening through which the sample can be optically probed;

[0095] positioning the sample container at a sample container location ;

[0096] aligning the label opening of the sample container with an optical axis of a first lens ;

[0097] employing a light source to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container ; and

[0098] employing a detector to detect at lea st a portion of the light beam scattered by the sample within the sample container .

[0099] Illustrative embodiment 17 . The method of illustrative embodiment 16 wherein the detector is positioned along the optical axis of the first lens .

[0100] Illustrative embodiment 18 . The method of one of the preceding embodiments wherein the first lens compri ses a spherical lens .

[0101] Illustrative embodiment 19 . The method of one of the preceding embodiments wherein the light source comprise s a broadband light source and the detector comprises a spectrometer .

[0102] Illustrative embodiment 20 . The method of one of the preceding embodiments further comprising employing a plurality of light sources to illuminate the sample through the label opening , each light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens .

[0103] Illustrative embodiment 21 . The method of one of the preceding embodiments wherein positioning the sample container at the sample container location so as to align the label opening with the optical axis of the f irst lens comprises moving the first lens so that the optical axis aligns with the label opening of the sample container at the sample container location .

[0104] Illustrative embodiment 22 . The method of one of the preceding embodiments further comprising a second lens having an optical axis positioned along the optical axis of the first lens .

[0105] Illustrative embodiment 23 . The method of one of the preceding embodiments further comprising employing the second lens to focus scattered light from the sample onto the detector .

[0106] Illustrative embodiment 24 . The method of one of the preceding embodiments further comprising positioning the sample container at a focal plane of the f irst lens .

[0107] Illustrative embodiment 25 . The method of one of the preceding embodiments wherein the light source and detector are positioned a same distance from the first lens .

[0108] Illustrative embodiment 26 . The method of one of the preceding embodiments wherein the detector is positioned a further distance from the first lens than the light source .

[0109] Illustrative embodiment 27 . The method of one of the preceding embodiments further comprising analyz ing response data generated by the detector and determining at least one sample characteristic based on the response data .

[0110] Illustrative embodiment 28 . The method of one of the preceding embodiments further comprising determining a presence of one or more interferents within the sample .

[0111] Illustrative embodiment 29 . The method of one of the preceding embodiments further comprising determining a concentration of one or more interferents within the sample .

[0112] Illustrative embodiment 30 . The method of one of the preceding embodiments further comprising analyz ing response data generated by the detector and performing a sample quality check .

[0113] Illustrative embodiment 31 . An optical inspection system, comprising :

[0114] a sample container location configured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed;

[0115] a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location ;

[0116] a plurality of light sources , each light source configured to output a light beam through the f irst lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion ofthe light beam contacts the sample through the label opening of the sample container ; and

[0117] a detector configured to detect at least a portion of light scattered by the sample within the sample container .

[0118] Illustrative embodiment 32 . The optical inspection system of illustrative embodiment 31 wherein each light beam is focused at a front surface of the sample container or the sample .

[0119] Illustrative embodiment 33 . The optical inspection system of one of the preceding embodiments wherein the detector is positioned along the optical axis of the first lens .

[0120] Illustrative embodiment 34 . The optical inspection system of one of the preceding embodiments wherein each light source comprises a broadband light source and the detector comprises a spectrometer .

[0121] Illustrative embodiment 35 . The optical inspection system of one of the preceding embodiments further comprising a proces sor coupled to the detector , the proces sor conf igured to analyze response data generated by the detector and determine at least one sample characteristic ba sed on the response data .

Claims

THE INVENTION CLAIMED IS :1 . An optical inspection system, compris ing : a sample container location configured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed; a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location ; a light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container ; and a detector configured to detect at least a portion of the light beam scattered by the sample within the sample container .2 . The optical inspection system of claim 1 wherein the detector is positioned along the optical axis of the first lens .3 . The optical inspection system of claim 1 wherein the first lens comprises a spherical lens .4 . The optical inspection system of claim 1 wherein the light source comprises a broadband light source and the detector comprises a spectrometer .5 . The optical inspection system of claim 1 further comprising a plurality of light source s , each light source configured to output a light beam through the f irst lens along a light path that is off set from the optical axis of the first lens .6 . The optical inspection system of claim 1 wherein the first lens is configured to move so that the optical axis aligns with the label opening of the sample container at the sample container location .7 . The optical inspection system of claim 1 further comprising a second lens having an optical axis pos itioned along the optical axis of the first lens .8 . The optical inspection system of claim 7 wherein the second lens focuses scattered light from the sample onto the detector .9 . The optical inspection system of claim 1 wherein the first lens has a focal plane and wherein the sample container location is configured to position sample container s at the focal plane .10 . The optical inspection system of claim 1 wherein the light source and detector are positioned a same distance from the first lens .11 . The optical inspection system of claim 1 wherein the detector is positioned a further distance from the first lens than the light source .12 . The optical inspection system of claim 1 further comprising a proces sor coupled to the detector, the processor configured to analyze response data generated by the detector and determine at least one sample characteristic ba sed on the response data .13 . The optical inspection system of claim 12 wherein the proces sor is configured to determine a presence of one or more interf erents within the sample .14 . The optical inspection system of claim 12 wherein the proces sor is configured to determine a concentration of one or more interf erents within the sample .15 . A sample quality check module compris ing the optical inspection system of claim 1 .16 . A method of inspecting a sample comprising : receiving a sample container containing a sample , the sample container having a label and a label opening through which the sample can be optically probed; positioning the sample container at a sample container location ; aligning the label opening of the sample container with an optical axis of a first lens ; employing a light source to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container ; and employing a detector to detect at lea st a portion of the light beam scattered by the sample within the sample container .17 . The method of claim 16 wherein the detector i s positioned along the optical axis of the f irst lens .18 . The method of claim 16 wherein the first lens comprises a spherical lens .-SO-19 . The method of claim 16 wherein the light source comprises a broadband light source and the detector comprise s a spectrometer .20 . The method of claim 16 further compri sing employing a plurality of light sources to illuminate the sample through the label opening , each light source configured to output a light beam through the first lens along a light path that is off set from the optical axis of the first lens .21 . The method of claim 16 wherein positioning the sample container at the sample container location so as to align the label opening with the optical axis of the first lens comprises moving the first lens so that the optical axi s aligns with the label opening of the sample container at the sample container location .22 . The method of claim 16 further compri sing a second lens having an optical axis positioned along the optical axi s of the first lens .23 . The method of claim 22 further compri sing employing the second lens to focus scattered light f rom the sample onto the detector .24 . The method of claim 16 further compri sing positioning the sample container at a focal plane of the first lens .25 . The method of claim 16 wherein the light source and detector are positioned a same distance from the first lens .-SI-26 . The method of claim 16 wherein the detector i s positioned a further distance from the fir st lens than the light source .27 . The method of claim 16 further compri sing analyzing response data generated by the detector and determining at least one sample characteristic based on the re sponse data .28 . The method of claim 27 further compri sing determining a presence of one or more interferents within the sample .29 . The method of claim 27 further compri sing determining a concentration of one or more interferents within the sample .30 . The method of claim 16 further compri sing analyzing response data generated by the detector and performing a sample quality check .31 . An optical inspection system, compris ing : a sample container location configured to receive a sample container having a sample , a label and a label opening through which the sample can be optically probed; a first lens having an optical axis configured to align with the label opening of the sample container at the sample container location ; a plurality of light sources , each light source configured to output a light beam through the f irst lens along a light path that is off set from the optical axis of the first lens , the light path extending between the light source and the sample container location so that at least a portion of the light beam contacts the sample through the label opening of the sample container ; anda detector configured to detect at least a portion of light scattered by the sample within the sample container .32 . The optical inspection system of claim 31 wherein each light beam is focused at a front surface of the sample container or the sample .33 . The optical inspection system of claim 31 wherein the detector is positioned along the optical axis of the first lens .34 . The optical inspection system of claim 31 wherein each light source comprises a broadband light source and the detector comprises a spectrometer .35 . The optical inspection system of claim 31 further comprising a proces sor coupled to the detector , the processor configured to analyze response data generated by the detector and determine at least one sample characteristic ba sed on the response data .

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