Patent ID: 12229626

The features and advantages of the embodiments will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, like reference numbers generally indicate identical, functionally similar, and/or structurally similar elements.

DETAILED DESCRIPTION

The present invention will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings. References to “one embodiment,” “an embodiment,” “some embodiments,” “an exemplary embodiment,” “for example,” “an example,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Some embodiments described in this application provide systems and methods for reading one- and two-dimensional barcodes on sample receptacles in applications in which there are one or more of the following design considerations: limited working space, strict field of view requirement, high resolution requirement, and high speed requirement (for example, when receptacles are manually moved by a user). For example, a system can include a housing (for example, a sample bay housing) configured to receive a plurality of sample racks along a plurality of lanes. Each sample rack holds sample receptacles having two-dimensional barcodes. The system includes a reader, for example, a laser barcode scanner or a camera, that reads the two-dimensional barcode. The system also includes a processing and control unit that decodes the read two-dimensional barcodes to obtain information from the barcodes and associate the information with a corresponding sample receptacle. Such systems and methods for reading two-dimensional barcodes on sample receptacles can be used for performing assays on fluid sample material and for identifying the contents of the sample receptacles, for example, patient information (e.g., patient identification numbers).

FIGS.1and2illustrate perspective and plan views, respectively, of an exemplary analyzer system10for performing assays on fluid sample material. In some embodiments, analyzer system10is configured to perform a multi-step analytical process (for example, a nucleic acid test (NAT) designed to detect microbe, such as a virus or a bacterium) or other chemical, biochemical or biological processes. Exemplary process steps include, for example, adding substances (e.g., fluids), such as samples, solid supports, buffers, oil, primers, polymerases, nucleotides, labels, probes, or other reaction fluids, to and/or removing substances from receptacles, agitating receptacles to mix the contents thereof, maintaining and/or altering the temperature of the contents of the receptacles (for example, using heated incubators configured to receive a plurality of reaction receptacles and maintain the receptacles in an elevated temperature environment), heating or chilling the contents of the receptacles (for example, using temperature ramping stations configured raise the temperature of the contents of reaction receptacles or chilling modules configured to reduce the temperature of the contents of the receptacles), altering the concentration of one or more content components of the receptacles, separating or isolating constituent components of the contents of the receptacles (for example, using magnetic separation wash stations configured to isolate a target nucleic acid immobilized on a magnetically-responsive solid support from the contents of the receptacle), detecting an electromagnetic signal emission (for example, light) from the contents of the receptacles (for example, using detector configured to detect a signal (e.g., an optical signal) emitted by the contents of the reaction receptacle), deactivating or halting an on-going reaction, or any combination of two or more of such processes. Fluid sample material may include, for example, urine, blood, plasma, sputum, saliva, mucus, pus, seminal fluid, amniotic fluid, cerebrospinal fluid, synovial fluid, and cultures.

In some embodiments, fluid sample material is introduced into analyzer system10via a sample bay100.FIG.2illustrates a cross-sectional view of analyzer10according to an embodiment. As shown inFIG.2, analyzer10includes a sample bay100configured to receive a plurality of sample racks, which is described further below. In some embodiments, analyzer10also includes a reagent bay12. Reagent bay12is configured to store one or more containers of reagents used during a multi-step analytical process. In some embodiments, analyzer10includes a reader14, for example, a barcode reader, configured to read machine-readable labels, for example, barcodes, on the reagent containers stored within reagent bay12. In some embodiments, analyzer10includes one or more tip drawers16configured to store a plurality of tips used by a fluid transfer device. In some embodiments, analyzer10includes a target capture reagent carousel18configured to support and rotate one or more containers of a target capture reagent (TCR). In some embodiments, analyzer10includes a reader20, for example, a barcode reader, configured to read machine-readable labels, for example, barcodes, on TCR containers on TCR carousel18.

FIGS.3and4illustrate front and rear perspective views, respectively, of a sample bay100according to an embodiment. Sample bay100is configured to receive a plurality of sample racks102along defined lanes within sample bay100. Sample racks102support a plurality of sample receptacles (not shown inFIGS.3and4) that contain fluid sample material. For example, as shown inFIG.3, sample bay100is configured to receive eight sample racks102that move along defined lanes within sample bay100. In other embodiments, sample bay100is configured to receive less than or more than eight sample racks102.

Referring toFIGS.3and4, sample bay100includes a housing101that defines an interior compartment that receives sample racks102. Housing101can be rectangular as shownFIGS.3and4or any other suitable shape. In some embodiments, housing101includes a base104that is planar and rectangular, a first sidewall106and a second sidewall108extending from opposing sides of base104, and a back wall110extending from a back side of base104between first and second sidewalls106and108. Housing101has an opening112at its front end to allow sample racks102to be inserted into and removed from the compartment defined by housing101.

In some embodiments, housing101defines a plurality of lanes along which sample racks102move, for example, eight lanes as shown inFIGS.3and4. In some embodiments, base104includes a plurality of guides114that define the lanes of housing101. Guides114are protrusions that extend from base104and are configured to operatively mate with a corresponding recess of sample racks102. Guides114can help ensure that sample racks102are accurately and repeatably positioned in the defined lanes of housing101as sample racks102move. As shown inFIGS.3and4, the lanes are straight and extend from the front end of housing101to the back end of housing101.

In some embodiments, housing101also includes a top panel116. In some embodiments, top panel116includes a plurality of guides118that define, along with guides114, the lanes in which sample racks102move. Guides118can be protrusions that extend from top panel116toward base104and that are configured to operatively mate with corresponding recesses on sample racks102. In some embodiments, top panel116defines a plurality of sample receptacle access openings126, which in some embodiments as shown inFIG.3, are arranged in a rectangular array of rows and columns. Each column of openings126is aligned with a respective sample rack102, providing the system, for example, an analyzer system, with easy access to receptacles held by sample racks102.

Sample bay100also includes a reader124configured to read machine-readable labels on sample racks102, including machine-readable labels on receptacles held by sample racks102. In some embodiments, as shown inFIGS.3and4, sample bay100includes a reader support120configured to support reader124. In some embodiments, reader124is coupled to reader support120and, thus, coupled to housing101. As shown inFIGS.3and4, reader support120is fixedly coupled to housing101, for example, fixedly coupled to side wall108. In some embodiments, when viewed from above, reader support120is U-shaped and forms a compartment sized to receive and support reader124. And reader124is coupled to reader support120, fixing the position of reader124relative to housing101in some embodiments.

Side wall108defines an opening122extending into the interior compartment defined by housing101such that reader124can read labels on sample racks102within housing101through opening122. In some embodiments, reader124is configured to read machine-readable labels as sample racks102are pushed into or removed from housing101or after sample racks102are fully inserted into housing101. In some embodiments, reader124is configured to read, for example, barcodes. In some embodiments, reading machine-readable labels comprises emitting light from a light source and measuring the intensity of light reflected back from the machine-readable label as the light source scans across the machine-readable label, for example, by using a laser barcode reader. In other embodiments, reading machine-readable labels comprises acquiring an image of the machine-readable label. In some embodiments, reader124is configured to read two-dimensional barcode labels (and in some embodiments, one-dimensional barcode labels or both one- and two-dimensional barcode labels) on sample racks102, including machine-readable labels on receptacles held by sample racks102.

In some embodiments, reader124is disposed outside of housing101and spaced was from opening122as shown inFIGS.3,4, and11-16. In some embodiments (not shown), reader124is disposed outside of housing101and directly adjacent opening122. In other embodiments (not shown), reader124is disposed within housing101.

In some embodiments, as shown inFIG.3, sample bay100includes a light source125, for example, a strobe light, configured to illuminate the interior of housing101. For example, light source125can illuminate labels on sample receptacles128within housing101. As shown inFIG.3, for example, light source125is near reader124and coupled to reader support120. In some embodiments, light source125includes an array of LEDs. In some embodiments (not shown), light source125is disposed inside housing101or any other suitable location. In some embodiments, light source125is embodied within reader124.

In some embodiments, sample bay100, including reader124and its data processing system, are configured as described in the various embodiments disclosed in International Application No. PCT/US2010/035146, filed on May 17, 2010, and in U.S. Patent Application Publication No. 2012/0261469, published on Oct. 18, 2012, both of which are incorporated by reference in this application.

FIGS.5-10illustrate various embodiments of sample rack102. Referring toFIG.5, sample rack102is configured to hold a plurality of sample receptacles128. For example, as shown inFIG.5, sample rack102is configured to hold 15 sample receptacles128. In some embodiments, sample rack102includes a base129that defines a plurality of pockets130for closely receiving sample receptacles128. Pockets130can be separated from each other by a vertical dividing wall in some embodiments. In some embodiments, sample receptacles128are tubular containers, for example, test tubes. In other embodiments, sample receptacles128can be any other container suitable for holding a fluid or liquid, for example, a cuvette, beaker, or microtiter plate. In some embodiments, as shown inFIG.5, sample receptacles128include a cap that seals sample receptacles128. The cap can be penetrated by the probe of a fluid transfer mechanism of analyzer system10. In some embodiments, sample rack102is made from a suitable, non-reactive material, for example, plastic or Delrin® acetyl resin.

In some embodiments, as best seen inFIGS.5and6, sample rack102includes a resilient element, such as a spring clip131, for each pocket130. Spring clip131comprises a bent element (made of, e.g., spring stainless steel) with one portion attached to a dividing wall defining pocket130and another portion extending at an acute angle into pocket130. Each spring clip131can accommodate sample receptacles128of varying sizes. A sample receptacle128is held in a relatively secure, fixed position within pocket130by means of spring clip131which urges sample receptacle128toward a dividing wall forming one side of pocket130.

As shown inFIG.5, sample rack102includes a handle132configured to allow a user to grasp and manually move sample rack102in some embodiments. For example, a user can grasp handle132to insert or remove sample rack102from housing101of sample bay100. In some embodiments, handle132defines an opening134that is configured to allow a user's fingers to pass through. And in some embodiments, opening134allows the optical path150(seeFIGS.11and12) of reader124to pass through sample rack102to read a machine-readable label on a sample rack102positioned on the other side of opening134from reader124.

In some embodiments, sample rack102includes a rack identifier136that provides unique rack-identifying information, for example, a rack identification number. In some embodiments (not shown), rack identifier136is an RFID tag. In such RFID embodiments, sample bay100includes an RFID reader configured to interrogate the RFID tag when sample rack102is within sample bay100. In other embodiments, rack identifier136is a machine readable label, for example, a one- (as shown inFIG.5) or two-dimensional barcode. In such machine-readable-label embodiments, reader124is a label reader configured to read rack identifier136. Rack identifier136can be positioned near handle132of sample rack102, as shown inFIG.5.

In some embodiments, sample rack102includes a pocket identifier138, for example, a one- (as shown inFIG.5) or two-dimensional barcode that provides unique pocket identifying information for each pocket130of sample rack102. In some embodiments, pocket identifier138indicates the position of a corresponding pocket130on sample rack102and, thus, the position of a sample receptacle128in the corresponding pocket130on sample rack102. In some embodiments, pocket identifiers138are located on the outer surface of dividing walls that separate adjacent pockets130from each other. In some embodiments, pocket identifier138includes an alphanumeric identifier, for example, “A,” “B,” “C,” etc., that uniquely identifies each pocket130. In some embodiments, sample rack102includes an empty-recess identifier140, for example, a machine-readable label such as a one- (as shown inFIG.5) or two-dimensional barcode, that is used to identify pockets130that do not contain a sample receptacle128. For example, as shown inFIG.5, empty-recess identifier140is located within each pocket130.

In some embodiments, sample rack102also includes a cover146configured to fit over the top of sample receptacles128held within pockets130of sample rack102. In some embodiments, cover146is transparent or translucent such that the contents of pockets130can be observed without removing cover146. Cover146is configured to be releasably secured to base129of sample rack102. In other embodiments, sample rack102does not include a cover146.

Referring toFIGS.5and6, cover146includes a machine-readable label137such as a one- (as shown inFIG.5) or two-dimensional barcode. Label137is configured to be used to determine whether cover146is coupled to base129and/or positioned properly relative to base129.

As shown inFIG.5, each sample receptacle128within sample rack102includes a label142in some embodiments. In some embodiments, labels142include machine-readable labels144, for example, one- or two-dimensional (as shown inFIG.5) barcodes. Two-dimensional barcodes express information in two directions, for example, in the horizontal and vertical directions, and include stacked barcodes and matrix barcodes. Two-dimensional barcodes include, for example, Aztec codes, PDF417 codes, MaxiCodes, Codablock codes, Data Matrix codes, and QR codes. Two-dimensional barcodes can improve decoding accuracy and increase the amount of information contained within the barcode relative to a one-dimensional barcode. In some embodiments, two-dimensional barcode labels144contain one or more of the following items of information: patient information such as a unique patient identifier (for example, patient name or patient identification number), patient metadata (for example, 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 date the sample was collected, the collection site, the type of assays to be performed, assay test results, and other suitable information.

In some embodiments, two-dimensional barcode labels144have features as small as 0.2 mm×0.2 mm. In such embodiments, reader124is configured to accurately read two-dimensional barcode labels144when sample rack102is moving at high speeds, for example, speeds greater than 100 mm/sec, for example, speeds greater than 300 mm/sec, 500 mm/sec, 600 mm/sec, and 1000 mm/sec.

Referring toFIG.7, which illustrates a bottom surface154of sample rack102, sample rack102includes a recessed guide track156configured to operatively mate with guides114on base104of housing101in some embodiments. For example, a bottom surface154of sample rack102can form recessed guide track156that engages sample rack guides114to ensure proper and repeatable positioning of sample racks102along the defined lanes in housing101. Although spring clips131are not illustrated inFIG.7, sample rack102inFIG.7can include spring clips131.

In some embodiments, sample bay100is configured such that sample racks102are manually inserted within housing101of sample bay100. In this application, “manually inserted,” “manually moved,” or similar phrases mean that sample racks102are inserted or moved without using automated or electrical device components. That is, sample racks102are inserted or moved within housing101along the defined lanes using only the user's hands. When sample racks102are manually moved, sample racks102can move at a high speed that exceeds 100 mm/sec, for example, speeds greater than 300 mm/sec, 500 mm/sec, 600 mm/sec, or 1000 mm/sec.

In other embodiments, sample bay100is configured to automatically move sample rack102within housing101of sample bay100. For example, sample bay100can include an automated actuator that moves sample racks102within housing101of sample bay100to a fully inserted position. In some embodiments, sample rack102is automatically moved within housing101at a known, constant speed.

To place a sample rack102within housing101of sample bay100, a user aligns guide track156with guides114on base104. The user then moves sample rack102in a direction148(as shown inFIG.11) along a lane defined by guides114from a first, initial position to a second, fully inserted position within housing101of sample bay100. In some embodiments, sample bay100includes sensors that detect the presence of sample rack102and whether sample rack102is fully inserted into the sample bay100. As best seen inFIG.5, sample receptacles128are placed in sample rack102such that labels142are aligned with the openings defined by the dividing walls that separate adjacent pockets130from each other. Accordingly, labels142are visible to reader124through opening122defined in side wall108of housing101. Thus, as sample rack102moves from the initial position to the fully insert, reader124can read labels142on each sample receptacle128on sample rack102.

In some embodiments, sample bay100includes a position measurement system that measures the position of sample rack102within housing101. In some embodiments, the position measurement system is configured to determine the absolute position of sample rack102. In this application, “absolute position” means the exact position of sample rack102within sample bay100. In contrast, for example, “incremental position” means an incremental range of positions that sample rack102could be within sample bay100from a reference point.

In some embodiments, in which sample bay100includes an absolute position measurement system, sample rack102includes an absolute position indicator158. In some embodiments, position indicator158extends along a length of sample rack102(for example, along base129or cover146) that overlaps with pockets130. For example, referring toFIGS.8and10, position indicator158extends along a length of cover146that overlaps all pockets130defined in sample rack102in some embodiments. InFIG.8, position indicator158is located on a side surface161of cover146, and inFIG.10, position indicator158is positioned on a top surface162of cover146. In some embodiments, position indicator158extends along a length of base129that overlaps all pockets130defined in sample rack102. And referring toFIG.7, in some embodiments, position indicator158is positioned on a bottom surface154of sample rack102. In some embodiments, structural features of sample rack102form position indicator158. For example, inFIG.7, guide track156also functions as position indicator158. Guide track156includes a repeating, alternating pattern of offset sections159and160. Position indicator158can be positioned at any other suitable locations.

In some embodiments, position indicator158can be an optical encoder strip affixed to sample rack102, a magnetic encoder strip affixed to sample rack102, a friction strip formed on sample rack102, or a plurality of recesses in a repeating pattern (including, for example, through-holes) formed on sample rack102, or a plurality of protrusions in a repeating pattern (including, for example, gear teeth) formed on sample rack102.

In some embodiments, the position measurement system includes a position sensor that operatively corresponds to the type of position indicator158coupled to sample rack102. For example, in some embodiments in which positioning indicator158is an optical encoder strip or a magnetic encoder strip affixed to sample rack102, the measurement system can include optical or magnetic read sensors164coupled to housing101and configured to read the optical encoder strip or the magnetic encoder strip as sample rack102passes near (for example, over, under, or to the side of) optical or magnetic read sensors164as shown inFIGS.13and14. In some embodiments, read sensors164are positioned on base104as shown inFIG.13when position indicator158is located on a bottom surface of sample rack102. As shown inFIGS.13and14, for example, each lane within housing101of sample bay100includes optical or magnetic read sensors164configured to sense a position indicator158on a sample rack102that is moving along the corresponding lane. In some embodiments in which an optical encoder strip or a magnetic encoder strip is fixed to top surface162of cover146, the measurement system can include optical or magnetic read sensors164positioned on top panel116that are configured to read an optical encoder strip or a magnetic encoder strip158as sample rack102passes sensors164, as shown inFIG.14. In other embodiments in which position indicator158is an optical encoder strip fixed to side surface161, the measurement system can include through-beam sensors165that generate a beam aligned with position indicator158to read optical encoder strip158. In some embodiments in which position indicator158is a plurality of repeating recesses formed on sample rack102, the measurement system can include a position sensor that includes a gear166which engages the plurality of corresponding recesses formed on sample rack102, as shown inFIG.15. As sample rack102moves between positions along the lane within housing101of sample bay100, gear166rotates to encode the absolute position of sample rack102. In some embodiments in which position indicator158is a friction strip affixed to sample rack102, the measurement system can include a position sensor that includes a friction wheel, similar to gear166shown inFIG.15, except without teeth and instead having a surface with a high coefficient of friction. As sample rack102, having a friction strip158, moves between positions along the lane within sample bay100, the friction wheel engages the friction strip158and rotates to encode the absolute position of sample rack102.

In some embodiments, the position measurement system is configured to determine the incremental position of sample rack102.

Referring toFIGS.11and12, in some embodiments, reader124has an optical path150and is configured to read a label at an object plane152along optical path150. In some embodiments, the working distance range of reader124is large enough to include each lane defined in housing101, along which sample racks102move. In some embodiments in which reader124is a camera, reader124is a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) camera. In some camera embodiments, reader124is a line scan or an area scan camera. In some camera embodiments, reader124has a field of view height sufficient to read a label, for example, label144, on sample rack102at each lane of housing101. In some camera embodiments, reader124samples at a rate sufficient to acquire an image of a label, for example, label144, on sample rack102moving at a rate up to 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, reader124samples at a rate of at least 35 Hz, such as 50 Hz or 60 Hz. For example, reader124can be a CMOS, line scan camera having a working distance range that includes each lane of housing101along which sample racks102move, a field of view greater than a height of sample rack102, and a sample rate of at least 60 Hz.

In some embodiments in which reader124is a camera, as a sample rack102is inserted into sample bay100along a lane defined by guides114(and in direction148), reader124is configured to acquire images of sample rack102as it passes through object plane152. For example, the acquired images can include images of labels138,140,144,137, and136, that pass-through object plane152of reader124. In some embodiments, the acquired images are transmitted to a processing and control unit configured to process the acquired images to decode information contained in labels138,140,144,137, and136of the acquired images. In some embodiments, the processing and control unit is coupled to or disposed in housing101. In some embodiments, this image decoding occurs after sample rack102is fully inserted into housing101of sample bay100. In some embodiments, decoding the acquired images after sample rack102is fully inserted allows camera reader124to have a higher sample rate. For example, with such post-processing, camera reader124can have a sample rate of at least 30 frames per second and, in some embodiments, at least 60 frames per second. In some embodiments, the processing and control unit is configured to decode a one-to-three second video stream captured by camera reader124after the images are acquired (in contrast to real-time decoding), which can increase the sample rate.

In some embodiments, in which position indicator158on sample rack102is an optical encoder strip, reader124can be configured to acquire images of the optical encoder strip in addition to acquiring images of labels138,140,144,137, and136. The acquired images of optical encoder strip158can be transmitted to the processing and control unit, and the processing and control unit decodes the acquired images of the optical encoder strip to determine the absolute position of sample rack102within housing101of sample bay100. In such embodiments, reader124can be a line scan camera. In some line scan camera embodiments, reader124has at least a 5 μm pixel resolution (e.g., 7 μm pixel resolution) and that samples at a rate of at least 50 frames per second (for example, 60 or 80 frames per second). For example, a line scan camera reader124that samples at a rate of 60 frames per second can capture an image about every 10 μm when sample rack102moves at a rate of 600 mm/sec. In some line scan camera embodiments, reader124has at least 1500 pixels (e.g., 2000 pixels) and a field of view of at least 50 mm (e.g., 100 mm). For example, when line scan camera reader124has 2000 pixels and a field of view of 100 mm, each of the pixel images is about 50 μm. In some embodiments, the optical encoder strip includes a plurality of lines having widths that cover at least three pixels of a line scan camera reader124. In some line scan camera embodiments, line scan camera reader124has a working distance in the range of 200 mm to 300 mm.

In some embodiments, sample rack102is moved between a first position in housing101of sample bay100to a second position in housing101of sample bay100. The first position can be, for example, when sample rack102first engages guides114on base104of housing101, and the second position can be, for example, any position between the first position and a position at which sample rack102is fully inserted in housing101.

In some embodiments, the user manually moves sample rack102between the first and second positions. When manually inserted, sample rack102can be moved at a rate that exceeds 100 mm/sec, for example, rates that exceed 300 mm/sec, 500 mm/sec, 600 mm/sec, or 1000 mm/sec.

As sample rack102is moved between the first position and the second position in housing101, a position measurement system, for example, any one of the above described embodiments of a position measurement system, measures the absolute position of sample rack102in some embodiments. Also, as sample rack102is moved between the first position and the second position, reader124acquires images of sample rack102, including images of machine-readable labels144of sample receptacle128, at object plane152of reader124. Reader124transmits the acquired images to the processing and control unit that decodes the acquired images, including decoding the acquired images of machine-readable labels144on each sample receptacle128passing through object plane152. In some embodiments, decoding the acquired images comprises processing the acquired images to determine if the acquired images include a machine-readable label and, if they do, extracting the information contained in the machine-readable label. In some embodiments, this decoding occurs after sample rack102is fully inserted within housing101of sample bay100.

In some embodiments, the processing and control unit determines the speed at which sample rack102is moved between first and second positions in housing101. For example, in embodiments using an optical encoder strip, the processing and control unit processes the acquired images to determine the rack insertion speed. In some embodiments, the processing and control unit also associates information decoded from an acquired image of the machine-readable label144with the corresponding sample receptacle128based on the measured absolute position of sample rack102when the decoded image of the machine-readable label144was acquired. The processing and control unit can store this association into a memory of the system.

In some embodiments, the processing and control unit decodes information from an acquired image of the machine-readable label144and associates the decoded information with the corresponding sample receptacle128without acquiring an image of pocket identifier138on sample rack102. For example, the processing and control unit can be configured to activate reader124when sample rack102is at predetermined positions that correspond to when the center of each pocket130of sample rack102is aligned with object plane152of reader124, when rack identifier136is aligned with object plane152of reader124, and when cover identifier137is aligned with object plane152. At these predetermined positions, reader124acquires images of empty-recess identifier140or two-dimensional barcode144, rack identifier136, and cover identifier144, respectively. The processing and control unit can also deactivate reader124when sample rack102is not at the predetermined positions that correspond to when the center of each pocket130of sample rack102is aligned with object plane152of reader124, when rack identifier136is aligned with object plane152of reader124, and when cover identifier137is aligned with object plane152. That is, activation of reader124is modulated based on the position of sample rack102. In such embodiments, reader124can be a two-dimensional barcode reader, for example, a laser barcode reader, having a sample rate less than 35 scans per second, for example, a scan rate of about 16-32 scans per second, even when sample rack102is traveling at speeds exceeding 100 mm/sec, for example, speeds exceeding 500 mm/sec—speeds associated with manual insertion of sample rack102within sample bay100. In some embodiments, sample rack102moves at a speed up to 1000 mm/sec. In such embodiments, the measured position of sample rack102is determined by a position measurement system having a sensor separate from reader124. For example, the measured position of sample rack102can be determined using position indicators158(for example, a pattern of recesses or protrusions, an optical encoder tape, a magnetic encoder tape, a capacitive strip) and position sensors (for example, optical or magnetic read sensors164, gear or friction wheel166, or through-beam sensors165) as described above. Determining the position of sample rack102using position indicators158and position sensors164,165, or166, separate from reader124, can help minimize the necessary performance requirements of reader124. In some embodiments, the processing and control unit is also configured to activate light source125when sample rack102is at each of the plurality of predetermined positions—simultaneously when acquiring the image with reader124. Using light source125when acquiring the image can further reduce the necessary performance requirement of reader124.

In some embodiments, this method of associating information from a decoded acquired image of the machine-readable label144with the corresponding sample receptacle128is used when manually moving sample rack102between the first and second positions in housing101, for example, when the sample rack102is moving at a rate of at least 100 mm/sec (e.g., at least 300 mm/sec or 500 mm/sec and as fast as 1000 mm/sec).

Referring toFIG.18, in some embodiments, an analyzer system10includes a sample bay100having a reader124, and a second module180that is separate from sample bay100. In some embodiments, second module180defines a compartment184configured to receive at least one sample rack102. Second module180also has a second reader186separate from reader124of sample bay100. In some embodiments, sample bay100and second module180are enclosed in separate housings that are coupled together—housing182of second module180is separate from the housing defining sample bay100as shown inFIG.18. In other embodiments, sample bay100and second module180are enclosed within the same housing, but the compartments of each sample bay100and second module180are separated by a wall.

Second reader186is configured to read a machine-readable label, for example, rack identifier136, cover identifier137, and two-dimensional barcode144on each sample receptacle128, when inserted within second module180. In some embodiments, second reader186is configured to read two-dimensional barcode144on each sample receptacle128as sample rack102is inserted within compartment184of second module180. In other embodiments, second reader186is configured to scan sample rack102to read two-dimensional barcode144for each sample receptacle128after sample rack102is inserted. The acquired images are transmitted to the processing and control unit to be decoded.

After acquiring the images of the barcodes, including two-dimensional barcodes144on receptacles128of sample rack102, in second module180, a user can manually remove sample rack102from second module180and insert the same sample rack102in sample bay100. In some embodiments, barcode reader124(for example, a one-dimensional laser barcode reader) does not read barcodes144on receptacles128as sample rack102is inserted along an available lane in sample bay100. Instead reader124only reads rack identifier136(for example, a one-dimensional barcode) to confirm the sample rack102that was just scanned in second module180was inserted in sample bay100. Reader124can also read cover identifier137to ensure the presence and proper positioning of cover146. The processing and control unit can then associate the information decoded from the acquired images of two-dimensional barcodes144at second module180with the rack identifier136of sample rack102inserted in sample bay100. In some embodiments, the processing and control unit can be configured to erase or otherwise disable reader124if sample rack102is not inserted into sample bay100within a predetermined time period, for example, 5 seconds. Thus, if sample rack102is not moved to sample bay100within the predetermined time period, the processing and control unit will not recognize sample rack102as having been previously scanned in the second module180, and sample rack102will have to be scanned again in second module180. This timing requirement can help minimize the risk that one or more un-scanned receptacles are switched for scanned receptacles128in the time between removing sample rack102from second module180and inserting sample rack102into sample bay100. In some embodiments, reader124is configured only to read one-dimensional barcode labels, and second reader186is configured to read one- and two-dimensional barcodes. In some embodiments in which rack identifier136is an RFID tag, system10includes an RFID reader in sample bay100configured to interrogate sample rack102having an RFID tag.

Referring toFIG.17, in some embodiments, sample bay100includes a reader support168that is moveable relative to the lanes along which sample racks102move within housing101of sample bay100. In some embodiments, sample bay100includes a camera170fixedly coupled to reader support168such that camera170moves along with reader support168. In some embodiments, camera170has a fixed focal length. In other embodiments, camera170has a variable focal length. The sample bay100can include an actuator that moves reader support168along a path169such that object plane152of camera170is operatively aligned with a lane having the sample rack102being imaged. In some embodiments, the actuator is a linear actuator such as mechanical, hydraulic, pneumatic, piezoelectric, and electro-mechanical linear actuators, for example. In some embodiments, reader support168is configured to move along path169in a range from about 150 mm to about 350 mm. Reader support168is configured such that object plane152of camera170can be aligned with each lane within sample bay100. In some embodiments, path169of reader support168is parallel to the lanes along which sample racks102move within sample bay100. In some embodiments, camera170is a CCD or CMOS camera. In some embodiments, camera170acquires images at a rate of at least 35 frames per second. For example, camera170can acquire images at a rate of 60 frames per second. In some embodiments, the direction of an optical path150from a lens172of camera170is bent. For example, as shown inFIG.17, bay100can include a mirror176that bends optical path150towards the lanes along which sample racks102move. For example, as shown inFIG.17, mirror176bends optical path150ninety degrees towards the lanes of sample bay100. In other embodiments, mirror176bends optical path150at other angles more than or less than ninety degrees. In some embodiments, sample bay100includes a light source174configured to illuminate the lanes within sample bay100. In some embodiments, light source174is also coupled to reader support168such that light source174moves along with reader support168and camera170. In some embodiments, the optical path of light waves emitted from light source174coincides with optical path150of camera170. Light source174can be one or more LEDs in some embodiments. In some embodiments, as shown inFIG.17, light source174comprises eight LEDs—for example, four above lens172of camera170and four below lens172. In other embodiments, light source174comprises four LEDs—for example, two above lens172and two below lens172. In embodiments in which light source174comprises LEDs, the number and configuration of the LEDs may vary to achieve the desired illumination within sample bay100. In some embodiments, light source174is incorporated into camera170.

In use, sample rack102is moved between a first position and a second position along a first lane in housing101of sample bay100. For example, sample rack102is manually moved along the first lane. The first position can be, for example, the position at which sample rack102engages guides114on base104, and the second position can be, for example, a position between the first position and a position at which sample rack102is fully inserted within sample bay100. As sample rack102moves between the first position and the second position along the lane, camera174acquires images of machine-readable label144on sample receptacles128supported by sample rack102. The acquired images are transmitted to the processing and control unit to be decoded. The acquired images can be decoded after sample rack102is fully inserted within sample bay100. Another sample rack102can be moved, for example, manually, between a first position and a second position along a different lane within a housing of sample bay100. The processing and control unit controls the actuator coupled to reader support168to move reader support168and, thus, position the object plane152of camera170at the second lane along which the second sample rack102is moving. As the second sample rack102moves between the first position and the second position along the lane, camera170acquires images of machine-readable label144on sample receptacles128supported by the second sample rack102. The acquired images are transmitted to the processing and control unit to be decoded. The acquired images of the second sample rack102can be decoded after sample rack102is fully inserted within sample bay100.

In some embodiments, camera170samples at a rate of 60 frames per second and has a 1/10,000 second shutter speed when using light source174to strobe the interior of housing101. In some embodiments, camera170has a working distance of 250 mm. In some embodiments, camera170has a focal distance of at least ±10 mm from the focal plane. In some embodiments, camera170has a field of view that is 80 mm tall and 25 mm wide. In some embodiments, camera170has 1600×1200 pixels.

In some embodiments, the processing and control unit activates light source174simultaneously when acquiring the images of machine-readable label144of each sample receptacle128supported on the first and second sample racks102.

In some embodiments, camera170and light source174are operatively coupled to the processing and control unit through one or more cables178. For example, the images acquired by camera170can be transmitted to the processing and control unit via one of the plurality of cables178. And for example, the control signals that activate light source174can be transmitted from the processing and control unit to light source174via one of the plurality of cables178. In some embodiments, one of the plurality of cables178is operatively coupled to an actuator that moves support168.

In any of the above disclosed embodiments, a user can insert sample rack102into housing101. For example, the user can align guide track156of sample rack102with guide113formed on base104of housing101. From this first position, the user can manually move sample rack102along the lane defined by guide114to a fully inserted position within housing101. As sample rack102is moved to the fully inserted position, reader124reads labels on sample rack102, for example, two-dimensional labels144on sample receptacles128held by sample rack102. In some embodiments, after sample rack102is fully inserted, the processing and control unit decodes the read labels to extract information, for example, the specific assay to perform and patient information. And, after sample rack102is inserted into sample bay10, sample material contained in sample receptacles128carried in the sample rack102can be accessed via a fluid transfer mechanism—such as the probe (e.g., a barrel with a protective tip, such as a pipette tip, mounted thereon) of an automated, robotically operated pipetting device through the access openings126formed in top panel116. Analyzer system10then performs the assay as indicated in the decoded information from, for example, two-dimensional barcode144.

Some embodiments are implemented via control and computing hardware components, user-created software, data input components, and data output components. Hardware components include, for example, the processing and control unit (e.g., system controller(s)), such as microprocessors and computers, configured to effect computational and/or control steps by receiving one or more input values, executing one or more algorithms stored on non-transitory machine-readable media (e.g., software) that provide instruction for manipulating or otherwise acting on the input values, and output one or more output values. Such outputs may be displayed or otherwise indicated to an operator for providing information to the operator, for example information as to the status of the instrument or a process being performed thereby, or such outputs may comprise inputs to other processes and/or control algorithms. Data input components comprise elements by which data is input for use by the control and computing hardware components. Such data inputs may comprise positions sensors, motor encoders, as well as manual input elements, such as graphic user interfaces, keyboards, touch screens, microphones, switches, manually operated scanners, voice-activated input, etc. Data output components may comprise hard drives or other storage media, graphic user interfaces, monitors, printers, indicator lights, or audible signal elements (e.g., buzzer, horn, bell, etc.). In some embodiments, the processing and control unit can comprise a single module that performs image processing and system control. In other embodiments, the processing and control unit comprises a plurality of modules that perform discrete processing and control steps. In some embodiments, the image processing module can be a component of reader124that processes (for example, post-processing) images stored in a buffer of reader124.

Software comprises instructions stored on non-transitory computer-readable media which, when executed by the control and computing hardware, cause the control and computing hardware to perform one or more automated or semi-automated processes. In some embodiments, the software for image processing is stored in memory on reader124, for example. In some embodiments, the software for image processing is stored in external memory in communication with the processing and control unit.

It is to be appreciated 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 may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.

The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.

The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are 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 phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

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.