Patent Description:
An analyzer system can perform assays on fluid sample material. For example, in the clinical laboratory context, the analyzer system can be configured to perform multi-step analytical processes (for example, a nucleic acid test (NAT) designed to detect microbe, such as a virus or a bacterium) that involve 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, heating or chilling 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, detecting an electromagnetic signal emission (for example, light) from the contents of the receptacles, deactivating or halting an on-going reaction, or any combination of two or more of such processes.

The analyzer system can be automated to perform the desired analytical process. Accordingly, the analyzer system can automatically identify the contents of a sample receptacle and the assay to perform. For example, the analyzer system can read labels, for example, a barcode, on the sample receptacle to identify the contents of the sample receptacle and the assay to perform.

<CIT> shows a laboratory device with slide-in paths and a bar code reader. The reader is equipped with an autofocus, but it is fixed and does not move.

The aspects and embodiments of the present invention are set forth in the claims.

The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the embodiments and, together with the description, further serve to explain the principles of the embodiments and to enable a person skilled in the relevant art(s) to make and use the embodiments.

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.

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.

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).

<FIG> and <FIG> illustrate perspective and plan views, respectively, of an exemplary analyzer system <NUM> for performing assays on fluid sample material. In some embodiments, analyzer system <NUM> is 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 system <NUM> via a sample bay <NUM>. <FIG> illustrates a cross-sectional view of analyzer <NUM> according to an embodiment. As shown in <FIG>, analyzer <NUM> includes a sample bay <NUM> configured to receive a plurality of sample racks, which is described further below. In some embodiments, analyzer <NUM> also includes a reagent bay <NUM>. Reagent bay <NUM> is configured to store one or more containers of reagents used during a multi-step analytical process. In some embodiments, analyzer <NUM> includes a reader <NUM>, for example, a barcode reader, configured to read machine-readable labels, for example, barcodes, on the reagent containers stored within reagent bay <NUM>. In some embodiments, analyzer <NUM> includes one or more tip drawers <NUM> configured to store a plurality of tips used by a fluid transfer device. In some embodiments, analyzer <NUM> includes a target capture reagent carousel <NUM> configured to support and rotate one or more containers of a target capture reagent (TCR). In some embodiments, analyzer <NUM> includes a reader <NUM>, for example, a barcode reader, configured to read machine-readable labels, for example, barcodes, on TCR containers on TCR carousel <NUM>.

<FIG> and <FIG> illustrate front and rear perspective views, respectively, of a sample bay <NUM> according to an embodiment. Sample bay <NUM> is configured to receive a plurality of sample racks <NUM> along defined lanes within sample bay <NUM>. Sample racks <NUM> support a plurality of sample receptacles (not shown in <FIG> and <FIG>) that contain fluid sample material. For example, as shown in <FIG>, sample bay <NUM> is configured to receive eight sample racks <NUM> that move along defined lanes within sample bay <NUM>. In other embodiments, sample bay <NUM> is configured to receive less than or more than eight sample racks <NUM>.

Referring to <FIG> and <FIG>, sample bay <NUM> includes a housing <NUM> that defines an interior compartment that receives sample racks <NUM>. Housing <NUM> can be rectangular as shown <FIG> and <FIG> or any other suitable shape. In some embodiments, housing <NUM> includes a base <NUM> that is planar and rectangular, a first sidewall <NUM> and a second sidewall <NUM> extending from opposing sides of base <NUM>, and a back wall <NUM> extending from a back side of base <NUM> between first and second sidewalls <NUM> and <NUM>. Housing <NUM> has an opening <NUM> at its front end to allow sample racks <NUM> to be inserted into and removed from the compartment defined by housing <NUM>.

In some embodiments, housing <NUM> defines a plurality of lanes along which sample racks <NUM> move, for example, eight lanes as shown in <FIG> and <FIG>. In some embodiments, base <NUM> includes a plurality of guides <NUM> that define the lanes of housing <NUM>. Guides <NUM> are protrusions that extend from base <NUM> and are configured to operatively mate with a corresponding recess of sample racks <NUM>. Guides <NUM> can help ensure that sample racks <NUM> are accurately and repeatably positioned in the defined lanes of housing <NUM> as sample racks <NUM> move. As shown in <FIG> and <FIG>, the lanes are straight and extend from the front end of housing <NUM> to the back end of housing <NUM>.

In some embodiments, housing <NUM> also includes a top panel <NUM>. In some embodiments, top panel <NUM> includes a plurality of guides <NUM> that define, along with guides <NUM>, the lanes in which sample racks <NUM> move. Guides <NUM> can be protrusions that extend from top panel <NUM> toward base <NUM> and that are configured to operatively mate with corresponding recesses on sample racks <NUM>. In some embodiments, top panel <NUM> defines a plurality of sample receptacle access openings <NUM>, which in some embodiments as shown in <FIG>, are arranged in a rectangular array of rows and columns. Each column of openings <NUM> is aligned with a respective sample rack <NUM>, providing the system, for example, an analyzer system, with easy access to receptacles held by sample racks <NUM>.

Sample bay <NUM> also includes a reader <NUM> configured to read machine-readable labels on sample racks <NUM>, including machine-readable labels on receptacles held by sample racks <NUM>. In some embodiments, as shown in <FIG> and <FIG>, sample bay <NUM> includes a reader support <NUM> configured to support reader <NUM>. In some embodiments, reader <NUM> is coupled to reader support <NUM> and, thus, coupled to housing <NUM>. As shown in <FIG> and <FIG>, reader support <NUM> is fixedly coupled to housing <NUM>, for example, fixedly coupled to side wall <NUM>. In some embodiments, when viewed from above, reader support <NUM> is U-shaped and forms a compartment sized to receive and support reader <NUM>. And reader <NUM> is coupled to reader support <NUM>, fixing the position of reader <NUM> relative to housing <NUM> in some embodiments.

Side wall <NUM> defines an opening <NUM> extending into the interior compartment defined by housing <NUM> such that reader <NUM> can read labels on sample racks <NUM> within housing <NUM> through opening <NUM>. In some embodiments, reader <NUM> is configured to read machine-readable labels as sample racks <NUM> are pushed into or removed from housing <NUM> or after sample racks <NUM> are fully inserted into housing <NUM>. In some embodiments, reader <NUM> is 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, reader <NUM> is 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 racks <NUM>, including machine-readable labels on receptacles held by sample racks <NUM>.

In some embodiments, reader <NUM> is disposed outside of housing <NUM> and spaced was from opening <NUM> as shown in <FIG>, <FIG>, and <FIG>. In some embodiments (not shown), reader <NUM> is disposed outside of housing <NUM> and directly adjacent opening <NUM>. In other embodiments (not shown), reader <NUM> is disposed within housing <NUM>.

In some embodiments, as shown in <FIG>, sample bay <NUM> includes a light source <NUM>, for example, a strobe light, configured to illuminate the interior of housing <NUM>. For example, light source <NUM> can illuminate labels on sample receptacles <NUM> within housing <NUM>. As shown in <FIG>, for example, light source <NUM> is near reader <NUM> and coupled to reader support <NUM>. In some embodiments, light source <NUM> includes an array of LEDs. In some embodiments (not shown), light source <NUM> is disposed inside housing <NUM> or any other suitable location. In some embodiments, light source <NUM> is embodied within reader <NUM>.

In some embodiments, sample bay <NUM>, including reader <NUM> and its data processing system, are configured as described in the various embodiments disclosed in International Application No. <CIT>, and in <CIT>.

<FIG> illustrate various embodiments of sample rack <NUM>. Referring to <FIG>, sample rack <NUM> is configured to hold a plurality of sample receptacles <NUM>. For example, as shown in <FIG>, sample rack <NUM> is configured to hold <NUM> sample receptacles <NUM>. In some embodiments, sample rack <NUM> includes a base <NUM> that defines a plurality of pockets <NUM> for closely receiving sample receptacles <NUM>. Pockets <NUM> can be separated from each other by a vertical dividing wall in some embodiments. In some embodiments, sample receptacles <NUM> are tubular containers, for example, test tubes. In other embodiments, sample receptacles <NUM> can be any other container suitable for holding a fluid or liquid, for example, a cuvette, beaker, or microtiter plate. In some embodiments, as shown in <FIG>, sample receptacles <NUM> include a cap that seals sample receptacles <NUM>. The cap can be penetrated by the probe of a fluid transfer mechanism of analyzer system <NUM>. In some embodiments, sample rack <NUM> is made from a suitable, non-reactive material, for example, plastic or Delrin® acetyl resin.

In some embodiments, as best seen in <FIG> and <FIG>, sample rack <NUM> includes a resilient element, such as a spring clip <NUM>, for each pocket <NUM>. Spring clip <NUM> comprises a bent element (made of, e.g., spring stainless steel) with one portion attached to a dividing wall defining pocket <NUM> and another portion extending at an acute angle into pocket <NUM>. Each spring clip <NUM> can accommodate sample receptacles <NUM> of varying sizes. A sample receptacle <NUM> is held in a relatively secure, fixed position within pocket <NUM> by means of spring clip <NUM> which urges sample receptacle <NUM> toward a dividing wall forming one side of pocket <NUM>.

As shown in <FIG>, sample rack <NUM> includes a handle <NUM> configured to allow a user to grasp and manually move sample rack <NUM> in some embodiments. For example, a user can grasp handle <NUM> to insert or remove sample rack <NUM> from housing <NUM> of sample bay <NUM>. In some embodiments, handle <NUM> defines an opening <NUM> that is configured to allow a user's fingers to pass through. And in some embodiments, opening <NUM> allows the optical path <NUM> (see <FIG> and <FIG>) of reader <NUM> to pass through sample rack <NUM> to read a machine-readable label on a sample rack <NUM> positioned on the other side of opening <NUM> from reader <NUM>.

In some embodiments, sample rack <NUM> includes a rack identifier <NUM> that provides unique rack-identifying information, for example, a rack identification number. In some embodiments (not shown), rack identifier <NUM> is an RFID tag. In such RFID embodiments, sample bay <NUM> includes an RFID reader configured to interrogate the RFID tag when sample rack <NUM> is within sample bay <NUM>. In other embodiments, rack identifier <NUM> is a machine readable label, for example, a one- (as shown in <FIG>) or two-dimensional barcode. In such machine-readable-label embodiments, reader <NUM> is a label reader configured to read rack identifier <NUM>. Rack identifier <NUM> can be positioned near handle <NUM> of sample rack <NUM>, as shown in <FIG>.

In some embodiments, sample rack <NUM> includes a pocket identifier <NUM>, for example, a one- (as shown in <FIG>) or two-dimensional barcode that provides unique pocket identifying information for each pocket <NUM> of sample rack <NUM>. In some embodiments, pocket identifier <NUM> indicates the position of a corresponding pocket <NUM> on sample rack <NUM> and, thus, the position of a sample receptacle <NUM> in the corresponding pocket <NUM> on sample rack <NUM>. In some embodiments, pocket identifiers <NUM> are located on the outer surface of dividing walls that separate adjacent pockets <NUM> from each other. In some embodiments, pocket identifier <NUM> includes an alphanumeric identifier, for example, "A," "B," "C," etc., that uniquely identifies each pocket <NUM>. In some embodiments, sample rack <NUM> includes an empty-recess identifier <NUM>, for example, a machine-readable label such as a one- (as shown in <FIG>) or two-dimensional barcode, that is used to identify pockets <NUM> that do not contain a sample receptacle <NUM>. For example, as shown in <FIG>, empty-recess identifier <NUM> is located within each pocket <NUM>.

In some embodiments, sample rack <NUM> also includes a cover <NUM> configured to fit over the top of sample receptacles <NUM> held within pockets <NUM> of sample rack <NUM>. In some embodiments, cover <NUM> is transparent or translucent such that the contents of pockets <NUM> can be observed without removing cover <NUM>. Cover <NUM> is configured to be releasably secured to base <NUM> of sample rack <NUM>. In other embodiments, sample rack <NUM> does not include a cover <NUM>.

Referring to <FIG> and <FIG>, cover <NUM> includes a machine-readable label <NUM> such as a one- (as shown in <FIG>) or two-dimensional barcode. Label <NUM> is configured to be used to determine whether cover <NUM> is coupled to base <NUM> and/or positioned properly relative to base <NUM>.

As shown in <FIG>, each sample receptacle <NUM> within sample rack <NUM> includes a label <NUM> in some embodiments. In some embodiments, labels <NUM> include machine-readable labels <NUM>, for example, one- or two-dimensional (as shown in <FIG>) 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 labels <NUM> contain 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 labels <NUM> have features as small as <NUM> x <NUM>. In such embodiments, reader <NUM> is configured to accurately read two-dimensional barcode labels <NUM> when sample rack <NUM> is moving at high speeds, for example, speeds greater than <NUM>/ sec, for example, speeds greater than <NUM>/sec, <NUM>/sec, <NUM>/sec, and <NUM>/sec.

Referring to <FIG>, which illustrates a bottom surface <NUM> of sample rack <NUM>, sample rack <NUM> includes a recessed guide track <NUM> configured to operatively mate with guides <NUM> on base <NUM> of housing <NUM> in some embodiments. For example, a bottom surface <NUM> of sample rack <NUM> can form recessed guide track <NUM> that engages sample rack guides <NUM> to ensure proper and repeatable positioning of sample racks <NUM> along the defined lanes in housing <NUM>. Although spring clips <NUM> are not illustrated in <FIG>, sample rack <NUM> in <FIG> can include spring clips <NUM>.

In some embodiments, sample bay <NUM> is configured such that sample racks <NUM> are manually inserted within housing <NUM> of sample bay <NUM>. In this application, "manually inserted," "manually moved," or similar phrases mean that sample racks <NUM> are inserted or moved without using automated or electrical device components. That is, sample racks <NUM> are inserted or moved within housing <NUM> along the defined lanes using only the user's hands. When sample racks <NUM> are manually moved, sample racks <NUM> can move at a high speed that exceeds <NUM>/ sec, for example, speeds greater than <NUM>/sec, <NUM>/sec, <NUM>/sec, or <NUM>/sec.

In other embodiments, sample bay <NUM> is configured to automatically move sample rack <NUM> within housing <NUM> of sample bay <NUM>. For example, sample bay <NUM> can include an automated actuator that moves sample racks <NUM> within housing <NUM> of sample bay <NUM> to a fully inserted position. In some embodiments, sample rack <NUM> is automatically moved within housing <NUM> at a known, constant speed.

To place a sample rack <NUM> within housing <NUM> of sample bay <NUM>, a user aligns guide track <NUM> with guides <NUM> on base <NUM>. The user then moves sample rack <NUM> in a direction <NUM> (as shown in <FIG>) along a lane defined by guides <NUM> from a first, initial position to a second, fully inserted position within housing <NUM> of sample bay <NUM>. In some embodiments, sample bay <NUM> includes sensors that detect the presence of sample rack <NUM> and whether sample rack <NUM> is fully inserted into the sample bay <NUM>. As best seen in <FIG>, sample receptacles <NUM> are placed in sample rack <NUM> such that labels <NUM> are aligned with the openings defined by the dividing walls that separate adjacent pockets <NUM> from each other. Accordingly, labels <NUM> are visible to reader <NUM> through opening <NUM> defined in side wall <NUM> of housing <NUM>. Thus, as sample rack <NUM> moves from the initial position to the fully insert, reader <NUM> can read labels <NUM> on each sample receptacle <NUM> on sample rack <NUM>.

In some embodiments, sample bay <NUM> includes a position measurement system that measures the position of sample rack <NUM> within housing <NUM>. In some embodiments, the position measurement system is configured to determine the absolute position of sample rack <NUM>. In this application, "absolute position" means the exact position of sample rack <NUM> within sample bay <NUM>. In contrast, for example, "incremental position" means an incremental range of positions that sample rack <NUM> could be within sample bay <NUM> from a reference point.

In some embodiments, in which sample bay <NUM> includes an absolute position measurement system, sample rack <NUM> includes an absolute position indicator <NUM>. In some embodiments, position indicator <NUM> extends along a length of sample rack <NUM> (for example, along base <NUM> or cover <NUM>) that overlaps with pockets <NUM>. For example, referring to <FIG> and <FIG>, position indicator <NUM> extends along a length of cover <NUM> that overlaps all pockets <NUM> defined in sample rack <NUM> in some embodiments. In <FIG>, position indicator <NUM> is located on a side surface <NUM> of cover <NUM>, and in <FIG>, position indicator <NUM> is positioned on a top surface <NUM> of cover <NUM>. In some embodiments, position indicator <NUM> extends along a length of base <NUM> that overlaps all pockets <NUM> defined in sample rack <NUM>. And referring to <FIG>, in some embodiments, position indicator <NUM> is positioned on a bottom surface <NUM> of sample rack <NUM>. In some embodiments, structural features of sample rack <NUM> form position indicator <NUM>. For example, in <FIG>, guide track <NUM> also functions as position indicator <NUM>. Guide track <NUM> includes a repeating, alternating pattern of offset sections <NUM> and <NUM>. Position indicator <NUM> can be positioned at any other suitable locations.

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

In some embodiments, the position measurement system includes a position sensor that operatively corresponds to the type of position indicator <NUM> coupled to sample rack <NUM>. For example, in some embodiments in which positioning indicator <NUM> is an optical encoder strip or a magnetic encoder strip affixed to sample rack <NUM>, the measurement system can include optical or magnetic read sensors <NUM> coupled to housing <NUM> and configured to read the optical encoder strip or the magnetic encoder strip as sample rack <NUM> passes near (for example, over, under, or to the side of) optical or magnetic read sensors <NUM> as shown in <FIG> and <FIG>. In some embodiments, read sensors <NUM> are positioned on base <NUM> as shown in <FIG> when position indicator <NUM> is located on a bottom surface of sample rack <NUM>. As shown in <FIG> and <FIG>, for example, each lane within housing <NUM> of sample bay <NUM> includes optical or magnetic read sensors <NUM> configured to sense a position indicator <NUM> on a sample rack <NUM> that is moving along the corresponding lane. In some embodiments in which an optical encoder strip or a magnetic encoder strip is fixed to top surface <NUM> of cover <NUM>, the measurement system can include optical or magnetic read sensors <NUM> positioned on top panel <NUM> that are configured to read an optical encoder strip or a magnetic encoder strip <NUM> as sample rack <NUM> passes sensors <NUM>, as shown in <FIG>. In other embodiments in which position indicator <NUM> is an optical encoder strip fixed to side surface <NUM>, the measurement system can include through-beam sensors <NUM> that generate a beam aligned with position indicator <NUM> to read optical encoder strip <NUM>. In some embodiments in which position indicator <NUM> is a plurality of repeating recesses formed on sample rack <NUM>, the measurement system can include a position sensor that includes a gear <NUM> which engages the plurality of corresponding recesses formed on sample rack <NUM>, as shown in <FIG>. As sample rack <NUM> moves between positions along the lane within housing <NUM> of sample bay <NUM>, gear <NUM> rotates to encode the absolute position of sample rack <NUM>. In some embodiments in which position indicator <NUM> is a friction strip affixed to sample rack <NUM>, the measurement system can include a position sensor that includes a friction wheel, similar to gear <NUM> shown in <FIG>, except without teeth and instead having a surface with a high coefficient of friction. As sample rack <NUM>, having a friction strip <NUM>, moves between positions along the lane within sample bay <NUM>, the friction wheel engages the friction strip <NUM> and rotates to encode the absolute position of sample rack <NUM>.

In some embodiments, the position measurement system is configured to determine the incremental position of sample rack <NUM>.

Referring to <FIG> and <FIG>, in some embodiments, reader <NUM> has an optical path <NUM> and is configured to read a label at an object plane <NUM> along optical path <NUM>. In some embodiments, the working distance range of reader <NUM> is large enough to include each lane defined in housing <NUM>, along which sample racks <NUM> move. In some embodiments in which reader <NUM> is a camera, reader <NUM> is a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) camera. In some camera embodiments, reader <NUM> is a line scan or an area scan camera. In some camera embodiments, reader <NUM> has a field of view height sufficient to read a label, for example, label <NUM>, on sample rack <NUM> at each lane of housing <NUM>. In some camera embodiments, reader <NUM> samples at a rate sufficient to acquire an image of a label, for example, label <NUM>, on sample rack <NUM> moving at a rate up to at least <NUM>/sec, including for example <NUM>/sec, <NUM>/sec, <NUM>/sec, and <NUM>/sec. For example, in some embodiments, reader <NUM> samples at a rate of at least <NUM>, such as <NUM> or <NUM>. For example, reader <NUM> can be a CMOS, line scan camera having a working distance range that includes each lane of housing <NUM> along which sample racks <NUM> move, a field of view greater than a height of sample rack <NUM>, and a sample rate of at least <NUM>.

In some embodiments in which reader <NUM> is a camera, as a sample rack <NUM> is inserted into sample bay <NUM> along a lane defined by guides <NUM> (and in direction <NUM>), reader <NUM> is configured to acquire images of sample rack <NUM> as it passes through object plane <NUM>. For example, the acquired images can include images of labels <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, that pass through object plane <NUM> of reader <NUM>. 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 labels <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> of the acquired images. In some embodiments, the processing and control unit is coupled to or disposed in housing <NUM>. In some embodiments, this image decoding occurs after sample rack <NUM> is fully inserted into housing <NUM> of sample bay <NUM>. In some embodiments, decoding the acquired images after sample rack <NUM> is fully inserted allows camera reader <NUM> to have a higher sample rate. For example, with such post-processing, camera reader <NUM> can have a sample rate of at least <NUM> frames per second and, in some embodiments, at least <NUM> 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 reader <NUM> after the images are acquired (in contrast to real-time decoding), which can increase the sample rate.

In some embodiments, in which position indicator <NUM> on sample rack <NUM> is an optical encoder strip, reader <NUM> can be configured to acquire images of the optical encoder strip in addition to acquiring images of labels <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>. The acquired images of optical encoder strip <NUM> can 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 rack <NUM> within housing <NUM> of sample bay <NUM>. In such embodiments, reader <NUM> can be a line scan camera. In some line scan camera embodiments, reader <NUM> has at least a <NUM> µm pixel resolution (e.g., <NUM> µm pixel resolution) and that samples at a rate of at least <NUM> frames per second (for example, <NUM> or <NUM> frames per second). For example, a line scan camera reader <NUM> that samples at a rate of <NUM> frames per second can capture an image about every <NUM> µm when sample rack <NUM> moves at a rate of <NUM>/sec. In some line scan camera embodiments, reader <NUM> has at least <NUM> pixels (e.g., <NUM> pixels) and a field of view of at least <NUM> (e.g., <NUM>). For example, when line scan camera reader <NUM> has <NUM> pixels and a field of view of <NUM>, each of the pixel images is about <NUM> 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 reader <NUM>. In some line scan camera embodiments, line scan camera reader <NUM> has a working distance in the range of <NUM> to <NUM>.

In some embodiments, sample rack <NUM> is moved between a first position in housing <NUM> of sample bay <NUM> to a second position in housing <NUM> of sample bay <NUM>. The first position can be, for example, when sample rack <NUM> first engages guides <NUM> on base <NUM> of housing <NUM>, and the second position can be, for example, any position between the first position and a position at which sample rack <NUM> is fully inserted in housing <NUM>.

In some embodiments, the user manually moves sample rack <NUM> between the first and second positions. When manually inserted, sample rack <NUM> can be moved at a rate that exceeds <NUM>/sec, for example, rates that exceed <NUM>/sec, <NUM>/sec, <NUM>/sec, or <NUM>/sec.

As sample rack <NUM> is moved between the first position and the second position in housing <NUM>, a position measurement system, for example, any one of the above described embodiments of a position measurement system, measures the absolute position of sample rack <NUM> in some embodiments. Also, as sample rack <NUM> is moved between the first position and the second position, reader <NUM> acquires images of sample rack <NUM>, including images of machine-readable labels <NUM> of sample receptacle <NUM>, at object plane <NUM> of reader <NUM>. Reader <NUM> transmits the acquired images to the processing and control unit that decodes the acquired images, including decoding the acquired images of machine-readable labels <NUM> on each sample receptacle <NUM> passing through object plane <NUM>. 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 rack <NUM> is fully inserted within housing <NUM> of sample bay <NUM>.

In some embodiments, the processing and control unit determines the speed at which sample rack <NUM> is moved between first and second positions in housing <NUM>. 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 label <NUM> with the corresponding sample receptacle <NUM> based on the measured absolute position of sample rack <NUM> when the decoded image of the machine-readable label <NUM> was 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 label <NUM> and associates the decoded information with the corresponding sample receptacle <NUM> without acquiring an image of pocket identifier <NUM> on sample rack <NUM>. For example, the processing and control unit can be configured to activate reader <NUM> when sample rack <NUM> is at predetermined positions that correspond to when the center of each pocket <NUM> of sample rack <NUM> is aligned with object plane <NUM> of reader <NUM>, when rack identifier <NUM> is aligned with object plane <NUM> of reader <NUM>, and when cover identifier <NUM> is aligned with object plane <NUM>. At these predetermined positions, reader <NUM> acquires images of empty-recess identifier <NUM> or two-dimensional barcode <NUM>, rack identifier <NUM>, and cover identifier <NUM>, respectively. The processing and control unit can also deactivate reader <NUM> when sample rack <NUM> is not at the predetermined positions that correspond to when the center of each pocket <NUM> of sample rack <NUM> is aligned with object plane <NUM> of reader <NUM>, when rack identifier <NUM> is aligned with object plane <NUM> of reader <NUM>, and when cover identifier <NUM> is aligned with object plane <NUM>. That is, activation of reader <NUM> is modulated based on the position of sample rack <NUM>. In such embodiments, reader <NUM> can be a two-dimensional barcode reader, for example, a laser barcode reader, having a sample rate less than <NUM> scans per second, for example, a scan rate of about <NUM>-<NUM> scans per second, even when sample rack <NUM> is traveling at speeds exceeding <NUM>/sec, for example, speeds exceeding <NUM>/sec-speeds associated with manual insertion of sample rack <NUM> within sample bay <NUM>. In some embodiments, sample rack <NUM> moves at a speed up to <NUM>/sec. In such embodiments, the measured position of sample rack <NUM> is determined by a position measurement system having a sensor separate from reader <NUM>. For example, the measured position of sample rack <NUM> can be determined using position indicators <NUM> (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 sensors <NUM>, gear or friction wheel <NUM>, or through-beam sensors <NUM>) as described above. Determining the position of sample rack <NUM> using position indicators <NUM> and position sensors <NUM>, <NUM>, or <NUM>, separate from reader <NUM>, can help minimize the necessary performance requirements of reader <NUM>. In some embodiments, the processing and control unit is also configured to activate light source <NUM> when sample rack <NUM> is at each of the plurality of predetermined positionssimultaneously when acquiring the image with reader <NUM>. Using light source <NUM> when acquiring the image can further reduce the necessary performance requirement of reader <NUM>.

In some embodiments, this method of associating information from a decoded acquired image of the machine-readable label <NUM> with the corresponding sample receptacle <NUM> is used when manually moving sample rack <NUM> between the first and second positions in housing <NUM>, for example, when the sample rack <NUM> is moving at a rate of at least <NUM>/sec (e.g., at least <NUM>/sec or <NUM>/sec and as fast as <NUM>/sec).

Referring to <FIG>, in some embodiments, an analyzer system <NUM> includes a sample bay <NUM> having a reader <NUM>, and a second module <NUM> that is separate from sample bay <NUM>. In some embodiments, second module <NUM> defines a compartment <NUM> configured to receive at least one sample rack <NUM>. Second module <NUM> also has a second reader <NUM> separate from reader <NUM> of sample bay <NUM>. In some embodiments, sample bay <NUM> and second module <NUM> are enclosed in separate housings that are coupled together-housing <NUM> of second module <NUM> is separate from the housing defining sample bay <NUM> as shown in <FIG>. In other embodiments, sample bay <NUM> and second module <NUM> are enclosed within the same housing, but the compartments of each sample bay <NUM> and second module <NUM> are separated by a wall.

Second reader <NUM> is configured to read a machine-readable label, for example, rack identifier <NUM>, cover identifier <NUM>, and two-dimensional barcode <NUM> on each sample receptacle <NUM>, when inserted within second module <NUM>. In some embodiments, second reader <NUM> is configured to read two-dimensional barcode <NUM> on each sample receptacle <NUM> as sample rack <NUM> is inserted within compartment <NUM> of second module <NUM>. In other embodiments, second reader <NUM> is configured to scan sample rack <NUM> to read two-dimensional barcode <NUM> for each sample receptacle <NUM> after sample rack <NUM> is 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 barcodes <NUM> on receptacles <NUM> of sample rack <NUM>, in second module <NUM>, a user can manually remove sample rack <NUM> from second module <NUM> and insert the same sample rack <NUM> in sample bay <NUM>. In some embodiments, barcode reader <NUM> (for example, a one-dimensional laser barcode reader) does not read barcodes <NUM> on receptacles <NUM> as sample rack <NUM> is inserted along an available lane in sample bay <NUM>. Instead reader <NUM> only reads rack identifier <NUM> (for example, a one-dimensional barcode) to confirm the sample rack <NUM> that was just scanned in second module <NUM> was inserted in sample bay <NUM>. Reader <NUM> can also read cover identifier <NUM> to ensure the presence and proper positioning of cover <NUM>. The processing and control unit can then associate the information decoded from the acquired images of two-dimensional barcodes <NUM> at second module <NUM> with the rack identifier <NUM> of sample rack <NUM> inserted in sample bay <NUM>. In some embodiments, the processing and control unit can be configured to erase or otherwise disable reader <NUM> if sample rack <NUM> is not inserted into sample bay <NUM> within a predetermined time period, for example, <NUM> seconds. Thus, if sample rack <NUM> is not moved to sample bay <NUM> within the predetermined time period, the processing and control unit will not recognize sample rack <NUM> as having been previously scanned in the second module <NUM>, and sample rack <NUM> will have to be scanned again in second module <NUM>. This timing requirement can help minimize the risk that one or more un-scanned receptacles are switched for scanned receptacles <NUM> in the time between removing sample rack <NUM> from second module <NUM> and inserting sample rack <NUM> into sample bay <NUM>. In some embodiments, reader <NUM> is configured only to read one-dimensional barcode labels, and second reader <NUM> is configured to read one- and two-dimensional barcodes. In some embodiments in which rack identifier <NUM> is an RFID tag, system <NUM> includes an RFID reader in sample bay <NUM> configured to interrogate sample rack <NUM> having an RFID tag.

Referring to <FIG>, in some embodiments, sample bay <NUM> includes a reader support <NUM> that is moveable relative to the lanes along which sample racks <NUM> move within housing <NUM> of sample bay <NUM>. In some embodiments, sample bay <NUM> includes a camera <NUM> fixedly coupled to reader support <NUM> such that camera <NUM> moves along with reader support <NUM>. In some embodiments, camera <NUM> has a fixed focal length. In other embodiments, camera <NUM> has a variable focal length. The sample bay <NUM> can include an actuator that moves reader support <NUM> along a path <NUM> such that object plane <NUM> of camera <NUM> is operatively aligned with a lane having the sample rack <NUM> being 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 support <NUM> is configured to move along path <NUM> in a range from about <NUM> to about <NUM>. Reader support <NUM> is configured such that object plane <NUM> of camera <NUM> can be aligned with each lane within sample bay <NUM>. In some embodiments, path <NUM> of reader support <NUM> is parallel to the lanes along which sample racks <NUM> move within sample bay <NUM>. In some embodiments, camera <NUM> is a CCD or CMOS camera. In some embodiments, camera <NUM> acquires images at a rate of at least <NUM> frames per second. For example, camera <NUM> can acquire images at a rate of <NUM> frames per second. In some embodiments, the direction of an optical path <NUM> from a lens <NUM> of camera <NUM> is bent. For example, as shown in <FIG>, bay <NUM> can include a mirror <NUM> that bends optical path <NUM> towards the lanes along which sample racks <NUM> move. For example, as shown in <FIG>, mirror <NUM> bends optical path <NUM> ninety degrees towards the lanes of sample bay <NUM>. In other embodiments, mirror <NUM> bends optical path <NUM> at other angles more than or less than ninety degrees. In some embodiments, sample bay <NUM> includes a light source <NUM> configured to illuminate the lanes within sample bay <NUM>. In some embodiments, light source <NUM> is also coupled to reader support <NUM> such that light source <NUM> moves along with reader support <NUM> and camera <NUM>. In some embodiments, the optical path of light waves emitted from light source <NUM> coincides with optical path <NUM> of camera <NUM>. Light source <NUM> can be one or more LEDs in some embodiments. In some embodiments, as shown in <FIG>, light source <NUM> comprises eight LEDs-for example, four above lens <NUM> of camera <NUM> and four below lens <NUM>. In other embodiments, light source <NUM> comprises four LEDs-for example, two above lens <NUM> and two below lens <NUM>. In embodiments in which light source <NUM> comprises LEDs, the number and configuration of the LEDs may vary to achieve the desired illumination within sample bay <NUM>. In some embodiments, light source <NUM> is incorporated into camera <NUM>.

In use, sample rack <NUM> is moved between a first position and a second position along a first lane in housing <NUM> of sample bay <NUM>. For example, sample rack <NUM> is manually moved along the first lane. The first position can be, for example, the position at which sample rack <NUM> engages guides <NUM> on base <NUM>, and the second position can be, for example, a position between the first position and a position at which sample rack <NUM> is fully inserted within sample bay <NUM>. As sample rack <NUM> moves between the first position and the second position along the lane, camera <NUM> acquires images of machine-readable label <NUM> on sample receptacles <NUM> supported by sample rack <NUM>. The acquired images are transmitted to the processing and control unit to be decoded. The acquired images can be decoded after sample rack <NUM> is fully inserted within sample bay <NUM>. Another sample rack <NUM> can be moved, for example, manually, between a first position and a second position along a different lane within a housing of sample bay <NUM>. The processing and control unit controls the actuator coupled to reader support <NUM> to move reader support <NUM> and, thus, position the object plane <NUM> of camera <NUM> at the second lane along which the second sample rack <NUM> is moving. As the second sample rack <NUM> moves between the first position and the second position along the lane, camera <NUM> acquires images of machine-readable label <NUM> on sample receptacles <NUM> supported by the second sample rack <NUM>. The acquired images are transmitted to the processing and control unit to be decoded. The acquired images of the second sample rack <NUM> can be decoded after sample rack <NUM> is fully inserted within sample bay <NUM>.

In some embodiments, camera <NUM> samples at a rate of <NUM> frames per second and has a <NUM>/<NUM>,<NUM> second shutter speed when using light source <NUM> to strobe the interior of housing <NUM>. In some embodiments, camera <NUM> has a working distance of <NUM>. In some embodiments, camera <NUM> has a focal distance of at least ± <NUM> from the focal plane. In some embodiments, camera <NUM> has a field of view that is <NUM> tall and <NUM> wide. In some embodiments, camera <NUM> has <NUM> x <NUM> pixels.

In some embodiments, the processing and control unit activates light source <NUM> simultaneously when acquiring the images of machine-readable label <NUM> of each sample receptacle <NUM> supported on the first and second sample racks <NUM>.

In some embodiments, camera <NUM> and light source <NUM> are operatively coupled to the processing and control unit through one or more cables <NUM>. For example, the images acquired by camera <NUM> can be transmitted to the processing and control unit via one of the plurality of cables <NUM>. And for example, the control signals that activate light source <NUM> can be transmitted from the processing and control unit to light source <NUM> via one of the plurality of cables <NUM>. In some embodiments, one of the plurality of cables <NUM> is operatively coupled to an actuator that moves support <NUM>.

In any of the above disclosed embodiments, a user can insert sample rack <NUM> into housing <NUM>. For example, the user can align guide track <NUM> of sample rack <NUM> with guide <NUM> formed on base <NUM> of housing <NUM>. From this first position, the user can manually move sample rack <NUM> along the lane defined by guide <NUM> to a fully inserted position within housing <NUM>. As sample rack <NUM> is moved to the fully inserted position, reader <NUM> reads labels on sample rack <NUM>, for example, two-dimensional labels <NUM> on sample receptacles <NUM> held by sample rack <NUM>. In some embodiments, after sample rack <NUM> is 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 rack <NUM> is inserted into sample bay <NUM>, sample material contained in sample receptacles <NUM> carried in the sample rack <NUM> can 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 openings <NUM> formed in top panel <NUM>. Analyzer system <NUM> then performs the assay as indicated in the decoded information from, for example, two-dimensional barcode <NUM>.

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 comprises 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 reader <NUM> that processes (for example, post-processing) images stored in a buffer of reader <NUM>.

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 reader <NUM>, for example. In some embodiments, the software for image processing is stored in external memory in communication with the processing and control unit.

The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof.

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.

Claim 1:
A method of reading machine-readable labels on sample receptacles, comprising:
moving, between a first position and a second position along a first lane in a housing, a first sample rack configured to hold a first plurality of sample receptacles each having a machine-readable label;
moving a camera to focus the camera at a point along the first lane;
reading the machine-readable label of each sample receptacle of the first plurality of sample receptacles of the first sample rack as the first sample rack moves from the first position to the second position;
moving, between a first position and a second position along a second first lane different than the first lane in the housing, a second sample rack configured to hold a second plurality of sample receptacles each having a machine-readable label; and
moving the camera to focus the camera at a point along the second lane; and
reading the machine-readable label of each sample receptacle of the second plurality of sample receptacles of the second sample rack as the second sample rack moves from the first position to the second position.