WO2015112791A1

WO2015112791A1 - Methods and apparatus for detecting sample containers

Info

Publication number: WO2015112791A1
Application number: PCT/US2015/012578
Authority: WO
Inventors: Vadim Filler
Original assignee: Siemens Healthcare Diagnostics Inc.
Priority date: 2014-01-24
Filing date: 2015-01-23
Publication date: 2015-07-30

Abstract

Methods of detecting a presence or absence of sample container containing a biological liquid specimen at a receiving station are disclosed. The methods include providing a receiving station adapted to receive one or more sample containers, providing a target machine-readable code, such as a target barcode, at a location adjacent to the receiving station, providing a capture device at a location adjacent to the receiving station, and attempting to read the target machine-readable code with the capture device.

Description

METHODS AND APPARATUS FOR DETECTING SAMPLE CONTAINERS

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application Serial Number 61/931 ,356 entitled "METHODS AND APPARATUS FOR DETECTING SAMPLE CONTAINERS" filed on January 24, 2014, the disclosure of which is hereby incorporated by reference in its entirety herein.

FIELD

[0002] The present invention relates generally to methods and apparatus for detecting sample containers, such as in a sample rack.

BACKGROUND

[0003] A wide variety of diagnostic instruments (e.g., clinical analyzers or immunoassay Instruments) are used to analyze patient specimens (biological samples). These diagnostic instruments may conduct assays or other tests using reagents or other additives to identify one or more analytes in, or characteristics of, a biological sample, such as urine, blood serum or plasma, cerebrospinal liquids, or the like. The biological samples may be contained within sample containers (e.g., sample tubes). In some instances, the biological samples may have undergone a centrifuging process to separate various components thereof.

[0004] In some diagnostic instruments, the sample containers (e.g., sample tubes) are provided in a sample rack. The sample rack may include several (e.g., five receptacles) that are adapted to receive and support the sample containers. Some of the receptacles may include sample tubes having a barcode label applied thereon. The barcode label may contain an accession number that may be correlated to demographic information that has been entered into a hospital's Laboratory Information System (LIS), along with test orders and/or other information. In one or more other receptacles, a sample tube may sometimes not include a barcode label (i.e., it is unlabeled), and such information may be entered manually by an operator. In other instances, a barcode label may be applied, but the label may be damaged (e.g., ripped), such that only a portion is readable. Other receptacles of the sample rack may not include a sample tube, i.e., they may be empty.

[0005] Thus, one challenge in performing analysis of the biological samples contained in the sample tubes is readily discriminating whether a sample tube is present in the various receptacles, and if so, whether it has a suitable barcode thereon.

[0006] Therefore, methods and apparatus that are adept at determining sample tube status are desired.

SUMMARY

[0007] According to a first aspect, a method of detecting a sample container is provided. The method includes providing a receiving station adapted to receive one or more sample containers, providing a target machine-readable code at a location adjacent to the receiving station, providing a capture device, and attempting to read the target machine-readable code with the capture device along a path between the capture device and the target machine-readable code, where the one or more sample containers reside along the path, if present.

[0008] According to another aspect, a sample container detection apparatus is provided. The sample container detection apparatus includes a receiving station adapted to receive one or more sample containers, a target machine-readable code at a location adjacent to the receiving station, and a capture device operable to attempt to read the target machine-readable code along a path between the capture device and the target machine-readable code.

[0009] According to another aspect, a diagnostic instrument is provided. The diagnostic instrument includes a receiving station, a sample rack containing a plurality of sample containers, the sample rack positionable such that one sample container is located at the receiving station, a target machine-readable code at a location adjacent to the receiving station, a capture device operable to attempt to read the target machine-readable code along a path between the capture device and the target machine-readable code, the receiving station located along the path, and an image processor operable to decode the target machine-readable code, or a machine-readable code on the one sample container. [0010] Still other aspects, features, and advantages of the present invention may be readily apparent from the following detailed description by illustrating a number of example embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not necessarily drawn to scale. The invention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[001 1] FIG. 1A illustrates a side plan view of a sample container detection apparatus according to embodiments.

[0012] FIG. 1 B illustrates a top plan view of a sample container detection apparatus according to embodiments.

[0013] FIG. 1 C illustrates a side plan view of a sample container including a barcode label affixed thereto according to embodiments.

[0014] FIG. 1 D illustrates a side plan view of a sample container including no label affixed thereto according to embodiments.

[0015] FIG. 1 E illustrates a side plan view of a sample container including a partial barcode label affixed thereto according to embodiments.

[0016] FIG. 2 illustrates a flowchart of a method of detecting according to embodiments.

[0017] FIG. 3 illustrates a method of detecting a sample container according to embodiments.

DESCRIPTION

[0018] In a first broad aspect, embodiments of the present invention provide methods and apparatus for readily determining a status of a sample container, such as at a receiving station. In particular, the status of the sample container may include the presence or absence of the sample container at the receiving station, whether the sample container has a machine-readable label on it or not, and if that machine- readable label is present, is it sufficient (is it partial label, or otherwise torn or damaged).

[0019] In one aspect, the sample container detection apparatus includes a receiving station adapted to receive one or more sample containers (e.g., contained in a sample rack), a target machine-readable code (e.g., a target barcode) at a location adjacent to the receiving station, and a capture device (e.g., barcode reader) that is operable to attempt to read the target machine-readable code along a path between the capture device and the target machine-readable code.

[0020] These and other aspects and features of the invention will be described with reference to FIGs. 1A-3 herein.

[0021] FIGs. 1 A-1 B illustrates an embodiment of a diagnostic instrument 100 (e.g., a clinical analyzer or immunoassay instrument) including a sample container detection apparatus 101 . Sample container detection apparatus 101 is capable of automatically and readily determining a presence or absence of a sample container (e.g., blood collection tube) that is located at a receiving station 104. This may be performed prior to testing and analysis by the diagnostic instrument 100.

[0022] In operation, specimen 102S (hereinafter "specimen") to be automatically processed by the diagnostic instrument 100 may be provided to the sample container detection apparatus 101 in the sample containers 102A, 102B, 102C, which may have been previously de-capped. The sample containers 102A, 102B, 102C may be made of transparent glass, plastic, or the like. The sample containers 102A, 102B, 102C may be presented to the sample container detection apparatus 101 in a sample rack 106. Sample rack 106 may be of any suitable configuration and may have one or more sample containers (e.g., sample containers 102A-102C) inserted in one or more receptacles in the sample rack 106. A sample rack 106 having five receptacles is shown. Other sizes of sample racks may be used.

[0023] Some of the sample containers 102A (e.g., sample tubes), if present, may be provided with a machine-readable code 103 thereon, such as shown in FIG. 1 C. The machine-readable code 103 may contain identification indicia and/or information, such as a barcode, alphabetic, numeric, or alphanumeric indicia, that may be machine readable (e.g., a machine-readable code). The identification indicia and/or information may indicate a patient's identification as well as the test procedures to be accomplished upon the particular specimen 102S therein, for example. In some embodiments, the patient's identification alone may be provided, and the test procedure(s) to be accomplished upon the particular specimen 102S may be provided by correlating the patient's identification with a database including test information. Such machine-readable code 103 may be provided on a label affixed or adhered to, or otherwise provided on the side of, the sample container 102A.

[0024] Other sample containers 102B (e.g., sample tubes), if present, may not be provided with a machine-readable code thereon, i.e., they may be unlabeled, such as shown in FIG. 1 D. In other embodiments, the sample container 102C may include only a portion of machine-readable code 103P thereon as shown in FIG. 1 E. The partial machine-readable code 103P may be torn, smeared, or otherwise not fully readable.

[0025] In some embodiments, one or more receptacles of the sample rack 106 may be devoid of a sample container, i.e., may be empty, such as receptacle 106E shown in FIGs. 1A-1 B.

[0026] As will be apparent from the following, the sample container detection apparatus 101 may be used to determine whether a sample container (e.g., 102A, 102B, or 102C) is present or not at the receiving station 104, and, if so, a determination may be made whether the sample container is a labeled sample container 102A or unlabeled 102B. Moreover, if labeled, embodiments of the invention may even determine if the sample container containing a machine- readable code 103 or 103P is sufficient (e.g., a partial - damaged or ripped label) such as in partially-labeled sample container 102C of FIG. 1 E.

[0027] The sample container detection apparatus 101 includes the receiving station 104, which is adapted to receive one or more sample containers 102A, 102B, or 102C thereat. The receiving station 104 may be a location in space within the diagnostic instrument 100, for example. The sample container detection apparatus 101 includes a target machine-readable code 108 at a location (e.g., on a first side 1 10) adjacent to the receiving station 104. The target machine-readable code 108 may be positioned within a few millimeters (e.g., 2 mm) from the sample rack 106, and may be positioned on a backstop 109 in some embodiments. Other spacing of the position of the target machine-readable code 108 may be used. The target machine-readable code 108 may contain identification indicia and/or information, such as a barcode, alphabetic, numeric, or alphanumeric indicia, that may be machine readable (e.g., a target machine-readable barcode).

[0028] A capture device 1 12 is provided, such as at another location adjacent to a second side 1 1 1 of the receiving station 104. The second side 1 1 1 may be opposite the first side 1 10. The capture device 1 12 is operable to attempt to read the target machine-readable code 108 along a path 1 16 between the capture device 1 12 and the target machine-readable code 108. The receiving station 104 is located along the path 1 16. The capture device 1 12 may be a suitable barcode reader and may be positioned on the second side 1 1 1 of the sample rack 106, as shown in FIG. 1 B. The capture device 1 12 may be positioned about 45 mm to about 90 mm from the sample rack 106, for example. Other spacing and orientations of the capture device 1 12 may be used. The capture device 1 12 may be scanned vertically (e.g., up and down) at the receiving station 104 at a rate of about 500 scans/sec, for example. Other scan rates may be used. Scanning may take place at the receiving station 104 for a scan time of between about 40 ms to 100 ms, for example. Other scan times may be used. Rack 106 may be stationary as scanning is occurring. The scanned information along the path 1 16 for each sample container 102A, 102B, 102C, or no sample container may then be processed. After scanning the first sample container 102B of the sample rack 106, the sample rack 106 may be moved by rack moving device 1 18 to scan another sample container (e.g., sample container 102C) in the sample rack 106, and so on.

[0029] Rack moving device 1 18 may include a rack support 120 on which the sample rack 106 is placed, a rack support drive 122, and a position controller 124. Rack support 120 may include a platform adapted to receive the sample rack 106 thereon. On or more locators 126 may be provided on the sample rack 106, platform, or both to precisely locate the sample rack 106 on the rack support 120. Rack support drive 122 may be driven to move the sample rack 106 along the direction arrow 125 by drive signals from position controller 124. Each of the sample containers (e.g., sample containers 102B, 102C, 102B, 102A) and empty receptacles 106E may be positioned sequentially at the receiving station 104 by position controller 124 and rack support drive 122.

[0030] An image processor 1 14 is coupled to the capture device 1 12 and is operable to decode the information provided by the capture device 1 12, such as the target machine-readable code 108 or another machine-readable code 103, 103P.

[0031] According to embodiments, a method 200 may be carried out to determine if a sample container (e.g., sample container 102A, 102B, 102C) is present at the receiving station 104. Before starting, as shown in FIG. 2, the method first includes positioning a sample container receptacle of a suitable carrier (sample rack 106) at the receiving station 104. The method 200 includes undertaking scanning in 202. Scanning may include scanning with a barcode scanner as the capture device 1 12 for a read cycle. Read cycle may include multiple scans (e.g., approximately 35 scans in one embodiment). Other numbers of scans at the sample container receptacle for a read cycle may be undertaken. At the end of the read cycle, in 204, it is determined if any symbol has been decoded by the image processor 1 14. If a code has been decoded in 204 (Yes), then an algorithm running in the image processor 1 14 determines in 206 if it is the target machine-readable code 108. If it is determined to be the target code (Yes), then it is determined in 208 if a good decode rate (GDR) is met. A GDR may be any suitable number of good reads during the read cycle (e.g., 20 good reads out of 35 total reads). If the GDR is not met (No), then the result in 210 is that the sample container at the receiving station 104 is an unlabeled sample container 102B with no code. The user may then be instructed to add the patient information and/or the test information of the desired test, for example.

[0032] If the GDR is met (Yes in 208), then the result in 212 is that there is no sample container at the receiving station 104, i.e., there is an empty receptacle like 106E then located at the receiving station 104.

[0033] If at the end of the read cycle, in 204, it is determined that no symbol has been decoded by the image processor 1 14 (No), then it may be determined, in 216, if any transitions from black to white are detected. If Yes, then the code is a bad code in 218. If No at 216, then only a partial label may be present, but no code result in 210 may be determined. The user may then be instructed to add applicable patient information and/or test information, for example.

[0034] If in 204 it is determined that a code exists, but then in 206 is determined that the code is not the target machine-readable code 108 (No), then it is tested in 220 to determine if a GDR is met. If Yes in 220, then a good code result in 222 is present. For example a proper barcode may be affixed on the sample container, like on sample container 102A. If No in 220, then a no code result in 210 is flagged. For example an improper barcode (partial or ripped) may be affixed on the sample container, like on sample container 102C.

[0035] In a broad aspect, a method of detecting a sample container is shown in FIG. 3. The method 300 includes, in 302, providing a receiving station (e.g., receiving station 104) adapted to receive one or more sample containers (e.g., sample containers 102A, 102B, 102C). Sample containers may include no labels (e.g., sample container 102B), damaged labels (sample container 102C), or complete labels (sample container 102A). Method includes, in 304, providing a target machine-readable code (e.g., target machine-readable code 108) at a location adjacent to the receiving station (e.g., on a first side 1 10), and, in 306, providing a capture device (e.g., capture device 1 12). In 308, the method 300 includes attempting to read the target machine-readable code with the capture device along a path (e.g., path 1 16) between the capture device and the target machine-readable code, where the one or more sample containers reside along the path, if present.

[0036] Having shown the preferred embodiments, those skilled in the art will realize many variations are possible that will still be within the scope of the claimed invention. Therefore, it is the intention to limit the invention only as indicated by the scope of the claims.

Claims

CLAIMS What is claimed is:

1 . A method of detecting a sample container, comprising:

providing a receiving station adapted to receive one or more sample containers;

providing a target machine-readable code at a location adjacent to the receiving station;

providing a capture device; and

attempting to read the target machine-readable code with the capture device along a path between the capture device and the target machine-readable code, where the one or more sample containers reside along the path, if present.

2. A method of claim 1 , comprising:

providing a sample rack at the receiving station, the sample rack including one or more receptacles adapted to receive the one or more sample containers.

3. The method of claim 1 , comprising:

providing a sample rack with multiple receptacles.

4. The method of claim 1 , comprising:

forming the target machine-readable code as a barcode.

5. The method of claim 1 , comprising:

forming the capture device as a barcode reader.

6. The method of claim 1 , comprising:

positioning the capture device on a first side of a sample rack, and positioning the target machine-readable code on a second side of the sample rack opposite the first side of the sample rack.

7. The method of claim 1 , wherein the attempting to read the target machine- readable code comprises:

decoding the target machine-readable code and determining no sample container is present in the path;

decoding a machine-readable code on the one or more sample containers located in the path; or

failing to decode a machine-readable code on the one or more sample containers located in the path, but also failing to decode the target machine-readable code.

8. The method of claim 7, further comprising:

determining that a good decode rate is not met, and that an unlabeled or an improperly labeled sample container is present in the path.

9. The method of claim 7, further comprising:

determining that a good decode rate is met, and that a properly labeled sample container is present in the path.

10. The method of claim 1 , wherein the attempting to read the target machine- readable code further comprises:

decoding a code;

determining based on a decoding that the code is not the target machine- readable code; and

determining that a good decode rate is met, indicating that a labeled sample container is present in the path.

1 1 . The method of claim 1 , further comprising:

decoding a code;

determining based the decoding that the code is not the target machine- readable code; and

determining that a good decode rate is not met, indicating that a sample container present in the path is either an unlabeled sample container.

12. A sample container detection apparatus, comprising:

a receiving station adapted to receive one or more sample containers;

a target machine-readable code at a location adjacent to the receiving station; and

a capture device operable to attempt to read the target machine-readable code along a path between the capture device and the target machine-readable code.

13. The apparatus of claim 12, comprising:

a sample rack received at the receiving station, wherein the one or more sample containers are inserted in one or more receptacles in the sample rack.

14. The apparatus of claim 12, wherein the target machine-readable code comprises a barcode.

15. The apparatus of claim 12, wherein the capture device comprises

a barcode reader.

16. The apparatus of claim 12, comprising:

an image processor coupled to the capture device and operable to decode the target machine-readable code or another machine-readable code.

17. The apparatus of claim 12, comprising:

a backstop onto which the target machine-readable code is applied.

18. A diagnostic instrument, comprising:

a receiving station;

a sample rack containing a plurality of sample containers, the sample rack positionable such that one sample container is located at the receiving station;

a target machine-readable code at a location adjacent to the receiving station; a capture device operable to attempt to read the target machine-readable code along a path between the capture device and the target machine-readable code, the receiving station located along the path; and

an image processor operable to decode:

the target machine-readable code, or

a machine-readable code on the one sample container.

19. The diagnostic instrument of claim 18, comprising:

a motion-producing apparatus adapted to move the sample rack to bring another one of the plurality of sample containers in the sample rack to the receiving station.

20. The diagnostic instrument of claim 18, wherein:

the target machine-readable code comprises a barcode located on a first side of the sample rack; and

the capture device comprises a barcode reader located on a second side of the sample rack.