Sample tracking card

Abstract

To provide a sample tracking card.SOLUTION: A sample tracking card for attachment to a container that contains a biological sample having been acquired for test is explained. The card includes an opening for receiving an edge of a sample collection container and a tab that engages with the other edge of the sample collection container and that is used for attaching the container to the card. The card enables a test result concerning the sample to be reliably matched to a subject without causing the identity of the subject to be exposed to the container. Also explained is a kit that comprises the card and the container.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to sample tracking cards, and more particularly to sample tracking cards for attachment to containers containing biological samples being obtained for testing, and kits comprising the cards and containers. [Background technology]

[0002] When a biological sample is collected from a subject, for example for testing to determine whether the subject is infected with an infectious disease, it is important that the subject's identity is not revealed on the container in which the biological sample is collected, and that once the results are obtained, the test results for the sample can be reliably matched to the subject, such that the sample is not mixed up with samples from other subjects. Thus, there is a need to provide a convenient method of tracking samples obtained from subjects, such that the anonymity of the subject is maintained, and such that the test results for the sample can be reliably matched to the subject. Summary of the Invention [Means for solving the problem]

[0003] In accordance with the present invention, a sample tracking card is provided that includes an opening for receiving an end of a sample collection container and a tab that engages another end of the sample collection container to attach the container to the card.

[0004] The sample collection container is held in place within the opening by a tab, optionally positioned to engage an end of the sample container after it is received within the opening.

[0005] Optionally, the opening is defined in a hinged flap of the card. A hinged flap is advantageous because it allows the card to be stored flat when not attached to a sample collection container.

[0006] Optionally, the hinged flap is defined by a cut through the card. Optionally, the flap is hinged to the card along a fold line in the card. Optionally, the fold line is defined by a cut in the card or by a perforation through the card along the fold line.

[0007] Optionally, the tab engages a recess in the lid of the container.

[0008] Optionally, the tab is defined by a cut-out from the card. Optionally, the cut-out also defines an edge of the hinged flap. Advantageously, the edge of the hinged flap defined by the cut-out is opposite a hinged edge of the flap, thereby minimizing the number of cuts required to be made in the card to provide the hinged flap and tab.

[0009] The sample collection container may comprise a tube having a narrower closed end for engaging an opening in the card and a wider open end with a removable cap to seal the tube. The opening may be large enough to receive the narrower end of the container, but may not be large enough to allow the container to pass through the card, for example, due to a step in the outer sidewall of the container.

[0010] Optionally, the container comprises a sidewall that gradually expands from the narrower end to the wider open end of the container, or is stepped outwardly from the narrower end to the wider end.

[0011] The cap may include a recess for engaging the tab. The cap may be a screw cap or a push-fit cap. The cap may be attached to a retention ring at the open end of the container, which is retained by a collar of a wider diameter than the inner diameter of the retention ring.

[0012] Optionally, the container is a tube of circular cross section and the opening is a circular opening.

[0013] Optionally, the sample tracking card is labeled with an ID code. Optionally, the card is labeled with a machine-readable ID code. For example, the ID code may include a barcode, such as a matrix barcode, e.g., a Quick Response (QR) code, etc. A machine capable of reading the machine-readable ID code (e.g., a scanning device built into a stand or a handheld scanning device) may store the ID code for uploading to a database (either immediately or at a later time) or may immediately transmit the ID code for uploading to a database.

[0014] Optionally, the card further comprises a removable sticker for adhering to the sample collection container for attachment to the card. For example, the removable sticker may be labeled with an identification (ID) code that is the same as the ID code on the sample card so that the sample collection container can be matched with the sample card once the container is removed from the card, e.g., for testing of a biological sample in the container.

[0015] Optionally, the card may be provided with more than one removable sticker, for example two removable stickers, such that one sticker can be attached to the sample collection container and the other to the paper record. For example, if the testing facility keeps a paper record, a second sticker can be attached to the paper record to avoid any risk of transcription errors in the step of recording the ID code.

[0016] Optionally, the card includes a marking area for marking the card.

[0017] Optionally, the card includes a labeling area for labeling the card with a subject (or patient) identification code.

[0018] For example, the labeling area may contain an area for recording (e.g., by handwritten recording) details on the card anonymously linking the subject to the card, general details about the subject, and details about the sample. For example, the labeling area may include an area for recording any of the following details: subject (or patient) identification code, sample identification code, sample collection date, general details of the subject such as the subject's age and / or sex.

[0019] Once the subject's ID code is recorded on the card, the ID code of the sample tracking card is thereby linked to the subject's ID code. This makes it possible to ensure that the results of any tests performed on the biological sample cannot be confused with test results for any other subject, while the anonymity of the subject is maintained. Once the test results for the biological sample are obtained, the ID code of the sample tracking card, associated with the sample, is matched with the subject's (or patient's) ID code on the card, which can then be used to identify the subject and inform them of the test results.

[0020] It should be understood that the sample tracking card (particularly the tabs and the portion of the card, e.g., flaps, that define the opening for receiving the end of the container) should be made from a suitable rigid material and hold the sample collection container in place once the container is attached to the card. Optionally, the sample tracking card is made from paper, cardboard, or plastic. The sample tracking card may be of any suitable size, so long as it is large enough to allow the sample collection container to be attached to it and the necessary identification code to be present. Examples of suitable dimensions are approximately A8 (52×74 mm), A7 (74×105 mm), A6 (105×148 mm), A5 (148×210 mm), or A4 (210×297 mm), e.g., 89×145 mm.

[0021] The biological sample may be any biological sample for which it is desirable to track using a sample tracking card and which may be attached to a card in a sample collection container. Examples include whole blood, plasma, or urine samples.

[0022] The sample collection container may be of any suitable size for collection of a biological sample and attachment to a sample tracking card. Optionally, the sample collection container is for drawing a low volume whole blood sample of up to 500 μl, for example, by finger prick or heel prick. The sample collection container may contain a sufficient amount of EDTA to prevent blood clotting. A suitable sample collection container is a capillary blood collection microtube manufactured by MarketLab Inc, (Caledonia) that contains a removable insert with a capillary blood collection tube (e.g., Capillary Blood Collection Tube 125 μl EDTA (Cat. #ML5599)).

[0023] In accordance with the present invention, there is also provided a sample tracking card of the present invention for attachment to a sample collection container.

[0024] According to the present invention, there is further provided a kit comprising the sample tracking card of the present invention and a sample collection container for attachment to the card. The kit may further comprise any of the following additional components (e.g., contained within a package such as a resealable plastic bag): a lancet for obtaining a sample of whole blood from a subject by finger or heel prick, a capillary blood collection tube for directing whole blood released by the lancet into the sample collection container, an alcohol swab for disinfecting an area of ​​the subject's skin immediately prior to obtaining the whole blood sample using the lancet, one or more gloves (e.g., one or more powder-free gloves) for protecting the individual collecting the sample from the subject, an isotonic solution for diluting the sample of whole blood obtained from the subject, and instructions for obtaining a biological sample from a subject and / or for attaching the sample collection container to the sample tracking card.

[0025] An example of a suitable lancet for obtaining low volume whole blood samples is the Accu-Chek Safe-T-Pro Plus blood sampling lancet. The present invention provides, for example, the following items. (Item 1) A sample tracking card, the sample tracking card comprising an opening for receiving an end of a sample collection container and a tab for engaging another end of the sample collection container to attach the container to the card. (Item 2) Item 2. The card of item 1, wherein the opening is defined in a hinged flap of the card. (Item 3) Item 3. The card of item 2, wherein the hinged flap is defined by a cut through the card. (Item 4) Item 4. The card of item 3, wherein the hinged flap is hinged to the card along a fold line in the card. (Item 5) 5. The card of claim 4, wherein the fold line is defined by perforations through the card along the fold line. (Item 6) The card of any preceding item, wherein the tab engages with a recess in a lid of the container. (Item 7) The card of any of the preceding items, wherein the tab is defined by a cutout from the card. (Item 8) 8. The card of claim 7, wherein the cutout also defines an edge of the hinged flap. (Item 9) Item 9. The card of item 8, wherein the edge of the hinged flap defined by the cutout is opposite a hinged edge of the flap. (Item 10) 2. The card of any of the preceding items, wherein the container is a tube and the opening is a circular opening. (Item 11) 2. The card of any preceding item, further comprising a removable sticker for adhering to a sample collection container for attachment to the card. (Item 12) 2. A card according to any of the preceding items, labelled with an identification code. (Item 13) 2. A card according to any of the preceding items, labeled with a machine-readable identification code. (Item 14) Item 14. The card of item 13, wherein the machine-readable identification code comprises a barcode, preferably a matrix barcode such as a Quick Response (QR) code. (Item 15) 2. A card according to any of the preceding items, comprising an area for labelling the card with a subject (or patient) identification code. (Item 16) 2. A card according to any of the preceding items attached to a sample collection container. (Item 17) 16. A kit comprising a sample tracking card according to any one of items 1 to 15 and a sample collection container for attachment to the card. (Item 18) Item 18. The kit of item 17, further comprising any of the following components: a lancet for obtaining a whole blood sample by finger or heel prick, an alcohol swab, a capillary blood collection tube, and gloves.

[0026] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 illustrates a sample tracking card according to one embodiment of the present invention. [Diagram 2] FIG. 2 shows the sample tracking card shown in FIG. 1 with the flap folded out of the plane of the card along the fold lines. [Diagram 3]FIG. 3 shows the sample tracking card shown in FIGS. 1 and 2 with a sample collection tube attached to the card. [Figure 4] FIG. 4 shows the sample collection tube of FIG. [Diagram 5] FIG. 5 shows the sample collection tube of FIGS. 4 and 5 with a capillary blood collection tube inserted. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] 1 and 2, a sample tracking card 10 includes a flap 12 on the right side of the card that defines an opening 14 through the card for receiving the end of a sample collection tube. A cutout 16 from the card defines a tab 18 for engaging a recess in the capped end of a sample collection tube. The cutout 16 also defines an upper edge 20 of the flap. Cuts 22, 24 through the card define the side edges of the flap. The flap is hinged to the card along opposing fold lines 26 on the upper edge of the flap such that the flap can be moved about the hinge out of the plane of the card. The fold lines are defined by perforations 28 through the card along the fold lines.

[0029] The sample tracking card 10 is labeled with a machine-readable code in the form of an identification code 30 and a matrix barcode 32 (a Quick Response (QR) code). The card 10 also includes two removable stickers 34, 36 adjacent to the flap. Each sticker is labeled with the sample tracking card's identification code. A labeling area 38 on the left side of the card 10 contains areas for handwritten recording of the sample collection date, subject (or patient) identification code, sample identification code, and the subject's age and sex.

[0030] As shown in FIG. 4, the sample collection tube 40 has a narrower closed end 42 and a wider open end 44. The tube 40 is circular in cross section. The sidewall 46 of the tube is stepped outwardly from the narrower closed end 42 to the wider open end 44. A push-fit cap 48 is attached to a retaining ring 50 that is retained at the open end 44 of the tube 40 by a collar 52 of a wider diameter than the inner diameter of the retaining ring 50. The outer end wall of the push-fit cap 48 includes a circular recess (not shown) for engagement by the tab 18 when the push-fit cap is pushed into place in the open end of the sample collection tube. The opening 14 in the card is large enough in diameter to receive the narrow end of the tube, but smaller in diameter than the wider end of the tube so that the tube cannot pass through the opening.

[0031] The sample tracking card is provided packaged with a lancet (not shown) for obtaining a whole blood sample from a subject by finger prick, an alcohol swab (not shown) for sanitizing an area on the subject's finger immediately prior to obtaining a whole blood sample using the lancet, a pair of powder-free examination gloves (not shown) for use by the person collecting the blood sample, and a capillary blood collection tube for collecting the whole blood sample and directing it into a sample collection tube. A capillary blood collection tube 54 (shown in FIG. 5) is held by a friction fit through an opening in a circular insert 56. The sidewall of the insert forms a press-fit with the open end 44 of the sample collection tube 40 to hold the capillary blood collection tube in place within the sample collection tube when collecting a blood sample from the subject. Once the sample is collected in the sample collection tube, the insert containing the capillary blood collection tube is removed from the open end of the sample collection tube and the tube is sealed with a press-fit cap.

[0032] Before a sample is collected, the flap 12 (as shown in FIG. 1) is aligned with the card so that the card is flat for storage. The person collecting the biological sample from the subject records the sample collection date, the subject's (or patient's) ID code, and / or the sample ID code, as well as the subject's age and gender on the sample tracking card. A scanning device (not shown) can be used to scan the matrix barcode to upload the codes to a database.

[0033] Once a biological sample has been collected in a sample collection tube, one of the stickers is removed from the card and affixed to the tube. The narrow end of the tube is then engaged with the opening in the flap and the top end of the tube is moved toward the tab, moving the flap about its hinged edge until the tube engages with a recess in the capped end of the tube (Figure 2 shows the flap in a position folded out of the plane of the card). A step in the sidewall of the tube prevents the tube from passing through the opening in the card so that the tube is held in place by the flap and tab (as shown in Figure 3).

[0034] The sample tracking card and attached sample collection tube can then be shipped to a testing facility for analysis. The remaining sticker on the sample tracking card can be removed at the testing facility and attached to a paper record kept by the testing facility. This avoids any risk of transcription error in the step of recording the ID code of the sample tracking card at the testing facility. Once the test results for the biological sample are obtained, the ID code of the sample tracking card associated with the sample can be matched with the sample tracking card, and the subject (or patient) ID code and / or sample ID code from the sample tracking card can be linked with the subject, and the subject can then be notified of the test results without the tester knowing the subject's identity.

Claims

[Claim 1] The invention as depicted in the drawings of this application.

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