Multi-well sample collection device and method of using the same

Abstract

A holder for test tubes or vials includes: a body with a top surface and an opposing bottom surface; and a plurality of elongated cavities or wells adapted to receive the test tubes or vials, the elongated cavities or wells including openings in the top surface, and extending at least a portion of a depth of the body, where the body is configured and arranged to engage a card on the top surface of the body, where the card includes at least one aperture, pre-formed or formed by removal of area of weakness, the at least one aperture being aligned with the cavities or wells upon attachment of the card to the body, and where the cavities or wells are blocked by the card in the absence of alignment with at least one aperture, whereby test tubes or vials cannot be received within blocked cavities or wells.

Description

MULTI- WELL SAMPLE COLLECTION DEVICE AND METHOD OF USING THE SAMETECHNICAL FIELD

[0001] The present disclosure relates to sample collection devices and methods of using sample collection devices in clinical trials.BACKGROUND

[0002] Typically, clinical sample collection kits are used to provide for the collection of biological samples according to a protocol for a given clinical trial. A conventional kit includes a standard-sized box with a lid for access to the contents of the kit by a user performing the clinical trial. The box includes a number of test tubes or vials for collecting biological samples according to a given clinical trial protocol. Some of the test tubes or vials may include reagents for use in the clinical trial, and the reagents may have different expiration dates. For the clinical trial, kits are typically shipped to multiple locations for collection of biological samples from subjects in the multiple locations. Each kit is customized based on each unique clinical trial protocol and specifically designed to allow for the collection, storage, and shipping of different biological samples.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIGS. 1 A and IB depict a top view and a bottom view, respectively, of an example of a multi-well sample collection device. FIGS. 1A and IB may collectively be referred to as FIG. 1.

[0004] FIG. 2 depicts an end view of the multi-well sample collection device of FIG. 1.

[0005] FIG. 3 depicts a cross-section view of the multi-well sample collection device of FIG. 1.

[0006] FIG. 4 depicts a perspective view of an example of a multi-well sample collection device.

[0007] FIG. 5 depicts a top view of the multi-well sample collection device of FIG. 4.

[0008] FIG. 6 depicts a top view of three example cards of a multi-well sample collection device.

[0009] FIG. 7 depicts a flowchart for a method of using a multi-well sample collection device.

[0010] FIG. 8 depicts a flowchart for a method of instructing a user on the use of a multiwell sample collection device.

[0011] FIG. 9 depicts a top view of an example of a multi-well sample collection device.

[0012] FIG. 10 depicts a top view of an example of a multi-well sample collection device.

[0013] Various embodiments are described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements.DESCRIPTION OF EMBODIMENTS

[0014] As recognized by the inventor, creation of clinical sample collection kits in the medical research or similar field is time-consuming, costly, and carries a greenhouse gas emissions cost. For example, assembly of a particular kit is very structured and rigid, requiring replacement with a new kit if the testing protocol is revised. As another example, the expiration of any of the items within the kit requires the disposal of the entire kit. As such, the first item to expire in a kit requires the entire kit to be disposed. As another example, packaging of kitscreates significant waste and is resource intensive. As another example, transportation of kits to the test sites and back to the analysis site can be expensive. One factor in the transportation costs of a kit is the size of the kit, and since a kit is often a standard-sized box having a significant amount of unused space in the box, transportation financial costs and greenhouse gas emissions are incurred for this unused space.

[0015] However, as discovered by the inventor, to conduct a clinical trial, a multi- well device having one or more clinical guidance sheets may be provided for sample collection in a clinical research laboratory environment. Such a multi-well sample collection device may eliminate or reduce the need for preselection and packaging of the various items (e.g., reagents, test tubes, vials, labels, etc.) before the performance of the various procedures, tests, or experiments in a clinical trial. The clinical guidance sheets may include apertures which allow access by test tubes or vials to wells in a multi-well holder according to the protocol for a clinical trial. The absence of apertures in the clinical guidance sheets may also block access to wells in the holder. The clinical guidance sheets may further include indicia for a clinical trial, such as instructions for the protocol of the clinical trial and / or a list of the sample(s) to be collected at specific patient visits. As such, to perform a clinical trial, a user may be provided with a multiwell holder and one or more corresponding clinical guidance sheets, and the user would then be provided with, or obtain, the necessary test tubes or vials and other necessary items from the supplies of the clinical research laboratory environment to conduct the clinical trial. The indicia on the clinical guidance sheets may provide information that can be used to make labels to attach to the test tubes or vials so that the test tubes or vials can be tracked as part of the clinical trial. The labels may be made by printing the labels on a portable label printer, or other device capable of printing labels attachable to a test tube or a vial.

[0016] Providing a multi-well holder and one or more corresponding clinical guidance sheets for a clinical tail may allow for the various items (e.g., reagents, test tubes, vials, labels, etc.) needed to perform a procedure for the clinical trial to be gathered when the procedure is ready to be performed, and not pre-packaged and shipped to the test site as part of a clinical trial kit. Not needing to package and ship such various items ahead of time may eliminate or reduce the need to assemble and pack the various items into a clinical trial package (e.g., with a standard-sized box) and then transport the clinical trial package to the test site prior to the procedure. As such, by not packing and shipping to a test site the various items (e.g., reagents, test tubes, vials, labels, etc.) needed to perform a procedure for the clinical trial, the time, cost, and greenhouse gas emissions needed to package and ship these various items may be eliminated or reduced.

[0017] Further, by not providing test tubes or vials with reagents or other materials having expiration dates, the waste associated with a pre-packaged clinical sample collection kit, in which one item expires and the entire kit must be discarded, may be eliminated or reduced. Instead, with some embodiments, when a procedure for the clinical trial is ready to be performed, the various items (e.g., reagents, test tubes, vials, labels, etc.) needed to perform the procedure for the clinical trial may be gathered from the supplies of the clinical research laboratory environment. As a clinical research laboratory environment may continually use these various items for other clinical trials or other purposes, unexpired supplies of these various items may be available for use in the clinical trial, or they may be supplied centrally.

[0018] FIGS. 1 A and IB depict a top view and a bottom view, respectively, of an example of a multi-well sample collection device 100, FIG. 2 depicts an end view of the multi-well sample collection device 100 of FIG. 1, and FIG. 3 depicts a cross-section view from line 3-3 ofthe multi-well sample collection device 100 of FIG. 1. The multi-well sample collection device 100 may accommodate most, if not all, test tube or vial sizes, within the clinical research laboratory environment. The multi-well sample collection device 100 may include a multi-well holder 10 and one or more cards (or clinical guidance sheets, or clinical instruction sheets) 12. The holder 10 may include a body 11 having a top surface 11 A opposing a bottom surface 1 IB. Top surface 11A may include openings 18, which be the same size or different sizes. As an example, openings 18 may include opening 13, opening 14, opening 15, and opening 16, each of which is a different size. For clarity, not all of the openings in the drawings are numbered. The openings 18 may define cavities or wells 40 within the body 11 and between the top surface 11A and the bottom surface 11 A. The cavities or wells 40 defined by the openings 18 may be a plurality of elongated cavities or wells adapted to receive the test tubes or vials (see examples of test tubes or vials 200 and 202 seated in FIGS. 4 and 5). The cavities or wells 40 defined by the openings 18 may be elongated cavities or wells extend perpendicularly from the top surface 11A towards the bottom surface 1 IB. The test tubes or vials may contain material such as, but not limited to, biological samples, reagents, additives, medicament, medical samples, or medical material. The contents of a particular test tube or vial may be determined by a protocol for a clinical trial.

[0019] The openings 18 may be configured and arranged to receive test tubes, vials, or similar devices. The openings 18 may be sized to accommodate standard sizes of test tubes or vials. As an example, the openings 16 may be somewhat larger than the openings 15, the openings 15 may be somewhat larger than the openings 14, and the openings 14 may be somewhat larger than the openings 13. As an example, as shown in FIG. 1 A, the body 11includes forty-three openings, namely ten openings 13, fifteen openings 14, ten openings 15, and eight openings 16.

[0020] The openings 18 may be arranged in rows and columns having same or different spacing. As an example, as shown in FIG. 1A, the openings 13 are arranged in an array of rows and columns having a first spacing, the openings 14 are arranged in an array of rows and columns having a second spacing, the openings 15 are arranged in an array of rows and columns having a third spacing, and the openings 16 are arranged in an array of rows and columns having a fourth spacing.

[0021] The openings 18 may be arranged in rows and columns, such as in a generally Cartesian array. As an example, as shown in FIG. 1A, the openings 13, 14, and 15 are arranged in a first array of thirty-five openings in five rows from left to right and seven columns from top to bottom, and the openings 16 are arranged in a second array of eight openings in four rows from left to right and two columns from top to bottom.

[0022] The openings 18 may be arranged in rows and columns of the same size or different sizes. In some embodiments, the openings 18 in a column may be the same size, and the size of the openings may vary along a row. In some embodiments, the openings 18 in a row may be the same size, and the size of the openings may vary along a column. In some embodiments, the openings 18 may be arranged in sets of arrays of rows and columns, where one array may vary from another array by having one or more different sizes of openings and / or one or more different sizes of spacing between openings. In some embodiments, the openings 18 may be arranged as an array or a grid of rows and columns, where the size of the openings may be the same in a row and / or the same in a column.

[0023] As an example, FIG. 9 depicts a top view of an example of a multi-well sample collection device 100 with openings 18 that include openings 91 of the same size, the same spacing between the openings 18 in each row, and the same spacing between the openings 18 in each column. The openings 18 in FIG. 9 are arranged in an array of forty openings in five rows from left to right and eight columns from top to bottom.

[0024] As an example, FIG. 10 depicts a top view of an example of a multi-well sample collection device 100 with openings 18 that include openings 93, 94, 95, 96, and 97 of the same size in each row (from left to right). The openings 93 in the top row are larger than the openings 94 in the row below, which are larger than the openings 95 in the row below, which are larger than the openings 96 in the row below, and which are larger than the openings 97 in the row below In other words, all of the openings 93 in the first row have a first diameter, all of the opening 94 in the second row have a second diameter, all of the openings 95 in the third row have a third diameter, etc., where the first diameter is smaller than the second diameter, which is smaller than the third diameter, etc. The openings 18 in each row (from left to right) are aligned in a column (from top to bottom) with the openings 18 in the other rows, and this arrangement forms an array or grid of forty openings in five rows and eight columns.

[0025] Referring back to FIGS. 1A, IB, 2, and 3, the body can comprise at least one fastener configured to engage the card 12 and hold the card 12 in a stationary position, such as a stationary position on the top surface 11 A. As an example, as shown in FIG. 1A, the perimeter of the top surface 11 A may include detent rim sections 32, 34, and 36 along three sides to engage the card 12. As an example, as shown in FIG. 4, edges 12A, 12B, and 12C of the card 12 are engaged with the detent rim sections 32, 34, and 36, respectively. Similar methods of engagement may be used to engage the card 12 to the body 11, such as, but not limited to,magnetic engagement, snap engagement, or peelable or other adhesive. Thus, the at least one fastener may alternatively comprise a magnet, snap, adhesive, or other suitable fastener.

[0026] In some embodiments, one or more cards 12 may be situated in a storage volume or cavity 30 in the body 11 (e.g., as shown in FIGS. 1, 2, 4 (card 12-1), 9, and 10) or may be situated on top of the surface 11 A (e.g., as shown in FIGS. 4 and 5). As an example, as shown in FIG. 4, a card 12 may be on top of the surface 11 A, and one or more cards 12-1 may be situated in the storage volume 30 in the body 11. As an example, during use of the multi-well sample collection device 100, a card 12 may be on top of the surface 11 A for use in collecting and organizing test tubes or vials for the clinical trial, and one or more cards 12-1 may be held in the storage volume 30 for later use in collecting and organizing additional test tubes or vials for the clinical trial.

[0027] As an example, the card 12 in FIGS. 1 and 2 is depicted as being partially removed from the storage volume 30. The cards 12 may fit partially or fully within the storage volume 30. Access to the storage volume 30 may be from an opening 32 in a side surface 11C of the body 11. The side surface 11C may be between the top surface 11A and the bottom surface 1 IB. One or more cards 12 in the storage volume 30 may be frictionally held in place in the storage volume 30. The storage volume 30 may be situated below the openings 18 and above the back surface 1 IB of the body 11. The storage volume 30 may be situated below a bottom surface 40B of the cavities or wells 40 and above the back surface 1 IB of the body 11. The storage volume 30 may include a top surface 30A and a bottom surface 30B. The top surface 30A may prevent a test tub or vial from entering the storage volume 30 via an opening 18. The bottom surface 30B may be between the top surface 30A and the back surface 1 IB.

[0028] The back surface 1 IB of the body 11 may include an opening 55 to access the one or more cards stored in the storage volume 30. The opening 55 may be through the back surface1 IB and the bottom surface 30B to access the one or more cards stored in the storage volume 30. The opening 55 may be through the side surface 11C. The opening 55 may be sized to accommodate a digit of a user (e.g., a thumb or a finger of a user). In use, a user may frictionally touch a card 12 with a digit of the user through the opening 55 and slide the card 12 out of the storage volume 30 through the opening 32. If the one or more cards 12 are situated fully within the storage volume 30, the opening 55 may be used by a user of the multi-well sample collection device 100 to readily access the one or more cards 12.

[0029] FIG. 4 depicts a perspective view of an example of a multi-well sample collection device 100, and FIG. 5 depicts a top view of an example of the multi-well sample collection device of FIG. 4. FIG. 6 depicts a top view of three example cards of a multi-well sample collection device. FIGS. 4 and 5 differ from FIGS. 1 and 2 in that a card 12 is removed from the storage volume 30 and placed on top of the upper surface 11A. As depicted in FIG. 4, one or more cards 12-1 may remain in the storage volume 30 while a card 12 is placed on top of the upper surface 11A.

[0030] Each of the one or more cards 12 may include at least one aperture 50, pre-formed or formed by removal of area of weakness, and the at least one aperture 50 may be aligned with the cavities or wells defined by the openings 18 upon attachment of the card 12 to the body 11. As an example, each of the cards 12, 12’, 12”, and 12’” in FIGS. 4, 5, and 6 include a plurality of apertures 50, such as apertures 21, 23, 23’, 25, 27, 27’, 27”, 29, and 29”. The various apertures 50 of a card 12 may be aligned with elongated cavities or wells 40 of different rows or columns in the holder 10 upon attachment of the card 12 to the body 11. Apertures 50 may be provided inthe card 12 in order to allow access to the selected openings 18 by test tubes or vials. As an example, as shown in FIGS. 4 and 5, test tube 200 is situated or inserted in aperture 27 of the card 12 and into an opening 13 and associated cavity or well 40 of the body 11 (where the opening 13 and the associated cavity or well 40 are not visible in FIGS. 4 and 5). As an example, as shown in FIGS. 4 and 5, test tube 202 is situated or inserted in aperture 29 and into another opening 13 and associated cavity or well 40 of the body 11 (where the another opening 13 and the associated cavity or well 40 are not visible in FIGS. 4 and 5) . The area of weakness may be a perforation circumscribing a portion of the card 50 to define a possible aperture. The area of weakness may be a line or an area of weakness, such as a perforated or scored line in a circular configuration, to allow the aperture 50 to be formed immediately prior to use of the card 12.

[0031] The one or more cards 12 may be customized to the protocol sampling schedule of the clinical trial. The one or more cards 12 may include indicia related to medical information, such as information related to a clinical trial or information to perform a clinical trial, and such indicia of the one or more cards 12 may include, for example: one or more of sampling schedules, different testing schema, processes to performed, medical information, and / or various items needed (e.g., reagents, test tubes, vials, labels, etc.). The indicia of the one or more cards 12 may include, for example, textual information, instructions, and / or data indicating, for example, test description, patient identification, protocol identifiers, QR code, test number, visit number, indication of placement of test tubes or vials, color coding, identifying size or type of the test tubes or vials to be received in the openings 18 and apertures 50. The card 12 may include header area 31 which, in combination with other indicia, may include information regarding a procedure to be performed for the clinical trial. The indicia of the card 12 mayinstruct the laboratory or medical personnel in selecting the test tubes or vials for each test so that the test tubes or vials need not be prepackaged in clinical sample collection kits.

[0032] The indicia of the card 12 may inform the content of labels needing to be printed and attached, affixed, or adhered to the test tube or vials. The labels may identify contents of the corresponding test tubes or vials pursuant to the medical protocol of the clinical trial. In some embodiments, this indicia informing the content of the labels may be a QR code on the card 12. As an example, in FIGS. 4 and 5, the card 12 includes a QR code 42. The QR code may provide access to one or more labels to be printed and attached, affixed, or adhered to corresponding test tubes or vials. The QR code may provide a link to a website for the clinical trial. The QR code may provide a link to a website that may provide one or more labels that need to be printed to accompany the collected samples identified by the card 12. Once printed, the labels may be attached to corresponding test tubes or vials. Prior to collecting a sample, a label may identify the sample to be collected and the corresponding test tube or vial to insert the sample. After collecting a sample, a label attached to a test tube or vial may identify information regarding the sample contained in the test tube or vial. The labels may be printed and adhered to the test tubes or vials before the test tubes or vials are placed in the multi-well sample collection device 100.To assist in properly inserting the test tubes or vials in the correct apertures 50 in the card 12, the indicia on labels may be coordinated with corresponding indicia on the card 12. As an example, the indicia on the labels and the corresponding indicia on the card 12 may share the same one or more colors, alphanumeric characters, symbols, patterns, etc.

[0033] The indicia of the card 12 may include indicia-coded rows or columns to align with rows or columns of the openings 18 of the holder 10 when the card is situated on top of the holder 10. The indicia identifying the rows or columns may be, for example, colors and / orpatterns. As depicted in FIGS. 4, 5, and 6, the card 12 may include color-coded rows 20, 22, 24, 26, and 28 which, in the engaged configuration with the holder 10, may be aligned over the rows of openings 13, 14, 15, and 16 depicted in FIGS. 1 and 2. The color-coding of these rows 20, 22, 24, 26, and 28 may correspond to industry-standard color coding used in the caps of test tubes or vials to identify reagents and / or similar characteristics. In the absence of apertures in the card 12, access to the openings 13, 14, 15, and 16 may be blocked. More specifically, the card 12 may block openings 13, 14, 15, and 16 of different rows or columns.

[0034] FIG. 7 is a flowchart depicting a method 700 of using the multi-well sample collection device 100. While an order of operations is indicated in FIG. 7 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0035] At step 702, the user may obtain a multi-well holder for test tubes or vials. The holder 10 may include: a body 11 with a top surface 11 A and an opposing bottom surface 1 IB; and a plurality of elongated cavities or wells 40 adapted to receive the test tubes or vials, the elongated cavities or wells 40 may include openings 18 in the top surface 11A, and extending at least a portion of a depth of the body 11.

[0036] At step 704, the user may obtain a clinical guidance sheet 12 including apertures 50, each pre-formed or formed by removal of area of weakness.

[0037] At step 706, the user may scan a QR code on the clinical guidance sheet 12. The QR code may be scanned with a mobile computing device (e.g., a smartphone) of the user. The QR code may provide a link to a website that may provide one or more labels that need to be printed in accordance with the samples that need to collected per the clinical guidance sheet 12. Using the website linked from the scanned QR code, the one or more labels may be printed by the userusing a portable label printer, or other device capable of printing labels attachable to or sized for attachment to a test tube or a vial. The labels may identify contents of the corresponding test tubes or vials pursuant to the medical protocol. At step 708, the user may attach the clinical guidance sheet 12 to the holder 10 such that each aperture 50 is aligned with a corresponding one of the cavities or wells 40 of the holder 10.

[0038] At step 710, the user may select the specific test tubes or vials based on the apertures 50 of the clinical guidance sheet 12. The one or more printed labels may be attached, affixed, or adhered to the corresponding test tubes or vials. The printed labels may be attached before the test tubes or vials are placed in the multi-well sample collection device 100.

[0039] At step 712, the user may insert the specific test tubes or vials through corresponding ones of the apertures 50 and into corresponding cavities or wells 40 of the holder 10. A test tube or vial may be placed in the holder 10 before or after a sample is collected in the test tube or vial.

[0040] FIG. 8 is a flow chart depicting a method 800 of instructing a user on the use of the multi-well sample collection device 100. While an order of operations is indicated in FIG. 8 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0041] At step 802, the user is provided with a clinical guidance sheet 12 that includes apertures 50, where each aperture 50 is pre-formed or formed by removal of an area of weakness.

[0042] At step 804, the user is instructed to obtain labels to be printed and attached, adhered, or affixed to corresponding test tubes or vials. The labels may identify contents of the corresponding test tubes or vials pursuant to the medical protocol. The indicia of the clinical guidance sheet 12 may inform the content of the labels needing to be printed. In some embodiments, the user is instructed to scan a QR code on the clinical guidance sheet 12 using amobile computing device (e.g., a smartphone) of the user. The QR code may provide a link to a website that may provide one or more labels that need to be printed in accordance with the samples that need to collected per the clinical guidance sheet 12. According to the website linked from the scanned QR code, the user may be instructed to print one or more labels. The user may print the one or more labels using a portable label printer, or other device capable of printing labels attachable to or sized for attachment to a test tube or a vial.

[0043] At step 806, the user is instructed to attach the clinical guidance sheet 12 to a test tube or vial holder 10 such that each aperture 50 is aligned a cavity or well 40 of the test tube or vial holder 10.

[0044] At step 808, the user is instructed to select the specific test tubes or vials needed for the medical protocol. Once test tubes or vials needed for the medical protocol are collected, the user may be instructed to attach, affix, or adhere the printed labels to the corresponding test tubes or vials. In some embodiments, the printed labels may be attached before the test tubes or vials are placed in the multi-well sample collection device 100.

[0045] At step 810, the user is instructed user to insert the specific test tubes or vials through the apertures 50 of the clinical guidance sheet 12 and into corresponding cavities or wells 40 of the test tube or vial holder 10. A test tube or vial may be placed in the holder 10 before or after a sample is collected in the test tube or vial.

[0046] In some embodiments, and in somewhat greater detail with respect to FIGS. 7 and 8, to use the multi-well sample collection device 100, a clinician may retrieve or otherwise access a clinical guidance sheet 12 (which may be in the storage volume 30 of the holder 10). If the apertures 50 are not pre-formed in the clinical guidance sheet 12, the clinician may break the lines or areas of weakness in the clinical guidance sheet 12 to form any necessary apertures 50.The clinician may engage the clinical guidance sheet 12 to the body 11 of the holder 10 by detent or other engagement. The clinician may read the instructions on the now-installed clinical guidance sheet 12 and locate and place the necessary test tubes or vials with the prescribed contents through the various apertures 50 and therefore into openings 18 of the holder 10. The clinician may follow the indicia of the clinical guidance sheet 12 to perform the prescribed procedure. The clinician may access one or more additional clinical guidance sheets 12 stored in the holder 10 to perform further procedures as indicated by the indicia of the clinical guidance sheet 12. The clinician may use the QR code from one or more clinical guidance sheets 12 to inform the labels needed to be printed and subsequently print and attach the printed labels to the corresponding test tubes or vials for holding the corresponding collected samples.

[0047] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context. For example, and without limitation, embodiments described in dependent claim format for a given embodiment (e.g., the given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0048] Numerous modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. It is intended that the present invention need not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

CLAIMSWhat is claimed is:

1. A holder for test tubes or vials, comprising: a body with a top surface and an opposing bottom surface; and a plurality of elongated cavities or wells adapted to receive the test tubes or vials, the elongated cavities or wells including openings in the top surface, and extending at least a portion of a depth of the body, wherein the body is configured and arranged to engage a card on the top surface of the body, wherein the card includes at least one aperture, pre-formed or formed by removal of area of weakness, the at least one aperture being aligned with the cavities or wells upon attachment of the card to the body, and wherein the cavities or wells are blocked by the card in the absence of alignment with at least one aperture, whereby test tubes or vials cannot be received within blocked cavities or wells.

2. The holder of claim 1 , wherein the at least one area of weakness is a perforation circumscribing a portion of the card to define a possible aperture.

3. The holder of claim 1, wherein the at least one area of weakness is a plurality of areas of weakness at least partially arranged in rows and columns.

4. The holder of claim 1, wherein the at least one area of weakness is a plurality of areas of weakness at least partially arranged in a Cartesian configuration.

5. The holder of claim 1, wherein the elongated cavities or wells extend perpendicularly from the top surface.

6. The holder of claim 5, wherein the card is engaged to the top surface of the body by the edges of the card engaging slots within a raised rim around edges of the top surface.

7. The holder of claim 6, wherein the card is engaged to the top surface of the body by magnets or snap engagement.

8. The holder of claim 5, wherein the card includes indicia related to medical information.

9. The holder of claim 8, wherein at least a portion of the indicia is chosen from the group consisting of test description, patient identification, protocol identifiers, QR code, test number, visit number, indication of placement of test tubes or vials, color coding, and combinations thereof.

10. The holder of claim 8, wherein the at least one aperture is adapted to receive the test tubes or vials, and wherein the indicia includes information identifying at least of one of size or type of the test tubes or vials to be received by at least one corresponding aperture.

11. The holder of claim 1 , further comprising a storage volume formed between the top and bottom surfaces for storing additional cards.

12. The holder of claim 1, wherein the plurality of elongated cavities or wells are arranged in at least one of rows or columns.

13. The holder of claim 12, wherein the apertures align with the elongated cavities or wells of different rows or columns.

14. The holder of claim 12, wherein the card blocks elongated cavities or wells of different rows or columns.

15. The holder of claim 1, wherein a row of apertures on the card is associated with a row of the elongated cavities or wells, wherein the card includes indicia associated with different reagents corresponding to the row of apertures.

16. A method of organizing specific test tubes or vials needed for a medical protocol, the method comprising: obtaining a multi-well holder for the test tubes or vials, the holder comprising: a body with a top surface and an opposing bottom surface; and a plurality of elongated cavities or wells adapted to receive the test tubes or vials, the elongated cavities or wells including openings in the top surface, and extending at least a portion of a depth of the body;obtaining a clinical guidance sheet including apertures, each pre-formed or formed by removal of area of weakness; attaching the clinical guidance sheet to the holder such that each aperture is aligned with a corresponding one of the cavities or wells of the holder; selecting the specific test tubes or vials based on the apertures of the clinical guidance sheet; and inserting the specific test tubes or vials through corresponding ones of the apertures and into corresponding cavities or wells of the holder.

17. The method of claim 16, wherein a portion of the elongated cavities or wells are blocked by the clinical guidance sheet in the absence of alignment with at least one aperture, whereby test tubes or vials cannot be received within the blocked elongated cavities or wells.

18. The method of claim 16, wherein a row of apertures on the clinical guidance sheet is associated with a row of the elongated cavities or wells, wherein the clinical guidance sheet includes indicia associated with different reagents corresponding to the row of apertures.

19. The method of claim 16, wherein the area of weakness is a perforation circumscribing a portion of the clinical guidance sheet to define a possible aperture.

20. The method of claim 16, wherein the elongated cavities or wells extend perpendicularly from the top surface.

21. The method of claim 16, wherein the clinical guidance sheet is attached to the top surface of the body by the edges of the clinical guidance sheet engaging slots within a raised rim around edges of the top surface.

22. The method of claim 16, wherein the clinical guidance sheet is attached to the top surface of the body by magnets or snap engagement.

23. The method of claim 16, wherein the clinical guidance sheet includes indicia related to medical information.

24. The method of claim 19, wherein at least a portion of the indicia related to medical information is chosen from the group consisting of test description, patient identification, protocol identifiers, QR code, test number, visit number, indication of placement of test tubes or vials, color coding, and combinations thereof.

25. The method of claim 24, wherein the indicia related to medical information comprises a QR code, wherein the QR code provides access to one or more labels to be printed and attached, affixed, or adhered to corresponding test tubes or vials.

26. The method of claim 25, further comprising: scanning the QR code; printing one or more labels provided by the QR code; andattaching, affixing, or adhering the one or more labels to corresponding specific test tubes or vials, wherein the labels identify contents of the corresponding specific test tubes or vials, wherein the specific test tubes or vials having the labels attached, affixed, or adhered thereto are inserted into the holder,27. The holder of claim 24, wherein the at least one aperture is adapted to receive the test tubes or vials, and wherein the indicia related to medical information includes information identifying at least of one of size or type of the test tubes or vials to be received by at least one corresponding aperture.

28. The method of claim 16, wherein the holder further comprises a storage volume formed between the top surface and the bottom surface for storing additional clinical guidance sheets.

29. A method for instructing a user how to select specific test tubes or vials needed for a medical protocol, the method comprising: providing a clinical guidance sheet that includes apertures, each aperture pre-formed or formed by removal of an area of weakness; instructing the user to attach the clinical guidance sheet to a test tube or vial holder such that each aperture is aligned a cavity or well of the test tube or vial holder; instructing the user to select the specific test tubes or vials needed for the medical protocol; andinstructing the user to insert the specific test tubes or vials through the apertures of the clinical guidance sheet and into corresponding cavities or wells of the test tube or vial holder.

30. The method of claim 29, wherein a portion of the cavities or wells are blocked by the clinical guidance sheet in the absence of alignment with at least one aperture, whereby test tubes or vials cannot be received within the blocked cavities or wells.

31. The method of claim 29, wherein a row of apertures on the clinical guidance sheet is associated with a row of the cavities or wells, wherein the clinical guidance sheet includes indicia associated with different reagents corresponding to the row of apertures, wherein the different reagents are related to the medical protocol.

32. The method of claim 29, further comprising: instructing the user to obtain labels to be printed and attached, affixed, or adhered to corresponding test tubes or vials, wherein the labels identify contents of the corresponding test tubes or vials pursuant to the medical protocol.

33. The method of claim 32, wherein the user is instructed to obtain the labels by scanning a QR code on the clinical guidance sheet, wherein the QR code provides access to the labels.

34. The method of claim 29, further comprising: instructing the user to print labels for the specific test tubes or vials; andinstructing the user to attach, affix, or adhere the labels to the specific test tubes or vials, wherein the user is instructed to insert the specific test tubes or vials having the one or more labels attached, affixed, or adhered thereto into the test tube or vial holder.

35. A method, machine, manufacture, and / or system substantially as shown and described.

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