Diagnostic assay strip cassette
10576475 ยท 2020-03-03
Assignee
Inventors
- Connor S. Kelly (Sammamish, WA, US)
- Darby Dawn McLean (Spokane Valley, WA, US)
- Jason Buck Somes (Spokane, WA, US)
Cpc classification
B01L2300/021
PERFORMING OPERATIONS; TRANSPORTING
B01L9/52
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/025
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/141
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/041
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/14
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0816
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5023
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A cassette removably holds assay strips. The cassette includes a cover and a base. The base includes a first face and a second face, the second face opposed across a thickness of the base from the first face. The base has at least a first channel in the first face that extends along at least a portion of the base, the at least first channel having a width, a length and a depth, at least the width and the depth of the first channel sized to at least partially receive an assay strip therein. The cover has a first face and a second face, the second face opposed across a thickness of the cover from the first face. The cover is releasably securable to the base in at least two orientations to alternatively expose a first set of markings and a second set of markings. The first and the second set of markings are carried by at least one of the cover or the base. The first set of markings is indicative of a first type of assay strip and the second set of markings is indicative of a second type of assay strip; the second set of markings being different from the first set of markings. The two different orientations include a first orientation in which the first face of the cover is exposed and the second face of the cover is adjacent one of the first or the second faces of the base, and a second orientation in which the second face of the cover is exposed and the first face of the cover is adjacent one of the first or the second faces of the base.
Claims
1. A cassette to removably hold assay strips, comprising: a base, the base having a first face and a second face, the second face opposed across a thickness of the base from the first face, the base having a first channel in the first face that extends along at least a portion of the base, the first channel having a width, a length and a depth, at least the width and the depth of the first channel sized to closely removably receive an assay strip therein; and a cover, the cover having a first face and a second face, the second face opposed across a thickness of the cover from the first face, the cover releasably securable to the base in at least two orientations to alternatively expose a first set of markings and a second set of markings, the first and the second set of markings carried by at least one of the cover or the base, the first set of markings indicative of a first type of assay strip and the second set of markings indicative of a second type of assay strip, the second set of markings different from the first set of markings, the two orientations including a first orientation in which the first face of the cover is exposed and the second face of the cover is adjacent one of the first or the second faces of the base, and a second orientation in which the second face of the cover is exposed and the first face of the cover is adjacent one of the first or the second faces of the base.
2. The cassette of claim 1 wherein the base has a length and a width, and the first channel extends along the length of the base.
3. The cassette of claim 2 wherein the cover has a window and an opaque frame about the window, the window transparent to light of at least one range of wavelengths, and the first set of markings are carried on the first face of the cover and the second set of markings are carried on the second face of the cover.
4. The cassette of claim 3 wherein the window of the cover is in registration with the first channel when the cover is releasably secured to the base in both the first and the second orientations.
5. The cassette of claim 1 wherein the base has a length and a width, and the first channel extends along the length of the base and is centered with respect to the width of the base.
6. The cassette of claim 1 wherein the base has a length and a width, and has a second channel in the first face of the base that extends along at least a portion of the length of the base, the second channel having a width, a length and a depth, at least the width and the depth of the second channel sized to closely removably receive an assay strip therein, the first channel laterally disposed in a first direction from a centerline of the base and the second channel laterally disposed in a second direction from the centerline of the base, the second direction opposite the first direction.
7. The cassette of claim 6 wherein the cover has a window and an opaque frame about the window, the window transparent to light of at least one range of wavelengths, and the first set of markings are carried on the first face of the cover and the second set of markings are carried on the second face of the cover, the window spaced relatively towards a first lateral edge of the cover with respect to a second lateral edge of the cover, the second lateral edge of the cover opposed across a width of the cover from the first lateral edge of the cover.
8. The cassette of claim 7 wherein the window of the cover is in registration with the first channel when the cover is releasably secured to the base in the first orientation, and the window of the cover is in registration with the second channel when the cover is releasably secured to the base in the second orientation.
9. The cassette of claim 1 wherein the base has a length and a width, and has a second channel in the second face of the base that extends along at least a portion of the length of the base, the second channel having a width, a length and a depth, at least the width and the depth of the second channel sized to closely removably receive an assay strip therein, the first channel laterally disposed in a first direction from a centerline of the base and the second channel laterally disposed in a second direction from the centerline of the base, the second direction opposite the first direction.
10. The cassette of claim 9 wherein the cover is transparent to light of at least one range of wavelengths, and the first set of markings are carried on the first face of the base and the second set of markings are carried on the second face of the base.
11. The cassette of claim 1 wherein the first set of markings are carried on the first face of the base, a number of the first set of markings spaced laterally to a first side of the first channel, and the second set of markings are carried on the first face of the base, a number of the second set of markings spaced laterally to a second side of the first channel, the second side opposed across the first channel from the first side of the first channel.
12. The cassette of claim 11 wherein the cover has a window and an opaque frame about the window, the window transparent to light of at least one range of wavelengths, and the window laterally disposed in a first direction from a centerline of the cover.
13. The cassette of claim 12 wherein the window of the cover is in registration with the first channel and the number of the first set of markings that are spaced laterally to the first side of the first channel when the cover is releasably secured to the base in the first orientation to expose the first channel and the number of the first set of markings and occlude the number of the second set of markings in the first orientation, and the window of the cover is in registration with the first channel and the number of the second set of markings that are spaced laterally to the second side of the first channel when the cover is releasably secured to the base in the second orientation to expose the first channel and the number of the second set of markings and occlude the number of the first set of markings in the second orientation.
14. The cassette of claim 1 wherein the first set of markings include a first number of markings that extend along at least a portion of the window and which align with respective portions of the first type of assay strip when the first type of assay strip is received in the first channel, and the second set of markings include a second number of markings that extend along at least a portion of the window and which align with respective portions of the second type of assay strip when the second type of assay strip is received in the first channel.
15. The cassette of claim 13 wherein the first set of markings include a number of human-readable markings that are laterally offset to a first side of the window and the second number of markings include markings that are laterally offset to a second side of the window, the second side opposed across the window from the first side.
16. The cassette of claim 1 wherein the first set of markings include a number of human-readable markings that are laterally offset to a first side of the window and the second number of markings include markings that are laterally offset to a second side of the window, the second side opposed across the window from the first side.
17. The cassette of claim 1 wherein the first set of markings include a first machine-readable symbol that encodes a first set of machine-readable information, and the second set of markings include a second machine-readable symbol that encodes a second set of machine-readable information, the second set of machine-readable information different from the first set of machine-readable information.
18. The cassette of claim 1 wherein the cover is a transparent substrate and the frame is an opaque layer carried by the transparent substrate, and the window provides environmental protection to an assay strip removably received in the first channel.
19. The cassette of claim 1 further comprising: a plurality of magnetic elements, at least one of the magnetic elements carried by the base and at least one of the magnetic elements carried by the cover, the magnetic elements carried by the base arranged with respect to the magnetic elements carried by the cover to magnetically releasably retain the cover to the base.
20. The cassette of claim 1, further comprising: a plurality of magnetic elements, at least one of the magnetic elements carried by the base and at least one of the magnetic elements carried by the cover, the magnetic elements carried by the base arranged with respect to the magnetic elements carried by the cover to magnetically releasably retain the cover to the base only in the first and the second orientations, and not in any other orientation, where: i) in the first orientation, a plurality of markings of the first set of markings align with respective indication lines of a first type of assay strip, and ii) in the second orientation, a plurality of markings of the second set of markings align with respective indication lines of a second type of assay strip, the second type of assay strip having a fewer total number of indication lines than a total number of indication lines of the first type of assay strip.
21. The cassette of claim 20 wherein the plurality of magnetic elements include a number of magnets.
22. The cassette of claim 21 wherein the plurality of magnetic elements include a number of pieces of ferrous metal.
23. The cassette of claim 1 wherein the base is a rectangular substrate with a length and a width, and the cover is a rectangular substrate with a length and a width, the length and the width of the cover being respectively equal to the length and the width of the base.
24. The cassette of claim 1 wherein the first channel extends to an end of the base and the length of the first channel is sized such that a portion of an assay strip received in the first channel extends partially outward from the end of the base.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
(1) In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not necessarily drawn to scale, and some of these elements may be arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not necessarily intended to convey any information regarding the actual shape of the particular elements, and may have been solely selected for ease of recognition in the drawings.
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
DETAILED DESCRIPTION
(10) Generally, a cassette includes a base and a cover, the base having at least one enclosure channel sized and dimensioned to hold a test strip during a testing cycle. The cassette provides a barrier between the reagent pads on the test strip and the testing surface of a testing device, thus preventing cross contamination during multiple test sequences. The cassette may be a disposable single use cassette or designed for multiple uses including withstanding repeated cleansing cycles. The cover of the cassette is removable for easy cleaning and to visually expose different sets of testing indicia when the cover is placed upon the base of the cassette. The cover may be placed upon the base of the cassette in one of a plurality of orientations. Each orientation enables the display of a different set of testing indicia adjacent to the test strip. The visible indicia may be carried or inscribed on the cover, the base or a combination thereof. A window in the cover enables the test strip to be viewed during the testing process, along with the testing indicia being used. The window can provide environmental protection while being transparent to at least some wavelengths of electromagnetic energy (e.g. light). Magnets or other suitable connectors (e.g., releasable connectors) ensure that the proper orientation of the cover relative to the base and the test strip is used with each test strip for proper analysis.
(11) In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures and methods (e.g., various components of computing devices, principles of operation of a lateral flow strip, etc.) have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments.
(12) Unless the context requires otherwise, throughout the specification and claims that follow, the word comprising is synonymous with including, and is inclusive or open-ended (i.e., does not exclude additional, unrecited elements or method acts).
(13) Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
(14) As used in this specification and the appended claims, the singular forms a, an, and the include plural referents unless the context clearly dictates otherwise. It should also be noted that the term or is generally employed in its broadest sense, that is, as meaning and/or unless the context clearly dictates otherwise.
(15) The headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
(16)
(17)
(18) With reference to
(19) The diagnostic assay test strips 106a, 106b can take a variety of forms. For example, one diagnostic assay test strips 106a can take the form of a 5 line test strip, with 5 distinct positons, collectively 110a, each position with a respective reagent responsive to a respective assay subject substance to test for a presence or absence of the respective assay subject substance. Also for example, one diagnostic assay test strips 106b can take the form of a 10 line test strip, with 10 distinct positons, collectively 110b, each position with a respective reagent responsive to a respective assay subject substance to test for a presence or absence of the respective assay subject substance.
(20) The base 102 can take the form of a substrate, having a first face 120a and a second face 120b. The second face 120b is positioned across a thickness T.sub.b of the base 102 across from the first face 120a. The base 102 can be comprised of any of a large variety of materials, and will typically comprise a polymer, for example a plastic. The base 102 includes at least a channel 122 positioned in the first face 120a of the base, the channel 122 extending along at least a portion (e.g., length) L.sub.b of the base 102. While the channel 122 is illustrated as positioned offset to one side or the other of a centerline of the base 102 in other implementations, the channel 112 can be positioned centrally with respect to a width W.sub.b of the base 102. The first channel 122 has a width W.sub.ch, a length L.sub.ch and a depth D.sub.ch, with at least the width W.sub.ch and the depth D.sub.chof the channel 122 sized and dimensioned to closely receive the diagnostic assay test strips 106a, 106b therein. In at least some implementations, the channel 122 is sized and dimensioned to closely removably receive the diagnostic assay test strips 106a, 106b therein. As illustrated in
(21) The cover 104 can take the form of a substrate, having a first face 124a and a second face 124b. The second face 124b of the cover 120 is positioned across a thickness T.sub.c of the cover 106 from the first face 124a. The cover 120 may be a transparent substrate 126, with an opaque layer 128 carried on one face 124a, or opaque layers 128 carried on both faces of the transparent substrate 126, and with a window 130 formed in the opaque layer(s) 128. The window 130 and transparent substrate 126 are transparent to light of at least one range of wavelengths allowing imaging of the diagnostic assay test strip 106a, 106b. The window 130 may provide environmental protection between the diagnostic assay test strip 106a, 106b received in the channel 122 and surfaces of a specimen analysis system or machine reader and/or the external environment.
(22) As illustrated in
(23) The two orientations include a first orientation in which the first face 124a of the cover 104 is exposed and the second face 124b of the cover 104 is adjacent one of the first or the second faces 120a, 120b of the base 102. In a second orientation, the second face 124b of the cover 104 is exposed and the first face 124a of the cover 104 is adjacent one of the first or the second faces 120a, 120b of the base 102. In each of the first and the second orientations, the window 130 is in registration with the channel 122, thereby exposing the relevant portions of the diagnostic assay test strip 106a, 106b.
(24) As illustrated, various magnetic elements (i.e., magnets, ferrous metal) 132a, 132b are positioned on the base 102 and cover 104, respectively, which properly align the cover 104 with respect to the base 102 in each of correct or acceptable orientations of the cover 120 with respect to the base 102. In particular, the magnetic elements 132a on the base 102 and the magnetic elements 132b on cover 104 are positioned and magnetic poles orientated such that the cover 104 only attaches to the base 102 in select orientations, e.g., with the window 130 of the cover 104 aligned with the channel 122 of the base 102 and with at least some of the respective set of human- and/or machine-readable markings or information 108a, 108b aligned with respective portions of the of diagnostic assay test strip 106a, 106b. While illustrated with magnetic elements 132a, 132b, other implementations can employ other types of attachment and registration mechanisms, including snap on or click together components, pins and apertures, adhesives or hook and loop fastener Velcro (with single use cassettes) and the like.
(25) The cassette channel 100 is constructed to enable the diagnostic assay test strip 106a, 106b to remain positioned therein during automated assaying testing. The cassette 100 can be constructed for a single use or it can be manufactured for multiple uses. Whether for a single use or a multiple use, the cassette 100 may be constructed using any appropriate material, e.g., plastic, glass, polymers, resins, metal, and the like. However, if the cassette 100 is constructed for multiple uses, then the materials must be capable of withstanding any required cleansing or sterilization process, e.g., autoclaving or chemical sterilization.
(26) The cassette 100 can be constructed for use with most, if not all, standard sized testing strips. The cassette 100 is rectangular in shape having a base length L.sub.b of 9.5 cm, a base width W.sub.b of 2.5 cm and a base thickness T.sub.b of 0.4 cm. The channel 122 that extends along a portion of the base 102 and has a channel width W.sub.ch of 0.5 cm and a channel depth D.sub.ch of 0.2 cm. The channel 122 can be centered within the base 102 as illustrated in
(27) The cover 104 corresponds in length and width to the base 102. The cover 104 includes a window cut 130 having a width of 0.5 cm that allows visibility of the diagnostic assay test strip 106a, 106b, residing within the channel 122. The cover 104 has a cover thickness T.sub.c of 1.5 mm in depth. The cover 104 includes, for example, a total of three magnetic elements 132b that align with the magnetic elements 132a of the base 102. This enables the cover 104 to be magnetically secured to the base 102 based in one of a defined set of orientations via the polarity of the magnetic elements 132a, 132b. By properly aligning the plurality of the magnetic elements 132a, 132b, the cover 104 may be magnetically secured to the base 102 in, for example, one of two different orientations. Depending on the orientation, different set of human- and/or machine-readable markings or information 108a, 108b carried by the cover 104 may be visible, some of the set of human- and/or machine-readable markings or information 108a, 108b displayed adjacent respective portions of the diagnostic assay test strip 106a, 106b. Additionally or alternatively, the cover 104 may expose indicia found on the surface of the base 102, that is only exposed for selected orientations of the cover 104 when attached to the base 102.
(28)
(29)
(30) To change orientations of the cover 104 of the cassette 100 illustrated in
(31)
(32)
(33) The cassette 400 is similar to the cassette 100 (
(34) As illustrated, various magnetic elements (i.e., magnets, ferrous metal) 132a, 132b are positioned on the base 102 and cover 104, respectively, which properly align the cover 104 with respect to the base 102 in each of correct or acceptable orientations of the cover 120 with respect to the base 102. Alternatively, other fasteners can be employed, for instance snaps, detents, pins and receptacles, slots and tabs.
(35) To change orientations of the cover 404 of the cassette 100 illustrated in
(36)
(37)
(38) In contrast to previously described implementations, the cassette 700 has a first channel 722a formed in a first face 720a and a second channel 722b formed in a second face 720b, the second face 720b opposed to the first face 720a across a thickness T.sub.b of the base 702. The first and the second channels 722a, 722b may be laterally offset along a width W.sub.b of the base 702. Also contrast to previously described implementations, the entire cover 704 is transparent.
(39) As illustrated, various magnetic elements (i.e., magnets, ferrous metal) 132a, 132b are positioned on the base 702 and cover 704, respectively, which properly align the cover 704 with respect to the base 702 in registration with one another. Alternatively, other fasteners can be employed, for instance snaps, detents, pins and receptacles, slots and tabs.
(40) To change orientations, the user simply rotates the base 702 by 180 about a longitudinal axis (i.e., extending along the length of the base 702 and centered along the width of the base 702) so the desired set of human- and/or machine-readable markings or information, collectively 108a is facing up, and secures the cover 704 to the upward facing face 720a, 720b of the base 702.
(41)
(42) As illustrated, various magnetic elements (i.e., magnets, ferrous metal) 132a, 132b are positioned on the base 802 and cover 804, respectively, which properly align the cover 804 with respect to the base 802 in registration with one another. Alternatively, other fasteners can be employed, for instance snaps, detents, pins and receptacles, slots and tabs.
(43) To change orientations, the user simply rotates the cover 804 by 180 about a longitudinal axis (i.e., extending along the length of the cover 804 and centered along the width of the cover 804), and secures the cover 804 to the base 802 with the desired or correct human- and/or machine-readable markings or information 108a visible through the window 830.
(44) In the various implementations and embodiments described above, at least one of a plurality of magnetic elements 132a is carried by the base and at least one of the magnetic elements 132b is likewise carried by the cover. The magnetic elements 132a carried by the base are arranged with respect to the magnetic elements 132b carried by the cover to magnetically releasably retain the cover to the base. This provides proper orientation of the cover to the base. In the various embodiments other than that of
(45) The magnetic elements 132a, 132b may be magnets. The magnets may include a number of pieces of ferrous metal. In addition or alternatively, non-magnetic elements may be used in lieu of or in combination with the magnetic elements to properly secure the cover to the base. For example, the cover may include various structures that enable it to properly snap in place with the base only when the proper connection elements align. Similarly, adhesives or hook and loop fastener Velcro may be used, particularly for single use cassette devices.
(46) In this or any other implementation, when a cassette is used with a specimen analysis system or machine reader, the specimen analysis system or machine reader may be used to automatically or autonomously read machine-readable information carried by the cover and/or the base of the cassette. Such optically encoded data/indicia may include one of or a combination of machine readable symbols such as barcode symbols, matrix or area code symbols, stacked code symbols, and the like. The machine-readable data can include the type of test strip being used, the manufacturer thereof, and any other information considered pertinent or desired. Other data and indicia may be read using alternative methods and systems in addition to the optically encoded data or indicia. Such systems are described in detail in U.S. Pat. No. 8,446,463 which is incorporated herein by reference in its entirety. The specimen analysis system or machine reader can employ the read information in properly automatically performing analysis of the diagnostic assay test strip, for example selecting between a variety of algorithms and/or parameters and determining assay or test results based on the detected optical properties or characteristics of the diagnostic assay test strip (e.g., presence or absence of lines, color of lines) using the selected algorithm and/or based on the selected parameters. This can allow a single specimen analysis system or machine reader to autonomously be used to read a variety types of diagnostic assay test strip, without a need for an end user to program the specimen analysis system or machine reader according to the particular type of diagnostic assay test strip.
(47) Any type of indicia may be used with the cassette disclosed herein. Tactile indicia, indicia sensitive to particular wavelengths, e.g., ultraviolet and infrared, temperature sensitive indicia, and the like. Further, the indicia may be displayed on both the base and the cover using various modalities, including, but not limited to ink, raised indicia, powered displays, e.g., organic light emitting diodes, active matrix light emitting diodes, and the like.
(48) Finally, by using the cassette described herein, the test strip may be held firmly in place within the channel. The channel and the cover can hold the test strip so that an accurate scan by a reader may be made. Further, both the channel and the cover may be used to prevent cross contamination of the test strip during use.
(49) Those of skill in the art will recognize that many of the methods or algorithms set out herein may employ additional acts, may omit some acts, and/or may execute acts in a different order than specified.
(50) The various embodiments described above can be combined to provide further embodiments. To the extent that they are not inconsistent with the specific teachings and definitions herein, all of the commonly assigned U.S. patents, U.S. patent application publications, U.S. patent applications referred to in this specification, including but not limited to U.S. Pat. No. 8,446,463, U.S. patent application Ser. No. 15/014,920, filed Feb. 3, 2016; U.S. Provisional Patent Application No. 62/395,150, filed Sep. 15, 2016; and U.S. Provisional Patent Application No. 62/111,418, filed Feb. 3, 2015 are incorporated herein by reference, in their entirety. Aspects of the embodiments can be modified, if necessary, to employ systems, circuits and concepts of the various patents, applications and publications to provide yet further embodiments.
(51) These and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.