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`US('](}5962336A
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`Ulllted States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,962,336
`
`Sun
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`[45] Date of Patent:
`
`Oct. 5, 1999
`
`I54‘ MULTI-TEST PANEL
`
`E56]
`
`References Cited
`
`I76‘
`
`[21
`
`[22
`
`Inventor: Ming Sun, V.P.R. Commerce Center,
`mm I-‘°""°' L““‘“"3- Rd" B1“°k“'°°"-
`N-1 (13012
`
`/\pp1,No_; 0s,.*953,93|]
`
`Filed:
`
`Oct. 20, 1997
`
`US PATENT DOCUMENTS
`4.931.7.% I.-"1901
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`Int. Cl.“ ................................................. _. (:tI1N 331543
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`[522 U.S. C].
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`............................ .. 436,518; 422,555; 422,456;
`423.58; 422361; 435_r"287.l; 435.-“E872;
`435f287.7; 435,-"2819; 435F805; 435.:"810;
`435E970; 435E973; 435975; 436514; -1363169;
`436E805; 43(ix'8l0
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`[531
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`Field of Search ................................ .. 42:55-53, 5:;
`435..-237.1, 237.2, 237.7, 237.9, sus, am,
`97(}. 973, 975; 436514, 518, 169, 810,
`805
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`Prirrtmtv Exmm'ner—('?|1rist0pher 1.» Chin
`Arrorrrey, Agem. or Hrm—Norman 1:}. Lx.-hrcr
`
`[57]
`
`ABSTRACT
`
`lesl sirips cunlaining a
`A rnulli-lcsl panel wilh several
`separate and diilercnl
`immtlnochromalographin: syslcrrl,
`each strip being housed in a separate structure so [hat [he
`slruulures may he joined logelher and inlcrchanged, depend-
`ing upon what substances within 2! fluid sample are being
`detected-
`
`9 Claims, 3 Drawing Sheets
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`I8
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`ALERE EX. 1007
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`Oct. 5, 1999
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`Sheet 1 of 3
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`U.S. Patent
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`Oct. 5, 1999
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`Sheet 2 MB
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`5,962,336
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`U.S. Patent
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`Oct. 5, 1999
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`Sheet 3 MB
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`5,962,336
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`5,962,336
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`1
`MUI.'I‘I-'I‘I<l§'I‘ PANEL
`
`BACKGROUND OF THE INVENTION
`
`The present invention is directed toward an analytical test
`device
`for
`analyzing body
`fluids
`using
`im munochromotography, and more particularly toward a
`pane} which consists of multiple tests which may be varied.
`The measurement of physiologically irnportant sub-
`stances in urine, serum, and tissue using immunological
`principles is well known. In particular, drug-specific anti-
`bodies and antigens have been used in a variety of immu-
`nological assay procedures for detecting antibodies or anti-
`gens in bodily fluids of humans and animals. Test devices are
`known which can identify the presence or absence of drugs
`of abuse, such as cocaine, opiates, and marijuana, using the
`protein conjugates of these drugs and their accompanying
`antibodies. Multiple tests for detecting various drugs in a
`fluid sample where the tests are contained within a single
`device in a predetermined arrangement that cannot be varied
`are also known.
`Such a multi-test device is disclosed in US. Pat. No.
`5,260,194 to Olson which is directed toward a method and
`device for determining the presence of an antigen or drug
`which specifically binds to an antibody contained on a test
`strip. The strip may be a single structure such as a sheet with
`several lanes so that a separate and different assay may be
`performed in each lane. However, this device does not
`provide for varying the tests to be conducted so that a wide
`variety of tests may be performed, as needed.
`U.S. Pat. No. 5,508,200 to 'I‘iffany et al discloses a method
`for conducting multiple chemical assays which involves
`placing small volumes of samplesfreagent combinations at
`discrete locations about a common test area on an analytical
`medium in order to test bodily fluids for various substances.
`Again, the tests contained in this device cannot be varied to
`suit the needs of the individual performing the test.
`Also. U.S. Pat. No. 5,238,652 to Sun et al discloses an
`analytical
`test for assaying various drugs using immuno-
`chromatography. The patent discloses the use of multiple
`test strips in one stnicture but it does not disclose a structure
`where the test strips can be easily rearranged and varied,
`depending upon the needs of the individual conducting the
`test.
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`ill
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`As indicated above, the problem with these multiple test
`devices is that
`the individual
`tests contained within the
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`50
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`device cannot be varied. Frequently, the person conducting
`the test may not have a need for all ofthe tests contained in
`the device. For example, a laboratory may find that they only
`test for marijuana, cocaine, and heroin in the bodily IIuid
`samples they collect. The only multi-test device available
`may be one that tests for marijuana, cocaine, and opium.
`Another, separate test would be needed to test for herein. In
`this case, the multi-test device does not eonta in the combi-
`nation of tests that the lab needs. As a result, the lab will
`waste the opium test every time they conduct the tests if they
`used the multi-test device. They must also find a separate test
`for heroin which may become time-consuming and expen-
`sive. If they don't use the multi-test device, they must find
`three individual
`tests, which may also become time-
`eonsuming and expensive. Furthermore. they will have at
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`2
`least two devices which will have to be labeled and kept
`together. Clearly, such a multi-test device does not fully suit
`the needs of the lab.
`
`SUMMARY OF THE INVENTION
`
`The present invention is designed to overcome the deli-
`ciencies of the prior art discussed above. It is an object of the
`present
`invention to provide a versatile multi-test panel
`structure which allows for testing various substances simul-
`taneously.
`Another object of the invention is to provide several test
`strips, each contained in separate structures where the struc-
`tures may be joined to one another.
`A further object of the invention is to provide a cost
`efficient and simple way of testing a bodily fluid sample for
`various drugs, disease, or pregnancy, as needed.
`In accordance with the illustrative embodiments, demon-
`strating features and advantages of the present invention,
`there is provided a multi-test panel with several test strips
`containing a separate and different immunochromatographie
`system, each strip being housed in a separate structure so
`that the structures may be joined together and interchanged,
`depending upon what substances are being detected in a
`bodily Iluid sample.
`Other objects, features, and advantages of the invention
`will be readily apparent from the following detailed descrip-
`tion of preferred embodiments thereof taken in conjunction
`with the drawings.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`there is
`For the purpose of illustrating the invention,
`shown in the accompanying drawings forms which are
`presently preferred; it being understood that the invention is
`not intended to be limited to the precise arrangements and
`instrumentalities shown.
`
`FIG. I is a front perspective view of a first embodiment
`of a test strip in one of the housings of the panel of the
`present invention;
`FIG. 2 is a rear perspective view of one of the housings
`of the panel of the first embodiment;
`FIG. 3 is an exploded view ofone of the housings and test
`strips of the panel of the first embodiment;
`FIG. 4 is a perspective view of the inside of the top half
`of the housing viewed in the direction of the line 4—4 of
`FIG. 3;
`FIG. 5 is a front perspective view of the multi-test panel
`of the present invention;
`FIG. 6 is a cross«sectionaI view of the multi-test panel of
`the invention taken through line 6-6 of FIG. 5;
`FIG. 7 is a diagrammatic view illustrating a second
`embodiment of a dip strip within a housing, and
`FIG. 8 is a diagrammatic view illustrating the second
`embodiment of the multi-test panel of the present invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Referring now to the drawings in detail wherein like
`reference numerals have been used throughout the various
`figures to designate like elements, there is shown in FIG. 5
`a multi-test panel constructed in accordance with the prin-
`ciples of the present invention and designated generally as
`10.
`
`includes two or more test strips
`The multi-test panel
`where each strip is contained in a separate housing. FIG. 5
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`depicts three such test strips 12, I4, and 16 contained in
`housings 18, 20, and 22, respectively, where the housings are
`joined together to form a panel. However, such a depiction
`is merely illustrative and should not be considered the only
`form of the multi—test panel of the present invention. Rather,
`any number of test strips and housings may be connected
`together to form the multi-test panel. Furthermore,
`the
`structure of each housing is the same, only the contents of
`each strip varies. Each housing is an individual, self-
`contained test, without being connected to another housing,
`and could be used as such. FIGS. 1-4 illustrate one housing
`and will be used to further describe the structure of the
`housings.
`As seen in FIG. 1, housing 18 has a top half 24 and a
`bottom half 26. Both halves 24 and 26 are elongated and
`generally rectangular pieces of plastic. The top halt'24 has
`a window 28 and a sample reception well 30 formed therein
`so that a test strip 12 resting within the housing 18 may be
`seen through both the window 28 and the well 30. The
`plastic may be clear or opaque. A drop of the sample to be
`tested is placed onto the test strip 12 through the well 30 and
`migrates to the rest ofthe strip. The result of the test can then
`be seen through the window 28. (The actual mechanism for
`the test
`is discussed in further detail below.) inside the _
`housing, pins 32a—!t are located along the perimeter of the
`inside surface of the top half24 with each pin extending into
`the housing. Each pin 32n—h fits into a respective hole 340-)’:
`formed along the perimeter of the inside surface of the
`bottom half 26 of the housing 18 and holds the two halves
`24 and 26 together. The bottom half 26 has teeth 36a—d
`located along the center thereof which hold the strip 12 in
`place. The top half 24 also has teeth 38n—c and protrusions
`40a-d in the center which help to hold the strip in place.
`Each test strip contains a ditferent
`imrnunoehromatov
`graphic system so that a different test may be conducted on
`each strip. That is, each strip contains a dilferent antibody at
`a pretletennined site on the strip. A few drops of the sample
`are placed into the well so that the drops migrate toward the
`antibody via capillary action. If the sample contains the
`antigen which conjugates with the antibody, colored par-
`ticles contained within the strip serve as a visual indicator
`from the specific antigenfantibody reaction. A more detailed
`discussion of the immunochromatographic mechanism of
`the present invention may be found in U.S. Pat. 5,238,652 to
`Sun et al which is herein incorporated by reference.
`The top half of each housing 18, 20, and 22 also has a
`projection 42tt—c,
`respectively.
`that
`runs along a length
`thereof and extends downwardly from the inside of the top
`half. The projection is formed along an inside edge ofthe top
`half. The bottom half of each housing 18, 20, and 22 has a
`groove or recess 4-4n—c, respectively,
`that runs along an
`inside edge of the bottom half and is formed along a length
`thereof. The groove 44a, for example. is delined by spaced
`apart walls 46:? and 48::
`that extend upwardly from the
`bottom inside surface of the bottom half 26. When the top
`halfand bottom half of a single housing are joined together,
`the groove of the bottom half and the projection of the top
`half are on opposing side edges of the housing. As shown,
`the projection and groove are exposed so as to be accessible
`from the outside of the housing.
`In order to connect one housing to another housing, the
`projection of one of the top halves is friction fitted into the
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`4
`groove of the bottom half of another housing. (See FIG. 6.)
`The housings are then in alignment with each other and can
`be easily fit together or detached. When the housings a re
`connected together, the outer surfaces of the top halves and
`the outer surfaces of the bottom halves are flush with each
`other. Thus, several housings, each containing a test strip
`detecting a dillerent substance within a fluid sample, may be
`joined and sold together, depending upon in which tests a
`physician. laboratory. or individual is interested.
`In a second embodiment, as illustrated diagrammatically
`in FIG. 7, a dip strip 112:: type test strip may be used in the
`multi-test panel. As in the lirst embodiment, each housing,
`seen as 1189 in FIG. 7, in this embodiment has a top half 124
`and a bottom half 126. With the dip strip type oftest strip an
`end of the strip extends from the housing 118a and is dipped
`into a sample. Also similar to the first embodiment, each dip
`strip contains a ditferent antibody at a predetermined site on
`the strip. The sample on the strip migrates toward the
`antibody via capillary action. If the sample contains the
`antigen which conjugates with the antibody, colored par-
`ticles contained within the strip serve as a visual indicator
`from the specific antigenfantibody reaction. The result of the
`test may be seen through window 128a. Alternatively,
`window 1280 may extend the enti.re length of the top half
`124 of the housing 118a.
`Also as in the first embodiment, the individual dip strips
`Il2n—ll2d of this embodiment are each contained in sepa-
`rate housings ll8a—1l8d,
`respectively. Each housing
`118rr—18d also has a window 128rt—128d, respectively. {See
`FIG. 8.) Each of the housings ll8n—ll8d in this embodiment
`has a construction similar to the housings of the first
`embodiment and are connected to one another in the same
`
`way that the housings in the first embodiment are connected.
`In this manner, the user is not confined to a set number and
`type of tests just because that is the only way the tests are
`packaged and sold. With the present invention a series of
`tests may be designed and custom-made for a user, depend-
`ing upon the user’s needs. Therefore, an unwanted test need
`not be included with a test that is needed, thereby saving
`money and preventing the waste of a test.
`The mu1ti~test panel may also be used for a single test
`where each strip can detect a different concentration level of
`a substance. Therefore, the particular concentration level of
`a drug in a positive sample may be determined.
`The present invention may be embodied in other specific
`forms without departing from the spirit or essential attributes
`thereof. For example, although a particular structural
`arrangement has been described for connecting the housings
`of two test strips together to form a panel,
`it should be
`readily apparent that numerous other arrangements are pos
`sible. The principle requirement
`is, of course,
`that
`the
`housings be relatively easily connected to each other to
`preferably form a relatively llat panel. Accordingly, refer-
`ence should be made to the appended claims rather than to
`the foregoing specification as indicating the scope of the
`invention.
`I claim:
`1. A multi-test panel for conducting more than one immu-
`nochromatographic test comprising:
`at least two housings;
`each of said housings having means for releasably attach-
`ing and detaching one of said housings to the other of
`said housings; and
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`a test strip containing an immunochrornalographic system
`within each of said housings wherein each of said
`systems detects a different substance or concentration
`level of a substance in a fluid sample.
`2. The multi-tcst panel of claim 1 wherein said attaching
`and detaching means includes a projection extending from
`one portion of each of said housings and a recess extending
`from another portion of each of said housings.
`3. The multi-lest panel of claim 1 wherein each of said
`housings has a top hall‘ and a bottom half, each of said halves
`having an inside surface. an outside surface, and side edges.
`4. The multi-test panel of claim 3 wherein a projection
`extends from a portion of said inner surface of said top half
`and a recess extends along a portion of said inner surface of
`said bottom half.
`5. The multi—test panel of claim 4 wherein said recess is
`defined by two walls.
`
`6
`6. The multi-test panel of claim 4 wherein said projection
`is on said side edge of said top half and said recess is on said
`side edge of said bottom half.
`7. The multi—tes1 panel of claim 4 wherein said projection
`of one of said housings is friction fitted into said recess of
`another of said housings.
`8. The multi-lest panel of claim 7 wherein said outer
`surfaces of said top halves are flush with each other and said
`outer surfaces of said bottom halves are flush with each other
`
`when said housings are connected.
`9. The multi-test panel of claim 7 wherein said housings
`are aligned with each other when said housings are con-
`neeled.
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