`
`USU(}5976895A
`
`United States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,976,895
`
`Cipkowski
`
`[45] Date of Patent:
`
`Nov. 2, 1999
`
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`[75]
`
`Inventor: Stan Cipkowski, Ancramdale. N.Y.
`
`[TF3] Assignec: American BioMedica Corporation,
`Hum» N-‘K
`
`[2]] Appl. No.: 08,363,487
`
`Mal‘ 11: 1995
`FiI°‘~'3
`[33
`Int. Cl.“ ......................... GOIN 331543; GOIN 33194
`[51]
`[523 U.S. (:1.
`........................... 4351513; 422153; 422!68.l;
`422.»-102; 435.»-7.1;435.»°7.93; 43.57.94; 43512312;
`435i'23s.7; 4351970; 4353975; 436525;
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`Field of Search ................................... .. 4351514, 513.
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`3373, 973, 3334’ 333,-_.v_ 975; 1351771;
`6{;W574 584
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`[53]
`
`[55]
`
`References cued
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`Adrug abuse 11:5! k1l has a lransparenl cup-like cuntalner lor
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`within the npencnd.Therc1s a slit In lhc Inner closure mscrt
`10 receive a multiple drug lest card having, a plurality of
`imznunoassay test strips lhcrcon with visual endpoints to
`indicale presence or absence of a parlicular drug. The
`conlainer is provided with an outer cover In close and seal
`lhc conlainer when a sample [herein is to be lransporled.
`
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`INSERTDOWNTHROUGHSLJTINFILLED
`URINE CUP
`
`FIG.9
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`l)l£VICE FOR THE C()I.l.I£C'l'ION, 'l'ES'l'lN(}
`AND SHIPMENT OF BODY FLUID SAMPLES
`
`The present invention relates to a test kit for the collec-
`tion and testing of urine samples for drugs of abuse and
`subsequent shipment of the sample, more particularly,
`to
`such a test kit having a cup-like container and a test card for
`indicating visually the presence of particular drugs of abuse.
`The increased availability and use of drugs of abuse by
`the general population has caused employers, governmental
`agencies, sports groups and other organizations to utilize
`drug screening both as a condition of employment and in
`order to maintain safety in the work place. Typical drug
`screening tests are performed for the purpose of quickly
`identifying on a qualitative basis the presence of drugs in a
`body fluid which may be urine. A complete analysis of the
`sample may then be carried out in a laboratory only if the
`preliminary screening results are positive. More and more
`such drug screenings are taking place on site or the work
`place and are generally carried out by testing personnel who
`are generally not
`technically trained, such as laboratory
`technicians.
`It
`is thus important
`that
`the drug screening
`procedure is simple but yet reliable. Further, the test appa-
`ratus must be such so as to enable the testing personnel to
`avoid all contact with the fluid specimen which is being
`tested.
`Various forms of devices have been proposed for the
`collection and taking of body lluirls, such as urine,which
`have Provided to be cumbersome in operation since they
`involve a number of separate steps. Initially, the sample was
`collected and several additional steps were then required to
`transfer the urine sample to an analysis device. This multiple
`step procedure required the manual handling of the speci-
`men through various devices and the use of such transfer
`devices inevitably caused spills which may result in con-
`tamination to the tester and surroundings. In addition, non-
`technical personnel who perform the screening tests on urine
`samples objected to coming into any kind of contact with the
`urine sample and even the handling of the sample itself.
`Many of the known testing devices were rather complex
`in that
`they included a container for the specimen, and,
`subsequently it was necessary to transfer the specimen or at
`least a portion thereof to another compartment of the con-
`tainer in order to perform the test. This transfer of the
`specimen required vigorous shaking of the container or
`tu rning the container upside down in order to cause the flow
`of the specimen into a test compartment. It was therefore
`necessary to make the containers leak proof under such
`condition and the result was a complicated and expensive
`container structure.
`Further,
`the containers incorporated the structure by
`means of which reagent strips were mounted in a test
`compartment of the container and which structure also
`enabled the lluid sample to flow into the test compartment
`into contact with the reagent strips. Such a mounting of the
`reagent strips further resulted in complicating the structure
`of the container since it was also necessary that provision be
`made to view the reagent strips from outside of the con-
`tainer. This was generally achieved by providing a transpar-
`ent window or some other mounting of the reagent strips so
`as to be visible to testing personnel.
`SUMMARY OF THE INVENTION
`
`It is therefore the principal object of the present invention
`to provide a simplified and inexpensive device for the
`collection and testing of body fluid samples. particularly
`urine, for drugs of abuse and subsequent shipment of the
`sample.
`
`ll!
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`invention to
`is an additional object of the present
`It
`provide such a device which includes a closed container for
`retaining a urine sample having such a closure structure that
`at plurality of test strips may be introduced into the container
`to contact the urine sample.
`It is a further object of the present invention to provide a
`test card having a plurality of immunoassay test strips
`thereon with each strip being responsive to a particular drug
`of abuse and having a visual endpoint
`to indicate the
`presence or absence of a particular drug.
`The objects of the present invention are achieved and the
`disadvantages of the prior art are eliminated by the drug
`abuse test device according to the present invention which
`may comprise a cup—likc transparent container for retaining
`a urine sample to be tested. The open top of the container has
`an inner closure insert seated therein and there is a diametri-
`cal slit in the insert. The slit is of such a size to accommodate
`a test card which has a plurality of immunoassay test strips
`mounted thereon in parallel on one side and each test strip
`is responsive to a particular drug o-17 abuse. The test card is
`insertable through the slit so as to have one end immersed in
`the urine sample to a predetermined depth whereby the
`visual results of each test strip can be seen through the
`transparent wall of the container without removing the test
`card from the container so as to indicate the presence or
`absence of a particular drug of abuse in the urine sample. If
`the sample should test “positive” to indicate the presence of
`a drug in the urine, it is then necessary to send the sample
`to a laboratory for confirmatory testing. For this purpose, an
`outer closure cap is provided which may be threaded onto
`the open end of the cup-like container. The insert; and the
`test card are removed from the container, the outer closure
`cap is threaded on to close the container and the container is
`then ready for shipment to a laboratory.
`As described above, the test kit includes a drug abuse test
`device for collecting and testing a urine sample. This test
`device comprises a cup-like container having a transparent
`wall and having an open top in which is seated an inner
`closure insert. The surface of the insert is spaced inwardly of
`the outer end of the container and is provided with a slit
`therein to receive a test card. An outer closure cap which
`threads over the outer end of the cup-like container is
`provided to seal the container to pcnnit the safe shipment of
`a fluid sample therein.
`The test kit also includes a screen test card for drugs of
`abuse which may comprise a thin llat member having the
`size and shape of a business card. A plurality of immunoas-
`say test strips are fastened side by side in parallel on one side
`ofthe test card within the outline ofthe card. Each test strip
`is reactive to provide a visual
`indication in response to a
`particular drug of abtuse. This test card thus provides for the
`simultaneous detection of multiple analytes.
`l3RII_{l'-' Dl_iSCRll"I'ION OI‘ Tl-IE DRAWINGS
`
`Other objects and advantages of the present invention will
`be apparent upon reference to the accompanying description
`when taken in conjunction with the following drawings,
`which are exemplary, wherein;
`FIG. 1 is an exploded perspective view ofthe drug abuse
`test kit according to the present invention generally showing
`the container, the test card inserted in the testing position in
`the container and a cover;
`FIG. 2 is an exploded perspective view of the container
`according to the present invention for collecting and testing
`a lluid sample and generally showing the container, an inner
`closure insert and an outer closure cap;
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`FIG. 3 is a plan view of the test side of the test card
`according to the present invention;
`FIG. 4 is a reverse view of the test card shown in FIG. 3;
`FIG. 5 is an end elevational view of the test card shown
`in FIG. 3;
`FIG. 6 is a sectional view taken along the lines Vl—VI of
`FIG. 3;
`FIG. 7 is a plan view of the opened two piece test card
`before it is folded over to form the test card shown in FIGS.
`3——6;
`FIG, 8 is an exploded perspective view of a modification
`ofthe container according to the present invention in which
`the inner closure insert is omitted;
`FIG. 9 is a plan view of the test side of a modification of
`the test card.
`
`FIG. 10 is a plan view of the test side of a further
`modification of the test card;
`FIG. 11 is an end elevational view ofthe test card shown
`in FIG. ll] viewed from the test end thereof.
`
`ill
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`15
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`DETAILED DESCRIPTION
`
`Proceeding next to the drawings wherein like reference
`symbols indicate the same parts throughout
`the various
`views a specific embodiment and modifications of the *
`present invention will be described in detail.
`As may be seen in FIG. 1, a drug abuse test kit according
`to the present
`invention is indicated generally at 10 and
`comprises a cup-like transparent container 11 having a
`cylindrical side wall 12, a closed bottom 13 and an open top
`14. The cylindrical wall 12 may have a slight taper or be
`straight. The open top end 14 is closed by an inner closure
`insert 15 which is shown disassembled in FIG. 2. The insert
`
`30
`
`15 comprises a circular base 16 from the periphery of which
`there is an upstanding vertical side wall 17 having an outer
`flange 18 at the top thereof. The flange 18 seats upon the
`peripheral edge of the cup open end 14 and fixes the position
`of the insert within the cup. The base 16 of the insert is
`provided with a substantially diantetrical slot 19 which is
`shaped to accommodate a test card as will be presently
`described.
`
`On the outer surface of the cylindrical wall 1'? there is a
`plurality of spaced triangular or wedge shaped reinforcing
`members 20 extending upwardly to the underside of the
`flange 18. These reinforcing members 20 also facilitate the
`removal of the insert from the open end of the cup.
`The open end 14 of the test cup 11 is provided with
`external threads 21 upon which is seated an outer closure
`member or cover 22 provided with corresponding internal
`threads which are not shown in the drawing. The outer cover
`22 comprises a circular top surface 23 from the periphery of
`which depends a cylindrical wall 24 on the inner surface of
`which are provided the internal threads.
`A test card 25 which will indicate the presence or absence
`of any one of five different dmgs of abuse is shown in I-"IG.
`I inserted within the slit [9 in the inner closure member 15.
`The test card is of the multiple drug type in that test strips
`for five different drugs of abuse are mounted on the test card.
`The test strips 26-30 are spaced apart in parallel on a test
`side 31 of the test card. These test strips indicate the
`presence or absence of the following specilic drugs of abuse:
`PCl’(P), cocaine (C), amphetamines (A), marijuana (M) and
`opiates (0). Test strips 26-30 may be of the type as made by
`Bionike of South San Francisco, Calif. and Applied Biotech,
`Inc. of San Diego, Calif. Such test strips are characterized as
`immunoassay strips and employ colloidal gold chemistry.
`
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`Each test strip is submerged up to a maximum line indicated
`at 32 and the results of the test are read in a test area
`indicated at 33. A blue line in the test area indicates positive
`or the presence of the particular drug in the test sample.
`The test strips are actually recessed in slots in the card so
`that portions of the test strips project above the test surface
`31 of the card as may be seen in FIG. 5. The test card is
`preferably formed of two plys 34 and 35 as may be seen in
`FIG. 7 and these plys in turn are formed from a single strip
`having a bend or fold 36. The ply 35 is formed within a
`plurality of dye cut slots 37 which are shaped and sized to
`receive each of the test strips. Thus, in the fabrication of a
`test card. the two portions 34 and 35 are folded over at end
`36 and are adhered together. The test strips are then placed
`into the slots as shown in FIG. 6 and each of the test strips
`is adhered to the surface of the Iirst portion 34 upon which
`the second portion 35 has been folded.
`It is also within the scope of this invention to make this
`test card of two separate or individual plys 34 and 35 which
`are then adhered together and the strips are fixed in the slots
`as described above.
`
`In order to conduct a drug abuse test utilizing the test card
`according to the present
`invention a person being tested
`must Iirst provide a urine specimen into the transparent test
`cup 11. The quantity of specimen provided must be such as
`to permit insertion of the test card up to about the maximum
`line indicated at 32. It is also possible to provide llll lines on
`the wall surface of the test container.
`
`The test cup with a sufficient quantity of test specimen
`therein is then closed by inserting the inner closure insert 15
`within the top of the test cup. The insert
`is preferably
`provided with a readily removable adhesive drug strip which
`is placed over the slit 19. Thus, when the container with
`the—tcst specimen is brought to the person conducting the,
`test, the protective strip is removed and the multiple drug
`test card 25 inserted into the slit so that the bottom of the test
`card rests upon the bottom of the test cup in the manner as
`shown in FIG. 1. 15 ml. of specimen will ensure that the
`specimen does not go above the maximum fill line 32. The
`test card then remains in place for at least three minutes and
`the results of the test can he read on each individual test strip
`through the transparent wall of the container. Thus, if a blue
`line appears on any one of the test strips,
`this indicates
`positive and the presence of that particular drug of abuse in
`the test specimen. However, if no such blue line appears then
`the absence of any of the live drugs of abuse from the
`specimen is indicated. With such a negative result, the urine
`sample and the container are discarded.
`However, when the results of the test are positive, it is
`preferable to send the specimen to a laboratory for a con-
`finnatory analysis.
`In order to shop the sample in the
`container. the inner closure insert is removed and the cover
`22 is threaded down tightly upon the open end of the
`container.
`
`As a modification. the inner closure insert 15 may be
`eliminated completely and an outer cover 38 for the con-
`tainer 11 is provided with a slit 39 through which the
`multiple drug test card is inserted. Such a modification is
`shown in FIG. 8. With this modification, if the results of the
`test are positive and it
`is contemplated to ship the urine
`sample to a laboratory for confirmatory testing, the slotted
`cover is removed and a solid cover such as 22 is. threaded
`upon the outer end of the container to seal the container
`against leakage from the fluid specimen therein.
`In FIG. 9, there is shown at 40 a modilication of the test
`card as described above and is similarly constructed with
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`is also provided with a third ply 41 which
`two plys but
`covers the test stripsas shown in FIG. 9. The third ply 41 is
`provided with an opening 42 through which the test and
`control
`lines may be seen.
`In this modificialion,
`those
`portions of the plys below the maximum fill
`line 32 are
`removed such that the test strips 26-30 project beyond the
`end 43 of the shortened test card. Otherwise. this test card
`functions in precisely the same manner as described above.
`A further modification of the test card is shown at 44 in
`FIG. 10. In this modification, the test strips are covered but
`the pertinent test and sample portions of the test strips are
`exposed through openings. The test card 4-4 comprises a
`central ply 45 which has a thickness corresponding to the
`thickness of the test strips and slots are provided in the
`center ply to receive the test strips. The top and bottom faces
`of the central ply 45 are covered by a bottom ply 46 and a
`top ply 47 which are preferably made from a single piece of
`material double scored at 48 and 49 so as to wrap around the
`central ply 45 in the manner as shown in FIG. 11. The top
`ply 4-7 is provided with a plurality of test windows 5|]
`through which the test results as indicated by the test strips
`can be seen. At
`the lower end of the card are provided
`sample openings 51 through which the test specimen is able
`to contact the absorbent or sample portions of the test strips.
`The test card 44 functions in the same manner as the *
`previously described test cards in that the card is inserted
`into the specimen up to the [ill line indicated by the wording
`"max line”. The test results are then read through the test
`windows 50.
`
`ill
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`15
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`30
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`The test strips are such that if a single band appears in the
`control zone and no band appears in the test zone then the
`results are "positive” which indicates that
`that particular
`drug is present above a predetermined level which is usually
`around 50 ngjml. If two color bands appear, one in the
`control region and the other in the test region then the test
`results are “negative” which indicates that the level of that
`particular drug is below the predetermined detection of
`sensitivity.
`In the event that there are no distinct color bands visible
`in both the test zone and the control zone or if there is a
`visible band in the test zone but not in the control zone, then
`the result is invalid and retesting of the specimen is recom-
`mended with another test card.
`
`As described above, the test card 44 of FIG. 10 may be
`made of a suitable cardboard or a plastic material.
`Thus it can be seen that the present invention discloses a
`novel and improved drug abuse test kit which comprises a
`container for the lluid specimen being tested and a multiple
`drug test card which is inserted in the specimen within the
`container and the visual results ofthe test are read on the test
`card through the transparent wall of the container. The test
`card thus comprises a number of individual test strips of the
`immunoassay type and each strip is responsive or indicative
`to a particular drug of abuse. The test card may be made of
`plastic coated cardboard or thin sheets of plastic which are
`laminated together.
`It will be understood that this invention is susceptible to
`modification in order to adapt
`it
`to different usages and
`conditions, and accordingly,
`it
`is desired to comprehend
`such modifications within this invention as may fall within
`the scope of the appended claims.
`What is claimed is:
`1. A test kit for testing of fluid samples for drugs of abuse
`comprising:
`a cup-like substantially transparent container having an
`open top end for retaining a fluid sample to be tested,
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`a closure cap positionable over the open top end of the
`Container to substantially seal the container, said clo-
`sure cap having a slit therein, and
`a drug of abuse immu no assay test card comprising
`a thin fiat member having a rectangular outline and
`having front and rear surfaces, said thin fiat member
`having a longitudinal dimension extending between
`top and bottom ends delining a length and having a
`width less than said length, and being shaped to be
`inserlable into said container longitudinally through
`said slit when said cap is positioned over the top end
`of the container,
`one or more immune assay test strips, each having
`thereon immunoassay means to visually indicate
`presence or absence of a selected drug of abuse,
`disposed longitudinally side-by-side in parallel
`within said thin flat member and enclosed between
`said front and rear surfaces,
`each said one or more test strips having a bottom end
`defining a sample receiving portion and further hav-
`ing a test portion spaced longitudinally therefrom
`wherein,
`in use,
`the presence or absence of the
`selected drug of abuse in the lluid sample is visually
`indicated, the bottom end of each said one or more
`test strips being disposed at the bottom end of said
`thin flat member but spaced from the bottom end of
`said thin flat member, the top end ofeach said one or
`more test strips being spaced from the top end ofsaid
`thin flat member,
`said front surface of said thin fiat member having a
`plurality of openings therein to register with and
`expose each of the sample receiving and test portions
`of each of said one or more test strips.
`2. The test kit as claimed in claim 1, further comprising
`a protective sealing strip over said slit which is removable
`prior to testing a fluid sample within said container.
`3. The test kit as claimed in claim 1 wherein said slit is
`diametrically disposed in said closure cap.
`4. The test kit as claimed in claim 1, Further comprising
`means within said thin flat member between said front and
`
`rear surfaces for defining one or more longitudinally extend-
`ing slots to longitudinally dispose said one or more test
`strips, each said one or more slots having both ends closed
`and spaced from the respective top and bottom ends of said
`thin llat member, and
`said one or more immuno assay test strips each seated
`within a respective slot.
`5. The test kit as claimed in claim 1 wherein said thin fiat
`member comprises a central ply having a lirst
`thickness
`sandwiched between a top ply defining said front surface
`and a bottom ply defining said rear surface,
`there being a plurality of side-by-side parallel longitudi-
`nally extending slots in said central ply to longitudi-
`nally dispose said test strips, said slots having both ends
`thereof closed and spaced from the respective top and
`bottom ends of said thin flat member, and
`said immuno assay test strips each seated within a respec-
`tive slot.
`6. The test kit as claimed in claim 1 and further compris-
`ing a second closure cap which is solid and positionable over
`the open end of the container to substantially seal
`the
`container.
`
`9 of 9
`9of9
`
`