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`US[)U6808682B1
`
`(12) United States Patent
`Bates ct al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,303,682 B1
`Oct. 26, 2004
`
`U.S
`
`A
`A
`A
`
`2_.TS6__f15'!
`1334,64]
`4-‘‘’34-‘*'29
`4_.981_'I86 IR
`5_.38I'!_,492
`
`References Cited
`.
`I.
`.. ,
`.
`.
`.
`' PA] LNI DOCUMLN 15
`3x'19:'\? Schwala cl :11.
`.'-¥."1‘J75 Kmffczyk :.'I all.
`"W55" U""‘3“
`l.ri0.01 Dafforn ct al.
`I F1995
`Sr: yrnour
`....
`
`422158
`
`.
`
`AAAA
`
`4m”, Owens cl all
`5‘89-L840
`tut-'1<:9s; Sun
`5L<m2L336
`II.-'l‘.-'|'J|'FJ Cipkowsk-i
`5.97I'J.3'.~'JS
`l"()RI;'[(}N [’A’l‘I;'N'l' [)()(TUME.N'lS
`
`:
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`tmggj
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`t;7;335|g
`we
`,, cued by examiner
`'
`Pn'H:ai'_1-‘ I:'.\mm'ner—I _y|t: A. Alexander
`(57)
`ABSTRACT
`
`ASSAYING DEVICE CONSISTING OF THE
`TEST CARTRIDGE OR CASSETTE WITH A
`CAP OR COVER WHICH ATTACHES ONTO
`THE CARTRIDGE OR CASSE'I'l'E T0
`COVER AND SEAL T]-[E WELL OR
`()1-‘l*lNIN(} [N'l‘() WHICH '1']-lESAMl’I..Iil HAS
`BEEN I)lCI-‘()SI'['EI)
`Inventors: E. Alan Bat:-.9. Allison Park. PA (US);
`.Iefl'rv:y Kovallk, Bclhcl Park, PA (US);
`G‘-“"3” H0‘T|‘"=|I|- Pilisbufghs PA (US)
`
`Assignec: Dtx, Inv‘.:., Pittsburgh, PA {US}
`
`Nulicu:
`
`Subject to any disclaimer, the term nflhis
`palcnl
`is uxtunclcd or <'E(Ijl.|51C(.I under 35
`U.S.(.‘. 1340)) by [1 days.
`
`Appl. No; 03,935,629
`
`S‘-‘IL 23: 1997
`
`Filfidi
`Cm“ 3348
`[M Cl 7
`'
`'
`'
`U'S‘ C!‘ """""""""""""" 42258‘ 423ml; 436E165;
`at ‘I69; 43s..r3{u.'.3; 435..-395.4
`Field at qmrch
`”
`417x56 S8 61
`4323.101‘ 99_i 4; 43('Jfl’5;L *1 65:
`_
`166, 169, 174, 808; 200E528, 533, :-39;
`435x'287.I, 304.], 304.3, 305.3, 305.4
`
`An arasayiflg device curnpuscd nfa lusl carl:idgu.fcas;-sullc and
`Capfcnvcr. When attached, Iht: caphcuwr seals lhc top of a
`.'
`lc wcllfopcning on lhs: carlridgcfcassusllc in a fluid light
`:|;1zr1r111]:|cr
`to amt-1 from conIa‘l
`'th
`:1
`‘
`1
`'
`1'
`f
`_‘
`I
`'“‘”
`‘ W‘
`.“" 3"" a"“"‘‘ E‘’." "
`the llcstcd 1-aamplc (for cxar-nplu. unm: for drug lasting).
`provide water, cleaner handhng of the last Larlndgefuasscltc
`and prevent Entermixing of another 5a mplc.
`
`2!} Claims, 4 Drawing Sheets
`
`ALERE EX. 1013
`
`ALERE EX. 1013
`1 of 8
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`Sheet 4 of4
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`US 6,808,682 B1
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`1
`ASSAYING DEVICE CONSISTING OI" THE
`TEST CARTRIDGE OR CASSETTE VVITH A
`CAP OR COVER WHICH ATTACHES ONTO
`THE CARTRIDGE OR CASSETTE TO
`COVER AND SEAL THE WELL OR
`OPENING INTO WHICH THE SAMPLE HAS
`BEEN IIEPOSITEI)
`
`BACKGROUND
`
`This invention generally relates to assaying devices and in
`particular the on-site immunoassay technology used to
`detect
`the presence of drugs in urine. On-site drug tests
`generally use an immunoassay method called antigen-
`antibody competitive binding to screen for the presence of
`drugs. Among the test kits used for such testing there are
`tests composed of a housing or container which contains a
`reagent
`test strip. an opening in which test
`results are
`displayed and a place for deposit of the sample. The sample
`wicks up into the reagent
`test strip and the results are
`displayed. The results are generally available within a few
`minutes. Often it is desirable to make a photocopy of the
`results, whether positive or negative, for a permanent record,
`since test results will change or disappear over time.
`Possible problems include spilling of the sample, con-
`tamination of the sample, and contact by the test adminis-
`trator or others with the sample during handling. A method
`is needed t'or a cleaner. more sanitary and easier handling of
`the test housing during and after the test administration.
`especially since specimens can be infections. In order to
`photocopy the results, the test device is placed face down on
`the copier, so it is desirable to insure that sample will not
`leak onto the copier. Also a method is needed to insure a
`second sample from another donor is not
`inadvertently
`placed in the same test cartridgefcassette.
`SUMMARY OF Tl-ll-3 IN\/I_lN'l‘10N
`
`The housing or cartridge.r'casscttc of the present invention
`will have one or two openings or “windows” in which the
`test results are displayed and one or two wells or openings
`in the top of the cartridgefcassette for deposit of the sample.
`The sample is placed in the wellfopening by use of a pipette.
`The results will be displayed in the window. The cartridge?
`cassette and the cap or cover of the present invention will
`prevent the sample used in the test from spilling out, will
`prevent contamination of the sample, and will permit
`cleaner. more sanitary and easier handling of the cartridge!
`cassette during and after the wicking test process. The
`capfcover when placed on the cartridgefcassette will provide
`a lluid light relationship. The cartridgeicassette with the _
`capfcovcr provide a compact, easy to handle unit. The
`caplcover if placed on the cartridgefcassette as soon as the
`sample begins wicking will prevent inadvertent commin-
`gling or intermixing of another sample.
`It
`is the principal object of this invention to provide a _
`convenient, compact, easily managed device for the con-
`tainment of the sample.
`It is also a further objective to provide a means to protect
`the sample from contamination once placed into the test
`wellfopening.
`It is a further objective to provide a means to protect the
`test administrator from undesirable contact with the sample
`while handling the test cartridge during the test administra-
`tion.
`
`_
`
`_
`
`It is a further objective to provide a means to protect the
`test administrator or others from undesirable contact with
`the sample during subsequent handling ofthc test cartridge.
`
`2
`It is a further objective of the present invention to provide
`a means of insuring that while photocopying the test results
`displayed in the test cartridgetcassette the sample will not
`leak from the well/opening onto the copier.
`It is a further objective ol‘ the present invention to provide
`a means to prevent the test administrator from inadvertently
`cornmingling or intermixing at second sample from another
`donon
`
`invention will
`These and other objects of the present
`become readily apparent upon further review of the follow-
`ing Spt.:ciIICElliLit1S and drawings.
`BRIEF DESCRIPTION OF THE DRAWING
`
`In the Drawing:
`FIG. I is a perspective view of the cartridgefcassette and
`capfcover separately as seen from the front or top;
`FIG. 2 is a perspective view of the cartridgefcassette and
`cap.-“cover snapped or slipped together as seen from the front;
`FIG. 3 is a perspective view of the cartridgefcassette with
`two windows and two sample welltopenings and the cap.’
`cover separately as seen from the front or top.
`FIG. 4 is a side view of the eartrittgefcassette and of the
`capfcover (shown in cross section} showing the addition of
`edges on the cartridgefcassette and indentations on the
`capfcover for further securing the captcover.
`FIG. 5 is a side view of the cartridgercassette and of the
`caprcover (shown in cross section) showing the addition of
`indentations on the cartridgufcasselte and raised buttons on
`the capfcover for further securing the caplcover.
`DI:‘.'I]AI[.l-LI) DI:'S(_‘RlP’l'ION OF THE
`INVILNTION
`
`FIG. 1 is a perspective view of the cartridgefcassette and
`capfcover separately as seen from the front or top. The
`cartritlgefcassettc 1 contains an opening or window 2 in
`which the results on the test strip 3 will be displayed. As
`viewed in FIG. 1, cartridgefcassette 1 shows a broad, lateral
`face In, a narrow, lateral face lb. and a narrow end face Ic.
`The sample will be dropped into the wellfopening 4 on
`lateral face la, by means of a pipette. Wellfopening 4, which
`is separate from window 2, has a top in the area of top edge
`4a and extends from there into the eartridgeiteas-tette to
`surround empty pace 4!: for reception of the sample. The
`capfcover 5 has not been placed onto the canridgelcassette
`yet.
`FIG. 2 is a perspective view showing the cartridge}
`cassette and eapfcover snapped or Slipped together following
`deposit at" the sample. FIG. 2 is a view as seen from the t'ront
`or top. ‘lhc cartridgelcassette 1 with the results window 2 has
`the capfcover 5 snapped or slipped into place. The sample
`wellfopening. 4 in the other Figures, is now covered and
`sealed by the capfcover 5 in a lluicl
`tight relationship. In
`sealing, wall 5’ of capfcover 5 faces the face 1:: containing
`the welllopening 4 and contacts the top of the wellfopening.
`By sealing the top of the sample wellfopening, the caprcover
`5 transforms space 4!) into a chamber for retention ofsample
`while the sample wicks for the test. As indicated by the
`capfcover region Sr: showing in FIG. 2, when assembled
`with the car1ridgc.t'cassette passes around. and.
`in fact,
`encircles. the cartridgefcassette,
`in order to hold the cape’
`cover in a fluid tight relationship against the top of the
`sample wellfopening.
`FIG. 3 shows a cartridgefcassette I with two results
`windows 2, two test strips 3, two sample wcllfopening with
`a connecting channel 4 and a separate capfcover 5. This type
`
`6 of 8
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`

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`US 6,808,682 B1
`
`3
`of cartr'idge!cassette will accommodate more separate tests
`and requires a greater quantity of the sample.
`FIG. 4 shows a side view of the invention with the side of
`the cap!cover 5 cut away. The cartridge!cassette 1 is
`designed with a raised edge 6 and the cap!cover (shown in
`cross section) with indentations 7 which when snapped
`together will further insure the attachment.
`FIG. 5 shows a side view of the invention with these of
`the cap!cover 5 cut away. The cartridgefizassette l
`is
`designed with an indentation 8 and the cap!cover (shown in
`cross section) with a raised button '! which when snapped
`together will further insure the attachment. The end of the
`cartridge!cassette where the well.!opening is located has been
`reduced in thickness with the result that when the cap!cover
`is attached it will he flush with the edges of the cassette!
`cover.
`
`What is claimed is new and to he protected as set forth in
`the appended claims. Obviously although the embodiments
`described herein are the preferred one, modifications can be
`made to the shape of the carlridge!cassette and the cap!cover,
`without departing from the spirit and scope of this invention.
`The cartridge!cassetle and the cap!cover may be formed or
`molded from any suitable material, usually plastic or other
`similar material, hut the invention should work as well with
`most drug test materials. The cap is elfective if it slips onto
`the cartridge!cassette snugly enough to insure that
`it will
`cover and seal the top of the sample well in a llttid tight
`relationship and will not detach. Raised buttons or edges can
`also be inoorporated into the design of the cartridge!casse1te
`and cap!cover to further insure that
`the cap!cover when
`snapped or slipped into place will not detach from the
`cartridge!cassette. The number of windows and urine well!
`openings shown are currently available, but more will not
`depart from the spirit and scope of this invention.
`What is claimed are:
`
`1. An assaying device for depositing and analyzing a U
`sample. comprising:
`a. a cartridgc!cassette means which contains a test strip, a
`window for viewing test results and a wellfopening
`consisting essentially of an empty chamber separate
`from the window. having a top and serving for deposit
`of the sample; and
`. a cap!cover means for sealing the top of the sample
`weluopening in a lluid tight relationship following
`deposit of the sample; the wel.l!opening being situated
`on a broad, lateral face of the cartridgehrassette means;
`and the cap!cover means when sealing the top of the
`sample well!opening completely encircling the
`cartridgc!c:rssette means, in order to hold the cap!cover
`means in a fluid tight relationship against the top of the .
`sample well!operliI1g.
`2. An assaying device as claimed in claim 1, the cartridge!
`cassette means having a raised edge and the cap/cover
`means having indentations,
`the raised edge and the
`indentations, when snapped together, insuring the attach— ..
`ment of the cartridge!cassette means with the cap!cover
`means.
`
`3. An assaying device as claimed in claim 1, the cartridge!
`cassette means having an i.ndentation and the cap!cover
`means having a raised button, the indentation and button,
`when snapped together.
`insuring the attachment of the
`cartridgeteassctte means with the cap!cover means.
`4. An assaying device as claimed in claim 1. the cap!cover
`means having a wall which, in sealing, faces said face and
`contacts the top of the well!opening.
`5. A method of using an assaying device as claimed in
`claim 1. comprising the steps of: depositing the sample into
`
`4
`the wcll!opening; and attaching the cap!cover means to
`cover and seal the top of the welllopcning in a lluid tight
`relationship.
`6. A method as claimed in claim 5, further comprising,
`following tl'tc step of attaching,
`the additional steps of
`placing the cartridge!cassetle on a photocopier and photo-
`copying test results showing in the window.
`7. An assaying device as claimed in claim 1, the well!
`opening extending from its top into the cartridge!cassette
`means to forni the chamber for reception of sample.
`8. An assaying device as claimed in claim 7, the space
`being empty.
`9. An assaying device as claimed in claim Tr‘, the cap!cover
`means when sealing the top of the sample well!opening
`closing the chamber for retention of sample.
`10. An assaying device as claimed in claim 1. the well!
`opening extending from its top into the cartridgekassette
`means to form the chamber for reception of sample.
`11. An assaying device as claimed in claim 10. the space
`being empty.
`12. A method of using an assaying device as claimed in
`claim 10, comprising the steps of: dropping the sample in the
`form of urine into the well!opening; and attaching the
`cap!cover means to cover and seal
`the top of the well!
`opening in a fluid. light relationship.
`13. A method as claimed in claim 12, wherein the drop-
`ping is done from a pipette.
`the
`14. An assaying device as claimed in claim 10,
`cap!cover means when sealing the top of the sample well!
`opening closing the chamber for retention of sample.
`the
`15. Art assaying device as claimed in claim 14,
`cap!cover means when sealing the top of the sample well!
`opening passing around the cartridge!cassette means,
`in
`order to hold the cap!cover means in a Iluid tight relationship
`against the top of the sample wellmpening.
`the
`16. An assaying device as claimed in claim 15.
`cap!cover means when sealing the top of the sample well!
`opening completely encircling the cartridge!cas$ette means,
`in order to hold the cap!cover means in a lluid tight rela-
`tionship against the top of the sample well!opening.
`17. An assaying device for depositing and analyzing a
`sample, comprising:
`a. cartridge!cassette means which contains a test strip, a
`window for viewing test results and a wcllfopening
`separate from the window, having a top and serving for
`deposit of the sample; and
`. a cap/cover means for sealing the top of the sample
`well!opening in a lluid tight relationship following
`deposit of the sample,
`the cartridgehsassette means containing a second test
`strip, a second window, for viewing test results and a
`second well!opening having a top and serving for
`deposit of the sample, whereby there are two well!
`openings whose tops are sealed by the cap!cover means
`in a lluid tight relationship following deposit of the
`sample.
`18. An assaying (.lt.!\-'lCC as claimed in claim 17. said two
`well!openings being connected by a channel.
`19. An assaying device for depositing and analyzing a
`50 sample, comprising:
`I. a cartridge!cassette having a broad, lateral face (In), a
`narrow. lateral face (lb). and a narrow end face (lc);
`A. the cartridgelcassettc containing a test strip, a window
`in the broad, lateral face for viewing test results and,
`separate from the window, a well consisting essentially
`of an empty chamber in the broad, lateral face to serve
`for deposit of the sample; and
`
`‘.
`
`7 of 8
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`US 6,808,682 B1
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`5
`ll. a capfcover means for covering and sealing the well in
`a
`fluid tight
`relationship following deposit of the
`sample the cap/cover means when sealing the top of the
`sample wellfopening completely encircling the
`cartridgefcassettc means, in order to hold the capfcover
`means in a fluid light relationship against the well.
`20. In a device having:
`[. a cartridgefeaseette having a broad, lateral face (In), a
`narrow. lateral face (lb), and a narrow end face (lc);
`A. the carttidgefcassette containing
`i.
`a test strip for the immunoassay method called
`antigen-anliltody competitive binding to lest a
`urine sample lhr drug use,
`
`6
`ii. a window in the broad, lateral face for viewing test
`results and. separate from the window,
`iii. a well
`in the broad, lateral faoe to serve for
`deposit of the sample; the improvement compris-
`ing:
`ll. a capfeover means for covering and sealing the well in
`a
`fluid tight
`relationship following deposit of the
`sample the capfcover means when sealing the top ofthe
`sample wcllfopening completely encircling the
`catlridgefcastsette means, in order to hold the capfcover
`rneans in a lluid tight relationship against the well.
`It
`It‘
`ill
`>3
`3
`
`8 of 8