CA2189540A1 - Medical test kit - Google Patents
Medical test kitInfo
- Publication number
- CA2189540A1 CA2189540A1 CA002189540A CA2189540A CA2189540A1 CA 2189540 A1 CA2189540 A1 CA 2189540A1 CA 002189540 A CA002189540 A CA 002189540A CA 2189540 A CA2189540 A CA 2189540A CA 2189540 A1 CA2189540 A1 CA 2189540A1
- Authority
- CA
- Canada
- Prior art keywords
- funnel
- kit
- nozzle portion
- membrane
- test
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/02—Adapting objects or devices to another
- B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0681—Filter
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
- B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/81—Packaged device or kit
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/97—Test strip or test slide
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/975—Kit
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/805—Optical property
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/807—Apparatus included in process claim, e.g. physical support structures
- Y10S436/81—Tube, bottle, or dipstick
Abstract
A medical diagnostic test kit includes a rectangular flat bottom member (10) having an external raised flange (12) and an internal raised flange (13) forming a cavity (14) therein: an elongate dry chemistry membrane (20) held within the cavity (14); an arcuate cover member (25) secured to the bottom member (10) with the membrane (20) therebetween; and a funnel assembly (35) comprising a funnel member (40) removably attached to the cover member (25) with its nozzle portion (41) extending into a sample opening (29) in tile cover member (25).
Description
WO 95/29756 ~1 8 3 ~i ~ O r~
ISI!:DICAL TE8T R:~T
FI~T~n OF q~ _l ~VL~ T
The present invention related to medical te6t kits and more particularly to the ~LLU~ LULe of diagnostic te~t 5 kits.
;3~ )UI~U OF ~ 1~V~
i Nedical diagnostic test kits come in uus forms, ~nrPn~l;nlT primarily upon the L~a~ Ls that are used in the test. For example, rLe~luellLly the re~gel-L~ are 10 liguid and the test kit ; nrl~ P~ one or more bottles of the testing reagent.
other types of diagnostic tent kits rely on Lc:ay.:l.Ls that are held within a solid matrix. For example, U.S. Patent 5,290,678, entitled "Diagnostic Kit For Di~rTnnCinlT and 15 Distin~liRhinr- Chest Pain In Early Onset ~.I.L.:or~
;UL~ULated herein by reference) describes a diagnostic test kit employing a dry chemistry - ~le. That e is positioned between front and back plastic panels. Although that patent describes an PYnQl 1 Pnt 20 diagnostic panel, to tlPtPrm;nP cardiac damage by ~lPtP~n;n;n~T the pl~Se~lCe of cardiac analytes in a patient's blood, i uv may be made in terms of convenience of use of the test kit and its use for various types of tests.
25 Nore particularly, the test kit 1nrlllrlQR a separating - ~lAe that serves as the initial reririPnt and filter for the liquid sperir . The role of this ~ne is to convey the ~R-:Pnti ;~ of the Rrer;- to the test strip for the peLroLIu~llce of the assay while 30 filtering out, if p~ssihle,, P-9 such as particulates, that may be present in the initial speci-as drawn. One of the dirficulties with the fabrication _ _ . _ .... . _ . . .. . . . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ of the device is the frngility of the separating membrane, and its ~ L tendency to rupture or offer a discontinuous surface. During r-n-lf7 rtllre, particularly of devices where the ' a~læ i5 ~li crnced in 5 curved relationship about the funnel, wrinkles frequently ~orm, or the alle LulJLuL~. during se~ uL. against the funnel. The result in either event is reduced productivity and failure in use, and UULL -, A;n~ly in.i.-as~d per unit cost and reduced desirability of the 10 product.
Other devices are known as r~L. st.lLad by U.S. Patent No.
4,943,522 to Eisinger et al. and U.S. Patent No.
5,149,622 to Brown et al. that purport to provide devices 15 to serve as self-contained devices for the P~:LfOLIIIa~lU~ of an i ~C?y for the analysis, for example, of a blood or like liquid sample. The devices tl; crl osQ~ in both references, however, are of compleY ~;ullaLLu~Lion and c~r~ ;n~ly limi~ed r:~r~h;l;ties. For example, the0 ~R;n~Qr et al. device uses a test - which is of ~ uuLvaLuL~ and is thus more bulky. Also, the Eisinger et al. device is ;nr~rs-h]P of ~ r~ ' ly after the CrQri- has been deposited, and this mandates that the portion of the spQr; that would be preferably 25 discarded after the sample is deposited, must be retained. The Brown et al. device suffers from a like drawback, in that the inlet for the deposit of the spQc; is fixed to the L~ ;n~lQr of the device, and the test strip is thus r-;nt~;nQd in registry with the non-30 QCcon~;~tl ;nAQr of the 81~PC;
Neither of the ~u..aLLuuLions of ~;A;n~er et al. or Brownet al. or any other UilDLLU- LiOn lcnown to the ~rPl;c~nt herein, would work well with the ~est kit of Jackowski, par~;c~ rly as the latter kit cnnt~ l~tes the easy 35 removal of the test strip from the kit from the ~ ~ ; nllQr of the device and the portion of the initial specimen WO 95/29756 r 2~ 8i g 5 4 0 that is to be discarded. A need therefore exists for a test kit device that that is capable of opt;m;7;nr3 the speed and rpli~h1l;ty of the Ja _'~; test kit, at a reduced cost and time expenditure.
~ RY OF T~F lNv~Ll~N
The test kit of the present invention comprises a rlat bottom member having a raised flange on its outside L~-La~yular edges and having an inner raised flange forming a 1- 1 . J l ~r cavity. A test ~i.e, having 10 suitable dry chemistry for the test to be ~_L~ -', i5 in the form of an elongated strip. That strip is positioned within the ~ ..J.~l ~r cavity of the bottom member.
An arcuate cover member is positioned over the strip and 15 the bottom member. The cover member has a L~L~..yular flange which mates with the upstanding flange of the bottom member. The cover member has two elongated orpnin~c. The first opening is adapted for receipt of the patient's sample or body fluid and i5 positioned over 20 one end of the test strip. The second elongated opening is a viewing port and permits the physician, or other medical peL~u.u.el, to view the reaction of the patient's serum with the rhPmi c~l c of the test strip.
In a~cuL.la.,ce with the present invention, the funnel 25 assembly comprises the funnel holder which removably snaps into the first opening in the cover member, a funnel member rl;cro5Pr~1 in ~ ;rs~tion with said funnel holder, which funnel member defines a nozzle portion for receiving a patient's body fluid or liquid sreri- such 30 as blood or serum, at least one opening for the egress of said body f luid, and a separation - rl,.e located in wrinkle-free disposition against said funnel member and said nozzle portion for receiving said body fluid and Wo 95ng7sc ~ 21 8 9 5 ~ O P
.. .
,` 4 delivering the same to the te6t ~ e or strip. In a p~rticular: ; L, the separation membrane i5 non-adhesively held in contact with said funnel member and said nozzle portion.
5 Nore particularly, the funnel assembly may include an outer frame or retainer member that is adapted to engage said funnel member and said nozzle portion, and to cooperate with said funnel member and said nozzle portion to wrap and hold said separation ~..e in sandwich-10 like relationship U.~.k_ __... The outer frame orretainer may engage the funnel member snap-f ittably or by a ~ri -ti on fit, within the scope of the invention.
In a variant: ~ L, the kit comprises a plastic funnel assembly having three members . The f irst member 15 is a funnel holder which removably snaps into the f irst opening in the cover member. A separate plastic elongated funnel member inr~ in~ a nozzle portion fits within the elongated opening Or the snap-in member. The separationg - c.i.e is retained at the bottom of the 20 nozzle portion adjacent an egress opening defined therein .
In operation, a few drops of the patient' s blood is taken from the patient and placed in the funnel member. The 25 funnel member leads the blood, by gravity, to the separation ~- which retains the red blood cells and permits the flow-through of the patient's plasma without red blood cells to expedite the completion and sllh~oq~ nt i~lLl:L~L~dtiOn of the test. The plasma flows by 30 capillary action along the length of the elongated test c.l~e or strip and reacts, in So~nre, with appropriate ~ntiho~ c on the test ' ~l~.e or strip.
The snap-in portion may be removed while the test reactions are taking place as it is no longer useful.
35 The physician, or other medical p r~ O] ~ will then look W095l29756 ~ r~l,L. S1 2I~9~O
through the second elongated opening of the cover member to ~ Q~m;nP whether the patient's plasma has caused a reaction. A suitable reaction indication is one, or a series, of colored stripes perpFn~;c~ r to the length of 5 the elongated test stripe, which become colored only if the ~n1-;ho~ q of the stripe react with analytes in the patient ' s plasma .
Accordingly, it is a principal object of the present invention to provide a device to serve as part of a 10 diagnostic test kit that is of simple and e- - c~
~ u-.~LLu- ~ion and r~ hil ;ty in use.
It is a further object of the present invention to provide a diagnostic test kit as aforesaid that rapidly and reliably receives a liquid medium ,u:,~e. Led of 15 containing one or more analytes under detection, and delivers the lis~uid medium rapidly and hyg;~n;n~lly to an indicator 2iuL,~LL~Le for deposition thereon.
It is a still further object of the present invention to provide a diagnostic test kit as aforesaid that is easily 20 tl;C~F~ rl to retrieve the indicator -uL~LLa~e for evaluation by a medical technologist.
It is yet a further obj ect of the present invention to provide a diagnostic test kit device that is of; u~
quality and durability during both r^-n~f~ct~lre and use.
25 Other objects and alva~lL~s will become ~u~ L-.~L to those skilled in the art from a cnnC;~ation of t_e ensuing detailed description taken in conjuction with the following illustrative drawings.
Bl~T~ DES~ .. OF TE~E DRAWI~Ç~
W095129756 21~9~D P~l.... l ~~
t r ' 6 Figure 1 is a perspective view of the test medical kit of the present invention, prior to assembly;
Figure 2 is a p~La~e-,Live view of the test kit of Figure 1, after assembly;
5 Figure 3 is a top plan view of the test kit of Figure 1, after assembly;
Figure 4 ls an oYr-l o~ view of the test kit of Figure 1 showing the aLL~Il, L of its parts;
Figure 5 i8 a side plan view of the test kit prior to 10 assembly;
Figure 6 is an side plan view of ~he snap-in member;
Figure 7 is a top plan view of the test kit prior to assembly;
Figure 8 is an end plan view of the test kit of Figure 7;
15 Figure 9 is a top plan view of the snap-in member;
Figure 10 is a side plan view of the snap-in memoer;
Figure 11 is a top plan view of a multi-unit;
Figure 12 is an end plan view of the multi-unit of Figure 11;
20 Figure 13 is a top plan view of a single unit;
Figure 14 is an end plan view of the single unit of Figure 13:
W095129756 . . ~
5~
Figure 15 i8 an DS~10~ view in p-~ r~ ve of the underside of a funnel assemoly in a~uL~ ..ce with an alternate ~ ' 'i L of the invention;
Figure 16 is a péL~ye.:Live view similar to that of Figure 5 15 showing the funnel assembly as fully A~:~DmhlDd;
Figure 17 is a péLn~e~Live view of the funnel assembly of Figure 15 taken from the top side thereof;
Figure 18 is a 6ide qect;nnAl view of the funnel assembly 10 of Figure 15;
Figure 19 is a peL:,~e~Live view of a frame member in Accordance with an alternate ~ of the invention;
Figure 20 is a p~L~y~=~Live view taken from the top with the funnel holder not shown, of an r-- ' lDd funnel 15 assem'oly in ac-_uL-la..~,e with the: ' '; ' of Figure 19;
Figure 21 is a fr~A.~; LIILY peL ~e~Live view of a frame me_ber in au~ dd~.ce with an alternate ~ ' of the invention;
20 Figure 22 is a side s~ct;nnAl view similar to Figure 18, showing a funnel assembly in accordance with an alternate : ' ';- L o~ the invention; and Figure 23 is a LL, L,~LY end view partly in phantom, of the funnel asse_bly of Figure 22.
~T~TTT~n DESl.:Kl~L~ OF T~ lNV~
In accordance with the present invention there is provided a test kit for diagnostic medical E uL~oses. The test kit is ~qpec;Ally useful in cnnnD~t;nn with a test W095/~9756 2~!4~~ ~j8 p~
strip based upon the antigen/antibody rP~rt~ n n~ of the t-ype disclosed in U.S. Patent No. 5,290,678 reLel-ed to above.
The test kit comprises:
(i) a bottom member forming a flat bottom wall and having joinder means to join the bottom member to another member;
(ii) an elongated dry chemistry test - ~l.e having at least one reagent which reacts with a patient's body fluid;
(iii) a cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the al~; wherein the ~ is held between the bottom member and the cover member; and (iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to
ISI!:DICAL TE8T R:~T
FI~T~n OF q~ _l ~VL~ T
The present invention related to medical te6t kits and more particularly to the ~LLU~ LULe of diagnostic te~t 5 kits.
;3~ )UI~U OF ~ 1~V~
i Nedical diagnostic test kits come in uus forms, ~nrPn~l;nlT primarily upon the L~a~ Ls that are used in the test. For example, rLe~luellLly the re~gel-L~ are 10 liguid and the test kit ; nrl~ P~ one or more bottles of the testing reagent.
other types of diagnostic tent kits rely on Lc:ay.:l.Ls that are held within a solid matrix. For example, U.S. Patent 5,290,678, entitled "Diagnostic Kit For Di~rTnnCinlT and 15 Distin~liRhinr- Chest Pain In Early Onset ~.I.L.:or~
;UL~ULated herein by reference) describes a diagnostic test kit employing a dry chemistry - ~le. That e is positioned between front and back plastic panels. Although that patent describes an PYnQl 1 Pnt 20 diagnostic panel, to tlPtPrm;nP cardiac damage by ~lPtP~n;n;n~T the pl~Se~lCe of cardiac analytes in a patient's blood, i uv may be made in terms of convenience of use of the test kit and its use for various types of tests.
25 Nore particularly, the test kit 1nrlllrlQR a separating - ~lAe that serves as the initial reririPnt and filter for the liquid sperir . The role of this ~ne is to convey the ~R-:Pnti ;~ of the Rrer;- to the test strip for the peLroLIu~llce of the assay while 30 filtering out, if p~ssihle,, P-9 such as particulates, that may be present in the initial speci-as drawn. One of the dirficulties with the fabrication _ _ . _ .... . _ . . .. . . . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ of the device is the frngility of the separating membrane, and its ~ L tendency to rupture or offer a discontinuous surface. During r-n-lf7 rtllre, particularly of devices where the ' a~læ i5 ~li crnced in 5 curved relationship about the funnel, wrinkles frequently ~orm, or the alle LulJLuL~. during se~ uL. against the funnel. The result in either event is reduced productivity and failure in use, and UULL -, A;n~ly in.i.-as~d per unit cost and reduced desirability of the 10 product.
Other devices are known as r~L. st.lLad by U.S. Patent No.
4,943,522 to Eisinger et al. and U.S. Patent No.
5,149,622 to Brown et al. that purport to provide devices 15 to serve as self-contained devices for the P~:LfOLIIIa~lU~ of an i ~C?y for the analysis, for example, of a blood or like liquid sample. The devices tl; crl osQ~ in both references, however, are of compleY ~;ullaLLu~Lion and c~r~ ;n~ly limi~ed r:~r~h;l;ties. For example, the0 ~R;n~Qr et al. device uses a test - which is of ~ uuLvaLuL~ and is thus more bulky. Also, the Eisinger et al. device is ;nr~rs-h]P of ~ r~ ' ly after the CrQri- has been deposited, and this mandates that the portion of the spQr; that would be preferably 25 discarded after the sample is deposited, must be retained. The Brown et al. device suffers from a like drawback, in that the inlet for the deposit of the spQc; is fixed to the L~ ;n~lQr of the device, and the test strip is thus r-;nt~;nQd in registry with the non-30 QCcon~;~tl ;nAQr of the 81~PC;
Neither of the ~u..aLLuuLions of ~;A;n~er et al. or Brownet al. or any other UilDLLU- LiOn lcnown to the ~rPl;c~nt herein, would work well with the ~est kit of Jackowski, par~;c~ rly as the latter kit cnnt~ l~tes the easy 35 removal of the test strip from the kit from the ~ ~ ; nllQr of the device and the portion of the initial specimen WO 95/29756 r 2~ 8i g 5 4 0 that is to be discarded. A need therefore exists for a test kit device that that is capable of opt;m;7;nr3 the speed and rpli~h1l;ty of the Ja _'~; test kit, at a reduced cost and time expenditure.
~ RY OF T~F lNv~Ll~N
The test kit of the present invention comprises a rlat bottom member having a raised flange on its outside L~-La~yular edges and having an inner raised flange forming a 1- 1 . J l ~r cavity. A test ~i.e, having 10 suitable dry chemistry for the test to be ~_L~ -', i5 in the form of an elongated strip. That strip is positioned within the ~ ..J.~l ~r cavity of the bottom member.
An arcuate cover member is positioned over the strip and 15 the bottom member. The cover member has a L~L~..yular flange which mates with the upstanding flange of the bottom member. The cover member has two elongated orpnin~c. The first opening is adapted for receipt of the patient's sample or body fluid and i5 positioned over 20 one end of the test strip. The second elongated opening is a viewing port and permits the physician, or other medical peL~u.u.el, to view the reaction of the patient's serum with the rhPmi c~l c of the test strip.
In a~cuL.la.,ce with the present invention, the funnel 25 assembly comprises the funnel holder which removably snaps into the first opening in the cover member, a funnel member rl;cro5Pr~1 in ~ ;rs~tion with said funnel holder, which funnel member defines a nozzle portion for receiving a patient's body fluid or liquid sreri- such 30 as blood or serum, at least one opening for the egress of said body f luid, and a separation - rl,.e located in wrinkle-free disposition against said funnel member and said nozzle portion for receiving said body fluid and Wo 95ng7sc ~ 21 8 9 5 ~ O P
.. .
,` 4 delivering the same to the te6t ~ e or strip. In a p~rticular: ; L, the separation membrane i5 non-adhesively held in contact with said funnel member and said nozzle portion.
5 Nore particularly, the funnel assembly may include an outer frame or retainer member that is adapted to engage said funnel member and said nozzle portion, and to cooperate with said funnel member and said nozzle portion to wrap and hold said separation ~..e in sandwich-10 like relationship U.~.k_ __... The outer frame orretainer may engage the funnel member snap-f ittably or by a ~ri -ti on fit, within the scope of the invention.
In a variant: ~ L, the kit comprises a plastic funnel assembly having three members . The f irst member 15 is a funnel holder which removably snaps into the f irst opening in the cover member. A separate plastic elongated funnel member inr~ in~ a nozzle portion fits within the elongated opening Or the snap-in member. The separationg - c.i.e is retained at the bottom of the 20 nozzle portion adjacent an egress opening defined therein .
In operation, a few drops of the patient' s blood is taken from the patient and placed in the funnel member. The 25 funnel member leads the blood, by gravity, to the separation ~- which retains the red blood cells and permits the flow-through of the patient's plasma without red blood cells to expedite the completion and sllh~oq~ nt i~lLl:L~L~dtiOn of the test. The plasma flows by 30 capillary action along the length of the elongated test c.l~e or strip and reacts, in So~nre, with appropriate ~ntiho~ c on the test ' ~l~.e or strip.
The snap-in portion may be removed while the test reactions are taking place as it is no longer useful.
35 The physician, or other medical p r~ O] ~ will then look W095l29756 ~ r~l,L. S1 2I~9~O
through the second elongated opening of the cover member to ~ Q~m;nP whether the patient's plasma has caused a reaction. A suitable reaction indication is one, or a series, of colored stripes perpFn~;c~ r to the length of 5 the elongated test stripe, which become colored only if the ~n1-;ho~ q of the stripe react with analytes in the patient ' s plasma .
Accordingly, it is a principal object of the present invention to provide a device to serve as part of a 10 diagnostic test kit that is of simple and e- - c~
~ u-.~LLu- ~ion and r~ hil ;ty in use.
It is a further object of the present invention to provide a diagnostic test kit as aforesaid that rapidly and reliably receives a liquid medium ,u:,~e. Led of 15 containing one or more analytes under detection, and delivers the lis~uid medium rapidly and hyg;~n;n~lly to an indicator 2iuL,~LL~Le for deposition thereon.
It is a still further object of the present invention to provide a diagnostic test kit as aforesaid that is easily 20 tl;C~F~ rl to retrieve the indicator -uL~LLa~e for evaluation by a medical technologist.
It is yet a further obj ect of the present invention to provide a diagnostic test kit device that is of; u~
quality and durability during both r^-n~f~ct~lre and use.
25 Other objects and alva~lL~s will become ~u~ L-.~L to those skilled in the art from a cnnC;~ation of t_e ensuing detailed description taken in conjuction with the following illustrative drawings.
Bl~T~ DES~ .. OF TE~E DRAWI~Ç~
W095129756 21~9~D P~l.... l ~~
t r ' 6 Figure 1 is a perspective view of the test medical kit of the present invention, prior to assembly;
Figure 2 is a p~La~e-,Live view of the test kit of Figure 1, after assembly;
5 Figure 3 is a top plan view of the test kit of Figure 1, after assembly;
Figure 4 ls an oYr-l o~ view of the test kit of Figure 1 showing the aLL~Il, L of its parts;
Figure 5 i8 a side plan view of the test kit prior to 10 assembly;
Figure 6 is an side plan view of ~he snap-in member;
Figure 7 is a top plan view of the test kit prior to assembly;
Figure 8 is an end plan view of the test kit of Figure 7;
15 Figure 9 is a top plan view of the snap-in member;
Figure 10 is a side plan view of the snap-in memoer;
Figure 11 is a top plan view of a multi-unit;
Figure 12 is an end plan view of the multi-unit of Figure 11;
20 Figure 13 is a top plan view of a single unit;
Figure 14 is an end plan view of the single unit of Figure 13:
W095129756 . . ~
5~
Figure 15 i8 an DS~10~ view in p-~ r~ ve of the underside of a funnel assemoly in a~uL~ ..ce with an alternate ~ ' 'i L of the invention;
Figure 16 is a péL~ye.:Live view similar to that of Figure 5 15 showing the funnel assembly as fully A~:~DmhlDd;
Figure 17 is a péLn~e~Live view of the funnel assembly of Figure 15 taken from the top side thereof;
Figure 18 is a 6ide qect;nnAl view of the funnel assembly 10 of Figure 15;
Figure 19 is a peL:,~e~Live view of a frame member in Accordance with an alternate ~ of the invention;
Figure 20 is a p~L~y~=~Live view taken from the top with the funnel holder not shown, of an r-- ' lDd funnel 15 assem'oly in ac-_uL-la..~,e with the: ' '; ' of Figure 19;
Figure 21 is a fr~A.~; LIILY peL ~e~Live view of a frame me_ber in au~ dd~.ce with an alternate ~ ' of the invention;
20 Figure 22 is a side s~ct;nnAl view similar to Figure 18, showing a funnel assembly in accordance with an alternate : ' ';- L o~ the invention; and Figure 23 is a LL, L,~LY end view partly in phantom, of the funnel asse_bly of Figure 22.
~T~TTT~n DESl.:Kl~L~ OF T~ lNV~
In accordance with the present invention there is provided a test kit for diagnostic medical E uL~oses. The test kit is ~qpec;Ally useful in cnnnD~t;nn with a test W095/~9756 2~!4~~ ~j8 p~
strip based upon the antigen/antibody rP~rt~ n n~ of the t-ype disclosed in U.S. Patent No. 5,290,678 reLel-ed to above.
The test kit comprises:
(i) a bottom member forming a flat bottom wall and having joinder means to join the bottom member to another member;
(ii) an elongated dry chemistry test - ~l.e having at least one reagent which reacts with a patient's body fluid;
(iii) a cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the al~; wherein the ~ is held between the bottom member and the cover member; and (iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to
2 0 extend and f it within the display window opening and into proximity with said test membrane, and means to removably attach the funnel assembly to the cover member.
The test kit includes a bottom member 10 which is 25 ~ al~yular in plan view. The bottom member 10, and the other DLLU~ LULal members may be ~L.,-luced from a number of commercially available materials, ;nn7~ in~ synthetic resins such as "ABS" (acrylonitrile-butA~ .LyL~l~e copolymers), polyolefins such as polypropylene, or 30 polycarbonates, the ~oregoing being Le~Lesel~Lative and not limitative hereof.
The bottom member 10 has a flat base ll and an upstanding flange 12 which runs along the edge of the base 11 on its four sides. An elongated int~rnAl flange 13 ~orms an ~Woss/29756 218gSqb''~
elongated r~ ul i r cavity 14 . A _uitable ~ L~c_.,Lc,tive and non-limitative size for the base may be 0 . 5 inche6 high, 2 . 0 inches wide and 3 . 5 inches long.
An elongated test strip 20 is positioned within the S cavity 14. The test strip is a ~ ' - which ir.c;uL~,L~.tes dry ~hQmi~ ~l L. agé~lts and may be ~u~LL~d on an ~ .1 strip of material. The reagents are adapted to react with in the patient's plasma or other fluid which flows, by ~ ~r;ll;~ry action, along 10 the length of the test strip 20.
A cover member 25 is adapted to fit over the test strip 20 and is secured on the bottom me_ber. The cover me_ber 25 has an arcuate end 26, an arcuate body portion 27, which may be L- ~L~..yular, and two depressions 28A and 28B
15 formed between the end 26 and the body portion 27.
The cover me_ber 25 has a first elongated opening 29 (sample window) adapted to receive the patient's blood and has rounded ends. For example, each test may use 2-5 drops of blood. A second elongated opening 30 (display 20 window), which may be Le~L l.yular, within the cover me_ber 25, permits the physician or other medical P-_L~ , to view the reaction between the patient's plasma and the dry ~h~mi r;~l reagents of the test strip 20 .
25 The funnel assembly of the invention may comprise a ~unnel holder in~lllflin~ releasable a~ or f~cto.nin~ means for gripping said cover member to secure said funnel assembly thereagainst in use. A funnel me_ber is fl i cpr~cc~rl in said funnel holder and eYtends 30 therefrom so as to facilitate iCs~tion with the display window opening in said cover member. The funnel me ber defines a nozzle portion that is adapted to eYtend into said display window opening as described. The WO 95/29756 2 1 8 g 5 4 o funnel member and the nozzle portion thereof as L.~.Led herein appear to extend away ~rom said funnel holder in a plane that i9 generally L-~ v-~ to the major plane cnntA;n;n~ the funnel holder.
5 As used herein, the terms "funnel member" and "nozzle portion" associated therewith, are intended to cover structures that are of tapering design as cnnt~ 1 Ated by the ~-olloq~ l meaning of "funnel", or of cylindrical or like tubular shape as contemplated by the col l o~ ~ A
10 meaning of "nozzle", as well as :.LLU~;LUL~SI some ~pec;f;--Ally illustrated herein, that are merely three-~; innAl pro~ections that, for example may be in the shape of a rhombus, a parAll~lo~ram or like ~LLU.;LUL~
where the walls are parallel to each other, skewed either 15 toward or away from each other, or other such variations in shape. All such aL-u- LUL.:s, i nollltl;n~ L-UL;LUL s that are largely cl~letAl in cu..aLLu~ Lion are ;nrl~ and ~ nnt~ lAted within the spirit and scope of the present invention, and both terms as used herein should be 20 accorded such ~u.. I , ltnqly broad interpretation.
~he funnel member and the nozzle portion thereof define at least one opening, and in a par~icular: ; L, plural opPn;ngc for the passage th~Let~l.uuul. of the 25 liguid ~r~; enroute to its delivery to the dry chemistry test ~ e. A 6eparation cl..e is posocl in Eluid registry with said opening(s) to receive the liquid spec;- and to convey the Fp-?C; to the test membrane, while in a particular ~
30 offect;n~ a filtration of the sre~ 1 to remove unwanted and t:~L-tllleuus materials such as particulates LL_L~LL.
In a~;coLIlal~ce with the present invention, the fieparation membrane is adapted to extended arcuately about the funnel member and the nozzle portion, and likewise into 35 maximal surface contact with the test -- c...e. Both 21~95~0 features optimize uniformity, speed and extent of speci- delivery.
Referring to the drawings wherein like 1~ denote like parts and partic~ rly to Figures 15 through 23, a 5 particular funnel assembly ~ullDLLu~Lion 135 is shown that comprises funnel holder 137 ~lnfin;n~ therein an opening 136 that as ill~lDLL~t.ed, is elongated and may appear Le-,Lal-~ular in perimeter. The exact shape of opening is subject to variation in accordance with the invention, 10 and all ~qnr;~tion~ are to be c~nai~9~red as illustrative and not limitative. Opening 136 is defined by funnel member 140 that may ~e at least partially integral with funnel holder 135. Funnel member 140 in turn, defines nozzle portion thereo 141 that defines at least one 15 egress port 143 through which the spec; may exit.
Referring to Figure 15, nozzle portion defines three such egress ports 143, two of which are located on opposite walls of nozzle portion 141 and the third on the bottom.
In this particular construction of funnel member 140 and 20 nozzle portion 141, nozzle portion 141 appears almost skeletal, as it defines a LL ..~Lk that defines its three-dimensional shape and leaving large egress ports 143. A further variant of this ~.UIlDLLU~:LiOn can be seen in Figure 19.
25 A separation mem~orane 145 is tl;~epos~rl against funnel member 140 and nozzle portion 141 and into registry with - egress port(s) 143. A feature of the invention is the ostensibly wrinkle-free ~ UL V- LUL~ of separation membrane 145 as it wraps about nozzle portion 141. In a 30 particular non-limitative -'; L, this achieved in part by the particular :UIID~LU~.~iOn of funnel member 140 that facilitates smooth disposition of the separation membrane 145 thereagainst. ~hus, separation ~ ~e 145 may be gently urged against the nozzle member 141 during 35 assembly, for eYample, by the disposition thereover of an W0 95/29756 218 9 ~i 4 ~ r~ L s t -~--outer frame or retainer 146 that is a part of funnel member 140, and that _uuuc:~c,Les with nozzle portion 141 to hold separatlon ~ e in a sandwich-like el ,_, L
L1~:L~:b~LW~S~II. Frame or retainer 146 may engage nozzle portion 141 by friction fit or by snap-fittable ~r~ L, both as illustrated herein.
Thus as shown in Figures 15, 16 and 18, frame 146 may define solid side panels 148 that may define either open~n~C 149 to mate with C:OLL- ~- Ain~ pro~ections 150 defined by the adjacent side walls of nozzle 141, or vice Yersa, the respective DLLU~LULt~i adapted in either event, to achieve a snap-fittable r- ~, L with each other.
SimilArly~ and as illustrated in Figures 19 and 20, the side panels 148 of both nozzle 141 and frame or retainer 146 may define open1n7c in registry with each other, thereby relying on an extent of separation 145 to define the wall thereof. In such event, the frame or retainer 146 and nozzle 141 are sized to achieve a fr;rtinn fit against each other when the separation 2 0 ~ e is ~ rn~A thel ~} _ A further feature of the present invention is the ability of the separation membrane 145 to achieve an optimal transfer of SpP~ri- to the test membrane. This is in part facilitated by the rnhA- of surface5 j ~ sition between the respective ~~ c,l~es and the l- increase in c~rill~ry flow between the two.
l~e~errin~ now to Figures 18 and 20, the _ _ ' ~uL~-LuL~ and projection of separation membrane 145 facilitates its maximal extent through display window 30 opening and into rArillAry registry with the adjacent surface of the test - ,ne when the device is fully r ~ d.
A5 - ~ lnn~-~A~ earlier, frame or retainer may vary widely 35 in its ~UllDLLUI LiOn and shape within the scope of the ~ W095/29756 IL~ t; 7~
2~9~40 invention. mus, and with reference to Figure 21, a Lt~L~S~ LaLiVe frame 146 is shown that defines along its perimeter proximate to funnel holder 137 in full as~embly, a capturing rim 152 that defines along at least 5 a part of the cil~,u.,LeLe,,c thereof a rounded cross-section. Though not wishing to be bound to a particular theory of operation or v,.~LLu~ Lion, it is cnncid~red that the :ULV~ILUL~ of capturing rim 152 would further enhance the smooth and wrinkle-free molding of separation 10 - ` ~ne 145 against the nozzle portion 141 during the fabrication of a funnel assembly of this cu,..,LLu~Lion.
.
Further to the above and with reference to Figures 22 and 23, frame 146 may comprise a band- or ring-like ~L~U~ LUL_ for application over nozzle portion 141 as shown, to 15 retain separation ~ e 145 securely in place. To enhance the wrinkle-free application and retention of geparation ~ ' a~l~ 145 against nozzle portion 141, nozzle portion 141 may define lateral bevels 153 along the leading edges distal to funnel holder 137. Bevels 20 153 serve to further reduce the angle of ,uLvaLuLa and c ,c~ L shear and distention that may be imposed on separation membrane 145 in the fabrication of funnel nssembly 135.
A further characteristic of this vvll~LL l.iLion is 25 lllustrated in Figures 22 and 23, where it can be seen that the ~; ~~jnnC of separation ~ ~ 145 are such as to achieve an overlap along the marginal edges of nozzle portion 141. Thus, the edges 154 of separation - ~l,e 145 can be seen to extend around and up the 30 sides o~ nozzle portion 141. This further assists in achieving the wrinkle-free application and disposition of separation a..e 145 in the finally ~-- led funnel assembly 135 of this illustrated: ; L.
WO 95/29756 2 ~ 8 ~ 4 ~
In a-_. .,r-lal~ce with an alternate ~ of the invention illustrated in Figures 2-4, 9 and 10, funnel assembly comprises a funnel holder or a snap-in member 35 is adapted to be removably c~ .P- ~ed withln the 5 depressions 28 and 29 defined by the cover member 25.
The snap-in member 35 has an elongated opening 36 which i3 of the same size and shape as the opening 29 of the cover member 25. An elongated funnel member 40 has ~
hollow nozzle portion 41 which fits through the opening 10 36. An P~torn~lly projecting rim 42 of the funnel member 40 mates with the top face 37 of the snap-in member 35 and ~L-:V~ ; the funnel member from passing through the opening 35. A separation ~ ,.e 45 is positioned at the bottom of funnel 40 and is held by the tapered shape 15 of the funnel nozzle portion 41.
It is to be understood that the ir~vention is not limited to the illustrations described and shown herein, which are deemed to be merely illustrative of the best modes of carrying out the invention, and which are susceptible of 20 1fl~ation of form, size, ~-L-c~r, of parts and details of operation . The invention rather is i ntPn~
to Pn~ _-RR all such -Sif;cations which are within its spirit and scope as defined bl the claims.
.
The test kit includes a bottom member 10 which is 25 ~ al~yular in plan view. The bottom member 10, and the other DLLU~ LULal members may be ~L.,-luced from a number of commercially available materials, ;nn7~ in~ synthetic resins such as "ABS" (acrylonitrile-butA~ .LyL~l~e copolymers), polyolefins such as polypropylene, or 30 polycarbonates, the ~oregoing being Le~Lesel~Lative and not limitative hereof.
The bottom member 10 has a flat base ll and an upstanding flange 12 which runs along the edge of the base 11 on its four sides. An elongated int~rnAl flange 13 ~orms an ~Woss/29756 218gSqb''~
elongated r~ ul i r cavity 14 . A _uitable ~ L~c_.,Lc,tive and non-limitative size for the base may be 0 . 5 inche6 high, 2 . 0 inches wide and 3 . 5 inches long.
An elongated test strip 20 is positioned within the S cavity 14. The test strip is a ~ ' - which ir.c;uL~,L~.tes dry ~hQmi~ ~l L. agé~lts and may be ~u~LL~d on an ~ .1 strip of material. The reagents are adapted to react with in the patient's plasma or other fluid which flows, by ~ ~r;ll;~ry action, along 10 the length of the test strip 20.
A cover member 25 is adapted to fit over the test strip 20 and is secured on the bottom me_ber. The cover me_ber 25 has an arcuate end 26, an arcuate body portion 27, which may be L- ~L~..yular, and two depressions 28A and 28B
15 formed between the end 26 and the body portion 27.
The cover me_ber 25 has a first elongated opening 29 (sample window) adapted to receive the patient's blood and has rounded ends. For example, each test may use 2-5 drops of blood. A second elongated opening 30 (display 20 window), which may be Le~L l.yular, within the cover me_ber 25, permits the physician or other medical P-_L~ , to view the reaction between the patient's plasma and the dry ~h~mi r;~l reagents of the test strip 20 .
25 The funnel assembly of the invention may comprise a ~unnel holder in~lllflin~ releasable a~ or f~cto.nin~ means for gripping said cover member to secure said funnel assembly thereagainst in use. A funnel me_ber is fl i cpr~cc~rl in said funnel holder and eYtends 30 therefrom so as to facilitate iCs~tion with the display window opening in said cover member. The funnel me ber defines a nozzle portion that is adapted to eYtend into said display window opening as described. The WO 95/29756 2 1 8 g 5 4 o funnel member and the nozzle portion thereof as L.~.Led herein appear to extend away ~rom said funnel holder in a plane that i9 generally L-~ v-~ to the major plane cnntA;n;n~ the funnel holder.
5 As used herein, the terms "funnel member" and "nozzle portion" associated therewith, are intended to cover structures that are of tapering design as cnnt~ 1 Ated by the ~-olloq~ l meaning of "funnel", or of cylindrical or like tubular shape as contemplated by the col l o~ ~ A
10 meaning of "nozzle", as well as :.LLU~;LUL~SI some ~pec;f;--Ally illustrated herein, that are merely three-~; innAl pro~ections that, for example may be in the shape of a rhombus, a parAll~lo~ram or like ~LLU.;LUL~
where the walls are parallel to each other, skewed either 15 toward or away from each other, or other such variations in shape. All such aL-u- LUL.:s, i nollltl;n~ L-UL;LUL s that are largely cl~letAl in cu..aLLu~ Lion are ;nrl~ and ~ nnt~ lAted within the spirit and scope of the present invention, and both terms as used herein should be 20 accorded such ~u.. I , ltnqly broad interpretation.
~he funnel member and the nozzle portion thereof define at least one opening, and in a par~icular: ; L, plural opPn;ngc for the passage th~Let~l.uuul. of the 25 liguid ~r~; enroute to its delivery to the dry chemistry test ~ e. A 6eparation cl..e is posocl in Eluid registry with said opening(s) to receive the liquid spec;- and to convey the Fp-?C; to the test membrane, while in a particular ~
30 offect;n~ a filtration of the sre~ 1 to remove unwanted and t:~L-tllleuus materials such as particulates LL_L~LL.
In a~;coLIlal~ce with the present invention, the fieparation membrane is adapted to extended arcuately about the funnel member and the nozzle portion, and likewise into 35 maximal surface contact with the test -- c...e. Both 21~95~0 features optimize uniformity, speed and extent of speci- delivery.
Referring to the drawings wherein like 1~ denote like parts and partic~ rly to Figures 15 through 23, a 5 particular funnel assembly ~ullDLLu~Lion 135 is shown that comprises funnel holder 137 ~lnfin;n~ therein an opening 136 that as ill~lDLL~t.ed, is elongated and may appear Le-,Lal-~ular in perimeter. The exact shape of opening is subject to variation in accordance with the invention, 10 and all ~qnr;~tion~ are to be c~nai~9~red as illustrative and not limitative. Opening 136 is defined by funnel member 140 that may ~e at least partially integral with funnel holder 135. Funnel member 140 in turn, defines nozzle portion thereo 141 that defines at least one 15 egress port 143 through which the spec; may exit.
Referring to Figure 15, nozzle portion defines three such egress ports 143, two of which are located on opposite walls of nozzle portion 141 and the third on the bottom.
In this particular construction of funnel member 140 and 20 nozzle portion 141, nozzle portion 141 appears almost skeletal, as it defines a LL ..~Lk that defines its three-dimensional shape and leaving large egress ports 143. A further variant of this ~.UIlDLLU~:LiOn can be seen in Figure 19.
25 A separation mem~orane 145 is tl;~epos~rl against funnel member 140 and nozzle portion 141 and into registry with - egress port(s) 143. A feature of the invention is the ostensibly wrinkle-free ~ UL V- LUL~ of separation membrane 145 as it wraps about nozzle portion 141. In a 30 particular non-limitative -'; L, this achieved in part by the particular :UIID~LU~.~iOn of funnel member 140 that facilitates smooth disposition of the separation membrane 145 thereagainst. ~hus, separation ~ ~e 145 may be gently urged against the nozzle member 141 during 35 assembly, for eYample, by the disposition thereover of an W0 95/29756 218 9 ~i 4 ~ r~ L s t -~--outer frame or retainer 146 that is a part of funnel member 140, and that _uuuc:~c,Les with nozzle portion 141 to hold separatlon ~ e in a sandwich-like el ,_, L
L1~:L~:b~LW~S~II. Frame or retainer 146 may engage nozzle portion 141 by friction fit or by snap-fittable ~r~ L, both as illustrated herein.
Thus as shown in Figures 15, 16 and 18, frame 146 may define solid side panels 148 that may define either open~n~C 149 to mate with C:OLL- ~- Ain~ pro~ections 150 defined by the adjacent side walls of nozzle 141, or vice Yersa, the respective DLLU~LULt~i adapted in either event, to achieve a snap-fittable r- ~, L with each other.
SimilArly~ and as illustrated in Figures 19 and 20, the side panels 148 of both nozzle 141 and frame or retainer 146 may define open1n7c in registry with each other, thereby relying on an extent of separation 145 to define the wall thereof. In such event, the frame or retainer 146 and nozzle 141 are sized to achieve a fr;rtinn fit against each other when the separation 2 0 ~ e is ~ rn~A thel ~} _ A further feature of the present invention is the ability of the separation membrane 145 to achieve an optimal transfer of SpP~ri- to the test membrane. This is in part facilitated by the rnhA- of surface5 j ~ sition between the respective ~~ c,l~es and the l- increase in c~rill~ry flow between the two.
l~e~errin~ now to Figures 18 and 20, the _ _ ' ~uL~-LuL~ and projection of separation membrane 145 facilitates its maximal extent through display window 30 opening and into rArillAry registry with the adjacent surface of the test - ,ne when the device is fully r ~ d.
A5 - ~ lnn~-~A~ earlier, frame or retainer may vary widely 35 in its ~UllDLLUI LiOn and shape within the scope of the ~ W095/29756 IL~ t; 7~
2~9~40 invention. mus, and with reference to Figure 21, a Lt~L~S~ LaLiVe frame 146 is shown that defines along its perimeter proximate to funnel holder 137 in full as~embly, a capturing rim 152 that defines along at least 5 a part of the cil~,u.,LeLe,,c thereof a rounded cross-section. Though not wishing to be bound to a particular theory of operation or v,.~LLu~ Lion, it is cnncid~red that the :ULV~ILUL~ of capturing rim 152 would further enhance the smooth and wrinkle-free molding of separation 10 - ` ~ne 145 against the nozzle portion 141 during the fabrication of a funnel assembly of this cu,..,LLu~Lion.
.
Further to the above and with reference to Figures 22 and 23, frame 146 may comprise a band- or ring-like ~L~U~ LUL_ for application over nozzle portion 141 as shown, to 15 retain separation ~ e 145 securely in place. To enhance the wrinkle-free application and retention of geparation ~ ' a~l~ 145 against nozzle portion 141, nozzle portion 141 may define lateral bevels 153 along the leading edges distal to funnel holder 137. Bevels 20 153 serve to further reduce the angle of ,uLvaLuLa and c ,c~ L shear and distention that may be imposed on separation membrane 145 in the fabrication of funnel nssembly 135.
A further characteristic of this vvll~LL l.iLion is 25 lllustrated in Figures 22 and 23, where it can be seen that the ~; ~~jnnC of separation ~ ~ 145 are such as to achieve an overlap along the marginal edges of nozzle portion 141. Thus, the edges 154 of separation - ~l,e 145 can be seen to extend around and up the 30 sides o~ nozzle portion 141. This further assists in achieving the wrinkle-free application and disposition of separation a..e 145 in the finally ~-- led funnel assembly 135 of this illustrated: ; L.
WO 95/29756 2 ~ 8 ~ 4 ~
In a-_. .,r-lal~ce with an alternate ~ of the invention illustrated in Figures 2-4, 9 and 10, funnel assembly comprises a funnel holder or a snap-in member 35 is adapted to be removably c~ .P- ~ed withln the 5 depressions 28 and 29 defined by the cover member 25.
The snap-in member 35 has an elongated opening 36 which i3 of the same size and shape as the opening 29 of the cover member 25. An elongated funnel member 40 has ~
hollow nozzle portion 41 which fits through the opening 10 36. An P~torn~lly projecting rim 42 of the funnel member 40 mates with the top face 37 of the snap-in member 35 and ~L-:V~ ; the funnel member from passing through the opening 35. A separation ~ ,.e 45 is positioned at the bottom of funnel 40 and is held by the tapered shape 15 of the funnel nozzle portion 41.
It is to be understood that the ir~vention is not limited to the illustrations described and shown herein, which are deemed to be merely illustrative of the best modes of carrying out the invention, and which are susceptible of 20 1fl~ation of form, size, ~-L-c~r, of parts and details of operation . The invention rather is i ntPn~
to Pn~ _-RR all such -Sif;cations which are within its spirit and scope as defined bl the claims.
.
Claims (18)
1. A medical diagnostic test kit comprising:
(i) a bottom member forming a flat bottom wall and having joinder means to join the bottom member to another member;
(ii) an elongated dry chemistry test membrane having at least one reagent which reacts with a patient's body fluid;
(iii) a cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the membrane; wherein the membrane is held between the bottom member and the cover member; and (iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to fit within the display window opening and means to removably attach the funnel assembly to the cover member.
(i) a bottom member forming a flat bottom wall and having joinder means to join the bottom member to another member;
(ii) an elongated dry chemistry test membrane having at least one reagent which reacts with a patient's body fluid;
(iii) a cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the membrane; wherein the membrane is held between the bottom member and the cover member; and (iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to fit within the display window opening and means to removably attach the funnel assembly to the cover member.
2. A kit as in claim 1 wherein the bottom member has a raised flange around the bottom wall.
3. A kit as in claim 1 and further including a flange integral with the bottom member and forming an elongated cavity.
4. A kit as in claim 3 wherein the membrane is positioned within the cavity.
5. A kit as in claim 1 and further including a separation membrane, the funnel having a hollow nozzle portion, and the separation membrane being in registry with the nozzle portion.
6. A kit as in claim 1 wherein the test membrane is positioned in contact with the receiving opening and the display window opening.
7. A kit as in claim 1 wherein said funnel assembly comprises a funnel holder adapted for removable attachment to said cover member, a funnel member communicating with said funnel holder for receiving said patient's body fluid, said funnel member defining a nozzle portion, said nozzle portion defining at least one opening for the egres of said body fluid toward said test membrane, and a separation membrane for the filtration and delivery of said body fluid to said test membrane, said separation membrane located in wrinkle-free disposition against said nozzle portion and in fluid registry with the at least one said opening defined therein.
8. A kit as in claim 7 wherein said separation is non-adhesively held against said nozzle portion.
9. A kit as in claim 7 wherein said separation membrane is adapted to make capillary contact with said test membrane.
10. A kit as in claim 7 wherein said separation membrane defines a generally rounded and arcuate outer surface and extends outwardly beyond said nozzle portion.
11. A kit as in claim 7 wherein said funnel member further includes a frame member located on the outer surface thereof, said frame member adapted to engage said funnel member and said nozzle portion, and to cooperate with said funnel member and said nozzle portion to wrap and hold said separation membrane in sandwich-like relationship therebetween.
12. A kit as in claim 11 wherein said frame member defines a capturing rim for the engagement of said funnel member and said separation membrane when said frame member is assembled therewith.
13. A kit as in claim 12 wherein said capturing rim defines means for the snap-fittable engagement of said funnel member.
14. A kit as in claim 12 wherein said capturing rim defines means for the frictional engagement of said said separation membrane and said funnel member.
15. A kit as in claim 14 wherein said capturing rim defines a curved circumference along at least a part of the cross-section thereof for the frictional engagement of said separation member and said funnel member.
16. A kit as in claim 7 wherein said nozzle portion defines a plurality of openings.
17. A kit as in claim 16 wherein said nozzle portion defines a plurality of openings, and said frame member defines a plurality of openings adapted for fluid registry with the openings in said nozzle portion.
18. A medical diagnostic test kit comprising:
(i) a bottom member forming a rectangular flat bottom wall and having a raised flange around the bottom wall to join the bottom member to another member, and an integral internal flange forming an elongated cavity;
(ii) an elongated dry chemistry test membrane within the cavity and having at least one reagent which reacts with a patient's body fluid;
(iii) an arcuate cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the membrane; wherein the membrane is held between the bottom member and the cover member and in contact with the receiving opening and the display window opening;
(iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to fit within the display window opening, means to removably attach the funnel assembly to the cover member, and a separation membrane means to separate red blood cells from serum and positioned in fluid registry with the nozzle portion.
(i) a bottom member forming a rectangular flat bottom wall and having a raised flange around the bottom wall to join the bottom member to another member, and an integral internal flange forming an elongated cavity;
(ii) an elongated dry chemistry test membrane within the cavity and having at least one reagent which reacts with a patient's body fluid;
(iii) an arcuate cover member having joinder means to join the cover member to the bottom member and having a receiving opening to receive the body fluid and a display window opening to display at least part of the membrane; wherein the membrane is held between the bottom member and the cover member and in contact with the receiving opening and the display window opening;
(iv) a removable funnel assembly comprising a funnel member having a nozzle portion adapted to fit within the display window opening, means to removably attach the funnel assembly to the cover member, and a separation membrane means to separate red blood cells from serum and positioned in fluid registry with the nozzle portion.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US23737494A | 1994-05-03 | 1994-05-03 | |
| US08/237,374 | 1994-05-03 | ||
| US08/368,791 | 1995-01-04 | ||
| US08/368,791 US5658801A (en) | 1994-05-03 | 1995-01-04 | Medical test kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2189540A1 true CA2189540A1 (en) | 1995-11-09 |
Family
ID=26930616
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002189540A Abandoned CA2189540A1 (en) | 1994-05-03 | 1995-05-03 | Medical test kit |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US5658801A (en) |
| EP (1) | EP0758269B1 (en) |
| JP (1) | JPH11503225A (en) |
| AT (1) | ATE170105T1 (en) |
| AU (1) | AU691281B2 (en) |
| CA (1) | CA2189540A1 (en) |
| DE (1) | DE69504328T2 (en) |
| IL (1) | IL113621A (en) |
| WO (1) | WO1995029756A1 (en) |
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| AU4963897A (en) * | 1996-11-18 | 1998-06-10 | Avraham Zer | Immunochromatography test strips |
| NZ504879A (en) | 1997-12-04 | 2003-05-30 | Roche Diagnostics Corp | Instrument for engaging a power cell |
| US6394952B1 (en) | 1998-02-03 | 2002-05-28 | Adeza Biomedical Corporation | Point of care diagnostic systems |
| US6267722B1 (en) | 1998-02-03 | 2001-07-31 | Adeza Biomedical Corporation | Point of care diagnostic systems |
| USD434153S (en) * | 1998-04-20 | 2000-11-21 | Adeza Biomedical Corporation | Point of care analyte detector system |
| USD432244S (en) * | 1998-04-20 | 2000-10-17 | Adeza Biomedical Corporation | Device for encasing an assay test strip |
| GB9827411D0 (en) | 1998-12-11 | 1999-02-03 | Axis Biochemicals Asa | Dipstick assay |
| ATE340360T1 (en) * | 2001-02-12 | 2006-10-15 | Immunivest Corp | CASSETTE AS A CONTAINER OF A SAMPLE FOR OPTICAL ANALYSIS |
| US6833111B2 (en) | 2001-04-13 | 2004-12-21 | Varian, Inc. | Multiple analyte assaying device with a multiple sample introduction system |
| AU2002331408B2 (en) * | 2001-08-20 | 2008-05-08 | Proteome Systems Ltd | Diagnostic testing process and apparatus |
| JP4551660B2 (en) * | 2001-12-12 | 2010-09-29 | プロテオム システムズ リミテッド | Diagnostic inspection method |
| US7011794B2 (en) * | 2002-11-25 | 2006-03-14 | Immunivest Corporation | Upon a cartridge for containing a specimen sample for optical analysis |
| ATE553378T1 (en) | 2003-02-06 | 2012-04-15 | Hologic Inc | SCREENING AND TREATMENT PROCEDURES TO PREVENT PREMATURE BIRTH |
| US20040168951A1 (en) * | 2003-02-27 | 2004-09-02 | Mackie Robert W. | Method and system for self administration of medications |
| US20040202571A1 (en) * | 2003-04-10 | 2004-10-14 | Epler Gary R. | Directed medication system and method |
| US20040204661A1 (en) * | 2003-04-10 | 2004-10-14 | Epler Gary R. | Genomics home test kit |
| US7393697B2 (en) * | 2003-06-06 | 2008-07-01 | Advantage Diagnostics Corporation | Diagnostic test for analytes in a sample |
| US20050102976A1 (en) * | 2003-11-19 | 2005-05-19 | Stroup David K. | Diagnostic kit flexible assembly system and method of using the same |
| US7943294B2 (en) | 2004-07-30 | 2011-05-17 | Hologic, Inc. | Methods for detecting oncofetal fibronectin |
| US7387890B2 (en) * | 2004-12-16 | 2008-06-17 | Chembio Diagnostic Systems, Inc. | Immunoassay devices and use thereof |
| WO2006098804A2 (en) | 2005-03-11 | 2006-09-21 | Chembio Diagnostic Systems, Inc. | Dual path immunoassay device |
| US7189522B2 (en) | 2005-03-11 | 2007-03-13 | Chembio Diagnostic Systems, Inc. | Dual path immunoassay device |
| US8480797B2 (en) | 2005-09-12 | 2013-07-09 | Abela Pharmaceuticals, Inc. | Activated carbon systems for facilitating use of dimethyl sulfoxide (DMSO) by removal of same, related compounds, or associated odors |
| WO2007033180A1 (en) | 2005-09-12 | 2007-03-22 | Abela Pharmaceuticals, Inc. | Materials for facilitating administration of dimethyl sulfoxide (dmso) and related compounds |
| EP1937286B1 (en) | 2005-09-12 | 2016-03-09 | Abela Pharmaceuticals, Inc. | Compositions comprising dimethyl sulfoxide (dmso) |
| EP1966229B1 (en) | 2005-09-12 | 2015-10-21 | Abela Pharmaceuticals, Inc. | Systems for removing dimethyl sulfoxide (dmso) or related compounds, or odors associated with same |
| WO2009140330A1 (en) * | 2008-05-14 | 2009-11-19 | Innovative Biosensors, Inc. | Surface sample transfer system |
| US20100022916A1 (en) | 2008-07-24 | 2010-01-28 | Javanbakhsh Esfandiari | Method and Apparatus for Collecting and Preparing Biological Samples for Testing |
| JP5066498B2 (en) * | 2008-09-19 | 2012-11-07 | 富士フイルム株式会社 | Assay method |
| BRPI0921494A2 (en) | 2008-11-03 | 2018-10-30 | Prad Reasearch And Development Ltd | method of planning a underground forming sampling operation, method of controlling a underground forming sampling operation, method of controlling a drilling operation for an underground formation, and method of sampling during the drilling operation. |
| US8422740B2 (en) | 2009-01-15 | 2013-04-16 | Scott Dylewski | Methods for determining a liquid front position on a test strip |
| US8692873B2 (en) | 2009-01-15 | 2014-04-08 | Alverix, Inc. | Video-frame data receiver with low frame capture rate |
| CA2779111C (en) | 2009-10-30 | 2019-08-13 | Abela Pharmaceuticals, Inc. | Dimethyl sulfoxide (dmso) and methylsulfonylmethane (msm) formulations to treat osteoarthritis |
| US10295472B2 (en) | 2010-05-05 | 2019-05-21 | Alverix, Inc. | Assay reader operable to scan a test strip |
| US8603835B2 (en) | 2011-02-10 | 2013-12-10 | Chembio Diagnostic Systems, Inc. | Reduced step dual path immunoassay device and method |
| EP3126486B1 (en) | 2014-04-02 | 2019-07-03 | Chembio Diagnostic Systems, Inc. | Immunoassay utilizing trapping conjugate |
| US20160116466A1 (en) | 2014-10-27 | 2016-04-28 | Chembio Diagnostic Systems, Inc. | Rapid Screening Assay for Qualitative Detection of Multiple Febrile Illnesses |
| GB201520657D0 (en) * | 2015-11-23 | 2016-01-06 | Mologic Ltd | Improvements in or relating to the detection of peritoneal Diaysis Fluid infection |
| CN111122856B (en) * | 2020-01-10 | 2023-05-12 | 中国农业科学院烟草研究所 | Time-resolved fluorescence immunochromatography test paper card for detecting butralin |
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| TW203120B (en) * | 1985-10-04 | 1993-04-01 | Abbott Lab | |
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| DE3786388T2 (en) * | 1986-10-16 | 1994-01-05 | Abbott Lab | Analytical device and method for the detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae. |
| US4943522A (en) * | 1987-06-01 | 1990-07-24 | Quidel | Lateral flow, non-bibulous membrane assay protocols |
| US4981786A (en) * | 1987-09-04 | 1991-01-01 | Syntex (U.S.A.) Inc. | Multiple port assay device |
| US4912034A (en) * | 1987-09-21 | 1990-03-27 | Biogenex Laboratories | Immunoassay test device and method |
| DE3804429A1 (en) * | 1988-02-12 | 1989-08-24 | Schleicher & Schuell Gmbh | DISPOSABLE FILTER |
| US5036569A (en) * | 1990-02-02 | 1991-08-06 | V-Tech, Inc. | Filter/funnel assembly machine |
| CA2027434C (en) * | 1990-10-12 | 1999-01-05 | George Jackowski | Diagnostic kit for diagnosing and distinguishing chest pain in early onset thereof |
| US5334538A (en) * | 1990-11-26 | 1994-08-02 | V-Tech, Inc. | Gold sol immunoassay system and device |
| IL96887A (en) * | 1991-01-06 | 1996-08-04 | Orgenics Ltd | Apparatus for dry chemical analysis of fluids |
-
1995
- 1995-01-04 US US08/368,791 patent/US5658801A/en not_active Expired - Fee Related
- 1995-05-03 AU AU23175/95A patent/AU691281B2/en not_active Ceased
- 1995-05-03 EP EP95916818A patent/EP0758269B1/en not_active Expired - Lifetime
- 1995-05-03 JP JP7528102A patent/JPH11503225A/en active Pending
- 1995-05-03 WO PCT/IB1995/000361 patent/WO1995029756A1/en active IP Right Grant
- 1995-05-03 AT AT95916818T patent/ATE170105T1/en not_active IP Right Cessation
- 1995-05-03 DE DE69504328T patent/DE69504328T2/en not_active Expired - Fee Related
- 1995-05-03 CA CA002189540A patent/CA2189540A1/en not_active Abandoned
- 1995-05-05 IL IL11362195A patent/IL113621A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| JPH11503225A (en) | 1999-03-23 |
| WO1995029756A1 (en) | 1995-11-09 |
| US5658801A (en) | 1997-08-19 |
| EP0758269A1 (en) | 1997-02-19 |
| EP0758269B1 (en) | 1998-08-26 |
| DE69504328D1 (en) | 1998-10-01 |
| AU2317595A (en) | 1995-11-29 |
| IL113621A (en) | 1998-08-16 |
| AU691281B2 (en) | 1998-05-14 |
| DE69504328T2 (en) | 1999-05-12 |
| IL113621A0 (en) | 1995-12-08 |
| ATE170105T1 (en) | 1998-09-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 20010503 |