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Title:
ASSAYING DEVICE
Document Type and Number:
WIPO Patent Application WO/2010/121119
Kind Code:
A1
Abstract:
This invention relates to assays, for example, to determine the presence of an analyte, e.g. an analyte indicative of a drug of abuse in a sample.

Inventors:
WU, John (10340 Camino Santa Fe, Suite FSan Diego, CA, 92121, US)
NG, Waiping (10340 Camino Santa Fe, Suite FSan Diego, CA, 92121, US)
Application Number:
US2010/031374
Publication Date:
October 21, 2010
Filing Date:
April 16, 2010
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
AMEDITECH, INC. (10340 Camino Santa Fe, Suite FSan Diego, CA, 92121, US)
WU, John (10340 Camino Santa Fe, Suite FSan Diego, CA, 92121, US)
NG, Waiping (10340 Camino Santa Fe, Suite FSan Diego, CA, 92121, US)
International Classes:
A61B10/00; B01L3/00; G01N33/497; G01N33/543; G01N33/551; G01N33/558; H04J3/06
Domestic Patent References:
2008-05-22
2001-11-29
1995-03-23
Foreign References:
US20030190745A12003-10-09
US20040132091A12004-07-08
Attorney, Agent or Firm:
BUCHACA, John D. et al. (Charmasson, Buchaca & Leach LLP,2635 Camino Del Rio South, Suite 15, San Diego CA, 92108, US)
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Claims:
CLAIMS

1. An assaying device for collecting a fluid sample, the device comprising: a container having an inner chamber, an open top, a peripheral wall and a bottom wall; a cartridge, the cartridge comprising at least one chromatographic assay strip and an aperture for allowing fluid sample to contact the at least one chromatographic assay strip, the cartridge being located within the chamber adjacent to a portion of the peripheral wall; and a cover to seal the open top; wherein a portion of the bottom wall located adjacent to the cartridge is positioned lower than a portion of the bottom wall located opposite from the cartridge..

2. The device of claim 1, wherein the peripheral wall includes a flat section having a transparent window.

3. The device of claim 1, further comprising a splash shield extending from the wall over an upper section of the cartridge.

4. The device of claim 3, wherein the shield is detachably secured to the wall in a position to hold the cartridge against the peripheral wall.

5. The device of claim 3, wherein the aperture is located in the lower portion of the cartridge.

6. The device of claim 3, wherein the aperture is located in the upper portion of the cartridge.

7. The device of claim 1, wherein the cartridge is placed within the container in an upright orientation with respect to the container.

8. The device of claim 1 , wherein the cartridge is placed within the container in an inverted orientation with respect to the container.

9. The device of claim 1, wherein the cover includes a depression.

10. The device of claim 8, wherein the depression is funnel-shaped.

Description:
Assaying Device

Field of the Invention

This invention relates to assays, for example, to determine the presence of an analyte, e.g. an analyte indicative of a drug of abuse in a sample.

Background

The sheer volume of chromatographic immunoassay tests that today must be processed by laboratories has prompted the development of structurally simple, inexpensive and disposable test devices of the type disclosed in U.S. Patent Nos. 5,403,551 Galloway et al, 5,770,458 Klimov et al., 6,726,879 Ng et al., and 7,300,626 Wu et al.

These tests typically include a number of chromatographic test strips which contact the fluid specimen collected. Devices such as the IMMUTEST brand cartridge commercially available from Ameditech, Inc. of San Diego, California can be dipped into a container holding a fluid specimen, or the specimen can be deposited on the strips using a pipette or similar device in order to initiate the test process.

In some devices such as the so called "no-step"-type devices, the test is initiated immediately by the act of depositing fluid into the cup. However, it is preferable in some situations that the test be initiated by a skilled technician who can promptly read the results. In these situations, initiation may not occur when the specimen donor deposits fluid into the cup. Devices such as U.S. Patent No. 7,300,626 Wu, et al. allow for initiation of the test by changing the orientation of the cup.

An additional problem with fluid specimen cup devices occurs when too little fluid is supplied such that contact cannot be made reliably with the strips.

It can be useful to store a subset of the fluid sample provided for later use in confirmatory testing in the lab as disclosed in U.S. Patent No. 6,726,879, Wu, et al.

Summary

This invention relates to assays, for example, to determine the presence of an analyte, e.g. an analyte indicative of a drug of abuse in a sample.

Testing may be initiated by reorientation of the cup. The cup may include a volume reducing structure to allow for specimens of reduced volume.

In some embodiments there is provided an assaying device for collecting and analyzing a fluid specimen for detection of spurious chemicals consist of a cup having its open top detachably closed by a circular lid. In some embodiments a common cartridge comprising at least one chromatographic test strip is located adjacent to a portion of the cup wall to allow a user to view the test strips. In some embodiments, the cartridge is located adjacent to a flattened and windowed portion of the cup wall. In some embodiments the cartridge is preferably oriented to admit the sample fluid from an aperture in its upper region. In some embodiments the cartridge is preferably oriented to admit the sample from an aperture in its lower region. In some embodiments a detachable splash shield extending from an area near the brim of the cup over the top of the cartridge opening prevents the fluid sample poured into the cup from entering the cartridge and directs sample toward the bottom center of the cup. In some embodiments the shield acts as a barrier that keeps the cartridge locked into place within the cup. In some embodiments a structure in the form of a depression of the lid top portion projects into the cup, reducing its volumetric capacity. In some embodiments, the depression in the lid is conical. In some embodiments, after the sample has been introduced into the cup, and the lid hermetically closed, the cup is flipped upside-down to bring part of the sample in contact with the cartridge aperture and consequently the testing strips. In some embodiments the sample contacts the cartridge aperture upon sample being introduced into the cup. In some embodiments the depression in the lid helps the access of the sample to the cartridge by increasing the level of fluid specimen in the lower peripheral region of the inverted cup.

In some embodiments a small tubular enclosure having an open lower end extends from the undersurface of the depressed lid all the way to the bottom of the cup where end opening is hermetically sealed by a compressibly resilient pad or ring of elastomeric material. In some embodiments, as the lid is secured over the top of the cup, the tubular enclosure automatically captures a small amount of fluid specimen that may be preserved for a later time control analysis.

In some embodiments there is provided an assaying device for collecting a sample, analyzing a first portion and preserving an unadulterated second portion, the device comprises: a container having an inner chamber, a central vertical axis, an open top, peripheral wall and a bottom wall; the peripheral wall including a flat section having a transparent window; a cartridge comprising at least one chromatographic test strip located adjacent to the flat section of the peripheral wall; a cover shaped and dimensioned to hermetically seal the open top; and including a structure projecting downwardly into the chamber when the cover is placed over the top. In some embodiments the device further comprises a tubular enclosure extending downwardly from an undersurface portion of the cover and having a bottom opening positioned to come in closing contact with a structure associated with the bottom wall when the cover is placed over the top.

In some embodiments the device further comprises a splash shield extending from the wall over an upper section of the chamber.

In some embodiments the device further comprises one of the cartridges including an upper portion having an aperture for admitting fluid sample.

In some embodiments the shield is detachably secured to the wall in a position to locking the cartridge into place within the cup.

In some embodiments the cartridge is further shaped and dimensioned to allow for mounting the cartridge in an upright orientation or an inverted orientation with respect to the container.

In some embodiments the device further comprises a resiliency compressible pad hermetically sealing the bottom opening against the bottom wall when the cover is placed over the top.

In some embodiments the structure comprises a depression in the cover. In some embodiments the depression is axially symmetric about a rotation axis of the cover. In some embodiments the depression is funnel-shaped.

In some embodiments the tubular enclosure is axially aligned with the major cylindrical axis of the cup.

In some embodiments the cover comprises a horizontal surface and a peripheral circular flange shaped and dimensioned to intimately lock over an upper wall section of the container.

In some embodiments the depression has a central cavity closed at a upper region and extends to contact the bottom wall when the cover is secured over the top.

In some embodiments the device further comprises means for releasably hermetically sealing the cavity against the bottom structure.

In some embodiments, it is provided that in a assay cup having a sealable top cover wherein a test strip is held in a peripheral region of the cup wall, an improvement which comprises a volumetric capacity-reducing body extending from the cover into the cup.

In some embodiments the body extends into contact with a structure associated with a bottom wall area of the cup; and has a central cavity open at a lower end, the cavity being sized to capture a small volume of fluid sample when the top cover is placed over the cup. In some embodiments the bottom wall is positioned perpendicular to the peripheral wall.

In some embodiments the bottom wall is positioned at an angle with respect to the peripheral wall. In some embodiments a portion of the bottom wall adjacent to the cartridge aperture is at a position lower than a portion of the bottom wall positioned opposite from the cartridge aperture. This allows a small volume of sample to be used in performing the test.

In some embodiments the device comprises a cartridge holding at least one test strip and having an aperture in an upper region of the cup. In some embodiments the device comprises a cartridge holding at least one test strip and having an aperture in a lower region of the cup.

In some embodiments the improvement further comprises a shield projecting from an internal wall area of the cup over the aperture.

In some embodiments the device comprises a sealable tubular enclosure having a lower portion secured to the bottom and an upper portion secured to an undersurface portion of the structure and being shaped and dimensioned to telescopically engage the upper portion when the cover is placed upon the container. In some embodiments one of the lower and upper portions comprises a surface formed to have a pit.

Embodiments of the assay device may reduce the amount of user's manipulation of the testing device. Embodiments of the assay device may reduce the volume of sampling fluid needed. Embodiments of the assay may minimize the risk of misinterpretation of the results.

Brief Description of the Drawings

Fig. lis a diagrammatic perspective view of a testing cup.

Fig. 2 is a diagrammatic cross-sectional view of Fig. 1 in an upright pre-test position.

Fig. 3 is the diagrammatic cross-sectional view of Fig. 1 in an inverted testing position.

Fig. 4 is a diagrammatic partially exploded cross-sectional view of an alternate embodiment of a testing cup having a confirmation sample preserving feature.

Fig. 5 is a diagrammatic cross-sectional view of an alternate embodiment of a testing cup having an alternate confirmation sample preserving feature having an enhanced low volume dispensing capability.

Fig. 6 is a diagrammatic partially exploded cross-sectional view of the confirmation sample enclosure of the embodiment of Fig. 5 in an inverted orientation.

Fig. 7 is a diagrammatic cross-sectional view of an alternate embodiment of a testing cup having a confirmation sample preserving feature having enhanced pouring capability.

Fig. 8 is a diagrammatic exploded cross-sectional view of an alternate embodiment of the testing cup having an alternate confirmation sample preserving feature.

Fig. 9 is a diagrammatic perspective view of an alternative embodiment of a testing cup. Fig. 10 is a diagrammatic bottom view of the embodiment of Fig. 9. Fig. 11 is a diagrammatic cross-sectional view of the embodiment of Fig. 9. Fig. 12 is a diagrammatic cross-sectional view of an alternative embodiment of a testing cup.

Description of the Exemplary Embodiments of the Invention

Referring now to the drawings, there is shown in Figs. 1-3 an assaying device 11 including a container 12, for example, a cup, having an open top closed by a circular cover or lid 14, a bottom wall 15 and peripheral wall 16 enclosing an internal chamber 9. A flattened section 17 of the peripheral wall forms a transparent window 18 through which is viewed a cartridge 19 mounting a number of chromatographic test strips 20 behind a transparent panel 5.

The cartridge is held in a pocket 21 formed against an inner surface of the flattened section 17. The cartridge has an aperture 22 accessible in the upper part of the cartridge 19 and spaced a distance H from the open top of the cup. A splash shield 23 is detachably secured below the brim 8 of the cup and extends over the upper section of the cartridge aperture. The shield prevents any part of a fluid specimen being poured into the cup from prematurely reaching the exposed part of the test strip exposed by the aperture 22 an inadvertently initiating the test. The shield can also act as a barrier to prevent the cartridge from slipping out of the pocket 21. The shield can be glued, welded or snapped into place.

The shape and dimensions of the pocket can be selected to accommodate commercially available-type cartridges such as the IMMUTESTâ„¢ brand cartridge commercially available from Ameditech, Inc. of San Diego, California, thus decreasing manufacturing costs. The shape and dimensions of the pocket can be further selected to allow such a cartridge and the test strips to be held in the preferred inverted orientation as shown, or optionally in an upright orientation where the aperture is located near the cup bottom.

The cover 14 comprises a generally flat horizontal surface portion 24 and a threaded peripheral circular flange 25. A generally conical or funnel-shaped depression 26 in the center of the cover extends into the chamber 9 so that the volume of the chamber is reduced. In this way, the conical depression acts as a volume reducing structure which helps in the access of the sample to the cartridge by increasing the level 29 of fluid specimen in the lower peripheral region of the inverted cup as shown in Fig. 3. This allows for a smaller amount of fluid to be used. The depression may be symmetric about the rotation axis 27 of the cover.

As illustrated in Fig. 2, after a fluid specimen 28 has been poured into the cup and the cover has been installed, the specimen does not reach the aperture 22 leading to the test strips until the cup is flipped upside-down as shown in Fig. 3. The generally flat horizontal surface portion 24 of the cup provides stable support for the cup in the inverted orientation when placed on a substantially flat horizontal surface 7.

Referring now to Fig. 4 there is shown an alternate embodiment of a testing device 40 which has a cover 41 which is prolonged by a tubular central enclosure 42 having an internal cavity 37 for trapping a separate aliquot, or small volume 43 of the fluid sample for later confirmatory testing. The enclosure has an open bottom 44 that extends all the way to the upper surface 49 of the bottom wall 45 of the cup. A ring or pad 46 of a resiliency compressible elastomeric material hermetically seals the enclosure 42 when the cover is tightly screwed upon the cup. An access port 47 closed by a releasable plug 48 is provided in the top of the enclosure.

A small volume 43 of fluid can be captured within enclosure 42. That volume can be accessed for subsequent controlled confirmation testing through the unplugged access port 47. That access port may conveniently be kept unplugged during installation of the cover to allow air to escape and thus ease entry of the fluid into the enclosure 42, then resealed before further handling or inverting the cup. The releasable plug is shown to have a threaded engagement with the port and a circumferential o-ring to provide a hermetic seal. To improve stiffness of the bottom wall, a peripheral flange 39 or other stiffening structures can be provided. The bottom surface is a structure associated with the cup bottom.

It should be noted that the internal dimensions of the central enclosure can be selected to trap an adequate amount of fluid for the small volume. Further, the outer dimensions of the central enclosure can be selected to help determine the amount of volume reducing capability of the enclosure. In other words, the shape and dimension of the central enclosure can be selected to allow the central enclosure to act as the volume reducing structure for the chamber of the cup. Because a subset of the sample is trapped for later confirmatory testing, the volume provided to the cartridge is reduced. The volume reducing depression may be used in all of the exemplary embodiments.

In the alternate embodiment of the assay device 50 illustrated in Fig. 5, the tubular enclosure 51 consists of two telescoping portions, namely, a plunger cap 52 associated with the cover and a well 53 associated with the cup bottom. The plunger cap is supported by a shank 54 projecting from the undersurface of the conical depression 55. The well 53 is bonded to the bottom 56 of the cup and has a releasably plugged access port 57 through the bottom. The cap telescopingly engages the well a distance 59 to seal off the enclosure and thus trap a small volume of sample for later confirmatory testing. An O-ring 58 surrounding the plunger further seals the tubular enclosure 51. The telescoping nature of the O-ring engagement between the plunger and well allows for a hermetic seal. This embodiment also provides a washer 6 nested within the thread flange of the cover and made from resilient material can enhance hermeticity of the seal between the cover and the cup. The tubular enclosure 51 may be centrally aligned with the central vertical axis 60 of the cup to allow for automatic alignment of the cap 52 and well 53 as the cover is being installed upon the cup.

Referring now to Fig. 6, there is shown a close-up view of the tubular enclosure 51 of the device of Fig. 5 shown in an inverted orientation. The inner surface 61 of plunger cap 52 is shaped to form a substantially conical receptacle 62 so that when the enclosure is in an inverted orientation, an aliquot of fluid forms a pool 63 within the receptacle where the apical portion of the conical receptacle forms a pit 64 in the deepest region of the pool. In this way, once the plug 65 has been removed from the access port 66, a pipette 67 or other fluid removing apparatus can be inserted into the pit to remove the maximum amount of fluid as the remainder collects in the pit.

In the alternate embodiment of the assay device 70 illustrated in Fig. 7, the tubular enclosure 72 includes two telescoping portions, namely, a plunger cap 73 and a well 74 similar to the embodiment of Fig. 5. However, in this embodiment the plunger cap 73 is an elongated tubular structure extending from the undersurface of the conical depression 75 of the cover 71, and provides an access port closed by a releasable plug 78 in the top of the enclosure similar to the embodiment of Fig. 4. The port and plug have been widened to substantially span the diameter D of the receptacle 74 formed by the internal surface of the plunger cap. In this way, substantially all of the fluid trapped within the enclosure 72 can be easily poured out of the open access port. In the present embodiment, the bottom surface 76 of well 74 is shaped to form a substantially semispherical concave receptacle 79 so that remaining fluid collects within the pit formed in the deepest portion of the receptacle. In this way, once the plug has been removed from the access port, a pipette or other fluid removing apparatus can be inserted and remove the maximum amount of fluid from the receptacle.

Referring now to Fig. 8, there is shown an alternate embodiment of a testing device 80 which is similar to the embodiment of Fig. 5. In this embodiment, the device has a tubular central enclosure 82 having two telescoping portions, namely, a well 84 and plunger cap 83 supported by a shank 85 projecting from the undersurface of the conical depression 86 of the cover 81. The plunger cap 83 has a series of lateral windows 87 to allow air to escape during the installation of the cover to trap of the small volume of fluid for later confirmatory testing. These windows are hermetically sealed by the wall 88 of the well once the cover has been installed. This embodiment also shows placement of a removable cartridge 90 within a retaining pocket 91 of the cup and being locked in place by a portion of the slash shield 92 contacting it when the shield is detachably secured to the cup.

Referring now to the drawings, there is shown in Figs. 9-11 an assaying device 111 including a container cup 112 having an open top closed by a circular cover or lid 114, a bottom wall 115 and peripheral wall 116 enclosing an internal chamber 109. A flattened section 117 of the peripheral wall forms a transparent window 118 through which is viewed a cartridge 119 comprising at least one chromatographic test strip 120 behind a transparent panel 105.

As shown in Fig. 11, the cartridge is held in a pocket 121 formed against an inner surface of the flattened section 117. The cartridge has an aperture 122 which allows fluid to contact the at least one chromatographic test strip 120. The specimen reaches the aperture 122 leading to the test strips when a fluid specimen 128 is poured into the cup. The bottom wall 115 is positioned at an obtuse angle A with respect to the peripheral wall 116. A portion 130 of the bottom wall 115 adjacent to the cartridge aperture 122 is at a position lower than a portion 131 of the bottom wall 115 positioned opposite from the cartridge aperture 122. This allows a small volume of sample to be used in performing the test.

Fig. 12 shows an assaying device 140 including a splash shield 146 which may be detachably secured below the brim 148 of the cup 142 and extends over an upper section of the cartridge 149 having an aperture 143. The shield prevents any part of a fluid specimen 144 being poured into the cup from prematurely reaching the exposed part of the test strip 145 exposed by the aperture 143. The shield can also act as a barrier to prevent the cartridge from slipping out of the pocket 141. The shield can be glued, welded or snapped into place. The shield can also be held in place by the lid of the cup.

The cartridgel49 and pocket 141 can be shaped and dimensioned to allow the cartridge to be installed either in the aperture up orientation, as shown in Fig. 12, so that fluid can reach the aperture by inverting the cup, or in the aperture down orientation so that fluid reaches the aperture when fluid is poured into the cup and flows down the bottom wall 150.

While the preferred embodiments of the invention has been disclosed, modifications can be made and other embodiments may be devised without departing from the spirit of the invention and the scopes of the appended claims.