WO2006094386A1

WO2006094386A1 - Card-type diagnostic device having a reservoir in fluid communication with membrane receiving receptacles

Info

Publication number: WO2006094386A1
Application number: PCT/CA2006/000319
Authority: WO
Inventors: Ayesha Siddiqui
Original assignee: Statim Diagnostics Inc.; Starplex Scientific Inc.
Priority date: 2005-03-07
Filing date: 2006-03-07
Publication date: 2006-09-14
Also published as: CA2499516A1

Abstract

An improved card-type diagnostics device for chemical screening is disclosed. The device is of the type having a housing defining one or more membrane-receiving receptacles, and a membrane for and fitted in each of said one or more membrane-receiving receptacles, the membrane being porous to permit the flow of liquid therethrough and adapted, when loaded with liquid, to present visual indicia as to the presence in said liquid of a chemical associated with the membrane. The improvement comprises a reservoir defined in the housing and in fluid communication with each of said one or more membrane-receiving receptacles such that, when the housing is operatively orientated, the deposit of a predetermined volume of fluid in the reservoir will result in the flow of liquid from the reservoir to said each receptacle, to load the membrane fitted in said each receptacle.

Description

Card-type diagnostic device having a reservoir in fluid communication with membrane receiving receptacles

FIELD OF THE INVENTION

The present invention relates to the field of diagnostics.

BACKGROUND OF THE INVENTION

In the field of point-of-care drugs-of -abuse diagnostics, two technologies are widely utilized.

The first technology is exemplified by the panel sold by Biosite Inc. under the trademark TRIAGE. This panel includes a covered receptacle which holds chemicals. The panel also includes a membrane. In use, the cover is removed, a measured amount of urine is transferred by pipette into the receptacle and a period of time is allowed to elapse, to permit the urine to be conditioned by the chemicals. After the allotted time has elapsed, a measured amount of urine is transferred by pipette from the receptacle to the membrane, and a further period of time is allowed to elapse. Several drops of a wash buffer are added to the membrane and then a period of time is allowed to elapse. The presence of drugs of abuse is indicated by the appearance/disappearance of markings on the membrane. The results are stable for only a relatively short period of time. This test is known to be useful, but suffers from certain drawbacks. Of note, the need to perform numerous steps in a timed sequence is problematic. Yet further, the relatively long time period required to complete the test is undesirable.

The second technology is embodied by "card" type diagnostic devices. These devices include a plurality of membranes. In use, the card is dipped in a specimen jar of urine, to bring the membranes in contact with the urine, and a predetermined period of time is allowed to elapse. The presence of drugs of abuse is indicated by the appearance/ disappearance of markings on the membranes. The results are stable for about 30 minutes. This technology is known to be useful, but also suffers from certain drawbacks. Of note, this technology requires the use of a relatively large sample in the urine cup. It is known to avoid the use of a urine cup, and to transfer urine to the membranes by pipette. However, this technique is very cumbersome, since the required sample volume for each membrane needs to be added slowly over several steps, to make sure there is no sample overflow.

SUMMARY OF THE INVENTION

An improved card-type diagnostics device for chemical screening forms one aspect of the invention. The device is of the type having a housing defining one or more membrane-receiving receptacles, and a membrane for and fitted in each of said one or more membrane-receiving receptacles, the membrane being porous to permit the flow of liquid therethrough and adapted, when loaded with liquid, to present visual indicia as to the presence in said liquid of a chemical associated with the membrane.

The improvement comprises a reservoir defined in the housing and in fluid communication with each of said one or more membrane-receiving receptacles such that, when the housing is operatively orientated, the deposit of a predetermined volume of fluid in the reservoir will result in the flow of liquid from the reservoir to said each receptacle, to load the membrane fitted in said each receptacle.

The housing may define, for each receptacle, a fluid channel extending between the reservoir and said each receptacle.

The housing may also define, for each receptacle, an air vent adapted to permit the escape of air from the membrane fitted in said each receptacle as said membrane is loaded with liquid.

The reservoir may have a bottom which slopes downwardly towards said one or more membrane-receiving receptacles. The invention permits a sample to be tested for the presence of a chemical in a method which consumes only a small volume of the sample, which requires only a single pipette step, and which provides visual indicia as to the presence of the chemical which are stable for a relatively long period of time.

Other advantages, features and characteristics of the present invention, as well as methods of operation and functions of the related elements of the structure, and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following detailed description and the appended claims with reference to the accompanying drawings, the latter being briefly described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 is a front, left side perspective view of a diagnostics device according to a first preferred embodiment of the present invention;

FIGURE 2A is a perspective view of a portion of the structure of FIGURE 1 ;

FIGURE 2B is a perspective view of a portion of the structure of FIGURE 1 ;

FIGURE 2C is a perspective view of a portion of the structure of FIGURE 1 ;

FIGURE 3 is a front plan view of a portion of the structure of FIGURE 1 ;

FIGURE 4 is a front plan view of another portion of the structure of FIGURE 1 ;

FIGURE 5 is a front, left side perspective view of a diagnostics device according to a second preferred embodiment of the present invention; and

FIGURE 6 is a side, elevational view of the structure of FIGURE 5, with interior details shown in phantom outline. DETAILED DESCRIPTION

With general reference to FIGURE 1, a first preferred embodiment of the present invention, a diagnostics device, is illustrated, and is designated by the general reference numeral 20.

As best seen in FIGURES 2A,2B,2C, the device includes a housing 22,24 and a plurality of membranes 26.

The housing 22,24 includes a back portion 22 and a front portion 24.

The back portion 22 defines one or more, more specifically, five, membrane- receiving receptacles 28. The back portion 22 further defines a reservoir 30, a plurality of fluid channels 32 and a plurality of air vents 34. The fluid channels 32 are provided one for each receptacle 28, each extending between the reservoir 30 and the receptacle 28 for which it is provided, such that the reservoir 30 is in fluid communication, via the fluid channels 32, with the receptacles 28. The air vents 34 extend from the receptacles 28 to the periphery of the housing 22,24. Back portion 22 is preferably injection-moulded out of plastic.

The front portion 24 defines a plurality of first viewing ports 36 and a plurality of second viewing ports 38 and is preferably constructed out a plastic stamping, the stamping having an adhesive on its rear surface (not shown) which is covered with a release film (not shown).

The membranes 26 are provided one for each receptacle 28. Each membrane 26 includes an upper portion 26A and a lower portion 26B. The upper portion 26A of each membrane includes a notation 37 as to the type(s) of drug or other chemical with which it is associated. The lower portion 26B is of a conventional construction, more specifically, is a porous material adapted to permit the flow of liquid therethrough, and is adapted, when loaded with liquid, to present visual indicia as to the presence in said liquid of the chemical(s) associated with the membrane 26. The membranes 26 shown are each adapted to detect the presence of two drugs of abuse, specifically, AMP/TCA, THC/OXY, OPI/BAR, COC/MTD and PCP/PPX.

To produce the device shown in FIGURE 1 , each membrane 26 is fitted into a respective receptacle 28, with the upper portion 26A disposed towards the air vent 34 and the lower portion 26B disposed towards the reservoir 30. Notches 40 are provided in the receptacles 28 to hold the membranes 26 in position in this step. As well, the release paper is peeled from the front portion 24, to expose the adhesive. Thereafter, the front portion 24 is stacked upon and adhesively secured to the back portion 22, with each membrane-receiving receptacle 28 in communication with a respective first viewing port 36 and a respective second viewing port 38, such that the indicia 37 on the membrane 26 is visible through the second viewing port 38.

In use, the housing 22,24 is operatively orientated with the front portion 24 presenting upwardly and the back portion 22 presenting downwardly. Thereafter, a predetermined volume of fluid is deposited in the reservoir 30 by pipette or the like.

This liquid flows from the reservoir 30 to said each receptacle 28, to load the membrane 26 fitted in said each receptacle 28. The air vents 34 permit the escape of air from the membrane 26 fitted in said each receptacle 28 as said membrane 26 is loaded with liquid. After a predetermined period of time has elapsed, visual indicia appear on each of the membranes 26 in a conventional manner, to indicate the presence of the drug or other chemical(s) with which said each membrane 26 is associated. The indicia (not shown) are visible through the first viewing port 36. A table 39 is provided on the front portion 24, to assist the user in reading the results. The device 20 can also be used in the manner of a conventional card-type device, that is, dipped into a specimen jar, if desired. This may be advantageous if the use of a large-volume specimen is not problematic.

Persons of ordinary skill will immediately recognize the advantage obtained by the device. The device permits a sample to be tested for the presence of a chemical in a method which consumes only a small volume of the sample, which requires only a single pipette step, and which provides visual indicia as to the presence of the chemical which are stable for a relatively long period of time. Another advantage associated with the device is the ease by which it can be customized to meet the needs of various users: in the assembly step, membranes adapted to test for the presence of any desired compounds can be inserted into the receptacles to meet the wishes of the user.

A second preferred embodiment of the device is shown in FIGURES 5,6 and designated with general reference numeral 20'. This device differs from the structure of FIGURES 1-4 in that the reservoir 30 is surrounded by a raised boss 42 and includes a bottom surface 44 sloped at an angle α of 20° to the vertical, as best seen by the phantom outline in FIGURE 6. The sloped bottom surface 44 of reservoir 30 assists in channelling or draining fluid from the reservoir 30 into the receptacles 28. Otherwise, device 20' is structurally and functionally similar to device 20 (with equivalent features in both structures bearing the same numbers) and as such is not described hereinafter in detail. Use of the device of the second preferred embodiment will be preferable to the first preferred embodiment in situations wherein specimen usage is to be minimized, and it is desired that most or all of the specimen enter the membranes (i.e. that there be no waste), or if maximum test speed is desired. Use of the device of the first preferred embodiment may be preferable if, for example, the nature of the membranes is such that it is preferable that the sample enter the membranes by wicking action, rather than under pressure.

Whereas but two preferred embodiments are illustrated herein, it will be understood that various changes can be made. For example, whereas the device of the preferred embodiment holds five membranes, the housing could readily be adapted to hold other numbers of membranes, for example, two membranes. Also, whereas the membranes illustrated are of the type adapted to test for two drugs, this need not be the case; membranes adapted to test for less or more than two drugs could readily be substituted. Yet further, whereas the membranes shown are adapted to test for various specific drugs, namely, AMP/TCA, THC/OXY, OPI/BAR, COC/MTD and PCP/PPX, membranes adapted for testing other possible combinations of these drugs and other drugs can readily be substituted therefor. Various changes in size and shape could also be made without departing from the spirit or scope of the invention. Without limitation, the bottom surface of the reservoir could slope at angles other than 20° to the vertical, or could be contoured. Accordingly, it should be understood that the scope of the invention is limited only by the claims appended hereto, purposively construed.

Claims

1. An improved card-type diagnostics device for chemical screening, the device being of the type having:

a housing defining one or more membrane-receiving receptacles, and

a membrane for and fitted in each of said one or more membrane-receiving receptacles, the membrane being porous to permit the flow of liquid therethrough and adapted, when loaded with liquid, to present visual indicia as to the presence of a chemical associated with the membrane in said liquid,

wherein the improvement comprises:

a reservoir defined in the housing and in fluid communication with each of said one or more membrane-receiving receptacles such that, when the housing is operatively orientated, the deposit of a predetermined volume of fluid in the reservoir will result in the flow of liquid from the reservoir to said each receptacle, to load the membrane fitted in said each receptacle.

2. A screening device according to claim 1 , wherein the housing defines, for each receptacle, a fluid channel extending between the reservoir and said each receptacle.

3. A screening device according to claim 1 , wherein the housing defines, for each receptacle, an air vent adapted to permit the escape of air from the membrane fitted in said each receptacle as said membrane is loaded with liquid.

4. A screening device according to claim 1 , wherein the reservoir has a bottom which slopes downwardly towards said one or more membrane-receiving receptacles.