AU2024284065A1 - A diagnostic device and a method of use - Google Patents

Abstract

Disclosed herein is a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient. The device comprises a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween. The upper portion comprises an opening configured to receive the liquid sample, and the lower portion is in fluid communication with the upper portion and configured to receive therein an ampoule containing a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species. The device also comprises a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached. In use, bending of the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix and a colour of the resultant mixture is visible through a transparent portion (e.g. a transparent wall or walls) of the container.

Description

A DIAGNOSTIC DEVICE AND A METHOD OF USE

Technical Field

[0001 ] Described herein are diagnostic devices for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient. Also described herein are methods for indicating the presence of a species indicative of a disease using the diagnostic device.

Background

[0002] Many reagents used for medicinal applications are toxic or otherwise dangerous and therefore need to be safely contained in order to prevent their escape. Liquid reagents may, for example, be dangerous to handle because they are toxic or corrosive (or both), due to them containing toxic substances or because they are highly acidic or alkaline. One example of a liquid reagent used for medicinal applications that is both toxic and highly acidic is Millon’s Reagent, which is obtained by dissolving mercury salts, and sometimes other substances, in mineral acids. Millon’s Reagent has a number of applications, one of which is its ability to indicate the presence of marker amino acids such as tyrosine, L-DOPA, tryptophan and their metabolites in a patient’s urine, which can be indicative of abnormal cell behaviour in the patient.

[0003] As Millon’s Reagent contains mercury, however, it needs to be very carefully handled. Conventionally, Millon’s Reagent was used in a glass ampoule with a frangible portion. Immediately before use, the ampoule was broken and a urine sample mixed with the Millon’s Reagent. However, the broken glass ampoule has sharp edges and presents a health hazard, and there is a risk that the user may be exposed to mercury (e.g. due to spillage). Furthermore, if the ampoule is not broken with a good sharp knock, it may shatter. For at least these reasons, existing tests involving Millon’s Reagent are not really suitable for non-specialised use.

[0004] In other test devices, such as those described in international (PCT) patent application no PCT/AU2016/050067, Millon’s Reagent, or other acidic and mercury- containing reagents, may be safely contained within a non-flowing carrier, such as a gel carrier or an absorbent material. Upon exposure to a liquid sample from a patient (e.g. a urine sample), the non-flowing carrier quickly disintegrates, thus enabling rapid and complete mixing of the fluid sample and mercury-containing reagent. In other test devices, such as those described in international (PCT) patent application no PCT/AU2022/051524, the Millon’s Reagent (or other acidic and mercury-containing reagents) may be provided in a test cell of the device and covered with a film of polymeric material. Upon exposure to a fluid sample having a different pH (e.g. a urine sample), the film quickly disintegrates, thus again enabling rapid and complete mixing of the fluid sample and mercury-containing reagent.

[0005] While such test devices are effective and have been successfully used to detect abnormal cell activity in many patients, stability issues can occur if the gel carrier or polymeric material are, contrary to their storage instructions, allowed to heat up too much, or if they are stored for particularly long periods of time.

[0006] Improved diagnostic devices for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient are desirable.

Summary

[0007] In a first aspect, there is provided a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient (e.g. a urine sample). The device comprises: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the liquid sample, and the lower portion being in fluid communication with the upper portion and configured to receive therein an ampoule containing a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species; and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached, wherein, in use, bending of the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix and a colour of the resultant mixture is visible through a transparent portion (e.g. a transparent wall or walls) of the container.

[0008] Advantageously, the diagnostic device of the present invention provides a reliable test kit that can be used by a patient themselves, potentially in the comfort of their own home, and without any need for specialised medical training. The diagnostic device also provides for the safe containment of toxic (or otherwise hazardous) liquid reagents required to produce the colorimetric result, such as mercury-containing reagents and biohazardous waste, (e.g. blood, urine or the like), due to it not being reopenable after the cap is attached. Further, the diagnostic device overcomes stability problems associated with mercury-containing reagents, such as those described above, because ampoules do not degrade upon prolonged storage or when exposed to extremes of temperature.

[0009] The species indicative of a disease may be an amino acid such as tyrosine (or its metabolites) and the disease a cancer (e.g. colorectal cancer). The liquid sample may be a urine sample. The reagent may be a mercury-containing liquid acid reagent, such as that described in international (PCT) application no. PCT/AU2016/050067, the contents of which are incorporated herein in their entirety.

[0010] In some embodiments, the cap may comprise one or more engagement elements configured to engage with corresponding elements on the upper portion, whereby such engagement prevents detachment of the cap after attachment to the container.

[0011] In some embodiments, the corresponding elements on the upper portion may comprise one or more projections extending outwardly from a periphery of the upper portion, wherein, when the cap is attached to the upper portion, the one or more projections irreversibly engage with the one or more engagement elements of the cap. [0012] In some embodiments, the one or more projections extending outwardly from the periphery of the upper portion may define a pawl and the engagement elements of the cap may define a ratchet.

[0013] In some embodiments, the engagement elements may be located on an inner wall of the cap.

[0014] In some embodiments, the upper portion of the container and the cap may comprise complementary screw-threaded portions.

[0015] In some embodiments, the cap may comprise one or more transparent portions.

[0016] In some embodiments, the lower portion may comprise one or more tabs extending outwardly from the lower portion. The one or more tabs may, for example, comprise a colour chart, whereby the colour of the resultant mixture can be compared to the colour chart to determine whether the sample contains the species.

[0017] In some embodiments, the upper portion may comprise a dividing wall, whereby one side of the dividing wall is in fluid communication with the lower portion and the other side of the dividing wall is in fluid communication with an overflow chamber.

[0018] In some embodiments, the dividing wall may be circular/annular in shape, with the overflow chamber being formed between the dividing wall and an outer wall of the upper portion.

[0019] In some embodiments, a height of the dividing wall may correspond to a predefined volume of the liquid sample.

[0020] In some embodiments, the upper portion may comprise one or more baffles.

[0021] In some embodiments, the reagent may be a toxic liquid reagent. In some embodiments, the reagent may be a liquid acidic reagent. In some embodiments, the reagent may be a mercury-containing reagent. [0022] In a second aspect, there is provided a method for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample taken from a patient.

The method comprises the steps of:

(a) providing a diagnostic device, the device comprising: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the liquid sample and being in fluid communication with the lower portion, wherein the lower portion houses an ampoule that contains a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species; and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion, and which upon attachment thereto, cannot be detached,

(b) pouring the liquid sample into the opening of the upper portion;

(c) securing the cap to the upper portion;

(d) bending the container at the weakened portion to break open the ampoule, whereupon the liquid sample and the reagent can mix;

(e) causing the sample and the reagent to become mixed; and

(f) viewing the colour of the resultant mixture through transparent portions of the container.

[0023] In some embodiments, viewing the colour of the resultant mixture through the transparent walls of the container may further comprise comparing the colour of the resultant mixture with a colour chart (e.g. a chart supplied on or otherwise associated with the diagnostic device).

[0024] In a third aspect, there is provided a cap for a container of a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient, the cap comprising: a body capable of covering an opening of the container, the body having an upper wall and a tubular skirt extending downwardly from the upper wall, and one or more engagement elements located on an inner wall of the cap, wherein, when the cap is received on the container, the one or more engagement elements are configured to engage with corresponding elements on the container, whereby such engagement prevents detachment of the cap after attachment to the container.

[0025] In some embodiments, the cap and the outer surface of the container may comprise complementary screw-threaded portions.

[0026] In some embodiments, the cap may comprise one or more transparent portions. The transparent portions may, for example, be located on the tubular skirt.

[0027] In some embodiments, the cap configured to close the open upper end of the container according to the first aspect is the cap according to the third aspect.

[0028] Additional features and advantages of the various aspects of the present invention will be described below in the context of specific embodiments. It is to be appreciated, however, that such additional features may have a more general applicability in the present invention than that described in the context of these specific embodiments.

Brief Description of Drawings

[0029] Embodiments of the invention will now be described with reference to the accompanying drawings, which are exemplary only and in which:

[0030] Figure 1 shows an isometric view of a container for a diagnostic device in accordance with an embodiment of the present invention.

[0031 ] Figure 2 shows a front and a sectional view of the container of Figure 1 , with Figure 2(a) showing a front view and Figure 2(b) showing a sectional view along the line A-A through the container of Figure 2(a). [0032] Figure 3 shows a side and a sectional view of the container of Figure 1 , with Figure 3(a) showing a side view and Figure 3(b) showing a sectional view along the line B-B through the container of Figure 3(a).

[0033] Figure 4 shows a top isometric view of an embodiment of a cap for a container such as that shown in Figure 1 .

[0034] Figure 5 shows a bottom isometric view of the cap of Figure 4.

[0035] Figure 6 shows a front view of a diagnostic device including the container of Figure 1 and the cap of Figure 4 in a closed configuration.

[0036] Figure 7 shows a sectional view along the line A-A through the container shown in Figure 6.

[0037] Figure 8 shows a sectional view along the line B-B through the diagnostic device shown in Figure 6.

[0038] Figure 9 shows steps of a method for colorimetrically indicating the presence of a species indicative of a disease.

[0039] In the drawings, like reference numerals designate similar parts.

Detailed Description

[0040] As noted above, in one aspect the invention provides a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient and, in another aspect, a method for detecting this species using such a diagnostic device. In both aspects, the diagnostic device includes a container configured to receive the patient’s liquid sample, where the container comprises an upper portion, a lower portion and a weakened portion therebetween. The upper portion comprises an opening configured to receive the liquid sample. The lower portion is in fluid communication with the upper portion and is configured to receive therein an ampoule containing a reagent which, when contacted with the patient’s sample, colorimetrically indicates whether the sample contains the species. The device also includes a cap for sealing the container, where the cap is configured for receipt at the opening of the upper portion and which cannot be detached upon attachment thereto. In use, bending the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix, with the colour of the resultant mixture being visible through one or more transparent portions (e.g. walls) of the container.

[0041] The diagnostic device of the present invention will be described below primarily in the context of the safe containment of liquid acidic reagents (pre- and post-use) and, in particular, mercury-containing liquid acidic reagents. It will be appreciated, however, that applications for the present invention are more extensive than this. For example, the diagnostic device may be used for the safe containment of any toxic or noxious reagent, biohazard, or system which generates a toxic or noxious by-product or a biohazardous waste. Liquid samples taken from patients are also potential biohazards, and safely containing them is therefore also advantageous.

[0042] Mercury-containing liquid acidic reagents, such as Millon’s Reagent and the improved forms of Millon’s Reagent described in detail in the applicant’s earlier international patent application nos. PCT/AU2016/050067 and PCT/AU2022/051524, the contents of which are hereby incorporated by reference in their entirety, can be used to colorimetrically indicate the presence of certain species indicative of disease in a sample. In brief, the presence of phenolic compounds such as tyrosine and its metabolites in a patient’s urine can be indicative of the patient having a cancer, for example, colorectal cancer. When Millon’s Reagent is exposed to a fluid sample containing phenolic compounds (e.g. tyrosine and its metabolites), a red-brown precipitate forms. The presence of such a red-brown precipitate following mixing of the patient’s urine with Millon’s Reagent would prompt the patient to undergo further tests (e.g. a colonoscopy), which would provide a more reliable diagnosis.

[0043] As described above, however, safely storing mercury-containing liquid acidic reagents is problematic, both in terms of the long term stability of the storage vessel and the risks attendant with accessing the reagent in order to mix with samples taken from patients. The present invention provides an elegant solution to this problem, enabling the hazardous reagent to be contained in a glass ampoule (with which it does not react nor degrade, at least over a clinically useful period of time) and eliminating the risks associated with accessing the liquid reagent in such ampoules. Glass ampoules have been used for many years to store liquids for use in medical applications, and the present invention thus necessitates no change to standard procedures in this regard.

[0044] Figures 1 to 3 depict a container (100) for a diagnostic device (102, see Figure 6) in accordance with an embodiment of the invention. The container (100) is configured to receive a liquid sample from a patient (e.g. a urine, saliva or blood sample) and to house a glass ampoule (50, see Figure 7). Container (100) has an upper portion (30), a lower portion (10) and a weakened portion (20) therebetween. The weakened portion (20) may be sufficient to allow the container (100) to bend or flex in the region of the weakened portion and may, for example, be provided in the form of an area of reduced thickness.

[0045] The container (100) may be fabricated from any material that is stable when exposed to highly acidic or alkaline substances (although, as the material is only exposed to the reagent in a diluted form, a high stability may not necessarily be essential), and which is at least partially optically transparent. For example, the container may be fabricated from acrylic or polymethyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), high density polyethylene, polymethyl pentene, polypropylene (PP), polyethylene terephthalate (PETE or PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS). bio thermoplastic polyurethane (Bio TPU) and polylactic acid (PLA), or the like.

[0046] The upper portion (30) has an opening (32) configured to receive the patient’s liquid sample. The lower portion (10) is in fluid communication with the opening (32) and is also shaped to contain an ampoule (described below). The diagnostic device (102) also includes a cap (described below, see Figures 4 to 8) that is configured for receipt at the opening (32) of the upper portion (30) in order to seal the container (100) such that no fluid can escape and which, upon attachment thereto, cannot be detached. [0047] In use, bending of the container (100) at the weakened portion (20) breaks open the ampoule (as described below), whereupon the sample and the reagent can mix, and a colour of the resultant mixture is visible through transparent walls (16) of the container (100).

[0048] As can be seen in Figures 2(b) and 3(b), the container (100) includes a chamber (18), which extends from the opening (32) of the upper portion (30) to the bottom of the lower portion (10). The chamber (18) is configured to receive and retain an ampoule therein and provides a reaction chamber in which the reagent and the sample can mix and react in order to produce the colorimetric effect. The chamber (18) is sized so as to receive a volume of the patient’s liquid sample sufficient to detect whether the sample contains the species, taking into consideration the volume of space occupied by the ampoule.

[0049] The lower portion (10) of the container (100) includes two tabs (14), which extend outwardly from the lower portion (10). The tabs (14) are shown extending longitudinally along the entire length of the lower portion (10), although they need only extend for a part thereof. As shown, the tabs (14) connect to the lower end (34) of the upper portion (30), with the weakened portion extending across the tabs.

Advantageously, connecting the tabs (14) to the upper portion (30) in this manner may improve stability of the container about the weakened portion (20).

[0050] A colour chart or swatch (not shown) may be supplied with the diagnostic device (102). The colour chart may be a printed label, card and/or instruction material. Alternatively, the colour chart may be printed on the container (100) and/or its cap (200, see Figure 4). In some embodiments, the colour chart may be located on the tabs (14), thus enabling a side by side comparison of the colours.

[0051] The container (100) and/or the cap (200) may also include printed information for a user, such as a warning or poisoning statement, expiry dates, instructions for use, branding, supplier information, or the like. [0052] The lower portion (10) of the container (100) has transparent walls (16), through which the colour of the resultant mixture in chamber (18) is visible. The colour of this mixture may be compared to the colour chart described above, for example, to determine whether the patient’s sample contains the species indicative of disease. The transparent walls (16) may be located on any suitable portion of the container (100). The transparent walls (16) may be located on the lower end (34) of the upper portion (30) and/or on the at least one side wall (12) of the lower portion (10). The transparent walls (16) may be located adjacent a tab (14) of the container (100). The container (100) may be formed entirely from an opaque material, through which the colour of the liquid in chamber (18) can be discerned.

[0053] The upper portion (30) includes a circular dividing wall (38), with the inside of the dividing wall being in fluid communication with the lower portion (10) and the outside of the dividing wall (38) being in fluid communication with an overflow chamber (40), which is formed between the dividing wall and an outer wall (36) of the upper portion (30). The height of the dividing wall (38) corresponds to a predefined volume of the liquid sample. In use, overflow will occur when the chamber (18) has been filled to the brim with the liquid sample, with the overflow being directed into the overflow chamber (40). When the container (100) is closed by the cap (200), as described below, any liquid overflow is retained within the overflow chamber (40) and cannot flow over the dividing wall (38), even when the container is shaken or inverted.

[0054] The upper portion (30) has a number of internal baffles (42). The baffles (42) are located on an inner surface of the dividing wall (38) and act to channel the sample away from the opening (32) to the chamber (18). Baffles (42) may also assist with alignment of an ampoule (40) during its insertion into the container (100) so as to minimise the risk of the ampoule breaking during insertion. Finally, the baffles (42) also ensure that the top of the ampoule (40) is supported in a manner that quickly results in it breaking from the bottom upon binding of the device (102) about the weakened portion (20), as discussed in further detail below. [0055] The upper portion (30) includes a screw-threaded portion (44). As will be described in further detail below, the screw-threaded portion enables cap (200) to be attached to the container (100).

[0056] The upper portion (30) also includes a number of elements in the form of projections (46), which extend outwardly from a periphery of the upper portion. When the cap (200) is attached to the upper portion (30), as will be described below, the projections (46) irreversibly engage with complementary engagement elements on the cap. In the illustrated embodiment, for example, the projections (46) define pawls which can irreversibly engage with corresponding ratchet elements of the cap.

[0057] As will be appreciated, other mechanisms might be used to achieve a similar effect. For example, the screw thread on the cap and/or upper portion of the container may be configured to operate in one way only, or include only a few threads which, once they have travelled over the corresponding threads of the other part, permanently disengage from that thread and effectively locking the cap to the container. Alternatively, the cap and upper portion of the container may be configured with a snap lock-type fitting, where pressing the cap onto the opening causes the snap lock to engage and the cap thus irreversibly locked onto the container.

[0058] Referring now to Figures 4 and 5, shown is a cap (200) for use with the diagnostic device (102, see Figure 6). Cap (200) is configured to be affixed to the opening (32), whereupon it seals the container (100) in a liquid-tight manner. Once screwed onto the container, the cap is prevented from moving in a direction that would unscrew the cap, thereby securely retaining the patient’s liquid sample and the reagent (i.e. once released from the ampoule, as described below) within the sealed device (102). Advantageously, providing the diagnostic device with a cap configured to be irremovably placed on the container prevents access to or spillage of the liquid acidic reagents, fluid sample (e.g. a urine sample) and/or reaction by-products in the chamber (18).

[0059] The cap (200) includes a body (60) having an upper wall (62) and a tubular skirt (64), which extends downwardly from the upper wall (62). A number of engagement elements, shown in the form of ratchet engagement elements (66), are located on the lower edge of an inner wall of the skirt (64), above which is a screw-thread (68) that is complementary to screw thread (44) of container (100). When the cap (200) is received on the container (100), as can be seen in Figure 6 for example, the pawl like projections (46) engage with the ratchet engagement elements (66), which prevents detachment of the cap (i.e. by unscrewing) after attachment to the container.

[0060] The cap (200) also has a transparent portion (70). The transparent portion (70) is, in the depicted embodiment, located on the upper wall (62), but may be located on any suitable portion of the body (60), such as on the tubular skirt (64). In use, when the container is closed by the cap, the colour of the liquid in the container may be viewed through the cap and compared with a colour chart to determine whether the patient’s liquid sample contains the species indicative of disease. Advantageously, the colour of the liquid in the chamber may be compared to a colour chart printed on the skirt of the cap (200) to determine whether the liquid contains the species to be detected.

[0061] Turning now to Figures 6 to 8, a diagnostic device (102) in a closed configuration is illustrated. The device includes a container (100) and a cap (200). As described above, cap (200) cannot be detached from container (100).

[0062] As can be seen in Figures 7 and 8, an ampoule (50) in an unopened condition is contained within the container (100) of the assembled device (102). The ampoule (50) is received within the chamber (18) of the container (100), the chamber extending from the opening (32) of the container to the bottom of the lower portion (10). The head (52) of the ampoule extends at least partially into the upper portion (30) of the container (100) where, as can be seen in Figure 7, it is located between opposing baffles (42). The neck of the ampoule (typically including a frangible portion in the form of a score line (54)) is located at the weakened portion (20). Manipulating (e.g. by bending or folding the upper portion (30) with respect to the lower portion (10)) the weakened portion (20) of the container (100) thus causes the ampoule (50) to break at the score line (54). Once the ampoule has been broken in this manner, its contents are released into the chamber (18), where they can mix with the patient’s liquid sample and react with any reactive species that may be present in the sample. A resultant change in colour of the mixture can be comparted with a colour chart, for example, to indicate the presence of species in the sample that are indicative of abnormal cell behaviour.

[0063] Turning finally to Figure 9, a flow diagram of a method (300) for detecting a species indicative of a disease in a patient is illustrated.

[0064] In Step A of the method, a diagnostic device is provided, such as that described above with reference to Figures 1 to 8, for example. Generally speaking, however, the device comprises an ampoule containing a reagent which, when contacted with the sample, colorimetrically indicates whether the sample contains the species; a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the sample, and the lower portion being in fluid communication with the upper portion and configured to receive therein the ampoule, and a cap configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached.

[0065] In Step B of the method, a liquid sample from a patient, such as a urine sample, for example, is poured into the opening of the upper portion. In some embodiments, an overflow chamber located in the upper end of the container (e.g. overflow chamber 40) receives any excess of the liquid sample. In use, when the upper end of the container is closed by a cap, any liquid overflow is retained within the overflow chamber, even when the container is shaken or inverted.

[0066] In Step C of the method, a cap is secured to the upper portion. Once so attached (e.g. by screwing onto the container), the cap cannot be detached from the container. When the cap is received on the container, one or more engagement elements engage with corresponding elements on the upper portion of the container located on an inner wall of the cap, whereby such engagement prevents detachment of the cap after attachment to the container. The engagement elements may substantially prevent the cap from rotating in a direction which would enable the cap to be detached from the container. [0067] In Step D of the method, the container is bent at its weakened portion to break open the ampoule so that the sample and the reagent can mix. Typically, bending the container at the weakened portion will break the ampoule at a micro-score in the ampoule, enabling the release of reagent held within the ampoule.

[0068] In Step E of the method, the sample and the reagent are caused to become mixed (e.g. by shaking, inverting or the like).

[0069] In Step F of the method, the colour of the resultant mixture is viewed through transparent walls of the container. The colour of the resultant mixture may be compared with a colour chart to indicate the presence of the species in the sample. The colour chart may be printed on the container, such as on a tab or tabs extending outwardly from the lower portion.

[0070] A positive result (e.g. a matching colour) would prompt the patient to contact their medical service provider to arrange for further testing (e.g. a colonoscopy), as described in PCT/AU2016/050067 and PCT/AU2022/051524.

[0071 ] Advantageously, the diagnostic device and method of the present invention enable users having no medical training to be able to test for markers that may indicate an underlying disease or condition. Any toxic reagents and biological species are safely and stably contained both pre- and post-use of the device.

[0072] It will be understood to persons skilled in the art of the invention that many modifications may be made without departing from the spirit and scope of the invention. All such modifications are intended to fall within the scope of the following claims.

[0073] It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.

[0074] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[0075] Any promises made in the present description should be understood to relate to some embodiments of the invention and are not intended to be promises made about the invention as a whole. Where there are promises that are deemed to apply to all embodiments of the invention, the applicant/patentee reserves the right to later delete them from the description and does not rely on these promises for the acceptance or subsequent grant of a patent in any country.

Claims

CLAIMS:

1 . A diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient, the device comprising: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the liquid sample, and the lower portion being in fluid communication with the upper portion and configured to receive therein an ampoule containing a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species, and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached, wherein, in use, bending of the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix and a colour of the resultant mixture is visible through a transparent portion of the container.

2. A diagnostic device according to claim 1 , wherein the cap comprises one or more engagement elements configured to engage with corresponding elements on the upper portion, whereby such engagement prevents detachment of the cap after attachment to the container.

3. A diagnostic device according to claim 2, wherein the corresponding elements on the upper portion comprise one or more projections extending outwardly from a periphery of the upper portion, wherein, when the cap is attached to the upper portion, the one or more projections irreversibly engage with the one or more engagement elements of the cap.

4. A diagnostic device according to claim 3, wherein the one or more projections extending outwardly from the periphery of the upper portion define a pawl and the one or more engagement elements of the cap define a ratchet.

5. A diagnostic device according to any one of claims 2 to 4, wherein the one or more engagement elements are located on an inner wall of the cap.

6. A diagnostic device according to any one of the preceding claims, wherein the upper portion of the container and the cap comprise complementary screw-threaded portions.

7. A diagnostic device according to any one of the preceding claims wherein the cap comprises a transparent portion.

8. A diagnostic device according to any one of the preceding claims, wherein the lower portion comprises one or more tabs extending outwardly from the lower portion.

9. A diagnostic device according to claim 8, wherein the one or more tabs comprise a colour chart, whereby the colour of the resultant mixture can be compared to the colour chart to determine whether the sample contains the species.

10. A diagnostic device according any one of the preceding claims, wherein the upper portion comprises a dividing wall, whereby one side of the dividing wall is in fluid communication with the lower portion and the other side of the dividing wall is in fluid communication with an overflow chamber.

11. A diagnostic device according to claim 10, wherein the dividing wall is annular and the overflow chamber is formed between the dividing wall and an outer wall of the upper portion.

12. A diagnostic device according to claim 10 or claim 11 , wherein a height of the dividing wall corresponds to a predefined volume of the liquid sample.

13. A diagnostic device according to any one of the preceding claims, wherein the upper portion comprises one or more baffles.

14. A diagnostic device according to any one of the preceding claims, wherein the reagent is a toxic liquid reagent.

15. A diagnostic device according to any one of the preceding claims, wherein the reagent is a liquid acidic reagent.

16. A diagnostic device according to any one of the preceding claims, wherein the reagent is a mercury-containing liquid reagent.

17. A method for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample taken from a patient, the method comprising the steps of:

(a) providing a diagnostic device, the device comprising: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween, the upper portion comprising an opening configured to receive the liquid sample and being in fluid communication with the lower portion, wherein the lower portion houses an ampoule that contains a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species; and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion, and which upon attachment thereto, cannot be detached,

(b) pouring the liquid sample into the opening of the upper portion;

(c) securing the cap to the upper portion,

(d) bending the container at the weakened portion to break open the ampoule, whereupon the liquid sample and the reagent can mix;

(e) causing the sample and the reagent to become mixed; and

(f) viewing the colour of the resultant mixture through transparent portions of the container.

18. A method according to claim 17, wherein viewing the colour of the resultant mixture through the transparent walls further comprises comparing the colour of the resultant mixture with a colour chart.