Diagnostic device and method of use

Abstract

Disclosed herein is a diagnostic device for colorimetrically indicating the presence of a disease marker in a liquid sample of a patient. The device includes a container configured to receive a liquid sample, the container including an upper portion, a lower portion, and a weakened portion therebetween. The upper portion includes an opening configured to receive a liquid sample, and the lower portion is in fluid communication with the upper portion and configured to receive an ampoule therein containing a reagent that, when in contact with the liquid sample, colorimetrically indicates whether the liquid sample contains the marker. The device also includes a cap for sealing the container, the cap being configured to fit at the opening of the upper portion and being non-removable upon assembly. In use, bending of the container at the weakened site breaks the ampoule, whereupon the liquid sample and reagent can be mixed, and the color of the resulting mixture is visible through the transparent portion of the container (e.g., one or more transparent walls).

Description

Technical Field

[0001] This article describes a diagnostic device for indicating the presence of disease biomarkers in patient fluid samples using colorimetry. The article also describes a method for indicating the presence of disease biomarkers using this diagnostic device. Background Technology

[0002] Many reagents used in the medical field are toxic or otherwise hazardous, thus requiring secure sealing to prevent leakage. For example, liquid reagents may exhibit toxicity or corrosiveness (or both) due to the presence of toxic substances, high acidity or alkalinity, making their handling dangerous. Milren's reagent is an example of a liquid reagent in medical applications that is both toxic and highly acidic; it is prepared by dissolving mercury salts (and sometimes other substances) in an inorganic acid. Milren's reagent has several uses, one of which is to indicate the presence of marker amino acids such as tyrosine, levodopa, and tryptophan, and their metabolites, in a patient's urine, which may indicate abnormal cellular activity in the patient's body.

[0003] However, because Milton's reagent contains mercury, it must be handled with extreme care. Traditionally, Milton's reagent is packaged in fragile glass ampoules. Just before use, the ampoule must be broken to mix the urine sample with the reagent. However, broken glass ampoules can create sharp edges, posing health risks, and users may come into contact with mercury (e.g., through splashing). Furthermore, if the ampoule is not subjected to a sufficiently strong impact, it may shatter and splatter. For at least these reasons, existing detection methods involving Milton's reagent are not truly suitable for non-professional scenarios.

[0004] In other testing devices, such as those described in International (PCT) Patent Application No. PCT / AU2016 / 050067, the Milren reagent or other mercury-containing acidic reagents can be safely stored in a non-flowing carrier (such as a gel carrier or absorbent material). Upon contact with a patient's liquid sample (such as a urine sample), this non-flowing carrier rapidly disintegrates, thereby achieving rapid and thorough mixing of the liquid sample with the mercury-containing reagent. Other testing devices, such as those described in International (PCT) Patent Application No. PCT / AU2022 / 051524, may have the Milren reagent (or other mercury-containing acidic reagent) in the test chamber covered by a polymer film. Upon contact with liquid samples (such as urine samples) of different pH values, the film rapidly disintegrates, again achieving rapid and thorough mixing of the liquid sample with the mercury-containing reagent.

[0005] Although such testing devices are highly effective and have been successfully applied to the detection of abnormal cell activity in many patients, stability issues may still occur if the gel carrier or polymer material is not stored according to the storage instructions (such as being overheated) or stored for too long.

[0006] Therefore, there is a need to develop improved diagnostic devices to indicate the presence of disease markers in patient fluid samples using colorimetry. Summary of the Invention

[0007] In a first aspect, a diagnostic device is provided for indicating the presence of disease markers in a patient's fluid sample (e.g., a urine sample) by colorimetric determination. The device includes:

[0008] A container configured to receive the liquid sample, the container including an upper portion, a lower portion, and a weakened portion between the upper portion and the lower portion;

[0009] The upper portion includes an opening configured to receive the liquid sample, and

[0010] The lower portion is in fluid communication with the upper portion and is configured to receive an ampoule containing a reagent, which, upon contact with the liquid sample, indicates by colorimetry whether the liquid sample contains the marker; and

[0011] A cap for sealing containers, configured to fit onto an opening at the top and not be detachable once installed.

[0012] In use, the bending of the container at the weakened part causes the ampoule to break, allowing the liquid sample and reagent to mix, and the color of the resulting mixture is visible through the transparent part of the container (e.g., one or more transparent walls).

[0013] Advantageously, the diagnostic device of the present invention provides a reliable test kit that can be used by the patient themselves, potentially comfortably in their own home, and without requiring any specialized medical training. The diagnostic device also provides safe containment of toxic (or otherwise harmful) liquid reagents, such as mercury-containing reagents, and biologically hazardous wastes (e.g., blood, urine, etc.) required to produce colorimetric results, as the cap is non-reopenable once attached. Furthermore, the diagnostic device overcomes stability problems associated with mercury-containing reagents (such as those described above) because the ampoule does not degrade during prolonged storage or when exposed to extreme temperatures.

[0014] Disease markers may be amino acids, such as tyrosine (or its metabolites), and the disease may be cancer (e.g., colorectal cancer). Liquid samples may be urine samples. Reagents may be mercury-containing liquid acid reagents, such as those described in International (PCT) application number PCT / AU2016 / 050067, the entire contents of which are incorporated herein by reference.

[0015] In some embodiments, the cap may include one or more engagement elements configured to engage with corresponding elements on the upper portion, thereby preventing the cap from detaching after being attached to the container.

[0016] In some embodiments, the corresponding element on the upper portion may include one or more protrusions extending outward from the periphery of the upper portion, wherein when the cap is attached to the upper portion, the one or more protrusions irreversibly engage with one or more engagement elements of the cap.

[0017] In some embodiments, one or more protrusions extending outward from the upper periphery may define a pawl, and the engaging element of the cap may define a ratchet.

[0018] In some embodiments, the engagement element may be located on the inner wall of the cap.

[0019] In some embodiments, the upper part of the container and the cap may include complementary threaded portions.

[0020] In some embodiments, the cap may include one or more transparent portions.

[0021] In some embodiments, the lower portion may include one or more tabs extending outward from the lower portion. The one or more tabs may include, for example, a colorimetric card, whereby the color of the resulting mixture can be compared with the colorimetric card to determine whether the sample contains the substance.

[0022] In some embodiments, the upper portion may include a partition wall, wherein one side of the partition wall is in fluid communication with the lower portion, and the other side of the partition wall is in fluid communication with the overflow chamber.

[0023] In some embodiments, the partition wall may be circular / annular, wherein an overflow chamber is formed between the partition wall and the upper outer wall.

[0024] In some embodiments, the height of the partition wall may correspond to a predetermined volume of the liquid sample.

[0025] In some embodiments, the upper portion may include one or more baffles.

[0026] 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.

[0027] In a second aspect, a method is provided for indicating the presence of disease biomarkers in patient fluid samples by colorimetry. The method includes the following steps:

[0028] (a) Providing a diagnostic device, the device comprising:

[0029] A container configured to receive the liquid sample, the container including an upper portion, a lower portion, and a weakened portion between the upper and lower portions; the upper portion including an opening configured to receive the liquid sample and in fluid communication with the lower portion, wherein the lower portion contains an ampoule containing a reagent that, upon contact with the liquid sample, indicates by colorimetry whether the liquid sample contains the marker; and

[0030] A cap for sealing the container, the cap being configured to fit over the opening at the top and being non-removable once fitted.

[0031] (b) Pour the liquid sample into the opening at the top;

[0032] (c) Secure the cap to the upper part;

[0033] (d) Bend the container at the weakened area to break the ampoule so that the liquid sample and reagent can be mixed;

[0034] (e) Mix the sample and the reagent; and

[0035] (f) Observe the color of the resulting mixture through the transparent portion of the container.

[0036] In some embodiments, observing the color of the resulting mixture through the transparent wall of the container may also include comparing the color of the resulting mixture with a colorimetric card (e.g., a chart provided on or otherwise associated with a diagnostic device).

[0037] In a third aspect, a cap is provided for a container of a diagnostic device for indicating the presence of disease markers in a patient's fluid sample by colorimetry, the cap comprising:

[0038] A main body capable of covering the opening of the container, the main body having an upper wall and a tubular skirt extending downward from the upper wall, and

[0039] One or more engagement elements are located on the 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, thereby preventing the cap from detaching after being attached to the container.

[0040] In some embodiments, the outer surfaces of the cap and container may include complementary threaded portions.

[0041] In some embodiments, the cap may include one or more transparent portions. These transparent portions may, for example, be located on the tubular skirt.

[0042] In some embodiments, the cap at the top of the opening of the closed container, which is constructed according to the first aspect, is a cap according to the third aspect.

[0043] Additional features and advantages of various aspects of the invention will now be described in the context of specific embodiments. However, it should be understood that these additional features may have a more general applicability in the invention than those described in the context of these specific embodiments. Attached Figure Description

[0044] Embodiments of the invention will now be described with reference to the accompanying drawings, which are merely exemplary, and wherein:

[0045] Figure 1 An isometric view of a container for a diagnostic device according to an embodiment of the present invention is shown.

[0046] Figure 2 It shows Figure 1 Front view and sectional view of the container, where Figure 2 (a) shows the front view. Figure 2 (b) shows the route along the crossing Figure 2 (a) is a sectional view of the container along line AA.

[0047] Figure 3 It shows Figure 1 The side view and sectional view of the container, where Figure 3 (a) shows a side view. Figure 3 (b) shows the route along the crossing Figure 3 (a) is a sectional view of the container with line BB.

[0048] Figure 4 It shows how to use such as Figure 1 Top isometric view of an embodiment of the container cap shown.

[0049] Figure 5 It shows Figure 4 Isometric view of the bottom of the cap.

[0050] Figure 6 The diagram shows the components in a closed configuration, including Figure 1 Containers and Figure 4 Front view of the diagnostic device with the cap on it.

[0051] Figure 7 It shows the passage along line AA Figure 6 The container shown is a cross-sectional view.

[0052] Figure 8 It shows the crossing along line BB. Figure 6 The diagram shows a cross-sectional view of the diagnostic device.

[0053] Figure 9 The steps for a method of indicating the presence of disease biomarkers by colorimetry are shown.

[0054] In the accompanying drawings, the same reference numerals denote similar parts. Detailed Implementation

[0055] As previously described, the present invention provides, on the one hand, a diagnostic device for indicating the presence of disease biomarkers in a patient's fluid sample by colorimetry, and on the other hand, a method for detecting such biomarkers using the diagnostic device. In both aspects, the diagnostic device includes a container configured to receive a patient's fluid sample, the container comprising an upper part, a lower part, and a weakened portion therebetween. The upper part has an opening for receiving the fluid sample. The lower part is in fluid communication with the upper part and is designed to contain an ampoule containing a reagent, which, upon contact with the patient sample, indicates the presence of a target biomarker in the sample by colorimetry. The device also includes a cap for sealing the container, the cap being designed to fit onto the upper opening and being non-removable once fitted. In use, the ampoule is broken by bending the weakened portion of the container, causing the fluid sample and reagent to mix. The resulting color change can be observed through one or more transparent portions (such as sidewalls) of the container.

[0056] The following description of the diagnostic device of the present invention will primarily focus on the safe sealing of liquid acidic reagents (especially mercury-containing liquid acidic reagents) before and after use. However, it should be understood that the application scope of the present invention extends far beyond this. For example, the diagnostic device can be used to safely seal any toxic or hazardous reagents, biohazards, or systems that can generate toxic or hazardous byproducts or biohazardous waste. Liquid samples collected from patients also possess potential biohazards, therefore, their safe sealing is also of significant value.

[0057] Mercury-containing liquid acidic reagents, such as Milren's reagent and its improved formulations (detailed descriptions can be found in the applicant's previous international patent applications PCT / AU2016 / 050067 and PCT / AU2022 / 051524, the entire contents of which are incorporated herein by reference), can be used to indicate the presence of specific disease markers in a sample by colorimetric methods. In short, the presence of phenolic compounds such as tyrosine and its metabolites in a patient's urine may indicate cancer (e.g., colorectal cancer). When Milren's reagent comes into contact with a liquid sample containing phenolic compounds (such as tyrosine and its metabolites), a reddish-brown precipitate forms. If such a reddish-brown precipitate forms after mixing a patient's urine with Milren's reagent, it suggests that the patient needs further testing (e.g., colonoscopy) to obtain a more reliable diagnostic result.

[0058] However, as mentioned earlier, the safe storage of mercury-containing liquid acidic reagents presents a dual challenge: it involves both the long-term stability of the storage container and the risk associated with mixing the reagent with patient samples. This invention provides an ingenious solution that encapsulates hazardous reagents in glass ampoules (ensuring they do not react with or degrade the glass, at least within their clinical shelf life), while completely eliminating the potential risks associated with handling the liquid reagents in such ampoules. Glass ampoules have been used for storing medical liquids for many years; therefore, this invention does not require changes to standard operating procedures in this field.

[0059] Figures 1 to 3 A diagnostic device (102) according to an embodiment of the present invention is shown (see...). Figure 6 The container (100) used is designed to receive fluid samples (such as urine, saliva, or blood samples) from a patient and to contain glass ampoules (50, see [reference]). Figure 7 The container (100) has an upper part (30), a lower part (10), and a weakened portion (20) between them. The weakened portion (20) needs to ensure that the container (100) can bend or flex in the weakened portion area, for example, by local thinning.

[0060] The container (100) may be made of any material that remains stable when in contact with strong acids or bases (although extremely high stability is not absolutely necessary since the material only comes into contact with diluted reagents), and the material must have at least some optical transparency. For example, the container may be made of acrylic or polymethyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), high-density polyethylene, polymethylpentene, polypropylene (PP), polyethylene terephthalate (PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), bio-thermoplastic polyurethane (Bio TPU), polylactic acid (PLA), or similar materials.

[0061] The upper part (30) has an opening (32) for receiving a patient's fluid sample. The lower part (10) is in fluid communication with the opening (32) and is shaped to accommodate an ampoule (described below). The diagnostic device (102) also includes a cap (described below, see [link]). Figures 4 to 8 The cap is designed to fit into the opening (32) of the upper part (30) to seal the container (100) to ensure that the liquid does not leak out, and it is not removable once assembled.

[0062] When in use, the ampoule (described below) can be opened by bending the weakened part (20) of the container (100), so that the sample and reagent can be mixed. The color of the resulting mixture can be observed through the transparent wall (16) of the container (100).

[0063] like Figure 2(b) and Figure 3 As shown in (b), the container (100) has a chamber (18) extending from the opening (32) of the upper part (30) to the bottom of the lower part (10). The chamber (18) is used to contain and fix the ampoule therein, and also serves as a reaction space for the reagent and sample to mix and react to produce a colorimetric effect. The size design of the chamber (18) needs to take into account the volume occupied by the ampoule to ensure that it can hold a sufficient amount of patient liquid sample for detecting the presence of the target substance.

[0064] The lower part (10) of the container (100) includes two tabs (14) extending outward from the lower part (10). The figure shows that the tabs (14) extend longitudinally along the entire length of the lower part (10), but in reality only a partial extension is required. As shown, the tabs (14) are connected to the lower end (34) of the upper part (30), and the weakened portion extends across the tabs. This design of connecting the tabs (14) to the upper part (30) helps to enhance the stability of the container around the weakened portion (20).

[0065] The diagnostic device (102) may be equipped with a colorimetric card or color chart (not shown). The colorimetric card may be a printed label, card, and / or instructional material. Alternatively, the colorimetric card may also be printed on the container (100) and / or its cap (200) (see [reference needed]). Figure 4 In some embodiments, the color chart may be set on the tab (14) to allow for side-by-side color comparison.

[0066] The container (100) and / or cap (200) may also be printed with information provided to the user, such as warning statements or poisoning warnings, expiration dates, instructions for use, brand logos, supplier information, etc.

[0067] The lower part (10) of the container (100) is provided with a transparent wall (16) through which the color of the mixture in the chamber (18) can be observed. The color of the mixture can be compared with the aforementioned colorimetric card, for example, to determine whether a patient sample contains a disease marker. The transparent wall (16) can be located at any suitable location on the container (100). The transparent wall (16) can be located on the lower end (34) of the upper part (30) and / or on at least one side wall (12) of the lower part (10). The transparent wall (16) can also be located adjacent to the tab (14) of the container (100). The container (100) as a whole can be made of an opaque material through which the color of the liquid in the chamber (18) can be identified.

[0068] The upper part (30) includes an annular partition wall (38), the inner side of which is in fluid communication with the lower part (10), and the outer side of which is in communication with an overflow cavity (40), which is formed between the partition wall and the outer wall (36) of the upper part (30). The height of the partition wall (38) corresponds to the preset capacity of the liquid sample. In use, when the chamber (18) is filled to the edge with liquid sample, an overflow occurs, and the overflowing liquid is directed into the overflow cavity (40). As described below, when the container (100) is sealed with a cap (200), even if the container is shaken or inverted, all overflowing liquid will be confined within the overflow cavity (40) and will not overflow beyond the partition wall (38).

[0069] The upper part (30) is provided with multiple internal baffles (42). These baffles (42) are located on the inner surface of the partition wall (38) and their function is to guide the sample from the opening (32) into the chamber (18). The baffles (42) also assist in alignment when the ampoule (40) is inserted into the container (100), thereby minimizing the risk of the ampoule breaking during insertion. Finally, the baffles (42) also support the top of the ampoule (40) in a specific manner to ensure that the ampoule breaks quickly from the bottom when the device (102) bends around the weakened part (20), the details of which will be further described below.

[0070] The upper part (30) includes a threaded portion (44). As will be described in detail below, this threaded portion enables the cap (200) to be attached to the container (100).

[0071] The upper part (30) also includes a plurality of elements in the form of protrusions (46) extending outward from the upper periphery. As will be explained below, when the cap (200) is attached to the upper part (30), the protrusions (46) form an irreversible engagement with complementary engagement elements on the cap. For example, in the illustrated embodiment, the protrusions (46) form a pawl structure that can irreversibly engage with a corresponding ratchet element on the cap.

[0072] As will be understood, similar effects can be achieved using other mechanisms. For example, the threads on the cap and / or top of the container can be configured to operate in only one manner, or include only a few threads, which, once they have traveled on the corresponding threads of another part, permanently disengage from those threads and effectively lock the cap to the container. Alternatively, the cap and top of the container can be configured with snap-lock type fittings, wherein pressing the cap onto the opening causes the snap-lock to engage and the cap is thus irreversibly locked to the container.

[0073] Now for reference Figure 4 and Figure 5 The diagnostic device (102) is shown in the image. Figure 6The device includes a matching cap (200). This cap (200) is designed to be secured at the opening (32) to seal the container (100) in a liquid-tight manner. Once the cap is screwed onto the container, its movement is restricted and it cannot be screwed off in the opposite direction, thereby ensuring that the patient's liquid sample and reagents (i.e., after release from the ampoule as described below) are securely sealed inside the device (102). Advantageously, the diagnostic device is provided with a cap configured to be non-removably placed on the container to prevent access to or spillage of liquid acidic reagents, fluid samples (e.g., urine samples), and / or reaction byproducts in the chamber (18).

[0074] The cap (200) includes a body (60) having an upper wall (62) and a tubular skirt (64) extending downward from the upper wall (62). A plurality of engagement elements, shown in the form of ratchet engagement elements (66), are located on the lower edge of the inner wall of the skirt (64), above which is a thread (68) complementary to the thread (44) of the container (100). When the cap (200) is received on the container (100), for example in… Figure 6 As can be seen, the pawl-shaped protrusion (46) engages with the ratchet engagement element (66), which prevents the cap from detaching after it has been attached to the container (i.e., by unscrewing).

[0075] The cap (200) also has a transparent portion (70). In the depicted embodiment, the transparent portion (70) is located on the upper wall (62), but it can be located on any suitable part of the body (60), such as on the tubular skirt (64). In use, when the container is closed by the cap, the color of the liquid in the container can be observed through the cap and compared with a colorimetric card to determine whether the patient's liquid sample contains disease markers. Advantageously, the color of the liquid in the chamber can be compared with a colorimetric card printed on the skirt of the cap (200) to determine whether the liquid contains the marker to be detected.

[0076] See now Figures 6 to 8 The diagram shows a diagnostic device (102) in a closed configuration. The device includes a container (100) and a cap (200). As described above, the cap (200) cannot be removed from the container (100).

[0077] from Figure 7 and Figure 8 As can be seen, the unopened ampoule (50) is contained within the container (100) of the assembled device (102). The ampoule (50) is contained within a chamber (18) of the container (100), which extends from the opening (32) of the container to the bottom of the lower part (10). The head (52) of the ampoule extends at least partially into the upper part (30) of the container (100), wherein, as in Figure 7As can be seen, it is located between opposing baffles (42). The neck of the ampoule (which typically includes a fragile section in the form of a score line (54)) is located at the weakened portion (20). Therefore, manipulating (e.g., by bending or folding the upper portion (30) relative to the lower portion (10)) the weakened portion (20) of the container (100) causes the ampoule (50) to break at the score line (54). Once the ampoule breaks in this manner, its contents are released into the chamber (18), where they can mix with the patient's fluid sample and react with any active substances that may be present in the sample. The color change of the mixture can be compared with a colorimetric card, for example, to indicate the presence of substances in the sample that indicate abnormal cellular activity.

[0078] See last. Figure 9 The diagram shows a flowchart of a method 300 for detecting disease markers in a patient.

[0079] In step A of the method, a diagnostic device is provided, for example, as described above (reference provided). Figures 1 to 8 The described diagnostic device. However, generally, the device includes an ampoule containing a reagent that, upon contact with a sample, indicates by colorimetry whether the sample contains the substance; a container configured to receive the liquid sample, the container including an upper portion, a lower portion, and a weakened portion between the upper and lower portions; the upper portion including an opening configured to receive the sample, and the lower portion being in fluid communication with the upper portion and configured to receive the ampoule therein; and a cap configured to receive at the opening in the upper portion and being non-removable once assembled.

[0080] In step B of the method, a fluid sample (e.g., a urine sample) from the patient is poured into the opening at the top. In some embodiments, an overflow chamber (e.g., overflow chamber 40) located at the top of the container receives any excess fluid sample. In use, when the top of the container is closed by the cap, any fluid overflow is retained in the overflow chamber even when the container is shaken or inverted.

[0081] In step C of the method, the cap is secured to the upper part. Once attached (e.g., screwed onto the container), the cap cannot be removed from the container. When the cap is received on the container, one or more engaging elements engage with corresponding elements located on the upper part of the container on the inner wall of the cap, thereby preventing the cap from detaching after attachment to the container. The engaging elements substantially prevent the cap from rotating in the direction that would allow it to be removed from the container.

[0082] In step D of this method, the container is bent at its weakened portion to break the ampoule, allowing the sample and reagent to mix. Typically, bending the container at the weakened portion will break the ampoule at micro-scratches within it, releasing the reagent held within.

[0083] In step E of the method, the sample and reagents are mixed (e.g., by shaking, inverting, etc.).

[0084] In step F of this method, the color of the resulting mixture is observed through the transparent wall of the container. The color of the resulting mixture can be compared with a colorimetric card to determine whether the target substance is present in the sample. The colorimetric card can be printed on the container, for example, on one or more raised tabs extending outward from the bottom.

[0085] If the test result is positive (e.g., color matching), the patient will be prompted to contact their healthcare provider to arrange further testing (e.g., colonoscopy). The specific procedures can be found in PCT / AU2016 / 050067 and PCT / AU2022 / 051524.

[0086] Advantageously, the diagnostic device and method of the present invention enable users without medical training to test markers that may indicate underlying diseases or conditions. Any toxic reagents and biological species are safely and stably contained before and after use of the device.

[0087] Those skilled in the art will understand that many modifications can be made without departing from the spirit and scope of the invention. All such modifications are intended to fall within the scope of the appended claims.

[0088] It should be understood that if this article refers to any prior art publication, such reference does not constitute an acknowledgment that such publication is common knowledge in the field in Australia or any other country.

[0089] In the following claims and the foregoing description of the invention, unless the context requires otherwise due to explicit language or necessary implication, the word “comprising” or variations such as “including” or “containing” are used in an inclusive sense, that is, to specify the presence of the said feature but not to exclude the presence or addition of further features in various embodiments of the invention.

[0090] Any commitments made in this specification should be understood to relate to certain embodiments of the invention and are not intended as commitments to the entire invention. Where commitments exist that are believed to apply to all embodiments of the invention, the applicant / patentee reserves the right to remove them from the description at a later date and without reliance on such commitments for acceptance or subsequent patent grant in any country.

Claims

1. A diagnostic device for indicating the presence of a marker of disease in a patient's liquid sample by colorimetry, 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 house therein an ampoule containing a reagent that, when the reagent comes into contact with the liquid sample, indicates by colorimetry whether the liquid sample contains the marker, and a cap for sealing the container, the cap being configured to fit over the opening of the upper portion and being non-removable once fitted, wherein, in use, the ampoule is broken by bending the container at the weakened portion, whereupon the liquid sample can mix with the reagent, and the color produced after mixing can be observed through a transparent portion on the container.

2. The diagnostic device of 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 the cap from being removed after attachment to the container.

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

4. The diagnostic device of claim 3, wherein, the one or more protrusions extending outwardly from the perimeter of the upper portion define a pawl, and the one or more engagement elements of the cap define a ratchet.

5. The 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. The diagnostic device according to any of the preceding claims, wherein, the upper portion of the container and the cap comprise complementary threaded portions.

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

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

9. The diagnostic device of claim 8, wherein, the one or more tabs comprise a colorimetric card, whereby the color of the resulting mixture can be compared to the colorimetric card to determine whether the sample contains the marker.

10. The diagnostic device according to any one of the preceding claims, wherein, the upper portion comprises a partition wall, wherein one side of the partition wall is in fluid communication with the lower portion, and another side of the partition wall is in fluid communication with an overflow chamber.

11. The diagnostic device of claim 10, wherein, the partition wall is annular, and the overflow chamber is formed between the partition wall and an outer wall of the upper portion.

12. The diagnostic device according to claim 10 or 11, wherein, a height of the partition wall corresponds to a predetermined volume of the liquid sample.

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

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

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

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

17. A method for indicating the presence of a marker of disease in a patient's liquid sample by colorimetry, 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 therein an ampoule containing a reagent that, when the reagent comes into contact with the liquid sample, indicates by colorimetry whether the liquid sample contains the marker; and a cap for sealing the container, the cap being configured to fit over the opening of the upper portion and being non-removable once fitted, (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 a weakened portion to break the ampoule, whereby the liquid sample can mix with the reagent; (e) mixing the sample and the reagent; and (f) observing the color of the resulting mixture through the transparent portion of the container.

18. The method of claim 17, wherein, Observing the color of the resulting mixture through the transparent wall can further comprise comparing the color of the resulting mixture to a color chart.

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