Disposable cartridge used in liquid in vitro diagnostic equipment using chemiluminescence

Abstract

The present invention relates to a disposable cartridge used in liquid in vitro diagnostic equipment using chemiluminescence. The cartridge according to the present invention comprises: a cartridge frame having a plurality of wells and a plurality of well connection parts connecting the plurality of wells; and a light blocking sector formed in at least one of the plurality of well connection parts. The cartridge according to the present invention can block light from entering a measurement well from the surroundings when used in liquid in vitro diagnostic equipment using chemiluminescence. In addition, the cartridge according to the present invention can increase the measurement sensitivity of liquid in vitro diagnosis using chemiluminescence.

Description

Disposable cartridges for use in liquid in vitro diagnostic equipment using chemiluminescence

[0001] The present invention relates to a disposable cartridge used in a liquid in vitro diagnostic device using chemiluminescence, and relates to a cartridge having a configuration for implementing a darkroom.

[0002] Liquid in vitro diagnostic devices using chemiluminescence utilize reagents packed in disposable cartridges. Disposable cartridges used for in vitro diagnostics are equipped with multiple wells for reagent filling, various reactions, purification, etc., and a cartridge frame. The cartridge frame is made of plastic and has multiple well connection parts that connect the wells. The wells include reagent wells, reaction wells, wash wells, measurement wells, sample wells, and other wells. Reagents required for diagnosis are filled in the reagent wells, and in the reaction wells, samples and diagnostic reagents are mixed to form antigen / antibody complexes. Wash wells remove unreacted substances from the antigen / antibody complexes to purify the target component. In the measurement wells, the luminescent signal is measured using a signal detection device such as a photo multiplier tube (PMT). Samples are added to the sample wells, and other wells are equipped with analysis tips or are used for auxiliary or reserve purposes.

[0003] Each well can be individually manufactured and inserted into the cartridge frame, or can be molded as an integral part of the cartridge frame. Individual wells are not separated from the cartridge frame during use, but are used for testing as an integral part of the cartridge frame. Individual wells in the cartridge can be arranged in a single row or in two or more rows.

[0004] Meanwhile, chemiluminescent reagents are used in high-sensitivity applications, so they primarily utilize PMTs as optical systems. PMTs must be used in a darkroom. Without a darkroom, the sensitivity of signal measurement decreases due to the incoming background signal.

[0005] In diagnostic equipment that uses a separate assay cup rather than a cartridge, the assay cup is placed in a small, sealed space, and chemiluminescence and signal capture are performed in a darkened room, blocking light. However, in diagnostic equipment that uses cartridges, it is difficult to place the entire cartridge in a dark room, so a dark room is required only for the measurement well where chemiluminescence occurs.

[0006] Conventional translucent plastic cartridge frames are inherently light-transmitting. Therefore, even if a measurement well is enclosed to create a darkroom, light still enters the measurement well through the cartridge frame, increasing the background signal and reducing measurement sensitivity. Therefore, a means of blocking light from the surrounding area into the measurement well is necessary.

[0007] If the entire cartridge frame is manufactured from a black, light-blocking material, the interior of the well cannot be viewed, making it difficult to check the presence or absence of filler and quantitative dispensing during actual product production, making quality control difficult. Furthermore, since the optical system must be positioned above the measurement well, there are limitations in selecting the optical system location. Furthermore, when measuring from the top, there is a high probability of errors occurring due to optical errors such as interference with the injector, refraction due to the irregular shape of the interface between the measured material, and uneven material distribution caused by bubbles.

[0008] Accordingly, the present invention aims to block light from entering the measurement well of a disposable cartridge used in a liquid in vitro diagnostic device using chemiluminescence.

[0009] In addition, another object of the present invention is to provide a disposable cartridge capable of increasing the measurement sensitivity of liquid in vitro diagnosis using chemiluminescence.

[0010] The present invention, in order to achieve the aforementioned object, is characterized by a disposable cartridge used in a liquid in vitro diagnostic device using chemiluminescence, comprising: a cartridge frame having a plurality of wells, a plurality of well connection parts connecting the plurality of wells, and a light blocking sector formed in at least one of the plurality of well connection parts.

[0011] At least one of the above-described plurality of wells is a measurement well, and the light-blocking sector may be formed in a well connection portion adjacent to the measurement well. Preferably, the measurement well is located at an end of the cartridge frame.

[0012] The above light-blocking sector is interlocked with the darkroom wall of the diagnostic equipment. In addition, the light-blocking sector may have a recessed portion interlocked with the darkroom wall.

[0013] The above light blocking sector may be formed of black or colored plastic capable of blocking the transmission of light. The above light blocking sector may cover the entire vertical cross-section of the well connection portion.

[0014] The cartridge of the present invention can block light from entering the measurement well from the surroundings when used in a liquid in vitro diagnostic device utilizing chemiluminescence. Furthermore, the cartridge of the present invention can enhance the measurement sensitivity of liquid in vitro diagnostic devices utilizing chemiluminescence.

[0015] Figure 1 is a configuration diagram of a cartridge according to one embodiment of the present invention.

[0016] Figure 2 is a configuration diagram of a cartridge according to another embodiment of the present invention.

[0017] Figure 3 is a configuration diagram of a cartridge according to another embodiment of the present invention.

[0018] Figure 4(a) illustrates light inflow into the measurement well in a conventional cartridge, and Figure 4(b) illustrates light blocking into the measurement well in the cartridge illustrated in Figure 1.

[0019] Figure 5(a) describes the state before the diagnostic equipment creates a dark room for the cartridge illustrated in Figure 1, and Figure 5(b) describes the state after the dark room is created.

[0020] Figure 6(a) describes the state before the diagnostic equipment creates a dark room for the cartridge illustrated in Figure 2, and Figure 6(b) describes the state after the dark room is created.

[0021] Figure 7 illustrates a darkroom wall of a cartridge and diagnostic equipment according to another embodiment of the present invention.

[0022] Figure 8 illustrates a darkroom wall of a cartridge and diagnostic equipment according to another embodiment of the present invention.

[0023] Figure 9 is a configuration diagram of a cartridge according to another embodiment of the present invention.

[0024] Figure 10 is a configuration diagram of a cartridge according to another embodiment of the present invention.

[0025] Fig. 11 is a configuration diagram of a cartridge according to another embodiment of the present invention.

[0026] Figure 12 illustrates the detailed configuration of the light blocking sector in the cartridge illustrated in Figure 1.

[0027] To fully understand the present invention, preferred embodiments of the present invention will be described with reference to the accompanying drawings. The embodiments of the present invention may be modified in various forms, and the scope of the present invention should not be construed as being limited to the embodiments described in detail below. These embodiments are provided to more completely explain the present invention to those with average knowledge in the art. Therefore, the shapes of elements in the drawings may be exaggerated to emphasize a clearer description. It should be noted that in each drawing, the same parts are sometimes depicted with the same reference numerals. Detailed descriptions of well-known functions and configurations that may unnecessarily obscure the gist of the present invention are omitted.

[0028] FIG. 1 is a configuration diagram of a disposable cartridge (100) used in a liquid in vitro diagnostic device using chemiluminescence according to one embodiment of the present invention. As illustrated, the cartridge (100) comprises a plurality of wells (102), a cartridge frame (104), and a light-blocking sector (106). The cartridge frame (104) comprises a plurality of well connection parts (103) connecting the plurality of wells (102). The light-blocking sector (106) is formed in at least one of the plurality of well connection parts (103).

[0029] At least one of the plurality of wells (102) is a measurement well (102a). The measurement well (102a) may be located at the end of the cartridge frame (104) as illustrated in FIG. 1. The light-blocking sector (106) is preferably formed in a well connection portion adjacent to the measurement well (102a). The light-blocking sector (106) may be formed of black or colored plastic capable of blocking the transmission of light. In addition, the light-blocking sector (106) is formed to cover the entire vertical cross-section of the well connection portion (103) in the thickness direction (T).

[0030] The cartridge (100) can be manufactured by applying a double injection method when casting the cartridge frame (104) to simultaneously inject a light-blocking material around the measurement well (102a), or by manufacturing the cartridge frame (104), the light-blocking sector (106), and the measurement well (102a) separately and then fusing them.

[0031] Fig. 2 is a configuration diagram of a cartridge (200) according to another embodiment of the present invention. The light blocking sector (206) of the cartridge (200) has concave portions formed on the upper and lower surfaces that are interlocked with the dark room star of the diagnostic equipment. Fig. 3 is a configuration diagram of a cartridge (300) according to another embodiment of the present invention. The light blocking sector (306) of the cartridge (300) has convex portions formed on the upper and lower surfaces that are interlocked with the dark room star of the diagnostic equipment. The uneven portions (concave portions or convex portions) of the upper and lower surfaces of the light blocking sectors (206, 306) increase the light blocking effect when the leading edge of the dark room wall of the interlocking diagnostic equipment has a shape that corresponds to the shape.

[0032] Fig. 4(a) describes the light inflow into the measurement well in a conventional cartridge (10), and Fig. 4(b) describes the light blocking into the measurement well in the cartridge (100) shown in Fig. 1.

[0033] A cartridge (10) has a plurality of wells (12) and a cartridge frame (14). The cartridge frame (14) has a well connection portion (13) that connects the wells. Even if the darkroom wall (22, 24) of the diagnostic equipment forms a darkroom (20) for the measurement well (12a) of the cartridge (10), light is introduced through the cartridge frame (14) because the cartridge frame (14) is usually made of a translucent plastic material.

[0034] In contrast, in the cartridge (100), when the darkroom wall (122, 124) of the diagnostic equipment forms a darkroom (120) with respect to the measurement well (102a), the light blocking sector (106) blocks the light transmitted through the cartridge frame (104), so that light cannot enter the darkroom (120).

[0035] FIG. 5(a) describes the state before the darkroom walls (122, 124) of the diagnostic equipment create a darkroom for the cartridge (100) illustrated in FIG. 1, and FIG. 5(b) describes the state after the darkroom (120) is created. One end (122a) of the darkroom wall (122) has a shape corresponding to the upper surface of the light-blocking sector (106), and one end (124a) of the darkroom wall (124) has a shape corresponding to the lower surface of the light-blocking sector (106), thereby preventing light from entering at the boundary. In addition, the other end (122b) of the darkroom wall (122) and the other end (124b) of the darkroom wall (124) have corresponding shapes, thereby preventing light from entering at the boundary. To enhance the light blocking effect, the boundary between the darkroom wall (122, 124) and the light blocking sector (106) may be tightly or interlocked and may include an elastic member (not shown).

[0036] FIG. 6(a) describes the state of the darkroom wall (222, 224) of the diagnostic equipment before creating a darkroom for the cartridge (200) illustrated in FIG. 2, and FIG. 6(b) describes the state after creating a darkroom (220).

[0037] The cartridge (200) has a plurality of wells (202), a cartridge frame (204), and a light-blocking sector (206). The cartridge frame (204) has a well connection portion (203) that connects the wells. In order to enhance the light-blocking effect, the light-blocking sector (206) has concave portions formed on the upper and lower surfaces, and a convex portion formed on one end (222a, 224a) of the darkroom wall (222, 224). The darkroom wall (222) descends and the darkroom wall (224) rises with the light-blocking sector (206) interposed therebetween, so that they interlock with each other, thereby forming a darkroom (220) with respect to the measurement well (202a).

[0038] FIG. 7 illustrates a cartridge (400) and a darkroom wall (422, 424) of a diagnostic device according to another embodiment of the present invention.

[0039] The cartridge (400) has a plurality of wells (402), a cartridge frame (404), and a light-blocking sector (406). The cartridge frame (404) has a well connection portion (403) that connects the wells to each other. The measurement well (402a) is installed at an end of the cartridge (400), and the cartridge (400) has a light-blocking sector (406) not at a well connection portion immediately adjacent to the measurement well (402a), but at a well connection portion adjacent to an adjacent well (402b). The darkroom walls (422, 424) of the diagnostic equipment, together with the light-blocking sector (406), form a darkroom (420) for the measurement well (402a) and the well (402b). As in the cartridge (400), embodiments of the present invention can configure the light-blocking sector and the darkroom wall to surround two or more wells, including the measurement well.

[0040] The light blocking sector is effectively inserted into a well connection immediately adjacent to the measurement well (402a), but is not limited to an immediately adjacent web connection, and may be configured to include a well connection and an adjacent well that are not immediately adjacent to the measurement well. In other words, the light blocking sector may be configured to include two or more adjacent wells or web connections, including the measurement well.

[0041] FIG. 8 illustrates a cartridge (500) and a darkroom wall (522, 524) of a diagnostic device according to another embodiment of the present invention.

[0042] The cartridge (500) has a plurality of wells (502), a cartridge frame (504), and light-blocking sectors (506, 507). The cartridge frame (504) has a well connection portion (503) connecting the wells to each other. The measurement well (502a) is installed in the center portion, not the end portion, of the cartridge (500), and the cartridge (500) has light-blocking sectors (506, 507) in the well connection portions immediately adjacent to the measurement well (502a) on the right and left sides. The darkroom walls (522, 524) of the diagnostic equipment form a darkroom (520) for the measurement well (502a) together with the light-blocking sectors (506, 507). When the measurement well (502a) is installed at a location other than the end of the cartridge (500), as in the cartridge (500), light blocking sectors (506, 507) must be provided on the right and left sides of the measurement well (502a), respectively, to create a darkroom surrounding the measurement well (502a).

[0043] Fig. 9 is a plan view of a cartridge (600) according to another embodiment of the present invention. As illustrated, in the cartridge (600), a well (602) is installed in a two-row structure, and a measurement well (602a) is installed at an end of the cartridge (600).

[0044] The cartridge frame (604) has a well connection portion (603) that connects wells in a horizontal direction (H) and a vertical direction (V). The cartridge (600) has a light-blocking sector (606) that crosses the cartridge frame (604) in a vertical direction (H) to form a dark room for the measurement well (602a). The dark room wall (not shown) of the diagnostic equipment is configured to form a dark room for the measurement well (602a) together with the light-blocking sector (606).

[0045] Fig. 10 is a plan view of a cartridge (700) according to another embodiment of the present invention. As shown, in the cartridge (700), a well (702) is installed in a two-row structure, and a measurement well (702a) is installed at an end of the cartridge (700).

[0046] The cartridge frame (704) has a well connection portion (703) connecting wells in a horizontal direction (H) and a vertical direction (V). The cartridge (700) has a light blocking sector (706a) that crosses the cartridge frame (704) in a vertical direction (V) on the left side of the measurement well (702a) to form a dark room for the measurement well (702a), and a light blocking sector (706b) that is formed in a horizontal direction (H) on the adjacent well connection portion below the measurement well (702a). One end of the light blocking sector (706b) is formed to the right end of the cartridge frame (704), and the other end intersects the light blocking sector (706a). The dark room wall (not shown) of the diagnostic equipment is configured to form a dark room for the measurement well (702a) together with the light blocking sectors (706a, 706b).

[0047] Fig. 11 is a plan view of a cartridge (800) according to another embodiment of the present invention. As shown, in the cartridge (800), a well (802) is installed in a two-row structure, and a measurement well (802a) is installed at an end of the cartridge (800).

[0048] The cartridge frame (804) has a well connection portion (803) connecting wells in a horizontal direction (H) and a vertical direction (V). The cartridge (800) has a light blocking sector (806a) formed in a vertical direction (V) at an adjacent well connection portion on the left side of the measurement well (802a) to form a darkroom for the measurement well (802a), and a light blocking sector (806b) formed in a horizontal direction (H) at an adjacent well connection portion below the measurement well (802a). The light blocking sector (806a) intersects the light blocking sector (806b). The darkroom wall (not shown) of the diagnostic equipment is configured to form a darkroom for the measurement well (802a) together with the light blocking sectors (806a, 806b).

[0049] Figures 9 and 10 illustrate embodiments in which wells are installed in a two-row structure in a cartridge. Those skilled in the art will readily appreciate that the present invention can be equally applied to cartridges in which wells are installed in three or more rows, and to cartridges in which measurement wells are installed at locations other than the ends of the cartridge.

[0050] In Fig. 12, (a) describes the overall configuration of the cartridge (100) illustrated in Fig. 1, and (b) and (c) describe the detailed configuration of part A of the cartridge (100). When manufacturing the cartridge (100) through double injection, the boundary between the light-blocking sector material and the remaining cartridge material may have a clear boundary as in (b) or an unclear boundary as in (c) depending on the injection method, and both are valid. In addition, the light-blocking sector material may be manufactured by partially flowing into the adjacent well beyond the well connection.

[0051] The embodiments of the present invention described above are merely exemplary, and those skilled in the art will readily appreciate that various modifications and equivalent other embodiments are possible. Therefore, it will be readily understood that the present invention is not limited to the forms mentioned in the detailed description above. Accordingly, the true technical protection scope of the present invention should be defined by the technical spirit of the appended claims. Furthermore, the present invention should be understood to include all modifications, equivalents, and alternatives within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. In a disposable cartridge used in a liquid in vitro diagnostic device using chemiluminescence, Multiple wells, A cartridge frame having a plurality of well connection parts connecting the plurality of wells, A light blocking sector formed in at least one of the above multiple well connections. A cartridge characterized by comprising:

2. In paragraph 1, A cartridge characterized in that at least one of the plurality of wells is a measurement well, and the light blocking sector is formed in a well connection portion adjacent to the measurement well.

3. In paragraph 2, A cartridge characterized in that the above measurement well is located at the end of the cartridge frame.

4. In paragraph 1, A cartridge characterized in that the above light-blocking sector is interlocked with the darkroom wall of the diagnostic equipment.

5. In paragraph 4, A cartridge characterized in that the light blocking sector has a recessed portion that engages with the darkroom wall.

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