In vitro diagnostic equipment employing cartridge using chemiluminescence

Abstract

The present invention relates to in vitro diagnostic equipment employing a cartridge using chemiluminescence. The in vitro diagnostic equipment according to the present invention includes: a cartridge holder which is made of an opaque material and supports the side surface of a cartridge; an upper dark chamber wall, having all remaining surfaces except for the bottom surface thereof enclosed with a light-blocking material, the upper dark chamber wall being configured to move upward or downward and descending during light quantity measurement so as to be in close contact with the upper surface of the cartridge holder and the upper periphery of a measurement well of the cartridge; and a lower dark chamber wall, having all remaining surfaces except for the top surface thereof enclosed with a light-blocking material, the lower dark chamber wall being configured to move upward or downward and ascending during light quantity measurement so as to be in close contact with the lower surface of the cartridge holder and the lower periphery of the measurement well of the cartridge. The in vitro diagnostic device according to the present invention can implement a dark chamber only for the measurement well among the plurality of wells in the cartridge.

Description

In vitro diagnostic equipment using cartridges that utilize chemiluminescence

[0001] The present invention relates to an in vitro diagnostic device using a cartridge utilizing chemiluminescence, and more particularly, to an in vitro diagnostic device capable of implementing a darkroom for a measurement well of a cartridge.

[0002] A device is known for qualitatively or quantitatively analyzing specific components in biological samples using an immunoassay, utilizing a disposable cartridge composed of multiple wells connected together and loaded with reagents. In particular, when using chemiluminescent reagents, extremely high-precision analysis is possible. Chemiluminescent cartridges include not only reagent wells loaded with various reagents, but also reaction wells, wash wells, and measurement wells. In particular, in the measurement wells, a biological sample reacts with the chemiluminescent reagent, generating light of an amount determined by the concentration of the target component. An optical system can measure the light intensity by positioning it close to the measurement wells.

[0003] Since the intensity of light generated when using chemiluminescent reagents is weak, a highly sensitive PMT (Photomultiplier Tube) is often used. Because the PMT optical system is highly sensitive, even a very small amount of light can generate a background signal, necessitating a high level of darkroom implementation. Furthermore, the PMT reacts to light even during the resting period when no measurement is being performed. When light enters the optical system, the background signal increases, and the optical system operates unnecessarily, causing electrons to accumulate inside the PMT, which can lead to various malfunctions. Therefore, a darkroom implementation is essential for in vitro diagnostic equipment that uses cartridges that utilize chemiluminescence. However, because the cartridges are long, implementing a darkroom for the entire device incurs a large darkroom size and high costs.

[0004] Therefore, the purpose of the present invention is to selectively implement a darkroom only in the measurement well of a cartridge using chemiluminescence.

[0005] In addition, the present invention has another purpose of allowing light generated from chemiluminescence to enter the PMT only during measurement, and preventing light from entering the PMT during a rest period when no measurement is being made.

[0006] In order to achieve the above-described object, the present invention is characterized by providing an in vitro diagnostic device using a cartridge utilizing chemiluminescence, comprising: a cartridge holder made of an opaque material and supporting a cartridge; an upper darkroom wall, the remaining surfaces except the lower surface being blocked with the opaque material and configured to be raised or lowered, and lowered when measuring the amount of light to come into close contact with the upper surface of the cartridge holder and the upper peripheral portion of the measurement well of the cartridge; and a lower darkroom wall, the remaining surfaces except the upper surface being blocked with the opaque material and configured to be raised or lowered, and rise when measuring the amount of light to come into close contact with the lower surface of the cartridge holder and the lower peripheral portion of the measurement well of the cartridge.

[0007] The above-mentioned in vitro diagnostic equipment is installed on the upper darkroom wall and may further include an injector needle capable of injecting a chemiluminescent reagent into the measurement well. The injector needle is installed on the upper darkroom wall at an acute angle with respect to the wall of the measurement well.

[0008] The above-described in vitro diagnostic equipment may further include an optical system including a PMT installed on the lower darkroom wall to measure the amount of light emitted from the side or bottom surface of the measurement well. The optical system includes a shield to prevent light from entering the PMT when the lower darkroom wall is lowered.

[0009] Preferably, the optical system comprises an optical system body part attached to the lower darkroom wall and having an optical path formed therein between the measurement well and the PMT, and a push pin connected to the lower portion of the blocking film, wherein the blocking film is configured to block the optical path when the push pin is pressed and to open the optical path when the push pin is not pressed.

[0010] The present invention, with the aforementioned configuration, can selectively implement a darkroom only in the measurement well of a cartridge that utilizes chemiluminescence. Furthermore, the present invention can allow light generated by chemiluminescence to enter the PMT only during measurement, and prevent light from entering the PMT during the resting period when no measurement is being performed.

[0011] Figure 1 is a schematic diagram of a cartridge utilizing chemiluminescence used in the present invention.

[0012] Figure 2 is a top view of a cartridge holder according to one embodiment of the present invention.

[0013] Figure 3 illustrates that the cartridge illustrated in Figure 1 is mounted in the cartridge holder illustrated in Figure 2.

[0014] Figure 4 illustrates a state in which the cartridge illustrated in Figure 1 is mounted in the cartridge holder illustrated in Figure 2.

[0015] FIG. 5 illustrates a diagnostic device according to one embodiment of the present invention implementing a darkroom for a measurement well of a cartridge.

[0016] Figure 6 illustrates the operation of a barrier film in an optical system according to one embodiment of the present invention.

[0017] 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.

[0018] FIG. 1 is an exemplary diagram of a cartridge utilizing chemiluminescence according to the present invention, wherein (a) is a top view and (b) is a side view. As illustrated, the cartridge (100) has a plurality of wells (102) and a cartridge frame (104). The cartridge frame (104) has a well connection portion (103) connecting the wells to each other. The cartridge (100) has a measurement well (102a) at an end.

[0019] Fig. 2 is a top view of a cartridge holder (200) according to one embodiment of the present invention. Fig. 3 illustrates a cartridge (100) being mounted on the cartridge holder (200). Fig. 4 illustrates a state in which a cartridge (100) is mounted on the cartridge holder (200), (a) is a top view and (b) is a side view.

[0020] The cartridge holder (200) has a holder frame (202), and the holder frame (202) forms three slits (204) that support the cartridge (100). The cartridge holder (200) is made of an opaque material, but for ease of understanding, the cartridge holder (200) is shown as translucent in FIG. 4(b). The holder frame (202) supports at least a portion of the side surface and at least a portion of the lower surface of the cartridge (100).

[0021] FIG. 5 illustrates a diagnostic device according to one embodiment of the present invention that implements a darkroom for a measurement well (102a) of a cartridge (100). As illustrated, the diagnostic device has an upper darkroom wall (502) and a lower darkroom wall (506). FIG. 5(a) illustrates a state in which the upper darkroom wall (502) descends and the lower darkroom wall (506) rises, and FIG. 5(b) illustrates a state in which the upper darkroom wall (502) and the lower darkroom wall (506) are in close contact with the cartridge (100) and the cartridge holder (200) to form a darkroom (500a, 500b) for the measurement well (102a).

[0022] The upper darkroom wall (502) is covered with an opaque material on all sides except the lower side facing the measurement well (102a). The upper darkroom wall (502) is configured to be able to rise or fall, and when measuring the amount of light, it falls to come into close contact with the upper surface of the cartridge holder (200) and the upper peripheral part of the measurement well (102a) of the cartridge. In this specification, the terms "upper surface," "lower surface," "upper part," and "lower part" refer to a state in which the well (102) can hold a sample, etc., as illustrated in FIGS. 5(a) and 5(b).

[0023] An injector needle (504) is installed on the upper dark chamber wall (502). The injector needle (504) is configured to inject a chemiluminescent reagent into the measurement well (102a). The injector needle (504) is integrally installed on the upper dark chamber wall (502) so as to be inclined at an acute angle, preferably 0 to 60 degrees, with respect to the wall surface of the measurement well (102a). Since the injector needle (504) is installed so as to be inclined with respect to the wall surface of the measurement well (102a), the chemiluminescent reagent can be stably injected into the measurement well (102a). If the inclination of the injector needle (504) is too great, the lower end of the injector needle (504) may collide with the wall surface of the measurement well (102a) while the upper dark chamber wall (502) is lowered.

[0024] The lower darkroom wall (506) is covered with an opaque material on all surfaces except the upper surface facing the measurement well (102a). The lower darkroom wall (506) is configured to be able to rise or fall, and when measuring light quantity, it rises and comes into close contact with the lower surface of the cartridge holder (200) and the lower peripheral portion of the measurement well (102a) of the cartridge.

[0025] An optical system (508) is installed on the lower darkroom wall (506) to measure the amount of light emitted from the side or bottom surface of the measurement well (102a). If the optical system is located at the top of the measurement well (102a), it may be affected by the surface condition, such as bubbles, of the reagent solution loaded in the measurement well (102a), which may cause the reproducibility of the signal to deteriorate. If the optical system measures the amount of light at at least one of the side surface, the bottom surface, and the middle position between the side surface and the bottom surface of the measurement well (102a), there is an advantage in that the signal can be measured without being affected by various surface changes. The PMT (510) illustrated in FIG. 5 measures the optical signal generated from the side surface of the measurement well (102a).

[0026] The shape of the contact area between the upper darkroom wall (502) and the lower darkroom wall (506) has a structure that blocks the inflow of external light by taking an interlocking structure such as a flat or uneven shape.

[0027] In the rest period when light quantity measurement is not in progress in the measurement well (102a), the upper darkroom wall (502) rises and stops to wait, and when light quantity measurement is in progress, the upper darkroom wall (502) descends so that the upper part and the edge of the measurement well (102a) of the cartridge (100) mounted on the cartridge holder (200) come into close contact, thereby implementing an upper darkroom (500a). Specifically, the upper surface of the cartridge holder (200) and the upper surface of the cartridge adjacent to the measurement well (102a) and the upper darkroom wall (502) come into close contact, thereby implementing a darkroom above the measurement well (102a).

[0028] During the idle period when light quantity measurement is not in progress in the measurement well, the lower darkroom wall (506) connected to the optical system (508) descends and stops to wait, and when light quantity measurement is in progress in the measurement well (102a), the lower darkroom wall (506) rises to implement a lower darkroom (500b) surrounding the measurement well (102a). Specifically, the lower darkroom wall (506) is in close contact with the lower surface of the cartridge holder (200) and the lower surface of the cartridge adjacent to the measurement well (102a) to implement a darkroom at the bottom of the measurement unit (102a).

[0029] When the lower darkroom wall (506) connected to the PMT optical system (508) is lowered during the measurement pause, external light may enter the PMT (510), so it is necessary to block this. When the lower darkroom wall (506) is raised to implement a darkroom, the path for light to enter the PMT (510) must be open so that a chemiluminescence signal can be measured, and when the PMT (510) is not in operation, the light inflow path of the optical system must be closed. For this purpose, a blocking curtain (or shutter) can be installed at the entrance of the light path. The blocking curtain can be controlled using power, or can be controlled in a non-powered manner using a spring, a push pin, etc.

[0030] Fig. 6 illustrates the operation of a blocking film in an optical system (508) according to one embodiment of the present invention. As illustrated, the optical system (508) includes a PMT (510), an optical system body (602), a blocking film (604), and a push pin (606). The PMT (510) is installed in a PMT housing (603) to block ambient light from entering. The optical system body (601) is attached to the lower darkroom wall (506) and has an optical path (512) therein between the measurement well (102a) and the PMT (510).

[0031] The optical system (508) is provided with a shield (604) that prevents light from entering the PMT (510) when the lower darkroom wall (506) is lowered from the measurement well (102a). The shield (604) is installed on the optical system body (602) so as to be able to move up and down. A push pin (606) is connected to the lower portion of the shield (604).

[0032] As shown in Fig. 6(a), when the lower darkroom wall (506) is lowered from the measurement well (102a) and the optical system (508) is lowered, the push pin (606) is pressed by the push pin bracket (608) and the blocking film (604) is raised to block the light path (512). In this state, the PMT (510) is completely sealed by the optical system body (602), the PMT housing (603), and the blocking film (604), thereby blocking the inflow of light.

[0033] As illustrated in Fig. 6(b), when the lower darkroom wall (506) rises to implement a darkroom for the measurement well (102a), the optical system (508) also rises. When the optical system (508) rises, the compressive force of the push pin (606) is released, and the blocking film (604) descends downwards by the elastic force of the elastic body (610) and gravity, and the blocking film hole (604a) is positioned in the light path (512), so that light generated in the measurement well (102a) enters the PMT (510), enabling light quantity measurement.

[0034] 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 an in vitro diagnostic device using a cartridge utilizing chemiluminescence, A cartridge holder made of an opaque material and supporting a cartridge, The remaining surfaces except the lower surface are blocked with an opaque material, and the upper darkroom wall is configured to be able to rise or fall, and when measuring light quantity, it falls and comes into close contact with the upper periphery of the measurement well of the cartridge, The remaining surfaces except the upper surface are blocked with an opaque material, and are configured to be able to rise or fall, and the lower darkroom wall rises when measuring light quantity and adheres closely to the lower periphery of the measurement well of the cartridge. An in vitro diagnostic device characterized by having:

2. In paragraph 1, An in vitro diagnostic device characterized by further comprising an injector needle installed on the upper darkroom wall and capable of injecting a chemiluminescent reagent into the measurement well.

3. In paragraph 2, An in vitro diagnostic device characterized in that the injector needle is installed on the upper dark room wall at an acute angle with respect to the wall surface of the measurement well.

4. In paragraph 1, An in vitro diagnostic device further comprising an optical system including a PMT installed on the lower darkroom wall to measure the amount of light emitted from the side or bottom surface of the measurement well.

5. In paragraph 4, An in vitro diagnostic device characterized in that the optical system comprises a blocking film that prevents light from entering the PMT when the lower darkroom wall is lowered.

6. In paragraph 5, the optical system, An optical system body attached to the lower darkroom wall and having an optical path formed inside between the measurement well and the PMT; It has a push pin connected to the lower part of the above barrier, An in vitro diagnostic device characterized in that the above-mentioned barrier is configured to block the light path when the above-mentioned push pin is pressed and to open the light path when the above-mentioned push pin is not pressed.

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