In-vitro diagnostic apparatus using a test cartridge employing chemiluminescence

Abstract

The present invention relates to an in-vitro diagnostic apparatus using a test cartridge employing chemiluminescence. The in-vitro diagnostic apparatus of the present invention has a test cartridge holder made of an opaque material and configured to support a side of a test cartridge, an upper dark chamber wall having its side surfaces other than a bottom surface closed by an opaque material, the upper dark chamber wall being configured to be movable up and down and to descend to closely contact an upper surface of the test cartridge holder and an upper peripheral portion of a measurement hole of the test cartridge at the time of light measurement, and a lower dark chamber wall having its side surfaces other than a top surface closed by an opaque material, the lower dark chamber wall being configured to be movable up and down and to ascend to closely contact a lower surface of the test cartridge holder and a lower peripheral portion of the measurement hole of the test cartridge at the time of light measurement. The in-vitro diagnostic apparatus of the present invention can realize a dark chamber only in a measurement hole among a plurality of holes of a test cartridge.

Description

Technical Field

[0001] This invention relates to in vitro diagnostic devices using chemiluminescent cartridges, and more particularly, to in vitro diagnostic devices capable of creating a darkroom solely through the measurement aperture of the cartridge. Background Technology

[0002] A known device utilizes a disposable test cartridge, constructed by connecting various wells and loaded with reagents, to perform qualitative or quantitative analysis of specific components from biological samples based on immunoassay. In particular, when using chemiluminescent reagents, analysis can be performed with very high precision. The test cartridge for chemiluminescence not only has reagent wells for loading various reagents but also reaction wells, cleaning wells, and measurement wells. Specifically, in the measurement well, the biological sample reacts with the chemiluminescent reagent, emitting light in an amount determined by the concentration of the target component. An optical system can measure the light intensity immediately adjacent to the measurement well.

[0003] Because the light intensity produced when using chemiluminescent reagents is relatively weak, photomultiplier tubes (PMTs) with very high sensitivity are typically used. Since PMT-based optical systems are extremely sensitive, even a minute amount of light entering the system can generate a background signal, necessitating a very high level of anechoic chamber implementation. Furthermore, the PMT responds to incoming light even during periods of inactivity. When light enters the optical system, the background signal increases, the optical system operates unnecessarily, and electrons accumulate within the PMT, potentially leading to various malfunctions. Therefore, anechoic chamber implementation is essential in in vitro diagnostic devices using chemiluminescent detection cartridges; however, due to the relatively long length of the detection cartridges, implementing a anechoic chamber for the entire cartridge results in a significantly increased anechoic chamber size and cost. Summary of the Invention

[0004] (a) Technical problems to be solved Therefore, one object of the present invention is to selectively implement a darkroom only in the measurement port of a chemiluminescent detection cartridge.

[0005] Furthermore, another objective of the present invention is to ensure that light generated by chemiluminescence enters the PMT only during measurement and to prevent light from entering the PMT during rest periods when no measurement is being performed.

[0006] (II) Technical Solution To achieve the above objectives, the in vitro diagnostic device of the present invention using a chemiluminescent detection cartridge is characterized in that the device comprises: a detection cartridge holder made of an opaque material and configured to support the detection cartridge; an upper dark chamber wall, the other surfaces of which are enclosed by an opaque material, the upper dark chamber wall being configured to rise or fall, and falling to make close contact with the upper surface of the detection cartridge holder and the upper peripheral portion of the measurement hole of the detection cartridge during light intensity measurement; and a lower dark chamber wall, the other surfaces of which are enclosed by an opaque material, the lower dark chamber wall being configured to rise or fall, and rising to make close contact with the lower surface of the detection cartridge holder and the lower peripheral portion of the measurement hole of the detection cartridge during light intensity measurement.

[0007] The in vitro diagnostic device may also include an injection needle, which is mounted in the upper darkroom wall and configured to inject a chemiluminescent reagent into the measurement port. The injection needle may be mounted in the upper darkroom wall at an acute angle relative to the wall surface of the measurement port.

[0008] The in vitro diagnostic device may also include an optical system mounted in the lower darkroom wall and comprising a photometer (PMT) configured to measure the amount of light emitted from the side or bottom of the measurement aperture. The optical system may also include a light-shielding plate configured to prevent light from entering the PMT when the lower darkroom wall descends.

[0009] Preferably, the optical system comprises: an optical system body attached to the lower darkroom wall and having an optical path formed therein between the measuring aperture and the PMT; and a pressure pin connected to the lower part of the light-shielding plate, wherein the light-shielding plate is configured to block the optical path when the pressure pin is pressed and to open the optical path when the pressure pin is not pressed.

[0010] (III) Beneficial Effects The present invention, having the above-described configuration, can selectively realize a dark chamber only in the measurement port of a chemiluminescent detection cartridge. Furthermore, the present invention enables light generated by chemiluminescence to enter the PMT only during measurement and prevents light from entering the PMT during rest periods when no measurement is being performed. Attached Figure Description

[0011] Figure 1 This is a structural diagram of the chemiluminescence detection cartridge used in this invention.

[0012] Figure 2 This is a top view (or top view) of a detection card holder according to an embodiment of the present invention.

[0013] Figure 3 illustrate Figure 1 The test card box shown is installed into Figure 2The situation on the test card holder is shown.

[0014] Figure 4 illustrate Figure 1 The detection card box shown is installed in Figure 2 The status of the test card holder shown.

[0015] Figure 5 This describes the situation where a darkroom is implemented for the measurement hole of the test card cartridge in a diagnostic device according to an embodiment of the present invention.

[0016] Figure 6 The operation of a light-shielding plate in an optical system according to an embodiment of the present invention is explained. Detailed Implementation

[0017] To fully understand the present invention, preferred embodiments are described with reference to the accompanying drawings. Embodiments of the present invention can be modified in various forms, and the scope of the invention should not be construed as limited to the embodiments described in detail below. These embodiments are provided to explain the invention more completely to those skilled in the art. Therefore, the shapes, etc., of elements in the drawings may be exaggerated to make the description clearer. It should be noted that the same components in the various drawings are sometimes shown with the same reference numerals. Detailed descriptions of well-known functions and structures that may unnecessarily obscure the essential points of the invention are omitted.

[0018] Figure 1 This is an example diagram of the chemiluminescence detection cartridge used in this invention, wherein... Figure 1 (a) is a top view. Figure 1 (b) is a side view. As shown, the detection cartridge 100 has a plurality of holes 102 and a detection cartridge frame 104. The detection cartridge frame 104 has a hole connecting portion 103 that connects one hole to another. The detection cartridge 100 has a measuring hole 102a at its end.

[0019] Figure 2 This is a top view (top view) of a detection card holder 200 according to an embodiment of the present invention. Figure 3 This describes the installation of the test card holder 100 onto the test card holder 200. Figure 4 This describes the state of the test card holder 100 installed on the test card holder frame 200, where... Figure 4 (a) is a plan view. Figure 4 (b) is a side view.

[0020] The test card holder 200 includes a frame 202 that forms three slits 204 supporting the test card holder 100. The test card holder 200 is made of an opaque material; however, for ease of understanding, Figure 4In (b), the detection card holder 200 is shown in a semi-transparent manner. The frame 202 supports at least a portion of the side surface and at least a portion of the bottom surface of the detection card holder 100.

[0021] Figure 5 This paper describes the implementation of a darkroom in the diagnostic device according to an embodiment of the present invention for the measurement port 102a of the test card cassette 100. As shown in the figure, the diagnostic device includes an upper darkroom wall 502 and a lower darkroom wall 506. Figure 5 (a) shows the state where the upper dark chamber wall 502 is lowered and the lower dark chamber wall 506 is raised. Figure 5 (b) explains that the upper dark chamber wall 502 and the lower dark chamber wall 506 are in close contact with the detection card box 100 and the detection card box holder 200, thereby forming dark chambers 500a and 500b in the measurement hole 102a.

[0022] The remaining surfaces of the upper dark chamber wall 502, except for the bottom surface facing the measurement hole 102a, are sealed with an opaque material. The upper dark chamber wall 502 is constructed to rise or fall, and during light measurement, it descends to make close contact with the upper surface of the detection card holder 200 and the upper periphery of the measurement hole 102a of the detection card holder. In this specification, "upper surface," "lower surface," "upper part," and "lower part" refer to the state in which the hole 102 can hold a sample, etc. Figure 5 (a) and Figure 5 As shown in (b).

[0023] An injection needle 504 is mounted in the upper darkroom wall 502. The injection needle 504 is configured to inject a chemiluminescent reagent into the measurement hole 102a. The injection needle 504 is integrally mounted in the upper darkroom wall 502 at an acute angle relative to the wall surface of the measurement hole 102a, preferably tilted at 0 to 60 degrees. Because the injection needle 504 is mounted at an angle relative to the wall surface of the measurement hole 102a, the chemiluminescent reagent can be stably injected into the measurement hole 102a. If the tilt angle of the injection needle 504 is too large, the lower end of the injection needle 504 may collide with the wall surface of the measurement hole 102a during the descent of the upper darkroom wall 502.

[0024] The remaining surfaces of the lower dark chamber wall 506, except for the top surface facing the measurement hole 102a, are sealed with an opaque material. The lower dark chamber wall 506 is configured to rise or fall, and during light measurement, it rises to make close contact with the lower surface of the detection card holder 200 and the lower periphery of the measurement hole 102a of the detection card.

[0025] An optical system 508 for measuring the amount of light emitted from the side or bottom surface of the measuring aperture 102a is installed in the lower darkroom wall 506. If the optical system is located at the upper end of the measuring aperture 102a, it may be affected by surface conditions such as air bubbles in the reagent solution loaded in the measuring aperture 102a, resulting in reduced signal reproducibility. When the optical system measures the amount of light at at least one of the side, bottom, or intermediate positions between the side and bottom surfaces of the measuring aperture 102a, it has the advantage of being unaffected by various surface changes in signal measurement. Figure 5 The PMT 510 shown measures the optical signal generated from the side of the measuring hole 102a.

[0026] The contact area between the upper darkroom wall 502 and the lower darkroom wall 506 is planar or has an interlocking structure such as concave and convex, so as to have a structure that blocks external light from entering.

[0027] During the rest period when no light quantity measurement is performed at the measurement hole 102a, the upper dark chamber wall 502 rises and remains stationary; when the light quantity measurement begins, the upper dark chamber wall 502 descends, and the upper part and edge of the measurement hole 102a of the detection card cassette 100 installed in the detection card cassette holder 200 come into close contact, thereby realizing the upper dark chamber 500a. Specifically, the upper surface of the detection card cassette holder 200, the upper surface of the detection card cassette adjacent to the measurement hole 102a, and the upper dark chamber wall 502 come into close contact, thereby realizing the dark chamber above the measurement hole 102a.

[0028] During periods of inactivity when no light intensity measurement is being performed at the measurement aperture, the lower dark chamber wall 506, connected to the optical system 508, descends and remains stationary. When light intensity measurement begins at the measurement aperture 102a, the lower dark chamber wall 506 rises to form a lower dark chamber 500b surrounding the measurement aperture 102a. Specifically, the lower dark chamber wall 506 is in close contact with the lower surface of the detection card holder 200 and the lower surface of the detection card adjacent to the measurement aperture 102a, thereby forming a dark chamber below the measurement aperture 102a.

[0029] During measurement pauses, when the lower dark chamber wall 506, connected to the PMT optical system 508, descends, external light may enter the PMT 510, thus requiring blocking of such entry. When the lower dark chamber wall 506 rises to establish a dark chamber, the light path into the PMT 510 must be open to allow measurement of the chemiluminescence signal; during pauses when the PMT 510 is not in operation, the light path into the optical system must be closed. For this purpose, a light shield (or shutter) can be installed at the light path entrance. The light shield can be controlled by power or by non-power methods such as springs or pressure pins.

[0030] Figure 6The operation of the light-shielding plate in an optical system 508 according to an embodiment of the present invention will be explained. As shown, the optical system 508 includes a PMT 510, an optical system body 602, a light-shielding plate 604, and a retaining pin 606. The PMT 510 is mounted in the PMT housing 603 to block ambient light from entering. The optical system body 602 is attached to the lower darkroom wall 506 and has an optical path 512 formed therein between the measurement aperture 102a and the PMT 510.

[0031] The optical system 508 includes a light-shielding plate 604 configured to prevent light from entering the PMT 510 when the lower dark chamber wall 506 descends from the measuring aperture 102a. The light-shielding plate 604 is mounted in the optical system body 602 in a vertically movable manner. A retaining pin 606 is connected to the lower part of the light-shielding plate 604.

[0032] like Figure 6 As shown in (a), when the darkroom wall 506 descends from the measuring aperture 102a and the optical system 508 descends, the pressure pin 606 is pressed by the pressure pin bracket 608, and the light shield 604 rises 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 light shield 604, and the entry of light is blocked.

[0033] like Figure 6 As shown in (b), when the darkroom wall 506 rises to establish a darkroom in the measuring aperture 102a, the optical system 508 also rises accordingly. When the optical system 508 rises, the compressive force on the pressure pin 606 is released, and the light-shielding plate 604 descends under the action of the elastic force of the elastic member 610 and gravity. The light-shielding plate aperture 604a is positioned in the optical path 512, allowing the light generated in the measuring aperture 102a to enter the PMT 510, thereby enabling light quantity measurement.

[0034] The embodiments of the present invention described above are merely exemplary, and those skilled in the art will recognize that various modifications and equivalent embodiments are possible. Therefore, it should be fully understood that the present invention is not limited to the forms mentioned in the above detailed description. Consequently, the true scope of protection of the present invention should be determined by the technical concept of the appended claims. Furthermore, it should be understood that the present invention includes all modifications, equivalents, and substitutions within the spirit and scope of the invention as defined by the appended claims.

Claims

1. An in vitro diagnostic device using a chemiluminescence detection cartridge, characterized in that, The device includes: A test card holder made of opaque material and constructed to support the test card holder; The upper dark chamber wall, except for the bottom surface, is sealed with an opaque material. The upper dark chamber wall is constructed to be able to move up and down and to descend during light measurement to make close contact with the upper periphery of the measurement hole of the detection card. as well as The lower darkroom wall, except for the top surface, is sealed with an opaque material. The lower darkroom wall is constructed to be able to move up and down and rise during light measurement to make close contact with the lower periphery of the measurement hole of the detection card.

2. The in vitro diagnostic device according to claim 1, characterized in that, It also includes an injection needle, which is mounted in the wall of the upper dark chamber and configured to inject a chemiluminescent reagent into the measuring orifice.

3. The in vitro diagnostic device according to claim 2, characterized in that, The injection needle is mounted in the upper darkroom wall at an acute angle relative to the wall of the measuring hole.

4. The in vitro diagnostic device according to claim 1, characterized in that, It also includes an optical system installed in the wall of the lower darkroom and includes a photomultiplier tube (PMT) configured to measure the amount of light emitted from the side or bottom of the measuring aperture.

5. The in vitro diagnostic device according to claim 4, characterized in that, The optical system includes a light shield configured to prevent light from entering the photomultiplier tube (PMT) when the lower darkroom wall descends.

6. The in vitro diagnostic device according to claim 5, characterized in that, The optical system includes: An optical system body, attached to the lower darkroom wall, and having formed an optical path within it between the measuring aperture and the photomultiplier tube (PMT); and A pressure pin, which is connected to the lower part of the light-shielding plate. The light-shielding plate is configured to block the light path when the pressing pin is pressed, and to open the light path when the pressing pin is not pressed.

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