A disposable test cartridge for a liquid phase in vitro diagnostic apparatus using chemiluminescence

Abstract

The present invention relates to a disposable test cartridge for a liquid phase in vitro diagnostic apparatus using chemiluminescence. The test cartridge of the present invention includes a test cartridge frame having a plurality of wells and a plurality of well connection portions connecting the plurality of wells, and a light shielding sector formed in at least one of the plurality of well connection portions. The test cartridge of the present invention is capable of preventing ambient light from entering a measurement well when used in a liquid phase in vitro diagnostic apparatus using chemiluminescence. Furthermore, the test cartridge of the present invention is capable of improving measurement sensitivity in a liquid phase in vitro diagnosis using chemiluminescence.

Description

Technical Field

[0001] The present invention relates to disposable test cartridges for use in liquid phase in vitro diagnostic devices employing chemiluminescence, and more specifically, to test cartridges having a configuration for realizing a darkroom. Background Technology

[0002] In chemiluminescence-based liquid chromatography-in vitro diagnostic devices, reagents are used and filled in disposable test cartridges. These cartridges for in vitro diagnostics have multiple wells for filling reagents or for various reactions, purifications, etc., and a cartridge frame. The cartridge frame is made of plastic and has multiple well connection parts that connect the wells to each other. The wells include reagent wells, reaction wells, washing wells, measurement wells, sample wells, and other wells. The reagent wells are filled with the reagents required for diagnosis; in the reaction wells, the sample and diagnostic reagents are mixed to form an antigen-antibody complex; in the washing wells, non-reactive substances are removed from the antigen-antibody complex to purify the target component; in the measurement wells, a signal detection device such as a photomultiplier tube (PMT) is used to detect the luminescence signal. The sample is introduced into the sample well, and the other wells are used to mount analytical pipette tips or for auxiliary or preparatory purposes.

[0003] Each hole can be manufactured individually and inserted into the test card holder frame, or it can be integrally injection molded with the test card holder frame. During use, the holes do not separate from the test card holder frame; instead, they are integrated with the frame for testing. The holes in the test card holder can be arranged in a single row or two or more rows.

[0004] Meanwhile, because chemiluminescent reagents are used at high sensitivity, PMTs are primarily employed as the optical system. PMTs must be used in a darkroom. Without a darkroom, background signals entering the system will reduce the sensitivity of signal measurements.

[0005] In diagnostic devices that use individual analysis cups instead of test cartridges, the analysis cups are placed in a small, enclosed space, and chemiluminescence and signal acquisition are performed in a darkroom. However, in diagnostic devices that use test cartridges, it is difficult to place the entire test cartridge in a darkroom; therefore, it is necessary to create a darkroom specifically for the measurement aperture where chemiluminescence occurs.

[0006] The typical translucent test card frame, made of plastic, is translucent. Therefore, even when the measurement aperture is enclosed to create a darkroom, light can still pass through the test card frame and enter the measurement aperture, increasing background signal and reducing measurement sensitivity. In other words, a means is needed to block light from the surrounding environment from transmitting through and entering the measurement aperture.

[0007] If the entire test card holder frame is made of black light-blocking material, the interior of the inspection hole cannot be visually observed, making it difficult to verify whether the hole is filled and quantitatively dispensed during actual product manufacturing, thus complicating quality control. Furthermore, the optical system must be unconditionally positioned above the measurement hole, limiting the choice of its location. Additionally, measurements taken from above are more likely to result in optical errors (such as interference from the syringe, refraction due to the irregular shape of the measured substance's interface), and uneven material distribution caused by air bubbles. Summary of the Invention

[0008] (a) Technical problems to be solved Therefore, one object of the present invention is to prevent ambient light from entering the measurement port of a disposable test cartridge used in a chemiluminescence-based liquid phase in vitro diagnostic device.

[0009] Furthermore, another object of the present invention is to provide a disposable test cartridge capable of improving the measurement sensitivity in liquid-phase in vitro diagnostics using chemiluminescence.

[0010] (II) Technical Solution The disposable test cartridge for a chemiluminescence-based liquid phase in vitro diagnostic device of the present invention, which aims to achieve the above-mentioned objectives, is characterized in that the test cartridge includes: a test cartridge frame having a plurality of holes and a plurality of well connection parts connecting the plurality of holes; and a light-shielding sector formed in at least one of the plurality of well connection parts.

[0011] At least one of the plurality of holes may be a measuring hole, and the light-shielding sector may be formed at the hole connection portion adjacent to the measuring hole. Preferably, the measuring hole is located at the end of the detection cartridge frame.

[0012] The light-shielding sector is engaged with the darkroom wall of the diagnostic equipment. Furthermore, the light-shielding sector may have protrusions and recesses that engage with the darkroom wall.

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

[0014] (III) Beneficial Effects The detection cartridge of the present invention, when used in a chemiluminescence-based liquid chromatography-in vitro diagnostic device, can prevent ambient light from entering the measurement aperture. Furthermore, the detection cartridge of the present invention can improve the measurement sensitivity in chemiluminescence-based liquid chromatography-in vitro diagnostics. Attached Figure Description

[0015] Figure 1This is a structural diagram of a detection card box according to an embodiment of the present invention.

[0016] Figure 2 This is a structural diagram of a detection card box according to another embodiment of the present invention.

[0017] Figure 3 This is a structural diagram of a detection card box according to another embodiment of the present invention.

[0018] Figure 4 (a) shows light entering the measurement aperture in a conventional detection cartridge. Figure 4 (b) shows that in Figure 1 The detection card box shown blocks the light reaching the measurement hole.

[0019] Figure 5 (a) shows the diagnostic device for Figure 1 The detection card box shown is in its state before the darkroom is formed. Figure 5 (b) shows the state after the darkroom has been formed.

[0020] Figure 6 (a) shows the diagnostic device for Figure 2 The detection card box shown is in its state before the darkroom is formed. Figure 6 (b) shows the state after the darkroom has been formed.

[0021] Figure 7 The description further illustrates the darkroom wall of the detection card holder and diagnostic device according to another embodiment of the present invention.

[0022] Figure 8 The description further illustrates the darkroom wall of the detection card holder and diagnostic device according to another embodiment of the present invention.

[0023] Figure 9 This is a structural diagram of a detection card box according to another embodiment of the present invention.

[0024] Figure 10 This is a structural diagram of a detection card box according to another embodiment of the present invention.

[0025] Figure 11 This is a structural diagram of a detection card box according to another embodiment of the present invention.

[0026] Figure 12 It shows Figure 1 The detailed configuration of the light-shielding sector in the detection card box is shown. Detailed Implementation

[0027] To fully understand the invention, preferred embodiments will be described with reference to the accompanying drawings. Embodiments of the invention may be modified in various ways, and the scope of the invention should not be construed as limited to the embodiments described in detail below. These embodiments are provided to illustrate the invention more completely to those skilled in the art. Therefore, the shapes of elements, etc., in the drawings may be exaggerated for clearer illustration. It should be noted that the same parts in the various drawings may be indicated by the same reference numerals. Detailed descriptions of well-known functions and configurations of the subject matter of the invention, which may unnecessarily obscure it, have been omitted.

[0028] Figure 1 This is a structural diagram of a disposable test cartridge 100 for a chemiluminescence-based liquid chromatography in vitro diagnostic device according to an embodiment of the present invention. As shown, the test cartridge 100 includes a plurality of holes 102, a test cartridge frame 104, and a light-shielding sector 106. The test cartridge frame 104 includes a plurality of hole connecting portions 103 connecting the plurality of holes 102. The light-shielding sector 106 is formed in at least one of the plurality of hole connecting portions 103.

[0029] At least one of the plurality of holes 102 is a measuring hole 102a. For example... Figure 1 As shown, the measuring hole 102a can be located at the end of the detection card holder frame 104. A light-shielding sector 106 is preferably formed at the hole connection portion adjacent to the measuring hole 102a. The light-shielding sector 106 can be formed of black or colored plastic capable of blocking light transmission. Furthermore, the light-shielding sector 106 is formed to cover the vertical cross-section of the hole connection portion 103 integrally along the thickness direction (T).

[0030] The detection cartridge 100 can be manufactured by applying a dual injection molding method when molding the detection cartridge frame 104 to simultaneously inject light-shielding material around the measuring hole 102a; or by manufacturing the detection cartridge frame 104, the light-shielding sector 106 and the measuring hole 102a separately and then fusing them together.

[0031] Figure 2 This is a structural diagram of a test card holder 200 according to another embodiment of the present invention. The light-shielding sector 206 of the test card holder 200 has recesses formed on its upper and lower surfaces that engage with the darkroom wall of the diagnostic device. Figure 3 This is a structural diagram of a test card holder 300 according to another embodiment of the present invention. The light-shielding sector 306 of the test card holder 300 has protrusions formed on its upper and lower surfaces where it engages with the darkroom wall of the diagnostic device. The light-shielding effect is enhanced when the front end of the darkroom wall of the engaging diagnostic device has a corresponding shape for the concave or convex portions (recesses or protrusions) on the upper and lower surfaces of the light-shielding sectors 206 and 306.

[0032] Figure 4 (a) shows light entering the measuring aperture in a conventional detection cartridge 10. Figure 4 (b) shows Figure 1 The detection card cassette 100 shown blocks the light reaching the measurement aperture.

[0033] The test cartridge 10 has multiple holes 12 and a test cartridge frame 14. The test cartridge frame 14 has hole connection portions 13 that connect the holes. Even though the darkroom walls 22 and 24 of the diagnostic device form a darkroom 20 for the measurement hole 12a of the test cartridge 10, light can still pass through the test cartridge frame 14 and enter because the test cartridge frame 14 is usually made of a translucent plastic material.

[0034] Conversely, in the test card holder 100, when the dark chamber walls 122, 124 of the diagnostic device form a dark chamber 120 for the measurement hole 102a, the light-blocking sector 106 blocks the light transmitted through the test card holder frame 104, thereby preventing light from entering the dark chamber 120.

[0035] Figure 5 (a) shows the darkroom walls 122, 124 of the diagnostic device for use with Figure 1 The state of the detection card box 100 before the darkroom is formed is shown. Figure 5 (b) shows the state of the darkroom 120 after its formation. One end 122a of the darkroom wall 122 has a shape corresponding to the upper surface of the light-shielding sector 106, and one end 124a of the darkroom wall 124 has a shape corresponding to the lower surface of the light-shielding sector 106, thereby preventing light from entering at the boundaries. Furthermore, the other ends 122b of the darkroom wall 122 and 124b of the darkroom wall 124 have corresponding shapes, thereby preventing light from entering at those boundaries. To enhance the light-shielding effect, the boundaries between the darkroom walls 122, 124 and the light-shielding sector 106 can be tightly fitted or joined, and can include elastic components (not shown).

[0036] Figure 6 (a) shows the darkroom walls 222, 224 of the diagnostic device for use with Figure 2 The state of the detection card box 200 before the darkroom is formed is shown. Figure 6 (b) shows the state after the darkroom 220 is formed.

[0037] The detection cartridge 200 includes multiple holes 202, a detection cartridge frame 204, and a light-shielding sector 206. The detection cartridge frame 204 has hole connecting portions 203 that connect the holes. To enhance the light-shielding effect, the light-shielding sector 206 has recesses formed on its upper and lower surfaces, and protrusions formed at one end 222a and 224a of the dark chamber walls 222 and 224. The dark chamber wall 222 descends, and the dark chamber wall 224 rises, joining together with the light-shielding sector 206 as the intermediate point, thereby forming a dark chamber 220 for the measurement hole 202a.

[0038] Figure 7The description includes a detection card holder 400 and darkroom walls 422, 424 of a diagnostic device according to another embodiment of the present invention.

[0039] The test cartridge 400 includes multiple holes 402, a test cartridge frame 404, and a light-shielding sector 406. The test cartridge frame 404 includes hole connecting portions 403 connecting the holes. A measurement hole 402a is installed at the end of the test cartridge 400. The test cartridge 400 does not have a light-shielding sector 406 in the hole connecting portion directly adjacent to the measurement hole 402a, but rather in the hole connecting portion adjacent to the adjacent hole 402b. The darkroom walls 422, 424 of the diagnostic device, together with the light-shielding sector 406, form a darkroom 420 for the measurement holes 402a and 402b. As with the test cartridge 400, embodiments of the present invention may configure the light-shielding sector and darkroom walls to surround two or more holes, including the measurement hole.

[0040] While it is effective to insert the light-shielding sector into the hole connection portion directly adjacent to the measuring hole 402a, the light-shielding sector is not limited to directly adjacent hole connections and can be configured to include non-directly adjacent hole connections and adjacent holes near the measuring hole. That is, the light-shielding sector can be configured to include two or more adjacent holes or their hole connections containing the measuring hole.

[0041] Figure 8 The description includes a test card holder 500 and darkroom walls 522 and 524 of a diagnostic device according to another embodiment of the present invention.

[0042] The test cartridge 500 includes multiple holes 502, a test cartridge frame 504, and light-shielding sectors 506 and 507. The test cartridge frame 504 has hole connecting portions 503 connecting the holes. The measuring hole 502a is not installed at the end of the test cartridge 500, but is installed in its central part, and the test cartridge 500 has light-shielding sectors 506 and 507 on the left and right sides, respectively, in the hole connecting portions directly adjacent to the measuring hole 502a. The darkroom walls 522 and 524 of the diagnostic device, together with the light-shielding sectors 506 and 507, form a darkroom 520 for the measuring hole 502a. If the measuring hole 502a is installed in a position other than the end of the test cartridge 500, light-shielding sectors 506 and 507 must be provided on the left and right sides of the measuring hole 502a to form a darkroom surrounding the measuring hole 502a.

[0043] Figure 9 This is a plan view of a detection card holder 600 according to another embodiment of the present invention. As shown, the detection card holder 600 has holes 602 mounted in a double-row configuration, and a measuring hole 602a is mounted at the end of the detection card holder 600.

[0044] The test cartridge frame 604 has hole connections 603 in the horizontal (H) and vertical (V) directions to connect the holes. To form a darkroom for the measurement hole 602a, the test cartridge 600 includes a light-shielding sector 606 that traverses the test cartridge frame 604 in the vertical (V) direction. The darkroom wall (not shown) of the diagnostic device is configured, together with the light-shielding sector 606, to form a darkroom for the measurement hole 602a.

[0045] Figure 10 This is a plan view of a detection card holder 700 according to another embodiment of the present invention. As shown, the detection card holder 700 has holes 702 mounted in a double-row configuration, and a measuring hole 702a is mounted at the end of the detection card holder 700.

[0046] The test cartridge frame 704 has hole connecting portions 703 in the horizontal (H) and vertical (V) directions to connect the holes. To form a darkroom for the measurement hole 702a, the test cartridge 700 includes: a light-shielding sector 706a that traverses the test cartridge frame 704 in the vertical (V) direction to the left of the measurement hole 702a; and a light-shielding sector 706b formed in the horizontal (H) direction in the adjacent hole connecting portion below the measurement hole 702a. One end of the light-shielding sector 706b extends to the right end of the test cartridge frame 704, and the other end intersects with the light-shielding sector 706a. The darkroom wall (not shown) of the diagnostic device is configured, together with the light-shielding sectors 706a and 706b, to form a darkroom for the measurement hole 702a.

[0047] Figure 11 This is a plan view of a detection card holder 800 according to another embodiment of the present invention. As shown, the detection card holder 800 has holes 802 mounted in a double-row configuration, and a measuring hole 802a is mounted at the end of the detection card holder 800.

[0048] The test cartridge frame 804 has hole connecting portions 803 in the horizontal (H) and vertical (V) directions to connect the holes. To form a darkroom for the measurement hole 802a, the test cartridge 800 includes: a light-shielding sector 806a formed in the vertical (V) direction in the hole connecting portion adjacent to the left side of the measurement hole 802a; and a light-shielding sector 806b formed in the horizontal (H) direction in the hole connecting portion adjacent to the bottom of the measurement hole 802a. The light-shielding sectors 806a and 806b intersect. The darkroom wall (not shown) of the diagnostic device is configured to form a darkroom for the measurement hole 802a together with the light-shielding sectors 806a and 806b.

[0049] Figures 9 to 11 An embodiment is shown with holes installed in a double-row configuration in a test cartridge. Those skilled in the art will clearly understand that the invention is also applicable to cases where three or more rows of holes are installed in the test cartridge, and to cases where the measuring holes are installed at a location other than the end of the test cartridge.

[0050] exist Figure 12 middle, Figure 12 (a) shows Figure 1 The overall configuration of the test card box 100 shown is as follows: Figure 12 (b) and Figure 12 (c) shows the detailed configuration of portion A of the detection cartridge 100. When the detection cartridge 100 is manufactured by dual injection molding, the boundary between the light-shielding sector material and the remaining detection cartridge material may produce... Figure 12 The clear boundary line shown in (b), or the line produced according to the injection method, is as shown in (b). Figure 12 The unclear boundary line shown in (c) is valid in both cases. Furthermore, during manufacturing, the material in the light-shielding sector may partially extend beyond the hole connection and into adjacent holes.

[0051] The embodiments of the present invention described above are merely illustrative examples, and those skilled in the art will recognize that various modifications and equivalent embodiments are possible. Therefore, those skilled in the art will fully understand that the present invention is not limited to the forms mentioned in the detailed description above. Thus, the true scope of protection of the present invention should be determined by the spirit of the appended claims. Furthermore, the present invention should be understood to include all modifications, equivalents, and substitutions within the spirit and scope of the invention as defined by the appended claims.

Claims

1. A disposable test cartridge for use in a chemiluminescence-based liquid chromatography in vitro diagnostic device, characterized in that, The detection cartridge includes: A detection card holder frame, the detection card holder frame having multiple holes and multiple hole connecting portions connecting the multiple holes; and A light-shielding sector is formed in at least one of the plurality of hole connections.

2. The detection card holder according to claim 1, characterized in that, At least one of the plurality of holes is a measuring hole, and the light-shielding sector is formed at the hole connection portion adjacent to the measuring hole.

3. The detection card holder according to claim 2, characterized in that, The measuring hole is located at the end of the detection card frame.

4. The detection card holder according to claim 1, characterized in that, The light-shielding sector is integrated with the darkroom wall of the diagnostic equipment.

5. The detection card holder according to claim 4, characterized in that, The light-shielding sector has protrusions and recesses that engage with the wall of the darkroom.

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