Calibration strip for in vitro diagnostic device and calibration method using the same

The calibration strip with varying absorbance filters and a barcode plate addresses LED-induced light deviation in in-vitro diagnostic devices, providing rapid and reliable calibration without liquid-based corrections.

JP2026505648APending Publication Date: 2026-02-17SD BIOSENSOR INC
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Patent Information

Application Number
JP2025539460
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-05-17
Filing Date
2024-01-02
Publication Date
2026-02-17

AI Technical Summary

Technical Problem

Conventional in-vitro diagnostic devices experience light deviation due to LED variations, leading to inconsistent test results, and existing correction methods using samples, control solutions, and dyes cause further deviations and prolonged calibration times.

Method used

A calibration strip for in-vitro diagnostic devices featuring a strip body with multiple cells and filters of varying absorbances, along with a barcode plate for storing measurement values, allows for rapid calibration without liquids, ensuring consistent results across devices.

Benefits of technology

The solution reduces detection time and ensures reliable, rapid calibration by minimizing light deviation and eliminating the need for liquid-based corrections, thereby standardizing test results.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to an improved correction strip for an in-vitro diagnostic device that can shorten the correction time without using a liquid containing a dye, thereby enabling rapid detection of a correction value. The correction strip for an in-vitro diagnostic device that is attached to an in-vitro diagnostic device includes a strip body having a plurality of cells that pass light generated by the in-vitro diagnostic device when attached to the in-vitro diagnostic device, and a filter unit including first and second filters sequentially arranged in each of the plurality of cells, onto which the light that has passed through the plurality of cells is irradiated.
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Description

[Technical Field]

[0001] The present invention relates to calibration strips for in vitro diagnostic devices. [Background technology]

[0002] An in vitro diagnostic device (IVD) is a medical device used to test specimens (tissue cells, blood, urine, feces, saliva, etc.) collected from the human body for the purposes of diagnosing and prognosing diseases, determining health conditions, assessing the effectiveness of disease treatment, and preventing diseases. An in vitro diagnostic device includes a diagnostic unit that diagnoses specimens and a housing that surrounds the diagnostic unit.

[0003] An in-vitro diagnostic device is equipped with a device called a strip or cartridge for collecting samples to diagnose the samples, and the strip may include a collection section for collecting samples and a channel section connected to the collection section, which is formed of a multi-layered plate having channels formed therein. When the strip is installed in the in-vitro diagnostic device, the collection section is located outside the housing of the in-vitro diagnostic device, and the channel section is located inside the housing of the in-vitro diagnostic device.

[0004] When such a strip is attached to an in-vitro diagnostic device, an optical module disposed inside the in-vitro diagnostic device irradiates light toward the channel portion of the strip, thereby enabling the in-vitro diagnostic device to detect the components and characteristics of the sample collected in the channel portion of the strip.

[0005] However, conventional in-vitro diagnostic devices have a problem in that light deviation occurs due to deviation between the LEDs of the optical modules installed in each in-vitro diagnostic device, resulting in different test results even when the light from different in-vitro diagnostic devices is irradiated on the same sample.

[0006] Therefore, a correction is required to reduce the light deviation caused by the deviation between the internal components of the LED of the optical module installed in each in-vitro diagnostic device, and a correction strip that can calculate the data for this purpose has been invented.

[0007] However, conventional correction strips use a method of correcting for deviations using a sample, control solution, and dye. However, using a sample, control solution, and dye can cause deviations between strips and deviations for each substance, and requires measurement for each concentration, resulting in delayed calculation of results. Summary of the Invention [Problem to be solved by the invention]

[0008] The problem to be solved by the present invention is to provide an improved calibration strip for an in vitro diagnostic device that can improve measurement deviation and shorten calibration time without using a liquid containing a specimen, a control solution, or a dye, thereby enabling rapid calibration. [Means for solving the problem]

[0009] A correction strip for an in-vitro diagnostic device to be attached to an in-vitro diagnostic device according to one embodiment of the present invention includes: a strip body including a plurality of cells through which light can pass; and a filter unit including a first filter and a second filter disposed in the plurality of cells.

[0010] The first filters may be disposed in succession in each of the plurality of cells, and the second filters may be disposed between the first filters, and the first filters and the second filters may have different absorbances.

[0011] The first filter may include a 1-1 filter, a 1-2 filter, and a 1-3 filter spaced apart from each other, and the absorbance may be gradually reduced from the 1-1 filter to the 1-3 filter.

[0012] The first filter may include a 1-1 filter, a 1-2 filter, and a 1-3 filter spaced apart from each other, and the absorbance may be gradually increased from the 1-1 filter to the 1-3 filter.

[0013] The second filter may include a 2-1 filter disposed between the 1-1 filter and the 1-2 filter; and a 2-2 filter disposed between the 1-2 filter and the 1-3 filter; and the 2-1 filter may have a lower absorbance than the 2-2 filter.

[0014] The second filter may include a 2-1 filter disposed between the 1-1 filter and the 1-2 filter; and a 2-2 filter disposed between the 1-2 filter and the 1-3 filter; and the 2-1 filter may have a higher absorbance than the 2-2 filter.

[0015] The 2-1 filter may have a lower absorbance than the 1-1 filter and a higher absorbance than the 1-2 filter, and the 2-2 filter may have a lower absorbance than the 1-2 filter and a higher absorbance than the 1-3 filter.

[0016] The 2-1 filter may have a higher absorbance than the 1-1 filter but a lower absorbance than the 1-2 filter, and the 2-2 filter may have a higher absorbance than the 1-2 filter but a lower absorbance than the 1-3 filter.

[0017] The strip body may include partition protrusions that protrude to form the plurality of cells, and a first length of each of the cells may be the same as a second length of the first filter or the second filter.

[0018] The strip body may include anti-flow protrusions arranged facing each other between the partition protrusions to prevent the first filter or the second filter from flowing; and a third length between the opposing anti-flow protrusions may be the same as a fourth length of the first filter or the second filter.

[0019] In addition, a calibration method according to one embodiment of the present invention includes the steps of: attaching calibration strips to a plurality of in vitro diagnostic devices, performing measurements, and then selecting a reference device; storing the measurement values ​​measured by the reference device in a barcode plate of the calibration strip; attaching the calibration strip with the stored measurement values ​​to devices other than the reference device, performing measurements, and simultaneously generating a calibration formula for the devices other than the reference device; and performing a calibration operation by comparing the measurement values ​​measured by the devices other than the reference device with the measurement values ​​measured by the reference device stored in the barcode plate.

[0020] The step of attaching the calibration strips to the in-vitro diagnostic devices, performing measurements, and then selecting a reference device may include attaching the calibration strips to the in-vitro diagnostic devices, performing measurements, and then selecting a device having a value most similar to an average value obtained by dividing the sum of the highest value and the lowest value by half.

[0021] The step of performing a correction operation by comparing the measurement values ​​measured by the equipment other than the reference equipment with the measurement values ​​measured by the reference equipment stored on the barcode plate may include a process of comparing a graph line calculated based on the measurement values ​​of the equipment other than the reference equipment with a graph line calculated based on the measurement values ​​of the reference equipment and correcting any differences. [Effects of the Invention]

[0022] According to one embodiment of the present invention, a solid-state filter having absorbance is used instead of the conventional liquid-based dye method, thereby reducing the detection time through the calibration strip. [Brief explanation of the drawings]

[0023] [Figure 1] 1 is a perspective view of a calibration strip for an in-vitro diagnostic device according to an embodiment of the present invention;

[0024] [Figure 2] 1 is an exploded perspective view of a calibration strip for an in-vitro diagnostic device according to an embodiment of the present invention;

[0025] [Figure 3] 2 is an enlarged view of part A in FIG. 1.

[0026] [Figure 4] FIG. 10 is a bottom perspective view of the correction strip.

[0027] [Figure 5] 1 is a flowchart illustrating a correction method using a correction strip. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention can be modified in various ways and can have various embodiments, and a specific embodiment will be described by way of example in the drawings. However, it is not intended to limit the present invention to the specific embodiment, and it should be understood that the present invention includes all modifications, equivalents, and alternatives that fall within the spirit and technical scope of the present invention.

[0029] Terms including ordinal numbers, such as "first," "second," etc., may be used to describe various components, but the components are not limited by these terms. These terms are used only to distinguish one component from another. For example, a second component may be designated as a "first component," and similarly, a first component may be designated as a "second component," without departing from the scope of the present invention. The term "and / or" includes a combination of multiple related listed items or any of multiple related listed items.

[0030] When a component is said to be "coupled" or "connected" to another component, it should be understood that it may be directly coupled or connected to the other component, but that there may be other components in between. Conversely, when a component is said to be "directly coupled" or "directly connected" to another component, it should be understood that there are no other components in between.

[0031] In the description of the embodiments, when one component is described as being formed "on or under" another component, "on" or "under" includes both cases where the two components are in direct contact with each other and where one or more other components are indirectly disposed between the two components. Furthermore, when "on or under" is used, it can include not only the upper direction but also the lower direction based on one component.

[0032] The terms used in this application are merely used to describe specific embodiments and are not intended to limit the present invention. The singular expressions include the plural expressions unless the context clearly dictates otherwise. In this application, the terms "comprise" or "have" are intended to specify the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and should be understood not to preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0033] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms as defined in commonly used dictionaries should be interpreted to have a meaning consistent with the meaning they have in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined in this application.

[0034] Hereinafter, a correction strip for an in-vitro diagnostic device will be described in detail with reference to the accompanying drawings. Regardless of the drawing number, the same or corresponding components will be given the same reference numerals, and redundant description thereof will be omitted.

[0035] FIG. 1 is a perspective view of a correction strip for an in vitro diagnostic device according to one embodiment of the present invention, FIG. 2 is an exploded perspective view of the correction strip for an in vitro diagnostic device according to one embodiment of the present invention, FIG. 3 is an enlarged view of part A in FIG. 1, and FIG. 4 is a bottom perspective view of the correction strip.

[0036] 1 to 3, a correction strip 1 for an in-vitro diagnostic device according to an embodiment of the present invention is mounted on an in-vitro diagnostic device (not shown) and can be illuminated by light generated by an optical module (not shown) disposed inside the in-vitro diagnostic device. The correction strip 1 for an in-vitro diagnostic device can include a strip body 100, a filter unit 200, and a barcode plate 300.

[0037] The strip body 100 is a part that forms the exterior of the correction strip 1, and the strip body 100 can be attached to an in-vitro diagnostic device. The strip body 100 can be formed with a plurality of cells 140a that transmit light generated from an optical module of the in-vitro diagnostic device when the correction strip 1 is attached to the in-vitro diagnostic device.

[0038] The strip body 100 may include a handle portion 120 , a location portion 140 and a stopper portion 160 .

[0039] The handle portion 120 is a portion that can be held by a user. When the correction strip 1 is attached to the in-vitro diagnostic device, the handle portion 120 can be placed outside the in-vitro diagnostic device. At this time, the movement of the correction strip 1 can be blocked by a stopper placed between the handle portion 120 and the placement portion 140, thereby stopping the advancement of the correction strip 1.

[0040] The placement portion 140 is a portion that is placed inside the in-vitro diagnostic device when the correction strip 1 is attached to the in-vitro diagnostic device. The filter unit 200 can be placed in the placement portion 140. The placement portion 140 may include a placement groove 142, a partition protrusion 144, a flow prevention protrusion 146, and a pass-through hole 148.

[0041] The placement groove 142 may be formed in the placement portion 140 along the longitudinal direction of the placement portion 140. Here, the longitudinal direction may refer to the direction in which the correction strip 1 is attached to the in-vitro diagnostic device. The placement groove 142 may have a rectangular shape, and a plurality of placement grooves 142 may be arranged in the placement portion 140 along a direction intersecting the longitudinal direction.

[0042] The partition protrusions 144 may protrude to form a plurality of cells 140a in the arrangement portion 140. More specifically, the partition protrusions 144 may be configured as a pair protruding from one inner surface and the other inner surface of the arrangement groove 142. The partition protrusions 144 may protrude from the arrangement groove 142 toward the inside of the arrangement groove 142 in a direction intersecting the longitudinal direction. The pair of partition protrusions 144 may be spaced apart in the arrangement groove 142 along the longitudinal direction. The partition protrusions 144 may form boundaries in the arrangement groove 142 so that a plurality of cells 140a are formed in the arrangement groove 142.

[0043] The anti-flow protrusions 146 may be disposed in the arrangement grooves 142. More specifically, as shown in FIGS. 1 to 3, the anti-flow protrusions 146 may be disposed between the respective partition protrusions 144. The anti-flow protrusions 146 may have a shape that protrudes from the arrangement grooves 142 toward the interior of the arrangement grooves 142 in a direction intersecting the longitudinal direction. The anti-flow protrusions 146 can prevent the flow of the first filter 220 or the second filter 240, which will be described later. The anti-flow protrusions 146 may be formed shorter than the partition protrusions 144. The anti-flow protrusions 146, together with the partition protrusions 144, can determine the size of each cell 140a formed by the partition protrusions 144.

[0044] 3, the first length L1 of each cell 140a formed by the partitioning protrusions 144 may be the same as the second length L2 of the first filter 220 or the second filter 240. That is, when the first filter 220 or the second filter 240 is disposed in each cell 140a, it may come into contact with the partitioning protrusions 144 to prevent movement such as rotation. Therefore, the reliability of the detection value detected through the first filter 220 or the second filter 240 may be ensured.

[0045] In addition, the third length L3 between the opposing flow prevention protrusions 146 may be the same as the fourth length L4 of the first filter 220 or the second filter 240. This can prevent the first filter 220 or the second filter 240 disposed in each cell 140a from flowing, similar to the partition protrusions 144. Therefore, the reliability of the detection value detected through the first filter 220 or the second filter 240 can be ensured.

[0046] The through holes 148 may be disposed in the area of ​​the handle portion 120 where the arrangement groove 142 is formed. More specifically, the through holes 148 may be disposed in each of the cells 140a formed by the partition protrusions 144 in the arrangement groove 142. A plurality of through holes 148 may be formed in the arrangement portion 140. The through holes 148 may be closed by the filter units 200 disposed in each of the cells 140a. The through holes 148 may expose the filter units 200. The through holes 148 may allow light generated by an optical module disposed inside the in-vitro diagnostic device to pass through.

[0047] The filter units 200 may be sequentially arranged in each of the plurality of cells 140a formed in the arrangement portion 140 of the strip body 100. The filter units 200 may be irradiated with light that has passed through the plurality of cells 140a. The filter unit 200 may include a first filter 220 and a second filter 240. The first filter 220 and the second filter 240 may be rectangular plates. The first filter 220 and the second filter 240 may be made of a material having optical density.

[0048] The first filter 220 may be disposed in each of the plurality of cells 140a. The first filter 220 may include a first filter 222, a second filter 224, and a third filter 226, which are spaced apart from one another. As shown in FIG. 2, the first filter 222 may be disposed at the top of the first filter 220 and the second filter 240.

[0049] The first-second filter 224 may be disposed between the first-first filter 222 and the first-third filter 226. More specifically, as shown in FIG. 2, the first-second filter 224 may be disposed in the cell 140a two cells below the cell 140a in which the first-first filter 222 is disposed.

[0050] The first-third filter 226 may be disposed in the cell 140a two cells below the cell 140a in which the first-second filter 224 is disposed. The first-third filter 226 may be the filter disposed at the bottom among the first filter 220 and the second filter 240.

[0051] 1 to 3, the optical density may gradually decrease from the 1-1 filter 222 to the 1-3 filter 226. That is, the 1-2 filter 224 may be a filter having a lower absorbance than the 1-1 filter 222, and the 1-3 filter 226 may be a filter having a lower absorbance than the 1-2 filter 224. In this case, the 1-2 filter 224 may have an absorbance that is intermediate between the absorbance of the 1-1 filter 222 and the absorbance of the 1-3 filter 226.

[0052] In this embodiment, the absorbance gradually decreases from the 1-1 filter 222 to the 1-3 filter 226, but the present invention is not limited to this. For example, the absorbance may gradually increase from the 1-1 filter 222 to the 1-3 filter 226. That is, the 1-3 filter 226 may have a higher absorbance than the 1-1 filter 222 and the 1-2 filter 224, and the 1-2 filter 224 may have a higher absorbance than the 1-1 filter 222.

[0053] The second filters 240 may be disposed between each of the first filters 220. The second filters 240 may include a 2-1 filter 242 disposed between the 1-1 filter 222 and the 1-2 filter 224, and a 2-2 filter 244 disposed between the 1-2 filter 224 and the 1-3 filter 226.

[0054] More specifically, the 2-1 filter 242 may be disposed in a cell 140a disposed between the cell 140a in which the 1-1 filter 222 is disposed and the cell 140a in which the 1-2 filter 224 is disposed. Also, the 2-2 filter 244 may be disposed in a cell 140a disposed between the cell 140a in which the 1-2 filter 224 is disposed and the cell 140a in which the 1-3 filter 226 is disposed. In other words, the 2-1 filter 242 and the 2-2 filter 244 may be disposed at a distance with the 1-2 filter 224 sandwiched therebetween.

[0055] The 2-1 filter 242 may have a lower absorbance than the 2-2 filter 244. However, this is not limiting, and the 2-1 filter 242 may be a filter having a higher absorbance than the 2-2 filter 244, for example.

[0056] The 2-1 filter 242 may have an absorbance lower than that of the 1-1 filter 222 but higher than that of the 1-2 filter 224. The 2-2 filter 244 may have an absorbance lower than that of the 1-2 filter 224 but higher than that of the 1-3 filter 226. That is, the 1-1 filter 222, the 2-1 filter 242, the 1-2 filter 224, the 2-2 filter 244, and the 1-3 filter 226 may have progressively lower absorbances. Conversely, the 2-1 filter 242 may have an absorbance higher than that of the 1-1 filter 222 but lower than that of the 1-2 filter 224, and the 2-2 filter 244 may have an absorbance higher than that of the 1-2 filter 224 but lower than that of the 1-3 filter 226. That is, contrary to the above case, the 1-1 filter 222, the 2-1 filter 242, the 1-2 filter 224, the 2-2 filter 244, and the 1-3 filter 226 may have gradually higher absorbance.

[0057] In this embodiment, the first filter 220 is configured with three filters and the second filter 240 is configured with two filters, but the present invention is not limited to this. The first filter 220 may be configured with three or more filters, and the second filter 240 may be configured with two or more filters.

[0058] The number of first filters 220 and second filters 240 may be determined by the number of arrangement grooves 142. That is, the number of first filters 220 and second filters 240 may be eight or nine in total, and the total number of first filters 220 and second filters 240 may vary depending on the number of arrangement grooves 142 formed in the arrangement portion 140 of the strip body 100. More specifically, if ten or more arrangement grooves 142 are formed along the longitudinal direction, a total of ten or more first filters 220 and second filters 240 may be provided. In addition, in this embodiment, the first-1 filter 222 is the first filter 220 or the second filter 240 that is arranged at the top of the arrangement portion 140 of the strip body 100, but this is not limiting. The first-3 filter 226 may be the first filter 220 or the second filter 240 that is arranged at the top of the arrangement portion 140 of the strip body 100. Furthermore, the 2-1 filter 242 may be disposed above the 2-2 filter 244, or the 2-1 filter 242 may be disposed below the 2-2 filter 244.

[0059] The first filter 220 and the second filter 240 may have different absorbances, so when light generated by an optical module disposed inside the in-vitro diagnostic device passes through the first filter 220 and the second filter 240, different correction values ​​may be generated for one light, the number of which is equal to the number of the first filters 220 and the second filters 240.

[0060] More specifically, light passes through the 1-1 filter 222, the 1-2 filter 224, and the 1-3 filter 226 to generate a correction value, and passes through the 2-1 filter 242 and the 2-2 filter 244 to generate a correction value; at this time, the values ​​generated by the 1-1 filter 222, the 1-2 filter 224, and the 1-3 filter 226 may be applied values, and the values ​​generated by the 2-1 filter 242 and the 2-2 filter 244 may be unapplied values.

[0061] The application value may be a value obtained by deriving a correction value by irradiating the correction strip 1 once with light from the optical module through the first filter 220 after the correction strip 1 is attached to an in-vitro diagnostic device (reference device), and then adding it to a correction equation programmed in the target device when the correction strip 1 attached to the reference device is attached to another in-vitro diagnostic device (target device). In this case, the correction equation may be a quadratic equation.

[0062] The unapplied value is a value that is compared with the applied value obtained by adding the unapplied value to the correction formula programmed in the target device when the correction strip 1 is attached to the in-vitro diagnostic device (reference device) and irradiated with light by the optical module once and passing through the first filter 220 to derive the correction value. At this time, the correction formula is also applied to the unapplied value, and the unapplied value to which the correction formula is applied can be compared with the applied value to determine whether the value to be corrected is the same as or similar to the applied value through the target device.

[0063] The barcode plate 300 may be placed in a hole formed in the handle portion 120 of the strip body 100. The barcode plate 300 may be composed of a plate portion placed in a hole formed in the handle portion 120 and a barcode portion formed on the plate portion. The barcode plate 300 can store the correction values ​​detected by the first filter 220 and the second filter 240 irradiated with light by the optical module when the correction strip 1 is attached to the in-vitro diagnostic device.

[0064] As such, the correction strip 1 for an in vitro diagnostic device according to one embodiment of the present invention can reduce the preparation time for correction compared to the conventional correction strip 1 using a liquid that uses a dye, by using the first filter 220 and the second filter 240 that are arranged sequentially and have different absorbances, thereby achieving the effect of quickly obtaining detection results.

[0065] Hereinafter, a method for correcting errors among a plurality of in-vitro diagnostic devices using a correction strip 1 for in-vitro diagnostic devices according to an embodiment of the present invention will be described.

[0066] FIG. 5 is a flow chart illustrating a calibration method using calibration strips.

[0067] 5, the calibration method using the calibration strip 1 first installs the calibration strip 1 in each of a plurality of in-vitro diagnostic devices, performs calibration, and then selects a reference device (S100). The step of selecting the reference device may include a process of installing the calibration strip 1 in each of a plurality of in-vitro diagnostic devices, performing calibration, and then selecting a device having a value most similar to an average value obtained by dividing the sum of the highest and lowest values ​​by half.

[0068] Next, the correction value obtained by the reference equipment is stored in the bar code plate 300 of the correction strip 1 (S200).

[0069] Next, the correction strip 1 in which the correction value is stored is attached to each of the devices other than the reference device to perform correction, and at the same time, a correction formula is generated for the devices other than the reference device (S300).

[0070] Next, a correction operation is performed by comparing the correction value of the equipment other than the reference equipment (hereinafter referred to as the "correction value of the equipment other than the reference equipment") with the correction value of the reference equipment stored in the barcode plate 300 (hereinafter referred to as the "correction value of the reference equipment") (S400). In this step, the process of comparing the correction value of the equipment other than the reference equipment with the correction value of the reference equipment involves comparing a graph line calculated using the correction value of the equipment other than the reference equipment with a graph line calculated using the correction value of the reference equipment, and correcting any differences that may occur. For example, the correction operation can be performed by comparing two graph lines and correcting the error. In this case, the error range between the two graph lines can be an absolute value of 1 to 65335, and the value between the two graph lines can be between -500 and +500. If the difference is outside this range, re-correction can be performed using the correction strip 1, or the optical module of the equipment other than the reference equipment can be re-inspected and then re-correction can be performed using the correction strip 1.

[0071] In this way, multiple pieces of equipment on which the calibration process has been performed can derive calibration results such that they have the same or similar values ​​for one sample collected on one calibration strip 1.

[0072] Although the present invention has been described above with reference to exemplary embodiments, it will be understood by those skilled in the art that various modifications and variations of the present invention may be made without departing from the spirit and scope of the present invention as defined in the following claims. Differences relating to such modifications and variations are to be construed as being included within the scope of the present invention as defined in the appended claims. [Explanation of symbols]

[0073] 1: Correction strip for in vitro diagnostic devices 100: Strip body 120: Handle 140: Placement section 140a: Cell 142: Placement groove 144: Compartment protrusion 146: Flow prevention protrusion 148: Passing hole 160: Stopper part 200: Filter unit 220: First filter 222: 1st-1st filter 224: 1st-2nd filter 226: 1st-3rd filters 240: Second filter 242: 2nd-1st filter 244: 2nd-2nd filter 300: Barcode plate L1: First length L2: Second length L3: Third length L4: Fourth length

Claims

1. A calibration strip for an in vitro diagnostic device to be attached to the in vitro diagnostic device, a strip body including a plurality of cells through which light can pass; and a filter unit including a first filter and a second filter disposed in the plurality of cells.

2. the first filter is disposed in each of the plurality of cells in sequence; the second filters are disposed between the first filters; 2. The calibration strip for an in-vitro diagnostic device according to claim 1, wherein the first filter and the second filter have different absorbances.

3. The first filter is The filter includes a first-first filter, a first-second filter, and a first-third filter, which are spaced apart from one another; 3. The calibration strip for an in-vitro diagnostic device according to claim 2, wherein the absorbance gradually decreases from the first filter to the third filter.

4. The first filter is The filter includes a first-first filter, a first-second filter, and a first-third filter, which are spaced apart from one another; 3. The calibration strip for an in-vitro diagnostic device according to claim 2, wherein the absorbance gradually increases from the first filter to the third filter.

5. The second filter is a second-first filter disposed between the first-first filter and the first-second filter; and a second-second filter disposed between the first-second filter and the first-third filter; 4. The calibration strip for an in-vitro diagnostic device according to claim 3, wherein the absorbance of the second-1 filter is lower than that of the second-2 filter.

6. The second filter is a second-first filter disposed between the first-first filter and the first-second filter; and a second-second filter disposed between the first-second filter and the first-third filter; 5. The calibration strip for an in-vitro diagnostic device according to claim 4, wherein the absorbance of the second-1 filter is higher than that of the second-2 filter.

7. the second-first filter has a lower absorbance than the first-first filter and a higher absorbance than the first-second filter; 6. The calibration strip for an in-vitro diagnostic device according to claim 5, wherein the second-second filter has an absorbance lower than that of the first-second filter and higher than that of the first-third filter.

8. the second-first filter has a higher absorbance than the first-first filter and a lower absorbance than the first-second filter; 7. The calibration strip for an in-vitro diagnostic device according to claim 6, wherein the second-second filter has an absorbance higher than that of the first-second filter and lower than that of the first-third filter.

9. the strip body includes partition protrusions that protrude to form the plurality of cells; 2. The calibration strip for an in-vitro diagnostic device according to claim 1, wherein the first length of each of the cells is the same as the second length of the first filter or the second filter.

10. the strip body includes anti-flow protrusions disposed between the partition protrusions so as to face each other and preventing the first filter or the second filter from flowing; 10. The calibration strip for an in-vitro diagnostic device according to claim 9, wherein a third length between the opposing anti-flow protrusions is equal to a fourth length of the first filter or the second filter.

11. a step of attaching the calibration strips to a plurality of in vitro diagnostic devices, performing measurements, and then selecting a reference device; storing the measurement values ​​measured by the reference device in a barcode plate of the calibration strip; Attaching the calibration strip in which the measurement values ​​are stored to equipment other than the reference equipment, and performing measurements, and simultaneously generating a calibration formula for the equipment other than the reference equipment; and performing a correction operation by comparing measurements taken with equipment other than the reference equipment with measurements taken with the reference equipment stored on the barcode plate.

12. The step of selecting a reference device after attaching calibration strips to the plurality of in vitro diagnostic devices and performing measurements thereon includes: The correction method according to claim 11, further comprising the step of: attaching the correction strip to each of the plurality of in-vitro diagnostic devices, performing measurements, and then selecting an equipment having a value most similar to an average value obtained by dividing the sum of the highest value and the lowest value in half.

13. The step of performing a correction by comparing the measurement values ​​measured by the equipment other than the reference equipment with the measurement values ​​measured by the reference equipment stored on the barcode plate includes:

12. The correction method of claim 11, further comprising the step of comparing a graph line calculated based on measurements of equipment other than the reference equipment with a graph line calculated based on measurements of the reference equipment, and correcting a portion where a difference occurs.

Citation Information

Patent Citations

  • Spectrometer standardizing system

    JP1998281984A

  • Accommodation tray of panel-shaped article

    JP2006347570A

  • Method for checking the operation of an optical measuring device and checking device

    US20030086085A1

  • Fluorescence validation plate

    US20050287040A1

  • Test strip with permutative grey scale calibration pattern

    US20070273928A1