KR102453637B1 - Test apparatus, and method for contotolling thereof - Google Patents

Abstract

The disclosed embodiment relates to an inspection apparatus and a control method of the inspection apparatus, wherein the inspection apparatus of the disclosed embodiment includes a measuring unit for measuring optical characteristic values of a target material and an interfering material included in a sample, and optics for the target material and the interfering material and a control unit for calculating concentrations of the target material and the interfering material based on the characteristic value, and determining the measurement time of the sample based on the calculated concentrations of the target material and the interfering material and the reaction rate of the target material.
According to the disclosed embodiment, even when the concentrations of the target material and the interfering material are high, it is possible to measure the concentration of the target material without separate dilution. In addition, when the concentration of the target substance and the interfering substance is low, it is not necessary to unnecessarily increase the test time.

Description

Inspection apparatus and control method of inspection apparatus {TEST APPARATUS, AND METHOD FOR CONTOTOLLING THEREOF}

The disclosed invention relates to an inspection apparatus and a control method of the inspection apparatus.

There is a need for an apparatus and method for testing a specimen in various fields such as environmental monitoring, food inspection, and medical diagnosis. In the past, in order to perform a test according to a set protocol, an experienced experimenter had to manually perform various steps such as reagent injection, mixing, separation and transfer, reaction, and centrifugation several times, and these tasks cause errors in test results. became the cause of

In order to improve this problem, a miniaturized and automated equipment capable of rapidly analyzing a test substance has been developed. In particular, since a portable cartridge can quickly analyze a sample regardless of location, improving its structure and function can perform more diverse functions in more diverse fields. Recently, research on precise analysis methods through miniaturized and automated sample analysis devices is in progress.

In particular, there are various substances in addition to the target substance in the sample, and these substances act as interfering substances, thereby inhibiting the reaction for detection of the target substance or causing an excessive reaction. As a result, there were cases where the test was carried out and retesting was performed after dilution. In this case, the cartridge was consumed twice, the inspection and measurement time increased, and errors could occur due to dilution.

One aspect of the disclosed invention provides a test apparatus capable of performing one test without dilution even when the concentration of a target material is high, and a method for controlling the same.

An inspection apparatus according to an embodiment includes a measuring unit for measuring optical characteristic values of a target material and an interfering material included in a sample, and the target material and the interfering material based on optical characteristic values of the target material and the interfering material and a control unit for calculating the concentration of the material, and determining the measurement time of the sample based on the calculated concentrations of the target material and the interfering material and the reaction rate of the target material.

When the concentration of the target material is less than the first concentration and the concentration of the interfering material is less than the second concentration, the controller may perform the test on the sample for a first time.

When the concentration of the target material is greater than or equal to the first concentration, the control unit considers whether the concentration of the interfering material is greater than or equal to the third concentration and the slope of the reaction graph of the target material and the linearity of the reaction graph. You can determine the inspection time for

The control unit, if the concentration of the interfering substance is the second concentration or more and the third concentration or less, the slope of the reaction graph of the target material is 0.08 or less, and the linearity of the reaction graph is 0.999 or less, inspection can be carried out.

When the control unit satisfies at least one of the case where the concentration of the interfering material is greater than the third concentration, the slope of the reaction graph of the target material is greater than 0.08, or the linearity of the reaction graph is greater than 0.999, the second The sample may be tested for 3 hours.

The controller may measure the slope of the reaction graph of the target material at a reaction time of 400 to 480 seconds.

The first time during which the control unit performs the test may be 5 to 7 minutes.

The second time during which the control unit performs the test may be 8 to 10 minutes.

The second time during which the control unit performs the test may be 11 to 13 minutes.

The measuring unit may include a first accommodating part in which the sample is accommodated, and a second accommodating part in which the reagent is accommodated.

The control unit may measure the concentration of the target material by using a difference between the optical characteristic value of the first accommodation unit and the optical characteristic value of the second accommodation unit.

The sample may include blood, the target substance may be creatinine, and the interfering substance may be creatine.

The method of controlling an inspection device according to another disclosed embodiment measures optical characteristic values of a target material and an interfering material included in a sample, and based on the measured optical characteristic values of the target material and the interfering material, the target and calculating the concentrations of the substance and the interfering substance, and determining the test time of the sample based on the calculated concentrations of the target substance and the interfering substance and the reaction rate of the target substance.

In determining the test time of the sample, when the concentration of the target material is less than the first concentration and the concentration of the interfering material is less than the second concentration, the test time of the sample may be determined as the first time.

To determine the test time of the sample, the concentration of the sample is greater than the first concentration, the concentration of the interfering substance is the second concentration or more and the third concentration or less, and the reaction time of the target material is 400 to 480 seconds. If the slope of is 0.08 or less and the linearity of the reaction graph is 0.999 or less, the test time of the sample may be determined as the second time.

Determining the test time of the sample, the concentration of the interfering substance is greater than the third concentration, the slope of the reaction graph in the reaction time of the target material 400 to 460 seconds is greater than 0.08, or a straight line of the reaction graph If at least one of the cases of sex greater than 0.999 is satisfied, the test time of the sample may be determined as the third time.

The first time may include 5 to 7 minutes.

The second time may include 8 to 10 minutes.

The third time may include 11 to 13 minutes.

The sample may include blood, the target material may be creatinine, and the interfering material may be creatine.

According to the inspection apparatus and the control method thereof according to the disclosed embodiment, even when the concentration of the target substance is high, it is possible to accurately measure the value of the target substance with one test.

1 is a view showing an inspection device to which a cartridge is coupled according to an embodiment disclosed.
2 is an exploded view showing the cartridge and the mounting member of the inspection device to which the cartridge is coupled according to the disclosed embodiment.
Figure 3 is a view showing a state in which the cartridge and the mounting member of the inspection device according to the disclosed embodiment is coupled.
4 is a diagram illustrating a cartridge according to one disclosed embodiment.
5 is an exploded view showing the inspection unit of the cartridge according to the disclosed embodiment.
6 is a cross-sectional view showing the inspection unit of the cartridge of FIG. 4 cut in the AA' direction according to the disclosed embodiment.
7 is a control block diagram of an inspection apparatus according to an embodiment of the disclosed invention.
8 is a diagram illustrating a measurement mechanism of a target material according to an embodiment of the present disclosure.
9 is a response curve when the response of the target material is normally measured according to the disclosed embodiment.
10 is a response curve when the response of the target substance is abnormally measured.
11 is a view for explaining an operation flow of the inspection apparatus according to the disclosed embodiment.
12 is a graph showing the correlation between inspection results by a conventional inspection apparatus.
13 is a graph showing the correlation between test results by the test apparatus according to the disclosed embodiment.

Hereinafter, an embodiment according to the present invention will be described in detail with reference to the accompanying drawings.

1 is a view showing an inspection device to which the cartridge is coupled according to the disclosed embodiment, Figure 2 is a view showing the disassembled mounting member of the cartridge and the inspection device to which the cartridge is coupled according to the disclosed embodiment. Figure 3 is a view showing a state in which the cartridge and the mounting member of the inspection device according to the disclosed embodiment are coupled, Figure 4 is a view showing the cartridge according to the disclosed embodiment. 5 is an exploded view showing the inspection unit of the cartridge according to the disclosed embodiment. In addition, FIG. 6 is a cross-sectional view showing the inspection unit of the cartridge of FIG. 4 cut in the AA' direction according to the disclosed embodiment, and FIG. 7 is a control block diagram of the inspection apparatus according to an embodiment of the disclosed invention. Hereinafter, FIGS. 1 to 7 will be described together to prevent duplication of description.

As shown in FIG. 1 , the inspection device 1 to which the cartridge 40 is coupled according to the disclosed embodiment includes a housing 10 forming an exterior and a door module 20 provided in front of the housing 10 . includes

The door module 20 may include a display unit 21 , a door 22 , and a door frame 23 . The display unit 21 and the door 22 may be disposed in front of the door frame 23 . As shown in FIG. 1 , the display unit 21 may be located above the door 22 , but may be located anywhere as long as it can visually provide various types of information to the user.

Meanwhile, the door 22 may be provided to be slidable, and when opened by sliding, the door 22 may be provided to be positioned at the rear of the display unit 21 .

As analysis information about the sample, the display unit 21 may display various information related to the sample, such as the concentration of the target material in the sample. Also, when the display unit 21 is implemented as a touch screen type, the display unit 21 may receive various types of information and commands from the user.

On the other hand, the door frame 23 may be provided with a mounting member 32 to which the cartridge 40 for accommodating various reagents can be mounted. After the user slides the door 22 upward to open it, mounts the cartridge 40 on the mounting member 32 , and then slides the door 22 downward to close it, the analysis operation can be performed.

A sample is injected into the cartridge 40 to react with the reagent in the test unit 45 . The cartridge 40 is inserted into the mounting member 32 , and the pressing member 31 presses the cartridge 40 so that the sample in the cartridge 40 flows into the inspection unit 45 .

In addition, the inspection apparatus 1 may further include an output unit 11 for outputting an analysis result as a separate printed matter separately from the display unit 21 . Accordingly, the user may not only check the test result through the display unit 21 , but also output the test result through the output unit 11 .

Meanwhile, referring to FIGS. 2 to 4 , the cartridge 40 may be inserted into the mounting member 32 of the inspection device 1 . The mounting member 32 may include a seating portion 32c on which the cartridge 40 is mounted and a support portion 32f for supporting the mounting member 32 in the inspection device 1 .

The support portion 32f is provided to extend to both sides of the body 32e of the mounting member 32 , and a seating portion 32c may be provided in the center of the body 32e. A slit 32d may be provided at the rear of the seating portion 32c to prevent an error occurring when the test unit 45 measures the test result of the sample.

The mounting member 32 includes contact portions 32a and 32b in contact with the cartridge 40, and the inspection unit 45 of the cartridge 40 has a recessed portion 45a having a shape corresponding to the contact portions 32a and 32b. may include. Accordingly, the recessed portion 45a and the contact portions 32a and 32b may contact each other. In this case, two recessed portions 45a may be provided, and two contact portions 32a and 32b may be provided correspondingly, but the present invention is not limited thereto.

On the other hand, the cartridge 40 includes a housing 41 forming an exterior and an inspection unit 45 in which a reaction occurs when a sample and a reagent meet.

The housing 41 may be implemented in a form in which a user can hold the cartridge 40 while supporting the cartridge 40 . In one embodiment, as shown in FIGS. 2 and 3 , the housing 41 may be implemented as a streamlined protrusion in the shape of a portion held by the user. Accordingly, the user can stably hold the cartridge 40 . However, the shape of the housing 41 is not limited to the shape shown in the drawings, and may be implemented in various shapes, and there is no limitation thereto.

In addition, the cartridge 40 may be provided with a sample supply unit 42 to receive a sample. The sample supply unit 42 may include a supply hole 42b through which a sample is introduced into the test unit 45 and a supply auxiliary unit 42a that assists in supplying the sample.

A sample that can be inspected by the inspection device 1 may be supplied to the sample supply unit 42 . Here, the sample may include, but is not limited to, a bio-sample such as blood, tissue fluid, and lymph-containing body fluid, saliva, and urine, or an environmental sample for water quality management or soil management. Meanwhile, as the sample, a diluted or undiluted sample may be used, and there is no limitation thereto.

The supply hole 42b may be formed in a circular shape as shown in FIG. 2 , but is not limited thereto and may be formed in a polygonal shape. The user may drop the sample into the sample supply unit 42 using a tool such as a pipet or a dropper.

The supply auxiliary part 42a is formed to be inclined in the direction of the supply hole 42b around the supply hole 42b, so that the sample falling on the periphery of the supply hole 42b can flow into the supply hole 42b. do. Specifically, when the user fails to accurately drop the sample into the supply hole 42b and a part falls on the periphery of the supply hole 42b, the sample that has fallen to the periphery is transferred to the supply hole 42b by the inclination of the supply auxiliary part 42a. can be imported.

In addition, the supply auxiliary unit 42a may not only assist the supply of the sample, but also prevent contamination of the cartridge 40 by the incorrectly supplied sample. Specifically, even if the sample is not accurately introduced into the supply hole 42b, the supply auxiliary part 42a around the supply hole 42b prevents the sample from flowing toward the inspection unit 45 or the gripping part, so It is possible to prevent contamination of the cartridge 40 and also to prevent a sample that may be harmful to the human body from coming into contact with the user.

As shown in the drawings, the sample supply unit 42 includes only one supply hole 42b, but is not limited thereto, and it is also possible to include a plurality of supply holes. When a plurality of supply holes are provided, a plurality of different samples may be simultaneously tested in one cartridge 40 . Here, a plurality of different samples may have the same type but different sources, may have different types and different sources, or may have the same type and source but have different states.

As described above, since the housing 41 has a shape that implements a specific function and is in contact with a sample, it is easy to mold and may be formed of a chemically and biologically inert material.

For example, the housing 41 may include acrylic such as polymetal methacrylate (PMMA), polysiloxane such as polydimethylsiloxane (PDMS), polycarbonate (PC), linear low density polyethylene (LLDPE), low density polyethylene (LDPE), etc. Polyethylene such as medium density polyethylene (MDPE), high density polyethylene (HDPE), polyvinyl alcohol, ultra-low density polyethylene (VLDPE), polypropylene (PP), acrylonitrile butadiene styrene (ABS), cycloolefin copolymer (COC) It may be made of various materials such as plastic materials such as glass, mica, silica, semiconductor wafers, and the like.

However, the above-described material is merely an example of a material that can be used as the material of the housing 41 , and the housing 41 is not limited to being implemented only with the above-described material. The housing 41 according to the embodiment may be implemented using any material having chemical and biological stability and mechanical processability.

On the other hand, the cartridge 40 may be provided so that the inspection unit 45 is coupled or bonded. The sample injected through the sample supply unit 42 is introduced into the test unit 45 and the test may be performed as a reaction occurs with the reagent. The test unit 45 includes a plurality of accommodating parts 45b, and a reagent reacting with a sample may be accommodated in the accommodating part 45b.

In this case, various types of reagents may be accommodated in the plurality of receiving portions 45b. For example, a reagent used to detect a concentration of a target material in a sample may be accommodated in the receiving unit 45b. For example, the reagent contains a colorant having different optical properties depending on the concentration of the target material in the sample, so the inspection device 1 detects the optical properties through the light receiving unit 52, and based on the detection result, concentration can be calculated.

The target substance described below means an analyte substance included in a sample. For example, the target material refers to a material included in a sample, such as a protein, an enzyme, an ion, and the like, without limitation. In one embodiment, when the sample is human blood, the target material may be one of various substances present in blood, such as sodium (Na) and potassium (K), but there is no limitation thereto. According to an embodiment of the disclosed invention, creatinine may be used as the target material. Hereinafter, the structure of the inspection unit 45 of the cartridge 40 will be looked at in more detail.

Referring to FIG. 5 , the inspection unit 45 of the cartridge 40 according to an embodiment may be formed in a structure in which three plates 46 , 47 , and 48 are bonded. The three plates 46 , 47 , and 48 may be divided into an upper plate 46 , a middle plate 47 , and a lower plate 48 . The upper plate 46 and the lower plate 47 print a light blocking ink to protect the sample moving to the receiving part 45b from external light or to prevent errors that may occur when measuring optical properties in the receiving part 45b. have. The upper plate 46 and the lower plate 48 may each have a thickness of 10 μm to 300 μm. The middle plate 47 may have a thickness of 50 μm to 300 μm.

The films used to form the upper plate 46 and the lower plate 48 of the inspection unit 45 are ultra-low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), low-density polyethylene (LDPE), medium-density polyethylene (MDPE), It can be selected from polyethylene films such as high density polyethylene (HDPE), polypropylene (PP) films, polyvinyl chloride (PVC) films, polyvinyl alcohol (PVA) films, polystyrene (PS) films, and polyethylene terephthalate (PET) films. have. However, the above-mentioned film is only an example, and in addition, if it is a film made of a material that is chemically and biologically inert and has mechanical workability, it may be a film forming the upper plate 46 and the lower plate 48 of the inspection unit 45, and there is no limitation on this. there is no

Unlike the upper plate 46 and the lower plate 48 , the middle plate 47 of the inspection unit 45 may be formed of a porous sheet. As an example of the porous sheet that can be used as the middle plate 47, one or more of cellulose acetate, nylon (Nylon 6.6, Nylon 6.10), and polyethersulfone may be used. Since the middle plate 47 is provided as a porous sheet, it acts as a vent by itself, and allows the sample to move in the inspection unit 45 without a separate driving source. Also, if the sample is hydrophilic, the middle plate In order to prevent the sample from permeating into the inside of the 47, the middle plate 47 may be coated with a hydrophobic solution.

An inlet portion 46a through which a sample is introduced is formed on the upper plate 46 , and an area 46b corresponding to the receiving portion 45b may be processed to be transparent. The lower plate 48 and the region 48a corresponding to the accommodating part 45b may be processed transparently, which is an example of optical characteristics according to the reaction occurring in the accommodating part 45b. to measure Here, the absorbance is also referred to as an optical density, but hereinafter, it will be referred to as an absorbance for convenience of description.

An inlet portion 47a for introducing a sample is also formed in the middle plate 47 , and the inlet portion 46a of the upper plate 46 and the inlet portion 47a of the middle plate 47 overlap to form an inlet portion of the inspection unit 45 . 44 is formed. In addition, a flow path 47c connecting the inlet portion 47a and the receiving portion 45b may be formed in the middle plate 47 .

Various reactions for sample analysis may occur in the test unit 45, and when blood is used as a sample, a reagent that reacts with a specific component of blood (especially plasma) to the receiving unit 45b to develop or change color is applied to the receiving unit 45b. It can be accommodated in (45b) and can be digitized by optically detecting the color expressed in the receiving part (45b). The presence or absence of a specific component in the blood, a ratio of a specific component, or a concentration, etc. can be confirmed through the above-described numerical value.

The cartridge 40 may be formed in such a way that the inspection unit 45 is bonded to the lower portion of the housing 41 . More specifically, the inspection unit 45 may be bonded to the lower side of the sample supply part 42 in which the supply hole 42b is provided.

A pressure sensitive adhesive (PSA) may be used for bonding the housing 41 and the inspection unit 45, and the pressure sensitive adhesive can be adhered to an adherend in a short time at room temperature with a small pressure of acupressure level and can be peeled off It does not cause cohesive failure and does not leave residues on the surface of the adherend. However, the housing 41 and the inspection unit 45 are not only bonded by the pressure-sensitive adhesive, but may be bonded by other double-sided adhesives in addition to the pressure-sensitive adhesive or in a way that they are fitted into the groove.

The sample introduced through the supply hole 42b passes through the filtering unit 43 and flows into the inspection unit 45 . The filtering part 43 may be fitted into the supply hole 42b of the housing 41 .

The filtering unit 43 may include at least one porous membrane including a plurality of pores to filter substances of a predetermined size or more included in the sample. For example, the filtering unit 43 may include a filter of two layers. In one embodiment, the first filter may be made of glass fiber, non-woven fabric, or paper filter (absorbent filter), and the second filter may include polycarbonate (PC), polyethersulfone (PES), polyethylene (PE), It may be made of polysulfone (PS), polyacrylsulfone (PASF), or the like.

On the other hand, when the filtering unit 43 is formed of a double layer, filtration may be performed once more in the filter of the lower layer with respect to the sample that has passed through the filter of the upper layer. In addition, when particles larger than the pore size of the filtering unit ( ) are introduced in a large amount at once, it is possible to prevent the filtering unit 43 from being torn or damaged. However, the present invention is not limited thereto, and the filtering unit 43 may be provided to include a triple layer or more. In this case, the filtering function for the sample is further strengthened, and the stability of the filtering unit 43 is further improved. Each of the filtering parts 43 may be processed by an adhesive material (not shown) such as a double-sided adhesive.

The inspection unit 45 may be provided with an inlet 44 through which the sample passing through the filtering unit 43 is introduced, a flow path 47c through which the introduced sample moves, and a receiving unit 45b in which a reaction between the sample and the reagent occurs. can The concentration of the target material may be detected using a difference in absorbance between the second receptor and the first receptor.

Meanwhile, the upper plate 46 , the middle plate 47 , and the lower plate 48 may be coupled by a double-sided tape 49 . More specifically, the double-sided tape 49 is attached to the upper and lower surfaces of the middle plate 47 so that the upper plate 46, the middle plate 47, and the lower plate 48 can be coupled.

A plurality of accommodating portions 45b of the cartridge 40 may be provided in isolation from each other. For example, the accommodating part 45b may include a first accommodating part, a second accommodating part, and a third accommodating part, but the number of the accommodating parts is not limited thereto. According to an embodiment of the disclosed invention, a sample including a target material may be accommodated in the first accommodating part, and a reagent may be accommodated in the second accommodating part.

7 is a control block diagram of an inspection apparatus according to an embodiment of the disclosed invention.

As shown in FIG. 7 , the inspection apparatus 1 includes a measurement unit 50 for measuring optical characteristic values at a specific wavelength, and a control unit 60 for controlling the overall operation of the inspection apparatus 1 . In addition, it may include a data processing unit 70 for calculating the concentration of the target material included in the sample by using the measured optical characteristic value.

The measuring unit 50 may include a light emitting unit 51 for generating and irradiating light and a light receiving unit 52 for detecting light transmitted through or reflected from the sample.

For example, the light emitting unit 51 may include a light-emitting diode (LED), and may be implemented with various types of light sources such as a semiconductor laser, a He-Ne laser, and a halogen lamp. In addition, the measuring unit 50 may further include an additional device such as a filter for irradiating light of a specific wavelength.

Since light having a desired wavelength among wavelengths of 300 nm to 800 nm may be irradiated through the light source, an appropriate wavelength may be selected according to the type and concentration of the target material and the interfering material.

The light receiving unit 52 detects the light passing through the sample, and converts the detected light into an electrical signal corresponding to the intensity thereof. To this end, the light receiving unit 52 may include a light receiving element such as a photodiode.

The controller 60 may control the overall operation of the inspection apparatus 1 . For example, the wavelength of the light irradiated from the measuring unit 50 may be controlled, or the position of the measuring unit 50 may be controlled to a position corresponding to the receiving unit 45b in which the sample is accommodated. According to an embodiment of the disclosed invention, the controller 60 may control the test time of the sample.

In addition, when the data processing unit 70 measures the concentration of the measured item using the value output from the light receiving unit 52 or performs a diagnosis on a specific disease, the result may be controlled to be provided to the user. have.

The data processing unit 70 and the control unit 60 may include a memory in which a program for an operation to be described above and an operation to be described later is stored, and a processor for executing the program stored in the memory. In addition, at least one memory and a processor may be allocated to the data processing unit 70 and the control unit 60 , respectively, and the data processing unit 70 and the control unit 60 may share a memory and a processor.

8 is a diagram illustrating a measurement mechanism of a target material according to an embodiment of the present disclosure. 9 is a response curve when the response of the target material is normally measured according to the disclosed embodiment, and FIG. 10 is a response curve when the response of the target material is abnormally measured. 11 is a view for explaining an operation flow of the inspection apparatus according to the disclosed embodiment. 12 is a graph showing the correlation of test results by a conventional inspection apparatus, and FIG. 13 is a graph illustrating the correlation of inspection results by the inspection apparatus according to the disclosed embodiment.

As shown in FIG. 8 , according to an embodiment of the disclosed invention, blood may be used as a sample, the target material may be creatinine, and the interfering material may be creatine.

R1 is a reaction that occurs in a sample, which is a material to be measured by the test device 1, and R2 is a reaction that occurs in a reagent. The concentration of the target substance is calculated using the difference between the absorbance of the target substance in the reagent and the absorbance of the target substance in the sample. Since creatine, which is a target substance, and creatine, cause a reversible reaction with each other, when the concentration of the target substance or the interfering substance is high, the concentration of the target substance may be measured incorrectly. Accordingly, in the prior art, the sample was diluted and retested, but in this case, an error could occur during the test.

9A, 9B and 9C are response curves when creatinine and creatine react normally. 9a, 9b and 9c, it can be seen that the slope of the creatinine response curve becomes gentler as time goes by.

10A and 10B are response curves when creatinine and creatine react abnormally. In the case of FIGS. 10A and 10B, it can be seen that the slope of the creatinine response curve does not become gentle even with time, and the slope increases or remains the same. This means that the concentration of creatinine is being measured as high even over time.

When the concentration of the target substance or interfering substance is high, it is necessary to increase the test time because a reversible reaction may occur continuously between the target substance and the reactant. However, in the case of extending the test time at once, when the concentration of the target substance and the interfering substance is low, the test time is unnecessarily extended at the same time, which may lengthen the test time. In order to prevent this, in one embodiment of the disclosed invention, the measurement time of the sample is determined based on the concentration of the target material and the interfering material, and the reaction rate of the target material.

11 is a view for explaining the flow of operation of the inspection apparatus according to the disclosed embodiment, and as shown in FIG. 11 , concentrations of the target material and the interfering material are calculated ( 100 ). The concentration of the target substance and the interfering substance is measured by the measuring unit 50 of the test device 1 . The measurement unit 50 may measure the concentration of the target material and the interfering material by numerically measuring the absorbance detected by the light irradiated from the light source passing through the sample.

When the concentration of the target substance is less than the first concentration (200) and the concentration of the interfering substance is less than the second concentration (300), the sample is tested for the first time (400). In this case, both the concentration of the target substance and the concentration of the interfering substance are below a certain concentration, which means that the test has been performed normally. In this case, the first concentration may be 5 mg/dL. Also, the second concentration may be 5 mg/dL. The first time may be 5 to 7 minutes. That is, when the concentration of the target substance is less than 5 mg/dL and the concentration of the interfering substance is less than 5 mg/dL, the test can be completed in 5 to 7 minutes.

On the other hand, when the concentration of the target substance is higher than the first concentration, the test time for the sample can be determined by considering whether the concentration of the interfering substance is the third concentration or higher, the slope of the reaction graph of the target substance, and the linearity of the reaction graph. have.

Specifically, when the concentration of the interfering substance is greater than or equal to the second concentration and less than or equal to the third concentration, the slope of the reaction graph of the target material is 0.08 or less, and the linearity of the reaction graph of the target material is 0.999 or less (310) for the second time The test of the sample proceeds ( 410 ). In this case, the concentration of the target material may be greater than the first concentration. The slope of the reaction graph of the target material means the slope at a reaction time of 400 to 480 seconds. If the target material in the sample is high in concentration, the reaction is not completed and the linearity of the reaction graph is greater than 0.999.

The second time is greater than the first time. In this case, since the concentration of the target material is equal to or greater than the first concentration or the concentration of the interfering material is greater than or equal to the second concentration, the test time is increased from the first time.

In this case, the first concentration may be 5 mg/dL. Also, the second concentration may be 5 mg/dL. Also, the third concentration may be 16 mg/dL. The second time period may be 8 to 10 minutes.

That is, the concentration of the target substance is greater than 5 mg/dL, the concentration of the interfering substance is 5 mg/dL or more and 16 mg/dL or less, and the slope of the reaction graph in the reaction time of the target substance is 400 to 480 seconds is 0.08 or less, and the If the linearity is 0.999 or less, the test can be completed in 8 to 10 minutes.

On the other hand, if at least one of the concentration of the interfering substance is greater than the third concentration, the slope of the reaction graph of the target material is greater than 0.08, or the linearity of the reaction graph is greater than 0.999, A test is performed ( 420 ).

In this case, the concentration of the target material may be greater than the first concentration. The slope of the reaction graph of the target material means the slope at a reaction time of 400 to 480 seconds. If the target material in the sample is at a high concentration, the reaction is not completed and the linearity of the reaction graph appears greater than 0.999.

The third hour is greater than the second hour. In this case, since the concentration of the target substance is greater than the first concentration or the concentration of the interfering substance is greater than the third concentration, the test time is increased than the second time.

In this case, the first concentration may be 5 mg/dL. Also, the second concentration may be 5 mg/dL. Also, the third concentration may be 16 mg/dL. The third time period may be 11 to 13 minutes.

That is, the concentration of the target substance is greater than 5 mg/dL and the concentration of the interfering substance is greater than 16 mg/dL, the slope of the reaction graph at the reaction time of the target substance is 400 to 480 seconds is greater than 0.08, or the linearity of the reaction graph If this is greater than 0.999, the test can be completed in 11 to 13 minutes.

However, when the concentration of the interfering substance is too high, the test cannot be completed even after the third hour has elapsed, and in this case, an error message is displayed on the display unit 21 . More specifically, when the concentration of the interfering substance is 32 mg/dL, the concentration of the target substance cannot be accurately measured even if the test is performed for 11 to 13 minutes, which is the third time.

12 is a graph showing the correlation of test results by a conventional test apparatus, and as shown in FIG. 12 , it can be confirmed that conventionally, when the concentration of creatine is high, an outlier is out of the correlation line.

13 is a graph showing the correlation of test results by the test apparatus according to the disclosed embodiment, and as shown in FIG. 13, according to the disclosed embodiment, even when the concentration of creatine is high, the correlation line does not deviate. You can check that the test is in progress without it.

As such, according to an embodiment of the disclosed invention, even when the concentration of the target substance and the interfering substance is high, the test can be performed without separate dilution. In addition, since the measurement time is determined in consideration of the concentration of the target material and the interfering material, and the reaction rate of the target material, it is possible to prevent the measurement time from being unnecessarily long when the concentration of the target material and the interfering material is low.

The configuration shown in the embodiments and drawings described in this specification is only a preferred example of the disclosed invention, and there may be various modifications that can replace the embodiments and drawings of the present specification at the time of filing of the present application.

In addition, the terminology used herein is used to describe the embodiments, and is not intended to limit and/or limit the disclosed invention. The singular expression includes the plural expression unless the context clearly dictates otherwise. In the present specification, terms such as “comprise” or “have” are intended to designate that a feature, number, step, operation, component, part, or combination thereof described in the specification exists, but one or more other features It does not preclude the possibility of the presence or addition of numbers, steps, operations, components, parts, or combinations thereof.

In addition, terms including an ordinal number, such as "first", "second", etc. used in this specification can be used to describe various elements, but the elements are not limited by the terms, and the terms are It is used only for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a second component, and similarly, a second component may also be referred to as a first component. The term “and/or” includes a combination of a plurality of related listed items or any of a plurality of related listed items.

In addition, terms such as "~ unit", "~ group", "~ block", "~ member", "~ module", etc. used throughout this specification are at least any It may mean a unit that processes one function or operation. For example, it may mean software, hardware such as FPGA or ASIC. However, "~ unit", "~ group", "~ block", "~ member", "~ module", etc. are not meant to be limited to software or hardware, " "~unit", "~ group", "~block", "~member", "~module" etc. are stored on an accessible storage medium and one or more It may be a configuration performed by a processor.

In the above, specific embodiments have been shown and described. However, it is not limited to the above embodiments, and those of ordinary skill in the art to which the invention pertains can make various changes without departing from the spirit of the invention described in the claims below. .

1: inspection device 10: housing
20: door module 21: display unit
22: door 23: door frame
31: pressing member 32: mounting member
40: cartridge 50: measurement unit
60: control unit 70: data processing unit

Claims (20)

a measuring unit for measuring optical characteristic values of the target material and the interfering material included in the sample; and
Concentrations of the target material and the interfering material are calculated based on optical characteristic values of the target material and the interfering material, and the concentration of the target material and the interfering material is calculated based on the concentration of the target material and the interfering material and the reaction rate of the target material. a control unit for determining a measurement time of the sample;
inspection device comprising a. According to claim 1,
The control unit is
When the concentration of the target substance is less than the first concentration and the concentration of the interfering substance is less than the second concentration, the test apparatus performs the test on the sample for a first time. According to claim 1,
The control unit is
When the concentration of the target material is equal to or greater than the first concentration, the test time for the sample is taken in consideration of whether the concentration of the interfering material is equal to or greater than the third concentration, the slope of the reaction graph of the target material, and the linearity of the reaction graph inspection device to determine 4. The method of claim 3,
The control unit is
If the concentration of the interfering substance is greater than or equal to the second concentration and less than or equal to the third concentration, the slope of the reaction graph of the target material is less than 0.08, and the linearity of the reaction graph is less than or equal to 0.999, the sample is tested for a second time inspection device. 4. The method of claim 3,
The control unit is
When at least one of the concentration of the interfering substance is greater than the third concentration, the slope of the reaction graph of the target material is greater than 0.08, or the linearity of the reaction graph is greater than 0.999, the Inspection device that conducts inspection of samples. 4. The method of claim 3,
The control unit is
Inspection apparatus for measuring the slope of the reaction graph of the target material in a reaction time of 400 to 480 seconds. 3. The method of claim 2,
The first time during which the control unit performs the test is 5 to 7 minutes. 5. The method of claim 4,
The second time during which the control unit performs the test is 8 to 10 minutes. 6. The method of claim 5,
The third time during which the control unit performs the test is 11 to 13 minutes. According to claim 1,
The measurement unit,
A test apparatus comprising a first accommodating part accommodating the sample and a second accommodating part accommodating a reagent. 11. The method of claim 10,
The control unit is
The concentration of the target material is measured using a difference between the optical characteristic value of the first accommodating part and the optical characteristic value of the second accommodating part. According to claim 1 ,
the sample comprises blood;
The target substance is creatinine, and the interfering substance is creatine. measuring optical characteristic values of target substances and interfering substances included in the sample;
calculating concentrations of the target material and the interfering material based on the measured optical characteristic values of the target material and the interfering material;
and determining an examination time of the sample based on the calculated concentrations of the target material and the interfering material and the reaction rate of the target material. 14. The method of claim 13,
Determining the test time of the sample comprises:
and determining the test time of the sample as a first time when the concentration of the target substance is less than the first concentration and the concentration of the interfering substance is less than the second concentration. 14. The method of claim 13,
Determining the test time of the sample comprises:
The concentration of the sample is greater than the first concentration, the concentration of the interfering substance is greater than or equal to the second concentration and less than or equal to the third concentration, and the slope of the reaction graph at the reaction time of the target material is 400 to 480 seconds is 0.08 or less, the reaction graph When the linearity of is 0.999 or less, the control method of the test apparatus comprising determining the test time of the sample as a second time. 14. The method of claim 13,
Determining the test time of the sample comprises:
At least one of a case in which the concentration of the interfering material is greater than the third concentration, the slope of the reaction graph in the reaction time of the target material 400 to 460 seconds is greater than 0.08, or the linearity of the reaction graph is greater than 0.999 If satisfied, the control method of the test apparatus comprising determining the test time of the sample as a third time. 15. The method of claim 14,
The first time is a control method of the inspection device comprising 5 to 7 minutes. 16. The method of claim 15,
The second time is a control method of the inspection device comprising 8 to 10 minutes. 17. The method of claim 16,
The third time is a control method of the inspection device comprising 11 to 13 minutes. 14. The method of claim 13,
the sample comprises blood;
The target substance is creatinine, and the interfering substance is creatine.

Images