KR102186835B1 - A cartridge of assay apparatus for in vitro diagnosis - Google Patents

Abstract

The cartridge of the in vitro diagnostic analysis device according to the present invention is equipped with a reagent storage unit for storing at least two reagents, has a sample injection port through which a sample is injected, and a membrane housing having a membrane at the top of one side is the sample injection port. And a first body formed such that the membrane is aligned and mounted; And a second body provided with a hole in the upper part and at least two capillary parts configured to be in communication with the capillary in the lower part of the upper hole, and having a perforation means formed at the lower end of the second body. The second body is movably coupled to a first position on the top of the first body to a second position on the lower side, and the reagent storage unit proposes a structure in which the upper end is shielded by a shielding means, thereby minimizing user handling and convenience. At the same time, it improves the reliability and accuracy of the test.

Description

Cartridge for in vitro diagnostic analysis device {A CARTRIDGE OF ASSAY APPARATUS FOR IN VITRO DIAGNOSIS}

The present invention relates to an in vitro diagnostic test, and more particularly, to a cartridge of an in vitro diagnostic analysis device that is provided with at least one assay reagent and can improve convenience by minimizing user handling and increase test accuracy. will be.

In the past, treatment was the center of medical care, but now the in vitro diagnostic industry is drawing attention as the focus is on prevention. In vitro diagnosis refers to measuring and analyzing specific components in samples of bodily fluids such as blood, sweat, and urine to check for signs of abnormalities or infections. Such in vitro diagnostics are widely used to confirm the safety of blood used for pregnancy diagnosis or transfusion, as well as professional disease identification.

In general, in vitro diagnostic analysis devices include glycosylated hemoglobin (HbA1c), albumin (u-Albumin, ACR), creatinine, C-Reactive Protein (CRP), and D-Dimer. ), etc. There are devices that measure and analyze. Conventional analysis devices for exclusion diagnosis mainly consisted of expensive and large-sized equipment, but with the development of miniaturized, low-cost equipment for point of care (PoC), various products are rushing to market and competing. to be.

On the other hand, for in vitro diagnosis, sample preparation is performed on the sample to be analyzed or tested, but most analysis devices do not support it and leave it to the user who handles it, requiring the user's professional handling. In addition, analysis results may vary due to user's carelessness, work environment, and user-to-user deviation, which has been a weakness in in vitro diagnostic analysis devices that require accuracy.

Recognizing these problems, leading companies are developing automated analysis devices that minimize handling of users and support all necessary tasks in the device.All of these automated analysis devices include cartridges that can be appropriately applied to each device ( Cartridge) is applied.

The present invention provides a cartridge of an in vitro diagnostic analyzer capable of improving convenience and accuracy and reliability of a test by minimizing user handling.

In order to solve the above-described problem, the cartridge of the in vitro diagnostic analysis apparatus according to the present invention is equipped with a reagent storage unit for storing at least two reagents, has a sample injection port through which a sample is injected, and has a membrane at one top. A first body in which the provided membrane housing is mounted so that the sample inlet and the membrane are aligned; And a second body provided with a hole in the upper part and at least two capillary parts configured to be in communication with the capillary in the lower part of the upper hole, and having a perforation means formed at the lower end of the second body. The second body is movably coupled to a first position on the top of the first body to a second position on the lower side, and the reagent storage unit is characterized in that the upper end is shielded by a shielding means.

Preferably, the second body is moved from the top of the first body to a second position below the first body by pressurization, and the shielding means is punctured with the puncturing means, and the capillary of the capillary part is in the reagent storage part. It is characterized in that it is immersed in the stored reagent.

Preferably, the reagent is characterized in that it contains at least one reaction reagent and at least one washing liquid that reacts with the analyte.

Preferably, the reaction reagent is characterized in that the XC-DAPOL-CPBA reacts with the affinity of the glycated hemoglobin and boronic acid among the blood components.

Preferably, the capillary unit is characterized in that the reaction reagent stored in the reagent storage unit is mixed with the sample collected by the lower capillary by pressurization or decompression applied to the upper hole.

Preferably, the sample mixed with the reaction reagent is injected into the membrane through the sample inlet.

Preferably, the membrane is a filtration layer having a pore size that filters a reaction material in which a component of a target analyte and the reaction reagent material are combined in the sample, and only the remaining components are filtered, and a filtration rate of the residual component is increased. It characterized in that it is configured to include an absorbing layer.

Preferably, the washing liquid is injected into the membrane through the sample injection port, leaving only the reactant material on the membrane and washing the remaining residual components downward.

The cartridge of the in vitro diagnostic analysis device according to the present invention has the effect of improving convenience so that the unskilled person can easily prepare a sample by allowing the user to manually proceed only the sample collection.

In addition, the present invention provides a structure in which the entire process of sample preparation except for sample collection can be automatically performed in the analysis device, thereby preventing foreign substances from entering during the sample preparation operation, and always operating at the same time and quantifying the sample. There is an effect of improving the reliability and accuracy of analysis by ensuring loading.

1 is an exploded perspective view showing the structure of a cartridge of an in vitro diagnostic analysis device according to an embodiment of the present invention.
Figure 2 is a side cross-sectional view of the cartridge of the in vitro diagnostic analysis device according to an embodiment of the present invention.
Figure 3 is another cross-sectional side view of the cartridge of the in vitro diagnostic analysis device according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION The detailed description of the present invention to be described later refers to the accompanying drawings, which illustrate specific embodiments in which the present invention may be practiced. These embodiments are described in detail sufficient to enable a person skilled in the art to practice the present invention.

It should be understood that the various embodiments of the present invention are different from each other, but need not be mutually exclusive. For example, specific shapes, structures, and characteristics described herein may be implemented in other embodiments without departing from the spirit and scope of the present invention in relation to one embodiment. In addition, it should be understood that the positions or arrangements of individual components in each disclosed embodiment may be changed without departing from the spirit and scope of the present invention.

Accordingly, the detailed description to be described below is not intended to be taken in a limiting sense, and if the scope of the present invention is properly described, it is limited only by the appended claims along with all the scopes equivalent to those claimed by the claims. Like reference numerals in the drawings refer to the same or similar functions over several aspects.

In addition, in the following description and accompanying drawings, detailed descriptions of known functions and configurations that may unnecessarily obscure the subject matter of the present invention will be omitted.

1 is an exploded perspective view showing the overall structure of a cartridge of an in vitro diagnostic analyzer according to an embodiment of the present invention, and FIGS. 2 and 3 are side cross-sectional views of the cartridge of an in vitro diagnostic analyzer according to an embodiment of the present invention, Shows the operation structure of.

1 and 2, the cartridge 100 includes a lower first body 200 and an upper second body 300.

In the first body 200, a space 220 in which at least two reagent storage units 210 are mounted is provided in a form in which respective openings are opened in a rectangular parallelepiped, and a measurement subject 230 provided with a sample injection port 232 ), a membrane housing 240 with a membrane 242 is mounted. The measurement target 230 is formed in a bar shape that extends from the lower portion of the hexahedron so that one side further protrudes.

The reagent storage unit 210 is configured in the form of a hexahedral container capable of storing at least one reaction reagent and at least one washing liquid. The reagent storage unit 210 may be composed of at least two parts 212 and 214 or at least three parts 212, 214 and 216 according to an analyte to which the cartridge 100 is used. Of course, it will be apparent to those skilled in the art that the number of parts may be 4 or 5 depending on the analyte to be analyzed. The reaction reagent may be in a liquid state or a solid state. When the reaction reagent is in a solid state, the reagent storage unit may further contain a hemolytic agent. In addition, the reagent storage unit 210 may be mounted through a lower or upper portion of the first body 200 and fixed by a fixing means such as a hook.

In addition, the upper end of the reagent storage unit 210 may be sealed by a shielding means 250 such as a foil.

It is preferable that the shielding means 250 is formed of a thin film to facilitate perforation and made of a material that does not transmit light. In particular, the shielding means 250 may be made of any material that does not affect the solution stored in the reagent storage unit 210 even if it is not a foil.

A membrane 242 is provided in the membrane housing 240, and the membrane 242 may filter a reactant formed by the combination of a target analyte and the reaction reagent. To this end, the membrane 242 is a filter layer having a pore size that filters only the remaining components and filters the reaction materials in which the components of the target analyte and the reaction reagent material are combined, and the remaining components It may be configured to include an absorption layer to increase the filtration rate of.

In addition, the membrane 242 may include an antigen that binds to a corresponding antibody according to an analyte to be analyzed.

The second body 300 may mount at least two capillary portions 310 in a mounting space 350 formed so that the capillary portions 310 are seated. The capillary part 310 is provided with a hole 320 in the upper part, and the upper hole 320 is configured to be in communication with the capillary 330 in the lower part, so that the liquid is sucked and discharged through the capillary 330 can do. For example, the upper hole 320 is connected to a pressure applying means (not shown) of an analysis device such as a peristaltic pump, and through the capillary 330 by depressurization or pressurization by a pressure applying means. Liquid can be inhaled or discharged.

In addition, the capillary part 310 may include at least two parts 312 and 314 or at least three parts 312, 314 and 316 according to the number of parts of the reagent storage part 210.

The second body 300 includes a perforation means 340 protruding at a lower end. As shown in FIG. 2, the second body 300 is fastened and fixed with the first body 200 at a first position H1. When a force is applied to the upper portion, the second body 300 is fixed at a second position H2 as in FIG. ), the upper shielding means 250 of the reagent storage unit 210 fixed to the first body 200 can be punctured with the perforation means 340 protruding at the lower end. On the other hand, it will be apparent to those skilled in the art that the second body 300 can be moved to the second position in a manner equivalent to or releasing a fixing means such as a hook, not a manner in which a force is applied to the upper portion.

The cartridge of the in vitro diagnostic analyzer according to the present invention includes Glycosylated hemoglobin (HbA1c), albumin (u-Albumin, ACR), creatinine, C-reactive protein (CRP), and di-dimer ( D-Dimer) can be applied to a device that measures and analyzes at least one target analyte among target analytes, or an equivalent level device.

Hereinafter, a sample preparation process for measuring and analyzing glycated hemoglobin using a cartridge of an in vitro diagnostic analyzer according to an embodiment of the present invention will be described.

At this time, the first reagent storage unit 212 of the first body 200 stores a reaction reagent that reacts with the glycated hemoglobin in the blood using the boronic acid affinity called XC-DAPOL-CPBA, and the second reagent storage unit ( Washing solution (washing solution) is stored in 214). Meanwhile, the third reagent storage unit 216 may be empty or the corresponding part may be removed from the cartridge 100. Likewise, the first capillary part 312 and the second capillary part 314 matching the corresponding part are mounted at the corresponding positions of the second body 300, and the third capillary part 316 is the second body. Even if mounted on the 300, it may not be used, or the corresponding part may be removed from the cartridge 100.

First, a blood sample is supplied to the first capillary part 312 by a user and seated on the second body 300, and then the cartridge 100 is inserted into the analysis device. After the cartridge 100 is inserted into the analysis device, all subsequent processes are performed by the driving part and the measurement part of the analysis device.

When the cartridge 100 is inserted into the analysis device, the second body 300 moves downward so that the drilling means 340 punctures the shielding means 250 of the reagent storage part 210. Accordingly, the lower capillary 330 of the capillary part 310 is immersed in the solution stored in the reagent storage part 210 and pressurized through the upper hole 320 of the first capillary 312. When applied, the blood sample stored in the capillary 330 is discharged and mixed with the reaction reagent (XC-DAPOL-CPBA) stored in the first reagent storage unit 212. In addition, when a reduced pressure is applied through the upper hole 320 of the first capillary 312, the reaction solution in which the reaction reagent and the blood sample are mixed in the first reagent storage unit 212 is transferred to the capillary 330. Is inhaled through. The pressurization and decompression are repeated several times for complete discharge of the blood sample and complete mixing reaction with the reaction reagent. In addition, it waits for a predetermined time for a stable mixing reaction, and the waiting time is preferably 1 minute to 2 minutes.

At this time, in the blood sample, glycated hemoglobin binds to the reaction reagent (XC-DAPOL-CPBA), and other components except glycated hemoglobin do not bind. In the reaction reagent, except for a certain amount bound to the glycated hemoglobin, the remaining reaction reagent remains as it is.

When the mixing is completed, a predetermined reaction solution is sucked by applying a reduced pressure, and injected into the sample injection port 242 of the first body 200. It is preferable that the injected reaction solution is 10 to 30 µl. Then, in the blood sample, the glycated hemoglobin bound to the reaction reagent remains on the membrane, and remains together with the remaining components that have not been escaped.

Thereafter, when a predetermined amount of the washing solution stored in the second reagent storage unit 214 is sucked through the second capillary unit 314 and injected into the sample inlet 242, the washing solution remains on the membrane 242. The remaining components are washed down to the lower layer of the membrane, and only the glycated hemoglobin component bound to the reaction reagent in the blood sample remains on the membrane 242. The washing solution to be injected is preferably 10 to 30 µl.

Thereafter, when the membrane 242 is optically analyzed, the glycated hemoglobin measurement and analysis are completed. For example, the membrane 242 is irradiated with light of a specific color and a specific wavelength with a light source such as an LED, and the amount of reflected light is detected and calculated with a detector, or the reflected light or the membrane 242 is photographed with a camera module and glycosylated through imaging. Hemoglobin values can be analyzed.

100: cartridge 200: first body
210: reagent storage unit 220: reagent storage unit mounting space
230: part to be measured 232: sample injection port
240: membrane housing 242: membrane
250: shielding means 300: second body
310: capillary part 320: upper hole
330: capillary 340: drilling means
350: capillary part mounting space

Claims (8)

In the cartridge of the analysis device for in vitro diagnosis,
A first body mounted with a reagent storage unit for storing at least two reagents, a membrane housing having a sample injection port through which a sample is injected, and having a membrane at an upper end of one side so that the sample injection port and the membrane are mounted in alignment; And
And a second body provided with a hole in the upper part and at least two capillary parts configured to communicate with the capillary in the lower part of the upper hole, and having a perforation means formed at the lower end, and
The second body is movably coupled to a first position on the top of the first body to a second position on the lower side, and the reagent storage unit is shielded by a shielding means,
The second body
It is characterized in that by moving from the top of the first body to a second position at the bottom of the first body by pressurization, the shielding means is punctured with the puncture means, and the capillary of the capillary is immersed in the reagent stored in the reagent storage unit. Cartridge for analysis device for in vitro diagnosis. delete The method of claim 1, wherein the reagent is
A cartridge of an in vitro diagnostic analysis device, comprising: at least one reaction reagent reacting with the analyte and at least one washing liquid. The method of claim 3, wherein the reaction reagent is
In vitro diagnostic analysis device cartridge, characterized in that the XC-DAPOL-CPBA reacts with the affinity of the glycated hemoglobin and boronic acid among blood components. The method of claim 1, wherein the capillary part
A cartridge of an in vitro diagnostic analyzer, characterized in that the sample collected by the lower capillary is mixed with the reaction reagent stored in the reagent storage unit by pressurization or decompression applied to the upper hole. The method of claim 5, wherein the sample mixed with the reaction reagent is
A cartridge of an in vitro diagnostic analyzer, characterized in that injected into the membrane through the sample inlet. The method of claim 6, wherein the membrane
Comprising: a filtration layer having a pore size for filtering a reaction material in which a component of the analyte and the reaction reagent material is combined in the sample, and filtering only the remaining components, and an absorption layer for increasing the filtration rate of the residual component Cartridge of the in vitro diagnostic analysis device, characterized in that the. The method of claim 7,
The reagent includes at least one reaction reagent and at least one washing liquid reacting with the analyte,
The washing solution is
A cartridge of an in vitro diagnostic analysis device, characterized in that it is injected into the membrane through the sample inlet, leaving only the reactant material on the membrane and washing the remaining components downward.

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