KR101190142B1 - Lateral Flow Assay Device Providing Pre-treatment of Blood - Google Patents

Abstract

The present invention provides a pretreatment process for obtaining an analyte contained in a cell component of blood and a measurement method for the analyte, which can be implemented in a single device using a two-way cross-membrane method. A flow assay device.
To this end, the present invention, the first housing; A first flow passage membrane stacked inside the first housing and configured to move a blood pretreatment solution; A sample pad laminated on one side of the first flow path membrane; A moisture absorption pad stacked on one side of the first flow path membrane so as to overlap a portion thereof; A second housing; A second flow path membrane stacked inside the second housing and configured to move the detection material; And a detection material inlet configured to penetrate through the outside of the second housing to one side of the second flow path membrane to inject the detection material. And a first flow path membrane and a second flow path membrane intersecting with respect to the sample pad which is joined to the second flow path membrane during fixed bonding of the first housing and the second housing. Provided is a lateral flow assay device capable of blood pretreatment.

Description

Lateral Flow Assay Device Providing Pre-treatment of Blood

The present invention relates to a lateral flow assay device capable of blood pretreatment, and more particularly, a two-way crossover between a pretreatment process and a measurement process for obtaining an analyte contained in a cell component of blood. A lateral flow assay device that can be implemented in a single device using a membrane approach.

Conventional lateral flow detection systems aim primarily at the detection of disease through plasma, a liquid component in the blood. Therefore, only a liquid component in the blood was used for the analysis by using a membrane for a special purpose that can filter out blood components of the blood. Therefore, when the disease detection material and analyte are included in the cell components of blood, it is difficult to use the lateral flow detection system without a special pretreatment process such as hemolysis.

Meanwhile, Korean Patent Laid-Open Publication No. 2004-0018893 discloses a method of dropping a blood pretreatment step separately from the outside of the device in order to overcome the above problems. However, this method has the disadvantage that the process is complicated, not easy to operate, and requires professional knowledge and skills.

Therefore, in the technical field to which the present invention belongs, it can be said that the development of a device that can easily be used for on-site diagnosis of disease diagnosis components including blood pretreatment is required.

Therefore, the present invention has an object of the present invention to solve the above technical problem, the measurement method by implementing a pre-treatment process and the measurement process of the analyte through a single device to obtain an analyte contained in the cell components of blood Its purpose is to simplify and increase the ease of use.

In addition, it has the purpose of reducing costs and increasing the portability of the measuring device by performing both pretreatment and analyte measurement through a single device.

In order to achieve the above object, the lateral flow assay device capable of blood pretreatment of the present invention comprises: a first housing; A first flow passage membrane stacked inside the first housing and configured to move a blood pretreatment solution; A sample pad laminated on one side of the first flow path membrane; A moisture absorption pad stacked on one side of the first flow path membrane so as to overlap a portion thereof; A second housing; A second flow path membrane stacked inside the second housing and configured to move the detection material; And a detection material inlet configured to penetrate through the outside of the second housing to one side of the second flow path membrane to inject the detection material. And a first flow path membrane and a second flow path membrane intersecting with respect to the sample pad which is joined to the second flow path membrane during fixed bonding of the first housing and the second housing. do.

In this case, the second housing may further include protruding partitions formed on both sides of the second flow path membrane.

The apparatus may further include a signal detector formed at the other side of the second flow path membrane.

The apparatus may further include a signal detection confirmation window formed on the first housing, wherein the signal detection confirmation window is formed to face the signal detection unit when the first housing and the second housing are fixedly bonded. .

At this time, it further comprises a hinge for pivot coupling between the first housing and the second housing.

The first flow path membrane and the second flow path membrane may cross each other in a cross shape around the sample pad.

According to the lateral flow assay device capable of pretreatment of blood according to the present invention, it is possible to perform both the pretreatment of blood and the measurement of analyte with one device, thereby making the measurement method simple and convenient.

In addition, since a separate blood pretreatment device is not required, the cost can be reduced, and the size of the device can be reduced by folding the device through the hinge, thereby increasing portability.

Therefore, it is possible to combine two devices with different functions such as blood pretreatment process and analyte measurement through the hinge to manufacture them in one piece, and to propose a method for completing complex and various blood measurement methods in one device. This aims to improve the simplicity and portability of the measurement method.

1 is a perspective view of a lateral flow assay device according to an embodiment of the invention.
2 is a front perspective view of a lateral flow assay device according to an embodiment of the invention.
3 is a rear perspective view of a lateral flow assay device according to an embodiment of the invention.
4 is a step diagram showing a method of using a lateral flow assay device according to an embodiment of the present invention.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art may easily implement the present invention.

The lateral flow assay device according to the invention relates to a strip housing structure made to allow lateral flow assays. In particular, the use of a two-way cross-membrane method provides a lateral flow assay device capable of performing blood pretreatment and analyte measurement through a single device.

1-3 illustrate a lateral flow assay device according to an embodiment of the invention. 1 illustrates a lateral flow assay device comprising a first housing 100 and a second housing 200 in accordance with an embodiment of the present invention, and FIG. 2 illustrates the first housing 100 and the second housing 200. 3 is a front perspective view of the fixed bonded state, and FIG. 3 shows a rear perspective view thereof. Meanwhile, in the present invention, the fixed bonding between the first housing 100 and the second housing 200 is a position in which corresponding configurations of the first housing 100 and the second housing 200 face each other, as described below. It means to join to come.

As shown, the lateral flow assay device according to the present invention may comprise a first joint 100 and a second housing 200 which can be fixedly bonded. First, the first housing 100 may be configured to include a first flow path membrane 120, a sample pad 110, and a moisture absorption pad 130, and perform a pretreatment process on blood through the configuration. can do.

In addition, the second housing 200 may include a second flow path membrane 220 and a detection material inlet 230, and fix the gap between the second housing 200 and the first housing 100. Conjugation can be used to perform analytical measurement.

First, the first flow path membrane 120 formed inside the first housing 100 is for the movement of the blood pretreatment solution, and one side thereof is in contact with the sample pad 110. A sample pad 110 for dropping a sample (blood) is stacked on one side of the first flow path membrane 120, and a moisture absorbing pad 130 for absorbing the blood pretreatment solution is also stacked to overlap one portion thereof. It is.

In an embodiment of the present invention, the blood pretreatment solution may be administered to the other end of the first flow passage membrane 120, and the blood pretreatment solution may move the sample pad 110 along the first flow passage membrane 120. It can be absorbed by moving to the moisture absorption pad 130.

Next, the second flow path membrane 220 formed inside the second housing 200 is for the movement of the detection material. The detection material is a material for measuring analyte on a sample, and generically refers to proteins and compounds such as antibodies that can determine the presence or absence of a disease through selective reaction with the analyte on the sample. In the present invention, the detection material may be administered through the detection material inlet 230 formed on one side of the second flow path membrane 220.

The detection material inlet 230 is preferably formed outside the second housing 200 and may be formed to penetrate to one side of the second flow path membrane 220 formed inside the second housing 200. have. Therefore, in the embodiment of the present invention, the detection material may be administered to the second flow path membrane 220 through the detection material inlet 230, and the second membrane 220 along the second flow path membrane 220. Move to the signal detection unit 240 formed at the other side.

In a preferred embodiment of the present invention, the first flow path membrane 120 formed inside the first housing 100 and the second flow path membrane 220 formed inside the second housing 200 are formed of the first flow path membrane. The first housing 100 and the second housing 200 may be formed to intersect at fixed bonding. More preferably, a portion of the second flow path membrane 220 intersects and overlaps with the sample pad 110 stacked on the first flow path membrane 120 at the time of the crossing. Through this, the pretreatment process is completed so that the analyte remaining on the sample pad 110 may react with the detection material moving along the second flow path membrane 220.

In addition, the second housing 200 may further include a protruding partition 250 formed on both sides of the second flow path membrane 220. Preferably, the protruding partition 250 may be formed parallel to the flow direction of the second flow path membrane 220 at the outside of the second flow path membrane 220. The protruding partition 250 pressurizes the periphery of the sample pad 110 during the fixed bonding of the first housing 100 and the second housing 200, thereby pre-preparing buffer solution administered to the first housing 100. Do not flow back into the second flow path membrane 220.

That is, the first flow path membrane 120 and the moisture absorption pad 130 formed in the first housing 100 are separated from the fluid transfer of the second flow path membrane 220 for the detection reaction by the protruding partition 250. Has In the embodiment of the present invention, the protruding partition 250 may be configured to have a triangular or rectangular cross section to maximize the isolation effect.

1 to 3 illustrate a configuration in which the first flow path membrane 120 formed vertically and the second flow path membrane 220 formed horizontally cross each other in a cross shape with respect to the sample pad 110. However, the cross shape may be variously modified as long as a part of the second flow path membrane 220 is formed to contact the sample pad 110.

Meanwhile, in the embodiment of the present invention, the first housing 100 may further include a signal detection confirmation window 140. The signal detection confirmation window 140 may be formed to overlap the signal detection unit 240 formed at the other side of the second membrane 220 when the first housing 100 and the second housing 200 are fixedly bonded. Can be. The signal detection confirmation window 140 may be formed of a transparent material such as glass, plastic, and the like. The signal detection confirmation window 140 may appear on the signal detection unit 240 when the first housing 100 and the second housing 200 are fixed to each other. Make changes visible from the outside.

In addition, the lateral flow assay device according to an embodiment of the present invention may further include a hinge 150 for pivot coupling between the first housing 100 and the second housing 200. Through the hinge 150, the first housing 100 and the second housing 200 may be kept in a mutually coupled state, and as described below, the hinge ( The first housing 100 and / or the second housing 200 may be rotated through the 150 to be easily fixed and bonded.

Meanwhile, in the present invention, the fixed bonding of the first housing 100 and the second housing 200 refers to a position in which corresponding configurations of the first housing 100 and the second housing 200 face each other as mentioned above. It means to join to come. That is, the signal detection confirmation window 140 formed in the first housing 100 and the signal detection unit 240 formed in the second housing 100 face each other, and the sample pad 110 formed in the first housing 100 In order to contact the portion of the second flow path membrane formed in the second housing 200.

4 illustrates performing a lateral flow assay in accordance with an embodiment of the invention. Hereinafter, referring to FIG. 4, a process of detecting glycated hemoglobin (HbA1c) in erythrocytes through a lateral flow assay device according to an embodiment of the present invention is illustrated, but the present invention is not limited to the following examples, and blood pretreatment is performed. It will be apparent to those skilled in the art that the present invention can be variously applied to all necessary lateral flow detection systems.

First, Figure 4 (a) shows the process of performing blood pretreatment according to an embodiment of the present invention. Glycated hemoglobin is a type of hemoglobin present inside red blood cells and refers to hemoglobin combined with glucose. The glycated hemoglobin is a very important diagnostic marker for the diagnosis and management of diabetes mellitus, the importance of the existing blood glucose measurement as an indicator of the long-term objective patient status. In order to detect the glycated hemoglobin present inside the erythrocytes, the pretreatment process must first remove the hemolysis of erythrocytes and the removal of sugar components and proteins in blood, which are other interference substances.

For the pretreatment, a small amount of blood is dropped onto the sample pad 110 stacked to overlap one side 120a of the first flow path membrane in the first housing 100 and the second housing 200 in an open state. . Next, a washing buffer (pretreatment solution) containing surfactants and zinc is administered to the other side 120b of the first flow path membrane so that hemoglobin hemolysis, hemoglobin aggregation and other proteins can be simultaneously washed in the blood. . Without this hemoglobin aggregation process, all of the samples move during the washing and measuring process, making it difficult to analyze the samples.

The washing buffer solution is moved from the other side 120b of the first flow path membrane to one side 120a of the first flow path membrane ('A' direction) by a capillary phenomenon, and is laminated on one side 120a of the first flow path membrane. After the reaction with the blood in the sample pad 110 can be absorbed and removed by the moisture absorbing pad 130. Only the hemoglobin coagulated in the gel form is present in the sample pad 110 through the above process.

Next, the first housing 100 and the second housing 200 may be fixedly bonded as shown in FIG. 4 (b) to detect the glycated hemoglobin. In the embodiment of the present invention, if the lateral flow assay device includes a hinge 150, the first housing 100 and / or the second housing 200 are rotated about the hinge 150 to be fixedly bonded to each other. can do.

In this case, the sample pad 110 formed in the first housing 100 may be in close contact with a portion of the second flow path membrane 220 formed in the second housing 200. As a result, the glycated hemoglobin, which has been completed in the pretreatment process, may be positioned on the flow path of the second flow path membrane 220 to be in a state capable of reacting with the sensing material to be administered.

In addition, the protruding partition wall 250 formed on the outer side of the second flow path membrane 220 has a pretreatment buffer solution present on the first flow path membrane 120 and the moisture absorption pad 130 formed on the first housing 100. Do not flow back into the second flow path membrane 220. Meanwhile, the signal detection confirmation window 140 formed on the first housing 100 may be positioned to face the signal detection unit formed on the second housing 200.

After the first housing 100 and the second housing 200 are fixedly bonded as described above, as illustrated in FIG. 4C, a detection substance for detecting the glycated hemoglobin is formed in the second housing 200. It can be administered through the detection material inlet 230 formed on the outside. The detection material inlet 230 is formed to penetrate to one side of the second flow path membrane 220 formed inside the second housing 200, so that the detection material is formed on one side of the second flow path membrane 220. May be administered. The detection material moves from one side to the other side of the second flow path membrane 220 by the capillary phenomenon ('B' direction), and the sample pad is joined to a portion of the second flow path membrane 220 during the movement. React with hemoglobin aggregated on (110).

The detection agent for detecting glycated hemoglobin is a buffer containing a detector capable of inducing a binding reaction with glycated hemoglobin, and the antigen-antibody reaction or cis-diol binding of boronic acid using a glycosylated hemoglobin chain. Various known materials are available that can accurately quantify the amount of glycated hemoglobin.

In this case, a signal depending on whether the detection substance on the sample pad 110 reacts with the glycated hemoglobin may be displayed on the signal detector 240 located at the other side of the second flow path membrane 220. That is, the detection material reaching the signal detection unit 240 through the sample pad 110 may change color of the signal detection unit 240 according to the presence or ratio of glycated hemoglobin on the sample pad 110. Through this, the glycated hemoglobin can be detected. As described above, the signal appearing in the signal detector 240 may be externally observed through the signal detection confirmation window 140 formed on the first housing 100.

As such, the present invention is designed to overcome the limitations of conventional lateral flow detection systems and to easily and accurately measure specific analytes present in cellular components of blood. In particular, by applying two-way cross-membrane, blood pretreatment and analyte measurement can be performed through one device, making the measurement process simple and convenient.

In addition, since a separate blood pretreatment device is not required, cost can be reduced, and the size of the device can be reduced, thereby increasing portability. That is, the device of the present invention including both the blood pretreatment device and the analyte measurement device can reduce its size through folding of the first housing and the second housing, and thus has the advantage of being easily portable.

In the above described the present invention through specific embodiments, those skilled in the art can make modifications, changes without departing from the spirit and scope of the present invention. Therefore, what can be easily inferred by the person of the technical field to which this invention belongs from the detailed description and the Example of this invention is interpreted as belonging to the scope of the present invention.

100: first housing 110: sample pad
120: first flow path membrane 130: moisture absorption pad
140: signal detection confirmation window 150: hinge
200: second housing 220: second flow path membrane
230: detection material inlet 240: signal detection unit
250: protruding bulkhead

Claims (6)

A first housing;
A first flow passage membrane stacked inside the first housing and configured to move a blood pretreatment solution;
A sample pad laminated on one side of the first flow path membrane;
A moisture absorption pad stacked on one side of the first flow path membrane so as to overlap a portion thereof;
A second housing;
A second flow path membrane stacked inside the second housing and configured to move the detection material; And
A detection material inlet for penetrating from one side of the second housing membrane to one side of the second flow passage membrane to inject the detection material;
And a first flow path membrane and a second flow path membrane intersecting with respect to the sample pad which is joined to the second flow path membrane during fixed bonding of the first housing and the second housing.
And the first flow passage membrane and the second flow passage membrane cross each other in a cross shape around the sample pad.
The method according to claim 1,
And the second housing further includes protruding partitions formed on both sides of the second flow path membrane.
The method according to claim 1,
And a signal detector formed at the other side of the second flow path membrane.
The method according to claim 3,
Further comprising a signal detection confirmation window formed on the first housing,
And the signal detection confirmation window is formed to face the signal detection unit during the fixed bonding of the first housing and the second housing.
The method according to claim 1,
And a hinge for pivotal engagement between the first housing and the second housing.
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