KR101069823B1 - Cassette for measuring the concentration of Glycosylated hemoglobin - Google Patents

Abstract

The present invention relates to a cassette for measuring glycated hemoglobin, the cassette according to the present invention comprises a first accommodating region containing a first reagent, a second accommodating region containing a second reagent, and a blood sample of the first reagent or the second A reaction zone that reacts with a reagent, a measurement zone that measures the amount of total hemoglobin or glycated hemoglobin in the blood sample, and is positioned below the measurement zone to absorb the finished blood sample mixture and block the flow of the blood sample mixture outward. A sample absorbing part to guide the movement of the blood sample mixture in the reaction region according to the rotation angle position, and a transfer guide part to block the inflow of the second reagent and an optical window through which light is reflected through an external optical sensor, Reagent migration guide and reaction to guide the first reagent and the second reagent into the first receiving region and the second receiving region, respectively, without mixing And a reagent movement prevention guide for preventing movement of the reagent due to capillary action, wherein the reaction zone and the measurement zone are distinguished according to the rotation angle position of the cassette, while the cassette comprises the first reagent and the first reagent. A cartridge for separating and accommodating two reagents, and including a blood collecting portion including a blood containing portion, and injecting the first and second reagents into the first receiving region and the second receiving region of the cassette, respectively, when bound to the cassette; Characterized in that it further comprises.

In the case of the glycated hemoglobin measurement cassette of the present invention, the first reagent and the second reagent are introduced into the first accommodating region and the second accommodating region, respectively, to prevent mixing of the two reagents, and between the upper plate and the structural frame of the cassette. A more accurate measurement result can be confirmed by suppressing the movement of the reagent by capillary action along the gap of the adhesion site and further reducing the error of the measurement result by a cartridge having a blood containing portion formed to provide a constant amount of blood to the cassette. Can be.

Glycated hemoglobin, cassette, cartridge, capillary phenomenon, guide

Description

Cassette for measuring the concentration of Glycosylated hemoglobin}

The present invention relates to a cassette used for measuring diabetes, and more particularly to a measurement cassette that can be used in the glycated hemoglobin measuring device.

In recent years, in the area of medical diagnosis or treatment through drugs, concentration measurement of analytes for anesthetics or harmful chemicals has been usefully used in the medical or environmental field. Among them, the measurement of the concentration of biological samples used in the field of medical diagnosis and treatment is of increasing interest with the increase in human desire to be free from various diseases. In particular, the glycated hemoglobin test, which can measure blood glucose in relation to diabetes, has a growing interest in determining a relatively long-term blood glucose average with a single measurement.

Hemoglobin A1c (HbA1c), also called glycated hemoglobin, is one of the hemoglobin contained in human red blood cells (Red Blood Cells). When blood glucose (glucose) rises in the blood, some of the glucose in the blood binds to hemoglobin. Hemoglobin combined with glucose is called glycated hemoglobin. Blood sugar can be measured through the glycated hemoglobin test, glycated hemoglobin test has the advantage that can be tested by taking blood regardless of meal time.

Meanwhile, in the case of US Pat. No. 6,300,142, the test sample is reacted with the first reactant through the first inlet, and subsequently with the second reactant through the second inlet to measure the analyte present in the sample. An apparatus for measuring is disclosed. In this case, the measurements must take place sequentially, at timed intervals. In addition, the measuring person must intervene in the measuring step to sequentially react by injecting a test sample. Furthermore, since the beads combined with the glycated hemoglobin must be filtered once, the measurement is complicated and takes a long time.

In other words, the task may be cumbersome because it requires the operator to take several steps of direct intervention. In addition, the intervention of the measurer can complicate the measurement process and there is a problem that the measurement time is naturally delayed.

In addition, Korean Patent No. 0798471 discloses a first accommodating region containing a first reagent, a second accommodating region containing a second reagent, a reaction region in which a blood sample reacts with a first reagent or a second reagent, and total hemoglobin in the blood sample. Or a cassette comprising a measuring region for measuring the amount of glycated hemoglobin, characterized in that the reaction region and the measuring region is formed to be divided according to the rotation angle position of the cassette.

However, in the case of the cassette, there is a problem in that a part of the two reagents are mixed in the process of the first reagent and the second reagent are introduced into the first receiving region and the second receiving region, respectively, and the manufacture of the cassette is a structure in which the internal structure is formed According to the process of attaching the upper plate to the mold, the movement of the reagent due to the capillary phenomenon occurs along the minute gap between the bonding portion of the upper plate and the structural frame may cause an error in the measurement result. Furthermore, when a cartridge including a blood sample configured to contain a blood sample injects a blood sample into the cassette, the amount of blood sample to be taken is not constant, and furthermore, an error in the measurement result when the sample exceeds a measurement limit amount. There is a problem that can bring. Therefore, there is a need for a structure of a cassette and a cartridge capable of displaying more accurate measurement results.

Accordingly, an aspect of the present invention is to provide a cassette which prevents mixing between reagents when the reagents are introduced into the receiving zone, and suppresses the capillary movement of the reagent introduced into the receiving zone.

Another aspect of the present invention is to provide a cartridge including a blood collecting portion having a blood containing portion capable of collecting a predetermined amount of blood and providing the same to a cassette.

According to one aspect of the invention, the first receiving region containing a first reagent, the second receiving region containing a second reagent, a reaction region in which a blood sample reacts with the first reagent or the second reagent, the blood sample A measurement area for measuring the amount of total hemoglobin or glycated hemoglobin in the sample, a sample absorbing part positioned under the measurement area to absorb the finished blood sample mixture and blocking the flow of the blood sample mixture outward, according to the rotation angle position And a light guide for guiding the movement of the blood sample mixture in the reaction zone and blocking the inflow of the second reagent and an optical window through which light is reflected through an external optical sensor, wherein the first reagent and the second reagent are mixed. Reagent transfer guides for guiding the first and second receiving zones into the first receiving zone and the second receiving zone, respectively. For a glycated hemoglobin measurement which comprises the reagents preventing movement guide, it formed such that the phase response region and measurement region divided according to the rotation angle position of the cassette the cassette is provided to prevent.

The reagent movement prevention guide is preferably formed in the upper plate of the cassette such that one end of the guide contacts the transfer guide in the vertical direction between the transfer guide and the region separation unit. .

The reagent movement prevention guide is preferably made of one to five linear irregularities, in particular embossed, the linear may include a polygonal column, hemispherical column, etc., but is not limited thereto.

The reagent movement guide is a first reagent movement guide and a second reagent movement formed in a direction perpendicular to the positions corresponding to the central portions of the first storage region and the second storage region of the cartridge, respectively, up to the first receiving region and the second receiving region. It is preferably a guide.

Preferably, the first reagent movement guide is formed longer than the second reagent movement guide.

The sample absorbing portion is preferably in the form of an absorbing pad.

Preferably, the first accommodating region and the reaction region are physically the same.

It is preferable that the rotation angle positions of the measurement area and the second accommodation area are in the same range.

The cassette includes a blood collection portion for separately accommodating the first reagent and the second reagent and including a blood containing portion, wherein the first reagent and the second reagent, when coupled to the cassette, respectively comprise a first receiving region of the cassette. And a cartridge to be put in the second receiving area.

The blood containing portion preferably includes a gap for containing blood.

The first reagent comprises a hemoglobin and a glycated hemoglobin binder-bead that selectively reacts with the glycated hemoglobin, wherein the beads are agarose beads, sepharose beads, latex beads or free It is preferred that it is at least one of glass beads.

The glycated hemoglobin binding material is preferably at least one of boronic acid, borcan acid, concanavalin A, and an antibody.

In the case of the glycated hemoglobin measurement cassette of the present invention, the first reagent and the second reagent are introduced into the first accommodating region and the second accommodating region, respectively, to prevent mixing of the two reagents, and between the upper plate of the cassette and the frame Restriction of reagents by capillary phenomena along gaps in the adhesion site and further reduction of measurement results by a cartridge having a blood-containing portion formed to provide a constant amount of blood to the cassette results in more accurate measurement results. You can check it.

SUMMARY OF THE INVENTION The present invention has been made to solve the problems of the prior art as described above, and an object thereof is to provide a cassette and a cartridge configured to produce more accurate results with reduced errors.

More specifically, according to one aspect of the present invention, the above object is a first receiving region for receiving a first reagent, a second receiving region for receiving a second reagent, the blood sample is the first reagent or the second reagent and A reaction zone, a measurement zone for measuring the amount of total hemoglobin or glycated hemoglobin in the blood sample, a sample positioned under the measurement zone to absorb the finished blood sample mixture and block the flow of the blood sample mixture outward An absorption part, a transfer guide part for guiding the movement of the blood sample mixture in the reaction zone according to the rotation angle position and blocking the inflow of a second reagent, and a light window through which light is reflected through an external optical sensor; During the reaction and the reagent movement guide for guiding the first reagent and the second reagent into the first receiving region and the second receiving region without mixing, It comprises a reagent movement prevention guide for preventing the movement of the reagent by the capillary phenomenon, it is achieved by the cassette for measuring glycated hemoglobin is formed so that the reaction zone and the measurement zone is divided according to the rotation angle position of the cassette.

In this case, the cassette includes a blood collection unit for separately accommodating the first reagent and the second reagent and including a blood containing portion, and when the first reagent and the second reagent are bound to the cassette, respectively, the first accommodation of the cassette is performed. It is preferable to further include a cartridge to be introduced into the zone and the second accommodation zone.

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

An exemplary glycated hemoglobin measuring device 30 in which the cassette for measuring glycated hemoglobin of the present invention may be used is shown in FIG. 1.

According to Figure 1, the cassette of the present invention is inserted into the glycated hemoglobin measurement device 30, wherein the glycated hemoglobin measurement device 30 can rotate the cassette clockwise or counterclockwise according to a predetermined pattern. This automatically agitates or moves the blood sample with the reagent to allow measurements to be made.

Furthermore, the glycated hemoglobin measuring device 30 may measure the amount of glycated hemoglobin according to the measuring method using the light reflection characteristic. For example, to measure the amount of glycated hemoglobin in a blood sample, the characteristic of hemoglobin that specifically absorbs an optical signal of a specific frequency is used. At this time, the glycated hemoglobin measuring device 30 preferably measures the amount of glycated hemoglobin using a light emitting element such as a photodiode and a light receiving element.

According to FIG. 1, the glycated hemoglobin measurement device 30 includes a cassette receiver 300, a cassette check sensor 312, a measurement sensor 314, a driver 320, a signal converter 330, and a controller 340. do.

The cassette accommodating part 300 includes a space into which the cassette 10 is inserted. At this time, the cassette receiving portion 300 preferably includes a sufficient insertion distance such that the cassette 10 is not interfered with when the cassette 10 is rotated clockwise or counterclockwise.

The cassette identification sensor 312 checks whether a solution including a reagent such as a first reagent and a second reagent in the cassette 10 is properly poured into the first receiving region 100 and the second receiving region 110. At this time, the detection of the reagent is confirmed by an absorption measurement method using an optical sensor that emits an optical signal through the light emitting element and receives the optical signal passing through the cassette 10 through the light receiving element. That is, it is possible to detect whether the first reagent and the second reagent are properly poured by outputting a light emission control signal to the light emitting device through the cassette identification sensor 312 and converting the optical signal input from the light receiving device into an electrical signal.

In other words, the light emitting device emits an optical signal having a specific wavelength. For example, when the amount of glycated hemoglobin is to be measured, the hemoglobin of the blood sample may specifically emit an optical signal having a wavelength of about 430 nm indicating absorption. In this case, the light receiving element receives an optical signal emitted from the light emitting element and passed through the cassette 10.

The measurement sensor 314 measures the amount of total hemoglobin and glycated hemoglobin contained in the measurement region 120 of the cassette 10. At this time, the light emission control signal may be output to the light emitting device, and the optical signal input from the light receiving device may be converted into an electrical signal to measure the amount of hemoglobin contained in the cassette 10.

Meanwhile, the driving unit 320 generates an external force on the cassette 10. For example, the driving unit 320 may be a motor. At this time, through the external force, the cassette 10 is rotated according to a predetermined rule. The signal converter 330 is a conventional A / D converter.

The controller 340 controls the entire system, and is preferably implemented as a microprocessor in which ROM, RAM, and peripheral devices are integrated. In this case, the controller 340 may recognize the cassette 10, detect an injection of a sample solution, or measure an amount of glycated hemoglobin.

That is, it is possible to detect whether the first reagent and the second reagent are properly injected into the cassette 10 by outputting the light emission control signal to the light emitting device and converting the optical signal input from the light receiving device into an electrical signal through an A / D converter. have. In this way, the amount of glycated hemoglobin contained in the measurement region 120 of the cassette 10 can be measured.

As the cassette for measuring glycated hemoglobin of the present invention may be used, recognizing information when the cassette is bound, confirming that the blood sample and the first reagent and the second reagent are poured, the blood sample and Reacting the first reagent, rotating the cassette to measure the amount of total hemoglobin in the blood sample from the blood sample mixture reacted with the first reagent, and rotating the cassette from the blood sample mixture reacted with the second reagent There is a method for measuring glycated hemoglobin comprising measuring the amount of glycated hemoglobin in the blood sample and calculating the amount of glycated hemoglobin in the blood sample based on the total amount of hemoglobin and the amount of glycated hemoglobin in the blood sample.

Hereinafter, a method for measuring glycated hemoglobin using the glycated hemoglobin measurement cassette 10 of the present invention will be described in detail with reference to FIGS. 2 and 3A-3D.

2 is a flowchart illustrating a method for measuring glycated hemoglobin using the cassette 10 according to one embodiment of the present invention. As shown in FIG. 2, the glycated hemoglobin measuring apparatus recognizes the combined cassette information by combining with the cassette (S100). Subsequently, it is confirmed that the first reagent, the blood sample, and the second reagent in the cassette 10 are poured out (S110). This can be confirmed through the cassette identification sensor 312. Furthermore, the first reagent and the second reagent can be poured through the cartridge. In this case, when the first reagent and the second reagent are introduced through the insertion of the cartridge, the first reagent and the second reagent may be separately received. This is to determine the amount of total hemoglobin and glycated hemoglobin, respectively, depending on the use of the first and second reagents.

Furthermore, it is preferable that the blood sample collected from the human body is injected through the blood containing part 221 at the end of the blood collecting part 220 of the cartridge 20. In this case, even if the cassette 10 is in a horizontal state, it is preferable that the blood-containing portion 221 at the end of the blood collecting portion 220 can be completely immersed in the first reagent of the first receiving region 100.

Subsequently, the glycated hemoglobin measuring device 30 allows the blood sample and the first reagent to react in the reaction zone (S120). At this time, it is preferable to shake the cassette 10 clockwise and counterclockwise to promote the reaction of the blood sample and the first reagent. This is to induce the blood sample of the blood containing portion 221 to be hemolyzed out by the first reagent and at the same time specifically react with the glycated hemoglobin binding material-bead. The hemolyzed blood sample may take some time, for example 3 minutes, to sufficiently react with the glycated hemoglobin binder-bead.

Subsequently, when the cassette 10 is rotated, the blood sample mixture reacted with the first reagent in the reaction zone is moved to the measurement zone 120 (S130). The amount of total hemoglobin in the blood sample is measured from the mixture of the first reagent and the blood sample moved to the measurement region 120 (S140). At this time, it is preferable to measure the amount of total hemoglobin in the blood sample by the light reflection measurement method through the optical sensor. Furthermore, the remaining solutions except the binding material-bead combined with the general hemoglobin and glycated hemoglobin are absorbed through the sample absorber 140.

Subsequently, when the glycated hemoglobin measuring device 30 rotates the cassette 10, the second reagent is moved to the reaction zone (S150). When the cassette 10 is rotated, the blood sample and the first reagent in the measurement zone are preferably not moved to the reaction zone. For this purpose, the binder-bead combined with normal hemoglobin and glycated hemoglobin may be in the form of jelly.

The cassette 10 is rotated to move the second reagent in the reaction zone to the measurement zone 120 (S160). Subsequently, the blood sample mixture is washed with the second reagent moved to the measurement region 120 to measure the amount of glycated hemoglobin (S170). Here, as the second reagent including the cleaning solution washes the blood sample mixture, non-specific hemoglobin (Ao) present in the blood sample is removed. In addition, it is preferable to measure the amount of glycated hemoglobin in the blood sample by the light reflection measurement method through an optical sensor as in the case of measuring the total hemoglobin amount from the blood sample mixture reacted with the first reagent.

Thereafter, the total amount of hemoglobin is divided by the amount of glycated hemoglobin and the relative amount of glycated hemoglobin in the blood sample is measured (S180). At this time, the glycated hemoglobin ratio is calculated by the following equation.

Ratio of glycated hemoglobin (%) = glycated hemoglobin / total hemoglobin × 100

Figures 3a-3d is an embodiment for measuring glycated hemoglobin using the glycated hemoglobin measurement cassette of the present invention, by way of example illustrates the rotation of the cassette.

First, when the first reagent and the second reagent are introduced through a separate cartridge 20 as shown in FIG. 3A, the glycosylated hemoglobin measurement device 30 inserts the cartridge 20 into the first receiving region ( 100), the second reagent is transferred to the second receiving region 110. At this time, the blood sample is collected from the human body and the blood sample is moved to the first receiving region 100 through the cartridge 20 to react with the first reagent. In particular, it is preferable to shake the cassette 10 using a glycosylated hemoglobin measuring device 30 for a sufficient time, for example, about 3 minutes, in a clockwise and counterclockwise direction so that the reaction with the first reagent is better.

As shown in FIG. 3B, the glycated hemoglobin measuring device 30 may rotate the cassette 10 clockwise. At this time, the blood sample mixture reacted with the first reagent in the reaction zone is moved to the measurement zone 120. Here, the concentrations of general hemoglobin and glycated hemoglobin in the blood sample mixture can be measured.

Subsequently, as shown in FIG. 3C, the cassette 10 is rotated in a counterclockwise direction to move the second reagent contained in the second accommodating region 110 to the reaction region so as to stay for a while. Thereafter, when the cassette 10 is rotated in the clockwise direction as shown in FIG. 3D, the second reagent of the reaction zone is moved to the measurement zone 120. At this time, the amount of glycated hemoglobin can be measured from the blood sample mixture from which the general hemoglobin has been removed through the second reagent.

In summary, the glycated hemoglobin measuring device 30 automatically rotates the cassette 10 clockwise or counterclockwise as shown in FIGS. 3A-3D. That is, at least one reagent automatically reacts or moves with glycated hemoglobin as it rotates. Therefore, the step of injecting the first reagent and the second reagent sequentially and the stirring step for mixing the first reagent and the blood sample may be omitted.

Meanwhile, FIGS. 3A-3D illustrate a rotation process of the cassette 10, and various other rotations may be implemented. In addition, in the case where the respective regions of the cassette 10 are symmetrically positioned compared to the above-described embodiment, it is preferable to rotate the cassette 10 as opposed to the above-described rotation process.

As described above, the cassette and the cartridge of the present invention may be used in a method for measuring glycated hemoglobin that can automatically measure glycated hemoglobin by sequential reactions by moving blood samples between regions according to the rotation angle of the cassette. .

According to the present invention there is provided a cartridge for measuring glycated hemoglobin that can be used in the method and apparatus for measuring glycated hemoglobin described above.

4 shows a cassette 10 according to one embodiment of the invention. As shown in Figure 1, the cassette 10 of the present invention can be used to measure the amount of glycated hemoglobin (HbA1c) in the blood. In this case, the cassette 10 is coupled to the glycated hemoglobin measuring device 30, and is rotatable in a clockwise or counterclockwise direction with respect to a horizontal axis.

The cassette 10 may be rotated through the glycated hemoglobin measuring device 30 so that the blood sample mixture may be moved between the regions of the cassette 10 according to the rotation angle position. Therefore, when the cassette 10 is rotated, the reagent reacts with the blood sample automatically and the reacted blood sample mixture can be moved. Here, the reaction refers to a comprehensive reaction including stirring and washing as well as chemical reaction.

Figure 5 shows the appearance of the cassette 10 and the cartridge 20 according to an embodiment of the present invention. The cassette 10 according to the present invention requires at least one reagent that reacts with a blood sample to measure glycated hemoglobin. In this case, the reagent may be stored through the cartridge 20. In this case, the cartridge 20 may be sold separately packaged. In the present invention, the first reagent and the second reagent refer to the reagents stored in the first receiving portion and the second receiving portion, respectively, and these are introduced into the first receiving region and the second receiving region of the corresponding cartridge, respectively.

In more detail, the cassette 10 includes a first accommodating region 100, a second accommodating region 110, a reaction region, and a measuring region 120. Furthermore, the cassette 10 includes a transfer guide 130 and a sample absorber 140.

However, the manufacturing process of the cassette is made according to the process of attaching the upper plate 11 to the structural frame 12, the inner structure is formed as shown in Figure 4, as a result of the bonding portion of the upper plate and the structural frame The movement of the reagent due to capillary phenomenon along the minute gap may cause an error in the measurement result.

In particular, when the second reagent is poured into the second accommodating region, the reagent may move to the measuring region by the cohesion force of the second reagent and the adhesion between the gap of the adhesive site and the reagent. In this case, the measured value may be higher than normal because the volume of the second reagent is reduced and thus the washing amount is reduced.

The reagent movement prevention guide is an unevenness formed in a vertical direction between the transfer guide and the region separation unit. When the upper plate of the cassette and the frame are coupled, the reagent movement prevention guide is formed on the upper plate of the cassette so that one end of the guide contacts the transfer guide. It is desirable to.

That is, as shown in Figure 4, the reagent movement prevention guide is an unevenness formed on the upper plate of the cassette, the reagent movement prevention guide may be made of one to five. It is preferable that the shape of the unevenness is a shape of a column whose one end is in contact with the conveying guide, and more specifically, a column having a semicircle or a polygonal cross section may be used. The length is less than or equal to the straight line distance between the conveyance guide and the area separator, and may be a column of various lengths within the range.

The first accommodating region 100 may accommodate the first reagent and the blood sample, and the second accommodating region 110 may accommodate the second reagent. In this case, when measuring the amount of glycated hemoglobin in the blood sample as described above in FIG. 2, the first reagent may be hemolytic and glycated hemoglobin binding material-beads, and the second reagent may be a washing solution (washing solution).

Here, it is preferable that the foil tab of the cartridge 20 is peeled off when the cartridge 20 is inserted into the cassette 10. Therefore, the first reagent and the second reagent stored in the cartridge 20 may be poured into the first receiving region 100 and the second receiving region 110 of the cassette 10, respectively. In this case, the cassette 10 may further include a region separator 150. The region separating unit 150 helps the first reagent move to the first receiving region and the second reagent to the second receiving region, respectively.

However, in spite of the area separating part 150, the transfer guide part 130 and the area separating part 150 are respectively introduced into the first and second receiving areas of the cassette. A portion of the sample may be mixed in the central region, including. When the added reagent is mixed, the composition of the reagent is changed to deviate from the optimized reaction condition, and as a result, an incorrect measured value is displayed.

Thus, the cassette of the present invention includes a reagent transfer guide 50. The reagent movement guide is preferably formed in the vertical direction up to each receiving region portion of the cartridge at a position in the center of each storage region as shown in FIG. The reagent movement guide for guiding the reagent in the first storage region is called the first reagent movement guide, and the reagent movement guide for guiding the reagent in the second storage region is called the second reagent movement guide.

Preferably, the reagent transfer guide is formed to be longer than the length of the second reagent transfer guide so as to correspond to the structure of the cartridge. The reagent transfer guide prevents each reagent from leaving the desired receiving area so that more accurate measurement values can be obtained.

The reagent movement guide may extend to the bottom of the first receiving region and the second receiving region, or may be connected to but not connected to the bottom to direct the flow of reagents.

Meanwhile, the reaction region is a region where the blood sample reacts with the first reagent or the second reagent. Here, the reaction may include all reactions including washing or bonding as well as chemical reactions of a plurality of substances.

The reaction zone is the same physical zone as the first receiving zone 100. That is, the blood sample reacts with the first reagent in the first receiving region 100 containing the first reagent and the blood sample. The cassette 10 is rotated to move the second reagent into the first receiving region 100. At this time, the cassette 10 is rotated again and the second reagent is moved to the measurement region 120 to wash the first reagent and the blood sample mixture.

The measurement area 120 is an area for measuring the amount of hemoglobin in the blood sample reacted with the first reagent or the second reagent in the reaction zone. In this case, the measurement region 120 may measure the amount of hemoglobin according to the light reflection characteristic measurement method. For example, hemoglobin takes advantage of its specific absorption of optical signals at specific frequencies. By the characteristics of such hemoglobin, it is possible to compare the concentration of light and the color tone, thereby measuring the concentration of hemoglobin.

Furthermore, the measurement area 120 may further include a light window 122 through which light is reflected through an external optical sensor to measure light reflection characteristics. At this time, the external optical sensor is preferably located in the glycated hemoglobin measuring device 30 is inserted cassette 10.

Meanwhile, the sample absorbing unit 140 absorbs the measured blood sample mixture and blocks the blood sample mixture from flowing to the outside. For example, in order to measure the amount of glycated hemoglobin, the sample absorbing unit 140 may absorb other substances other than the glycated hemoglobin binding material-beads that bind to the general hemoglobin and glycated hemoglobin present in the measurement region 120. In this case, the sample absorber 140 is preferably located below the measurement region 120. An example of the sample absorber 140 may be an absorbent pad type, but is not limited thereto.

Furthermore, the cassette 10 may include a first blocking part 132 and a second blocking part 134 around the measurement area 120. The first blocking unit 132 serves to block the second receiving area 110 and the measuring area 120 from each other. In addition, the second reagent in the second receiving region 110 may be blocked from moving to the first receiving region 100 within a predetermined rotation angle. The second blocking unit 134 is stably positioned at each position of the blood sample mixture located in the measurement region 120 and the second receiving region 110 within a range of a constant rotational angle, for example, -15 to 70 degrees. Guide the reagents and reactants to help. It also blocks the movement of the blood sample mixture to other regions within a range of rotation.

Meanwhile, when the cassette 10 receives the first reagent and the second reagent through the cartridge 20, the cassette 10 may further include a partition wall (not shown), an insertion guide part 162, and a cartridge locking step 164. Can be.

The partition wall (not shown) partitions the first reagent and the second reagent such that the first reagent, the blood sample, and the second reagent are not mixed with each other when the cartridge 20 is inserted. At this time, the region separating unit 150 guides the first reagent and the blood sample to separate from each other and pour better when the second reagent is moved to the first receiving region 100 and the second reagent is moved to the second receiving region 110. do. The insertion guide 162 guides the cartridge 20 to be inserted into the cassette 10.

Meanwhile, the cartridge catching jaw 164 may take off the foil cover covering the cartridge 20 by catching the foil tab of the cartridge 20 when the cartridge 20 is coupled. Therefore, the first reagent and the second reagent may be poured into the first receiving region and the second receiving region, respectively.

A separate cartridge may be inserted into the cassette of the present invention, and the cartridge 20 is preferably inserted into the upper portion of the cassette 10. Accordingly, when the cartridge 20 is inserted into the cassette 10, at least one reagent contained in the cartridge 20 may be poured into the cassette 10.

6 is a cross-sectional view of a cassette 10 and a cartridge 20 according to one embodiment of the invention. As shown in FIG. 6, the cartridge 20 further includes a blood sampling unit 220 including a first storage region 200 and a second storage region 210 and further including a blood containing portion 221. It may include.

The first storage area 200 and the second storage area 210 store at least one reagent, respectively. The first storage area 200 stores the first reagent. In this case, the first reagent may react with the blood sample. Here, the amount of glycated hemoglobin can be measured from the blood sample reacted with the first reagent. For example, the first reagent may be a glycated hemoglobin binder-bead that selectively reacts with hemolytic and glycated hemoglobin to hemolyze a blood sample.

The hemolyte may be embodied, for example, as a buffer solution containing a surfactant, such as 20 mM Hepes buffer solution (N-2-Hydroxyethylpiperazine-N'-2-ethanesulfonic Acid HEPES; pH 8.1). Hemoglobin and hemoglobin are present in hemolyzed blood samples.

The glycated hemoglobin binding material is a substance capable of specifically binding to glycated hemoglobin. For example, it may be at least one of boronic acid (BA), concanavalin A (Lectin), and an antibody.

The beads are polymer polysaccharide supports such as agarose, cellulose or sepharose, polystyrene, polymethylmethacrylate, polyvinyl toluene, and the like. It may be at least one of latex beads and glass beads.

At this time, the glycated hemoglobin binding material-bead particle size may be selected in consideration of the glycated hemoglobin binding material-bead precipitation time and the degree of reaction with glycated hemoglobin after the reaction.

In summary, the first reagent may comprise glycated hemoglobin binding agent-beads that selectively react with hemolytic blood and hemolytic hemoglobin, and it is desirable to measure the amount of total hemoglobin from blood samples reacted with the first reagent. Do.

Meanwhile, the second storage area 210 of the cartridge 20 stores the second reagent. In this case, the second reagent may be a reagent including a cleaning solution for washing the mixture of the first reagent and the blood sample.

Hemoglobin (Hb) present in red blood cells of blood samples is mostly unglycosylated normal hemoglobin (Ao), wherein only 4-14% of normal hemoglobin is present as glycated hemoglobin (HbA1c) in response to glucose. Thus, glycated hemoglobin binder-beads reacted with blood samples via a first reagent include glycosylated hemoglobin as well as normal hemoglobin. Therefore, to measure glycated hemoglobin in the blood, the normal hemoglobin must be removed. For this purpose, it is preferable that the second reagent includes a cleaning solution capable of washing general hemoglobin so that hemoglobin can be measured.

Furthermore, the cartridge 20 may further include a blood collecting unit 220 for injecting a blood sample to be measured. At this time, the blood collection unit 220 is preferably in the form of a capillary tube. This is to infiltrate the blood sample to be measured according to the capillary shape of the blood collection unit 220. In particular, the blood collection unit 220 is preferably manufactured to make the inner diameter of the tip thin so that the capillary phenomenon occurs well.

On the other hand, when the cartridge including the blood sampling unit 220 containing the blood sample injects the blood sample into the cassette, if the amount of the blood sample to be collected is not constant or exceeds the measurement limit amount, an error in the result value may occur. Can be. That is, since the amount of the reagent held in the cartridge is limited, when the blood is contained in the blood containing portion in excess, it may be out of the measurable range of the measuring device, resulting in an excessive value. For example, CloverA1, available from Infopia Co., Ltd., has a measurable total hemoglobin level of 7-20 g / dl, and when the blood is infused, the instrument recognizes that the hemoglobin level is outside the measurable range The value results in a measured value that is higher than the normal value.

Therefore, the shape of the blood containing portion is important, and the present invention provides a cartridge having the blood containing portion as shown in FIG. As shown in FIG. 7, the end of the blood-containing portion includes a gap formed parallel to the center, and the width of the end has a shape that narrows toward the end of the end, and the formed gap forms a groove close to the curve.

It is preferable that the amount of blood required for the measurement is about 3.5 to 4.5 ul. The blood-containing portion according to the present invention may contain about 4 ul of blood. Prevent sticking.

Since the cassette 10 for measuring glycated hemoglobin is automatically rotated to allow a reaction including binding and agitation between reactants, the first and second reagents may be simultaneously injected through the cartridge 20.

The cartridge 20 may further include a foil cover and a foil tab. The foil cover may seal the first reagent and the second reagent stored in the first storage area 200 and the second storage area 210 of the accommodation container 20 to block the outside. Here, when the cartridge 20 is coupled to the cassette 10, it is preferable that the foil tab of the cartridge 20 is caught by the cassette 10 and the foil cover is peeled off. Accordingly, the foil cover may be peeled off when the cartridge 20 is coupled, and the first reagent and the second reagent may be poured into the cassette 10. To this end, the cassette is preferably formed with a cartridge engaging jaw that the foil tab of the cartridge is caught when the cartridge is coupled.

So far I looked at the center of the preferred embodiment for the present invention. Those skilled in the art will appreciate that the present invention can be implemented in a modified form without departing from the essential features of the present invention. Therefore, the disclosed embodiments should be considered in an illustrative rather than a restrictive sense. The scope of the present invention is shown in the claims rather than the foregoing description, and all differences within the scope will be construed as being included in the present invention.

Figure 1 shows an exemplary glycated hemoglobin measurement device that can be used for the glycated hemoglobin measurement cassette of the present invention.

Figure 2 shows a flowchart of a method for measuring glycated hemoglobin using a cassette according to an embodiment of the present invention.

Figures 3a-3d is an embodiment for measuring glycated hemoglobin using the glycated hemoglobin measurement cassette of the present invention, by way of example illustrates the rotation of the cassette.

4 shows a cassette according to one embodiment of the invention.

Figure 5 shows the appearance of a cassette and a cartridge according to an embodiment of the present invention.

6 is a cross-sectional view of a cassette and a cartridge according to one embodiment of the present invention.

7A-7C illustrate a cartridge including a blood collection section having a blood containing section.

<Description of the symbols for the main parts of the drawings>

10: cassette 11: top plate

12: frame 20: cartridge

30: glycated hemoglobin measuring device 40: reagent movement prevention guide

50: reagent transfer guide 100: first receiving area

110: second receiving area 120: measuring area

122: light window 130: transfer guide

132: first blocking unit 134: second blocking unit

140: sample absorber 150: region separator

162: insertion guide unit 164: cartridge engaging jaw

200: first storage area 210: second storage area

220: blood collection unit 221: blood containing unit

300: cassette accommodating part 312: cassette confirmation sensor

314: measuring sensor 320: drive unit

330: signal conversion unit 340: control unit

Claims (12)

A first receiving region containing a first reagent, a second receiving region containing a second reagent, a reaction region in which a blood sample reacts with the first or second reagent, and an amount of total hemoglobin or glycated hemoglobin in the blood sample The measurement area for measuring the, the sample absorbing portion to absorb the finished blood sample located in the lower measuring area, the guide and the outside to guide the movement of the blood sample according to the rotation angle position and block the inflow of the second reagent A capillary tube during the reaction and a reagent movement guide that includes an optical window through which light is reflected through an optical sensor and guides the first and second reagents into the first and second receiving regions without mixing. A reagent movement prevention guide for preventing movement of the reagent due to development, wherein the reagent movement guide includes a first storage area and a second storage area of the cartridge. And a first reagent movement guide and a second reagent movement guide formed up to a first receiving region and a second receiving region in a direction perpendicular to the position corresponding to the central portion of the first reagent movement guide, wherein the first reagent movement guide is the second reagent. It is formed longer than the movement guide, and the reagent movement prevention guide is an unevenness formed in the vertical direction between the transfer guide and the region separation unit, when one side of the guide when the upper plate and the structural frame of the cassette is combined with the transfer guide It is formed on the upper plate of the cassette to contact, consisting of 1 to 5 columnar irregularities, the cassette for measuring glycated hemoglobin is formed so that the reaction zone and the measurement zone is divided according to the rotation angle position of the cassette. delete delete delete delete The cassette for measuring glycated hemoglobin according to claim 1, wherein the sample absorbing portion is formed of an absorbing pad. The cassette for measuring glycated hemoglobin of claim 1, wherein the first receiving region and the reaction region are physically the same region. The cassette for measuring glycated hemoglobin according to claim 1, wherein the measurement region and the second receiving region have rotation angle positions in the same range. The cassette of claim 1, wherein the cassette comprises a blood collection portion having a blood containing portion, wherein the cassette contains a first reagent and a second reagent, and when the first reagent and the second reagent are bound to the cassette, respectively, the first reagent of the cassette. A cassette for measuring glycated hemoglobin further comprising a cartridge to be placed in the receiving region and the second receiving region. 10. The cassette for measuring hemoglobin hemoglobin of claim 9, wherein the blood-containing portion becomes narrower in width toward the distal end, and includes a gap formed in parallel in the center of the distal end for containing blood. The method of claim 1, wherein the first reagent comprises a glycated hemoglobin binder-bead that selectively reacts with the hemolysin and the glycated hemoglobin, the beads are agarose beads, sepharose beads, latex (latex) A cassette for measuring glycated hemoglobin, which is at least one of beads or glass beads. The cassette for measuring glycated hemoglobin according to claim 11, wherein the glycated hemoglobin binding material is at least one of boronic acid, concanavalin A, and an antibody.

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