KR20160075386A - Bio measurement system - Google Patents

Abstract

A biometric system is disclosed. The biometric system includes a measurement cartridge, and a meter equipped with the measurement cartridge and measuring the analyte present in the sample of the measurement cartridge. The measurement cartridge includes a reagent vessel, a capillary module and a reagent rod. The reagent vessel receives the liquid reagent and the top is sealed with a sealing film. The capillary module is located on the upper side of the reagent vessel, and includes a capillary tube for collecting the sample by the capillary phenomenon, and the capillary tube is introduced into the reagent vessel by rupturing the contact portion to the sealing film by the applied pressure. And contains a plurality of dry reagent receiving portions in which the drying reagent is received, and the contact portion to the sealing film is ruptured by the applied pressure to enter the reagent container.

Description

[0001] The present invention relates to a bio-

The present invention relates to biometric techniques.

Korean Patent Publication No. 10-1365939 relates to a cartridge and a biological sample component measuring device for measuring a biological sample component. In order to measure the amount of micro albumin and creatinine during urination, the user is required to actively manipulate the fluid to prepare a desired reagent and sample Lt; RTI ID = 0.0 > and / or < / RTI >

Korean Patent Registration No. 10-1365939 (issued on February 24, 2014)

A biometric system that facilitates various biometric measurements is disclosed.

According to one aspect, a biometric system includes a measurement cartridge, and a meter equipped with the measurement cartridge and measuring the analyte present in the sample of the measurement cartridge. The measurement cartridge includes a reagent vessel, a capillary module and a reagent rod. The reagent vessel receives the liquid reagent and the top is sealed with a sealing film. The capillary module is located on the upper side of the reagent vessel and includes a capillary tube for collecting the sample by the capillary phenomenon. The capillary tube ruptures the contact portion to the sealing film by the applied pressure and flows into the reagent vessel. The reagent rod is located on the upper side of the reagent container and includes a plurality of dry reagent receiving portions in which the drying reagent is received, and the contact portion to the sealing film is ruptured by the applied pressure to enter the reagent container.

According to one aspect, the measuring device can measure an analyte present in a sample of the measurement cartridge while rotating the rotator equipped with the measurement cartridge, with at least one of the capillary and the reagent rod being introduced into the reagent container.

According to one aspect, the capillary of the capillary module ruptures the contact portion with respect to the sealing film by the applied pressure and flows into the reagent vessel, but flows only to the extent that the capillary does not directly contact the liquid reagent. And can be introduced into the liquid reagent.

According to one aspect, the drying reagent of the reagent rod may dissolve in the liquid reagent and react with the sample particles coexisting in the reagent vessel.

According to one aspect, some of the drying reagents contained in the plurality of dry reagent receiving portions may be dissolved in direct contact with liquid reagents.

According to one aspect, at least some of the drying reagents accommodated in the plurality of drying reagent receiving portions can be dissolved by the rotation of the rotating body and dissolved in the liquid reagent.

According to one aspect, at least a portion of the plurality of dry reagent receiving portions of the reagent rod are vertically spaced apart and sequentially introduced into the reagent vessel by the applied pressure, so that the drying reagent can be sequentially dissolved in the liquid reagent.

According to one aspect, the reagent vessel of the measurement cartridge may include a particle receiving portion for receiving particles of the sample. The particle accepting part may be a part of the bottom surface of the reagent container being recessed, or the particle receiving part may be a surface having irregularities formed on the bottom surface of the reagent container.

According to one aspect, a state in which particles of a sample coexist in a reagent vessel may be a state in which particles of the sample are accommodated in the particle accommodating portion.

According to one aspect, the reagent bar may contain at least one of a dried protease, and dried ketoamine oxidase, fructosyl-amino acid oxidase, and fructosyl-peptide oxidase.

According to one aspect, the reagent bar may further include a reagent bar sealing film that seals a plurality of the drying reagent receptacles.

According to one aspect, the capillary module may further include an air outlet for discharging air in the capillary.

According to one aspect, the capillary module includes a first sample recognition electrode in contact with an air outlet, and a second sample recognition electrode spaced apart from the first sample recognition electrode, the second sample recognition electrode being in contact with an air outlet, The sensing electrode is electrically connected to the capillary through a sample filled with the capillary, and the measuring device can sense the electrical connection between the first sample recognition electrode and the second sample electrode.

On the other hand, a measurement cartridge for a biometric system according to an aspect includes a reagent vessel which receives the liquid reagent and which is sealed with a sealing film at the upper portion, and a capillary tube which is located above the reagent vessel and collects the sample by capillary action. A capillary module in which the capillary tube is introduced into the reagent vessel by rupturing the contact portion with respect to the sealing film and a plurality of dry reagent receiving portions located above the reagent vessel and containing the drying reagent, And may include reagent rods that rupture and enter the reagent vessel.

According to the disclosed invention, the sample, the drying reagent and the liquid reagent can be reacted in a desired order so that various biometric data can be easily measured.

1 is a block diagram of a biometric system in accordance with one embodiment.
FIG. 2 is a diagram illustrating a schematic configuration of a biometric measurement system according to an embodiment.
3 is a perspective view of a measurement cartridge according to one embodiment.
4 is a cross-sectional view of a measurement cartridge according to one embodiment.
5 is a perspective view of a capillary module according to one embodiment.
6 is a cross-sectional perspective view of a capillary module according to one embodiment.
7 is a perspective view of a reagent bar according to an embodiment.
8 is a cross-sectional perspective view of a reagent rod according to one embodiment.
9 is a reference view for explaining the operation of the measurement cartridge according to the embodiment.
10 is a perspective view of a measurement cartridge according to another embodiment.
11 is a cross-sectional view of a measurement cartridge according to another embodiment.
12 is a perspective view of a capillary module according to another embodiment.
13 is a cross-sectional perspective view of a capillary module according to another embodiment.
14 is a perspective view of a reagent rod according to another embodiment.
15 is a reference diagram for explaining the operation of the measurement cartridge according to another embodiment.
16 is a reference view for explaining the operation of the measurement cartridge according to another embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and further aspects of the present invention will become more apparent from the following detailed description of preferred embodiments with reference to the accompanying drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a block diagram of a biometric system according to one embodiment. FIG. 2 is a reference diagram for explaining the rotation of the measurement cartridge 100. Referring to FIG. The biometric system includes a measurement cartridge 100 and a measurement device 200. The measurement cartridge 100 holds the sample, the drying reagent, and the liquid reagent in their respective regions so as not to be premixed. Then, the sample and the drying reagent are introduced into the liquid reagent in the state of being mounted on the measuring device 200, and the measurement process is performed. The measuring apparatus 200 performs optical measurement using the optical module 220 including the light emitting unit 221 and the light receiving unit 222 in a state where the measurement cartridge 100 is mounted on the mounting unit 210. According to an aspect, the measuring device 200 rotates the measurement cartridge 100 and performs a measurement process. To this end, the measuring device 200 may include a rotor 230 and a motor 240 for rotating the same. The measurement cartridge 100 is mounted on the mounting portion 210 of the measuring device 200 and is rotated by the rotating body 230. The measuring device 200 can rotate the measuring cartridge 100 by turning the rotating body 230 by driving the motor 240 and can also rotate the measurement cartridge 100 Can be moved.

FIG. 3 is a perspective view of a measurement cartridge according to an embodiment, and FIG. 4 is a sectional view of a measurement cartridge according to an embodiment. The measurement cartridge 100 may include a reagent vessel 110, a capillary module 120, a reagent rod 130, and a housing 140. The reagent vessel 110 is a transparent vessel, which is for optical measurement. The reagent vessel 110 accommodates a liquid reagent therein. The amount of the liquid reagent is such an amount that does not fill the inner space of the reagent vessel 110. The amount of the reagent vessel 110 is appropriately adjusted so that the upper portion of the inner space becomes a somewhat empty space. Can be determined. The reagent vessel 110 may include a buffer or a surfactant or a preservative and may be used to dilute the sample and to dissolve the dried reagent and to allow the reaction or coupling between the reagent and the analyte As well as a role in the medium. In addition, particles immobilized with an antigen or an antibody may be introduced into the liquid reagent. As such particles, latex particles, gold particles, silver particles, and magnetic particles can be used. The liquid reagent may further include an enzyme, an enzyme substrate, a dye reactive with the enzyme, and the like

The reagent vessel 110 includes a sealing film 111. The sealing film 111 serves to seal the open top of the reagent vessel 110 to prevent evaporation of the liquid reagent. The sealing film 111 is preferably made of a material which can not permeate the liquid and can not permeate the gaseous vapor. Further, the sealing film 111 is easily ruptured by the capillary module 120 and the reagent rod 130. The sealing film 111 may be bonded to the reagent vessel 110 through a method such as an adhesive, heat welding, ultrasonic welding or the like. As the sealing film 111, an aluminum foil can be used, and a polymer layer can be coated to prevent direct contact of the liquid reagent with aluminum, and an adhesive can be coated. Plastic films can also be used. On one side of the sealing film, information such as a bar code, a character, a number, and a pattern containing information of the measurement cartridge 100 may be printed.

Additionally, the reagent vessel 110 may include a particle receiving portion 112 for collecting the particles. In one embodiment, the particle receiving portion 112 is formed on the inner bottom surface of the reagent container 110, and has a form in which particles are precipitated and collected by the centrifugal force according to the rotation of the measurement cartridge 100. In this form, a part of the inner bottom of the reagent vessel 110 may be depressed or a concavo-convex structure may be exemplified. In another embodiment, the particle receiving portion 112 may mean only a region where particles are precipitated by centrifugal force. And reference numeral 113 denotes a measuring area for measuring the analyte and a product produced by reacting or combining with the reagent introduced from the reagent rod 130. In one embodiment, the reagent vessel 110 may be made of a transparent material only in a portion of the measurement region 113.

The capillary module 120 includes a capillary 121 for collecting a sample as a capillary phenomenon and the reagent rod 130 has a reagent in a dry state selectively reacting or selectively binding with the analyte in the sample. The housing 140 serves to couple the capillary module 120 and the reagent rod 130 to the reagent container 110. The capillary module 120 may be detachable to the housing 140 and the reagent rod 130 may also be detachable to the housing 140.

On the other hand, the barcode 150 may be formed on one surface of the measurement cartridge 100. As illustrated in FIG. 3, the bar code 150 may be formed on one side of the housing 140. These bar codes may include Lot NO., Measurement items, shelf life, calibration curve information, and so on.

FIG. 5 is a perspective view of a capillary module according to one embodiment, and FIG. 6 is a cross-sectional view of a capillary module according to an embodiment. The capillary module 120 includes a capillary 121 for collecting a liquid sample using a capillary action, and a body 122 integrally formed with the capillary 121. [ One end of the capillary tube 121 is a sample inlet 121-1 that first makes contact with the sample. The other end of the capillary tube 121 may be provided with an air outlet 121-2 for discharging the air inside the capillary tube 121 in the process of flowing the sample into the capillary tube 121. When the sample inlet 121-1 is brought into contact with the sample, the sample flows into the capillary 121 by the capillary phenomenon. The inner wall of the capillary tube 121 may be treated with a surfactant to have a hydrophilic property in order to easily flow the sample through the capillary phenomenon.

And the air outlet 121-2 of the capillary 121 is exposed on the upper surface of the body 122. When the body 122 is pushed, the capillary 121 module moves downward, and the capillary 121 passes through the sealing film 111 of the reagent vessel 110 and moves into the reagent vessel 110. At this time, the rupture portion of the sealing film 111 is preferably limited to only the portion where the capillary 121 contacts. That is, when a pressure is applied to the body 122 to allow the capillary 121 to pass through the sealing film 111, a film of suitable material is selected so that the rupture portion of the sealing film 111 is as much as the contact portion of the capillary 121 . If the rupture portion of the sealing film 111 is minimized to the extent of the contact portion of the capillary 121, the sample buried on the outer surface of the capillary 121 can be filtered by the sealing film 111 contacting the outer surface. When the sample on the outer surface of the capillary tube 121 flows into the reagent vessel 110, the total amount of the sample flowing into the reagent vessel 110 exceeds an appropriate amount and an error may occur in the measurement result. The measurement error can be prevented by introducing only a proper amount of the sample into the reagent vessel 110. [

In addition, the first sample recognition electrode 122-1 and the second sample recognition electrode 122-2 may be formed on the upper surface of the body 122. The first sample recognition electrode 122-1 and the second sample recognition electrode 122-2 are apart from each other and are in contact with the air outlet 121-2. The first sample recognition electrode 122-1 and the second sample recognition electrode 122-2 are used to prevent the risk that the sample is inadvertently collected due to the user's inadequate amount of sample. The sample recognition electrode may be formed by printing a conductive ink such as silver (Ag), silver chloride (AgCl), carbon, graphite or copper, and may be formed by printing gold (Au), indium tin oxide ) May be formed by sputtering a conductive material. The first sample recognition electrode 122-1 and the second sample recognition electrode 122-2 may be connected to each other in the process of the sample inlet 121-1 of the capillary 121 passing through the sealing film 111. In this case, ) Is measured.

FIG. 7 is a perspective view of a reagent rod according to an embodiment, and FIG. 8 is a cross-sectional perspective view of a reagent rod according to an embodiment. The reagent rod may be formed of a plastic material. The reagent rod 130 comprises one or more dry reagent receptacles. In FIG. 8, the number of the drying reagent accommodating portions is four, but the present invention is not limited thereto. Each of the drying reagent receptors contains a surfactant, an enzyme, an enzyme substrate, an antibody, an aptamer, a coloring reagent, a fluorescent reagent, a fluorescent reagent, an antibody or an antigen The fixed particles may be provided in a dried state.

As illustrated in FIG. 8, the first-1 drying reagent receiving portion 131-1 and the second-1 drying reagent receiving portion 132-1 may be formed on the same surface and spaced apart from each other in the longitudinal direction. The first to second drying reagent receiving portions 131-2 and 132-2 may be formed on the opposite surface and spaced apart from each other in the longitudinal direction. When the reagent rod 130 is seen to be coupled to the housing 140, the first-first drying reagent receiving portion 131-1 and the first-second drying reagent receiving portion 131-2 are connected to the second- And is located lower than the drying reagent receiving portion 132-1 and the second-2 drying reagent receiving portion 132-2. Accordingly, the first-1 drying reagent receiving portion 131-1 and the 1-2 drying reagent receiving portion 131-2 are connected to the lower drying reagent receiving portion 131 and the 2-1 drying reagent receiving portion 131 -1) and the second drying reagent receiving portion 132-2 may be divided into the upper drying reagent receiving portion 132 and the second drying reagent receiving portion 132-2.

The reagent rod 130 may further include a solution blocking portion 134 between the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132. 7 and 8, the solution blocking portion 134 may be provided in a state in which only the lower drying reagent receiving portion 131 of the reagent bar 130 flows into the reagent container 110, So that the liquid reagent does not contact the drying reagent in the upper drying reagent receiving part 132 even if the liquid reagent in the reagent container 110 moves by the fluid. That is, even if a gap is formed in the contact portion of the sealing film 111 that contacts the reagent bar 130, the liquid reagent is prevented from reaching the upper drying reagent receiving portion 132 through the gap.

The reagent rod 130 may further include a rupturing portion 133. The rupturing portion 133 is formed in a pointed shape at one end of the reagent rod 130, and is formed at a position close to the lower drying reagent receiving portion 131. The role of the rupturing part 133 is to break the sealing film 111 of the reagent container 110 so that the reagent rod 130 can penetrate the sealing film 111. Further, the reagent bar 130 may further include a guiding portion 135. When the pressure is applied to the pressure applying portion of the reagent rod 130 while the reagent rod 130 is mounted on the housing 140, the guiding portion 135 moves the reagent rod 130 along the inner guide of the housing 140 And may be a guiding means for moving the lower part of the apparatus.

4, a plurality of reagent bars 130 may be provided, and the reagent rods 130 may be mounted on the housing 140 at a predetermined distance or more. At this time, the reagent rod 130 is provided with one or more drying reagent receiving portions.

9 is a reference view for explaining the operation of the measurement cartridge according to the embodiment. 9A shows a state in which the housing 140 including the capillary module 120 and the reagent bar 130 is mounted from above the reagent vessel 110. FIG. At this time, both the capillary tube 121 and the reagent rod 130 of the capillary module 120 are located above the sealing film 111 of the reagent vessel 110. When the body 122 of the capillary module 120 is pressed by the pressure, the capillary 121 penetrates the sealing film 111 and flows into the reagent vessel 110 as shown in FIG. 9 (b). When the measurement cartridge 100 is rotated while the capillary tube 121 flows into the reagent vessel 110, the sample filled in the capillary tube 121 is discharged as a liquid reagent by the centrifugal force.

9 (b), the capillary 121 can be introduced to such an extent that the sample inlet 121-1 can be in contact with the liquid reagent contained in the reagent vessel 110, or only to the extent that the capillary 121 can not be contacted . This can be achieved by suitably controlling the applied pressure. A step may be formed in at least one of the capillary module 120 and the reagent container 110 so that the degree of inflow of the capillary tube 121 is limited. When the capillary 121 is introduced into the reagent vessel 110 so that the sample inlet 121-1 and the liquid reagent do not directly contact with each other, the background signal of the liquid reagent is measured, Deterioration and the like can be detected.

9 (c), the reagent bar 130 passes through the sealing film 111 of the reagent container 110 and is supplied to the reagent container 110 through the sealing film 111, Lt; / RTI > 9 (c), only the lower drying reagent accommodating portion 131 can be introduced into the reagent container 110 by adjusting the pressing depth of the reagent bar 130 at this time. In this state, when the measurement cartridge 100 is rotated to the left and right, the drying reagent introduced into the lower drying reagent accommodating portion 131 is dissolved in the liquid reagent by swinging of the liquid reagent. The upper portion of the upper drying reagent receiving portion 132 is blocked by the liquid blocking portion 134 provided between the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132. 9 (d), when the drying reagent introduced into the lower drying reagent accommodating portion 131 is dissolved in the liquid reagent and after the necessary function is performed, a further pressure is applied to the pressure applying portion of the reagent rod 130, The upper drying reagent receiving portion 132 passes through the sealing film 111 and flows into the reagent container 110 as shown in FIG. In this state, when the measurement cartridge 100 is rotated to the left and right, the dry reagent introduced into the upper dry reagent receiving portion 132 is dissolved in the liquid reagent by the rocking of the liquid reagent.

For example, in the case of a measurement cartridge 100 for measuring cholesterol present in a sample, a surfactant for dissolving lipoprotein is provided in the 1-1st dry reagent receiving portion 131-1 , And a dye which reacts with the peroxidase (HRP) in the presence of hydrogen peroxide (H 2 O 2) is provided in the first to second drying reagent receiving part 131 - 2. The second-1 drying reagent receiving unit 132-1 may be provided with a cholesterol esterase, a cholesterol oxidase, and a peroxidase (HRP) in a dried state. For example, in the case of measuring creatinine present in a sample, creatine, which is an intermediate product of the reaction, is present in the sample and causes an error in measurement. For accurate measurement, it is necessary to remove the creatine present in the sample. To this end, Creatine amidinohydrolase enzyme, Sarcosine oxidase and peroxidase are provided in the 1-1 th dry reagent receiving part 131-1. The Creatine amidohydrolase enzyme is contained in the 2-1 drying reagent receiving portion 132-1 and the dye which reacts with the hydrogen peroxide and the peroxidase in the 2-2 drying reagent receiving portion 132-2. 9 (c), the enzymes introduced into the 1-1 drying reagent receiving unit 131-1 are first reacted with the liquid reagent into which the sample is introduced to remove the creatine present in the sample, Creatinine amidohydrolase provided in the drying reagent receiving part 132-1 and the second drying reagent receiving part 132-2 and the dye are reacted with the liquid reagent to eliminate the measurement error caused by the creatine.

Meanwhile, the drying reagent receiving portion of the reagent bar 130 may include an enzyme that selectively reacts with a measurement substance present in the sample. Examples of such factors include glucose oxidase, glucose dehydrogenase, Horseradish peroxidase, Ascorbate oxidase, Cholesterol esterase, Cholesterol oxidase, Creatine amidinohydrolase, Diaphorase, Glucose-6-phosphate dehydrogenase, Glutamate dehydrogenase, Glycerol kinase, Glycerol dehydrogenase, Hexokinase, 6-phosphate dehydrogenase (G-6) has been shown to inhibit the formation of glucose-6-phosphate dehydrogenase (G-6) -PDH). There are no limitations on the type of these enzymes, and enzymes that selectively react with analytes present in the sample can be used.

In addition, the dry reagent receiving unit may include a coloring dye, a fluorescent substance, and a light emitting substance for measuring a substance produced by reaction of an analyte in the sample with an enzyme or a consumed substance. The product or consumable material of such a reaction may be hydrogen peroxide, NADH, and the substance to be measured is Tetrazolium derivative; 2- (4-Iodophenyl) -3- (4-nitrophenyl) -5-phenyl-2H-tetrazolium chloride (INT) tetrazolium bromide (MTT), 3,3'- [3,3'-Dimethoxy- (1,1'-biphenyl) -4,4'-diyl] -bis 2- (4- nitrophenyl) -5- 2H-tetrazolium chloride (Nitro-TB), 3,3 '- [3,3'-Dimethoxy- (1,1'-biphenyl) -4,4'- tetrazolium chloride (TB), 2- (4-iodophenyl) -3- (4-nitrophenyl) -5- (2,4- disulfophenyl) -2H- tetrazolium, monosodium salt (WST- (2,4-dinitrophenyl) -5- (2,4-disulfophenyl) -2H-tetrazolium, monosodium salt (WST-3), 2-Benzothiazolyl-3- (4-carboxy-2-methoxyphenyl) -5 [4- (2-sulfoethylcarbamoyl) phenyl] -2H-tetrazolium (WST-4), 2,2'-Dibenzothiazolyl- 4-Aminoantipyrine, N-Ethyl-N- (2-hydroxy-3-sulfopropyl) phosphate which reacts with hydrogen peroxide, 3 '- (3,3'-dimethoxy 4,4'- biphenylene) ditetrazolium, disodium salt -3-methoxyaniline, sodium salt, dehydrate (ADOS), N-Ethyl-N- (3-sulfopropyl) -3-methoxyaniline , sodium salt, monohydrate (ADPS), N-Ethyl-N- (3-sulfopropyl) aniline, sodium salt (ALPS), 3,3'-Diaminobenzidine, tetrahydrochloride -3-sulfopropyl) -3,5-dimethoxyaniline, sodium salt (DAOS), N- (2-Hydroxy-3-sulfopropyl) -3,5-dimethoxyaniline, sodium salt (HDAOS) N-bis (4-sulfobutyl) -3-methylaniline, disodium salt (TOBM), 3,3 ', 5,5'-tetramethylbenzidine (TMBZ) ), N-Ethyl-N- (2-hydroxy-3-sulfopropyl) -3-methylylaniline, sodium salt (TOOS) Sodium 10- (carboxymethylaminocarbonyl) -3,7-bis (dimethylamino) phenothiazine (DA-67), N- (Carboxymethylaminocarbonyl) -4,4'- , N-Ethyl-N- (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline (MAOS).

Also, the drying reagent receiving part may include 2,5-dichlorophenyldiazonium tetrafluoroborate (DPD), bromocresol green (BCG), o-cresolphthalein complexone, nitroblue tetrazolium (NBT) or the like which directly binds to or reacts with the analyte in the sample. In addition, the acceptor of the dry reagent is composed of ρ-Nitrophenyl phosphate, L-Alanine, α-Ketoglutarate, L-Aspartate, L-γ-Glutamyl-3-carboxy-4-nitroanilide, Glycylglycine and L-Lactate . In addition, the dry reagent receiving part may include an antigen, an antibody, and an aptamer that selectively binds to the analyte in the sample. The latex particle, the gold particle, , Silver particles, magnetized magnetic particles, and the like. Also, the drying reagent receiving part may have a surfactant such as Triton X-100, bile acid, sodium cholate, Tween 20, and sodium dodecyl sulfate (SDS).

According to one aspect, the drying reagent receiving portions 131 and 132 of the reagent rod 130 can be sealed. The reagents introduced into the drying reagent receiving portions 131 and 132 of the reagent rod 130 in a dried state are sensitive to light or humidity and can be sealed with an aluminum foil or a polymer film to protect the drying reagent from light or moisture have. Such sealing foil or film may be removed before the dry reagent receiving portions 131, 132 are inserted into the reagent vessel 110. Or the sealing foil or film may be removed in the course of inserting the drying reagent receptacle 131, 132 into the reagent vessel 110. A dehumidifying agent such as silica gel beads or molecular sieve beads is introduced into the interior of the sealing film 111 in order to keep the humidity of the drying reagent accommodating portions 131 and 132 low .

Hereinafter, a specific measurement process using the measurement cartridge 100 will be described. When gulcose present in a whole blood is measured, a gulcose oxidase (gulcose oxidase) and a peroxidase (HRP ) And 4-aminoanthipyrine are introduced in a dry state, and N-Ethyl-N- (2-hydroxy -3-sulfopropyl) -3,5-dimethylaniline (MAOS) is introduced in a dry state. The reagent rod 130 equipped with the dried reagent is mounted on the housing 140.

The measurement cartridge 100 is mounted on the rotating body 230 and the capillary module 120 is detached from the housing 140 to collect a blood sample and then mount it on the housing 140 as shown in FIG. At this time, the sample inlet 121-1 of the capillary 121 is allowed to flow through the sealing film 111 of the reagent container 110 and into the inside of the reagent container 110 by the pressing pressure in the process of mounting on the housing The sample inlet 121-1 of the capillary tube 121 may be introduced into the reagent vessel 110 by using a separate pressing device provided in the measuring device 200. [ When the sample inlet 121-1 of the capillary tube 121 flows into the reagent vessel 110, the measuring instrument 200 rotates the rotating body 230 to rotate the whole blood sample flowing into the capillary tube 121 by centrifugal force Elute with liquid reagent. When the blood is eluted with the liquid reagent, the measuring device 200 rotates the rotator 230 to the left or right to allow blood to be completely dispersed in the liquid reagent. When the dispersion is completed, the measuring device 200 rotates the rotating body 230 to move the measuring cartridge 100 to the optical area provided with the light emitting part 221 and the light receiving part 222, and then controls the optical module 220 And the amount of red blood cells is measured. This is called erythrocyte measurement phase.

When the erythrocyte measurement is completed, the measuring device 200 rotates the rotator 230 to separate the red blood cells from the liquid reagent and collect them in the particle receiving portion 112 of the reagent container 110. When the red blood cells are separated from the liquid reagent, the measuring device 200 moves the measurement cartridge 100 to the optical region and measures hemolysis, turbidity, and bilirubin. This is called the background signal measurement step. When the measurement of the background signal is completed, pressure is applied to the reagent rod 130 to introduce the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132 into the reagent vessel 110, And the drying reagent is dissolved in the liquid reagent. When the rotating body 230 is rotated to the left and right, the liquid reagent is swelled by contact with the drying reagent and dissolved. In this process, the red blood cells collected in the particle receiving portion 112 can be dispersed again into the liquid reagent. After the enzymatic reaction is induced for a certain period of time, the rotator 230 is rotated to collect the red blood cells dispersed in the liquid reagent again into the particle receiving portion 112. Then, the measurement cartridge 100 is moved to the optical region, The amount of the dyestuff is measured. This is called the analysis signal measurement step. When the collected red blood cells are not dispersed in the liquid reagent due to the fluctuation of the liquid reagent according to the structure of the particle receiving part 112, the rotating body 230 is rotated to collect the red blood cells again into the particle receiving part 112 Can be omitted.

Glucose measurements in whole blood samples can be affected by the amount of red blood cells present in the whole blood sample and are also influenced by the hemolysis and turbidity of whole blood samples. Therefore, the analysis signal by glucose needs to be corrected with the measured value of the red blood cell or the background signal such as hemolysis and turbidity.

When cholesterol is measured using the measurement cartridge 100, Triton X-100, which dissolves lipoportein, is added to the 1-1 reagent receiving part 131-1 of the reagent bar 130, (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline (MAOS) is added to the first to second drying reagent accommodating portion 131-2. ) Dye. The 2-1 drying reagent receiving unit 132-1 is provided with a cholesterol esterase, a cholesterol oxidase and a peroxidase (HRP) in a dried state, and the 2-2 drying reagent 4-Aminoantipyrine is provided in the container 132-2 in a dry state. The reagent rod 130 equipped with the dried reagent is mounted on the housing 140.

The measurement cartridge 100 is mounted on the rotating body 230 and the capillary module 120 is detached from the housing 140 to collect a blood sample and then mount it on the housing 140 as shown in FIG. The sample inlet 121-1 of the capillary 121 penetrates through the sealing film 111 of the reagent vessel 110 and flows into the inside of the reagent vessel 110 by the pressing pressure in the process of mounting the reagent vessel 110 to the housing 140. [ Or the sample inlet 121-1 of the capillary 121 may be introduced into the reagent vessel 110 by using a separate pressing device provided in the measuring device 200. [ When the sample inlet 121-1 of the capillary tube 121 flows into the reagent vessel 110, the measuring instrument 200 rotates the rotating body 230 to rotate the whole blood sample flowing into the capillary tube 121 by centrifugal force Elute with liquid reagent. When the blood is eluted with the liquid reagent, the measuring device 200 rotates the rotator 230 to the left or right to allow blood to be completely dispersed in the liquid reagent. When the dispersion is completed, the measuring device 200 rotates the rotating body 230 to move the measuring cartridge 100 to the optical region, and measures the amount of red blood cells. This is called erythrocyte measurement phase.

When the erythrocyte measurement is completed, the measuring device 200 rotates the rotator 230 to separate the red blood cells from the liquid reagent and collect them in the particle receiving portion 112 of the reagent container 110. When the red blood cells are separated from the liquid reagent, the measuring device 200 moves the measurement cartridge 100 to the optical region and measures hemolysis, turbidity, and bilirubin. This is called the background signal measurement step.

When the measurement of the background signal is completed, pressure is applied to the reagent rod 130 to introduce the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132 into the reagent vessel 110, And the drying reagent is dissolved in the liquid reagent. When the rotating body 230 is rotated to the left and right, it is dissolved in contact with the drying reagent due to the oscillation of the liquid reagent. When the red blood cells collected in the particle receiving portion 112 are dispersed again with the liquid reagent, Hemolysis may be caused by the surfactant introduced into the reagent storage portion 131-1. When red blood cells are hemolyzed and hemoglobin flows out to the liquid reagent, it can not be collected by the rotation of the rotating body 230 into the particle receiving portion 112. Therefore, the red blood cells collected in the particle receiving portion 112 are swung Should not be dispersed by the liquid reagent. Since the absorption spectrum of hemoglobin appears in the entire UV-visible light range, errors are caused by spectrum overlap when measured by colorimetry. In order to prevent the red blood cells collected in the particle receiving portion 112 from being dispersed, the particle receiving portion 112 may have a recessed structure or a concave-convex structure. After the enzymatic reaction is induced for a certain period of time, the rotator 230 is rotated to move the measurement cartridge 100 to the optical region to measure the amount of dye produced by the cholesterol. This is called the analysis signal measurement step. Since the amount of cholesterol present in the serum / plasma of a whole blood sample is inversely proportional to the hematocrit of the red blood cell, the amount of red blood cells present in the whole blood must be measured to correct the analytical signal.

When measuring the glycated hemoglobin (HbA1c) using the measurement cartridge 100, the liquid reagent includes a surfactant for hemolysis. Protease is contained in the first-1-1 drying reagent receiving portion 131-1 of the reagent bar 130 and 2- (4 (2,4-dinitrophenyl) -5- (2,4-disulfophenyl) -2H-tetrazolium and monosodium salt (WST-3). The fructosyl-amino acid oxidase or fructosyl-peptide oxidase is dried together with the peroxidase (HRP) in the second-first drying reagent receiving part 132-1, and the second-2 drying reagent receiving part 132- 2), sodium 10- (carboxymethylaminocarbonyl) -3,7-bis (dimethylamino) phenothiazine (DA-67) is provided in a dry state. The reagent rod 130 equipped with the dried reagent is mounted on the housing 140.

The measurement cartridge 100 is mounted on the rotating body 230 and the capillary module 120 is detached from the housing 140 to collect a blood sample and then mount it on the housing 140 as shown in FIG. The sample inlet 121-1 of the capillary 121 penetrates through the sealing film 111 of the reagent vessel 110 and flows into the inside of the reagent vessel 110 by the pressing pressure in the process of mounting the reagent vessel 110 to the housing 140. [ Or the sample inlet 121-1 of the capillary 121 may be introduced into the reagent vessel 110 by using a separate pressing device provided in the measuring device 200. [ When the sample inlet 121-1 of the capillary tube 121 flows into the reagent vessel 110, the measuring instrument 200 rotates the rotating body 230 to rotate the whole blood sample flowing into the capillary tube 121 by centrifugal force Elute with liquid reagent. When the blood is eluted with the liquid reagent, the measuring device 200 rotates the rotator 230 to the left or right to allow blood to be completely dispersed in the liquid reagent. In this process, hemolysis is caused by the surfactant present in the liquid reagent, and hemoglobin is leaked out as a liquid reagent.

When the hemolysis is completed, the measuring device 200 rotates the rotating body 230 to move the measurement cartridge 100 to the optical area, and then measures the amount of hemoglobin. When the hemoglobin measurement is completed, pressure is applied to the reagent rod 130 to transfer the first-1-1 drying reagent receiving unit 131-1 and the 1-2th drying reagent receiving unit 131-2 to the reagent vessel 110 . When the first-first drying reagent receiving portion 131-1 and the first-second drying reagent receiving portion 131-2 flow into the reagent vessel 110, the rotating body 230 is rotated to the left and right, And WST-3. When the glycated peptide or the glycated amino acid is decomposed from the glycosylated hemoglobin (HbA1c) by the proteolytic enzyme after the reaction for a predetermined time, the second-1 drying reagent accommodating part 132-1 and the second- 2-2 The drying reagent receiving portion 132-2 is introduced into the reagent vessel 110 and brought into contact with the liquid reagent. When reacted for a certain period of time, hydrogen peroxide is produced by fructosyl-amino acid oxidase or fructosyl-peptide oxidase, and reaction occurs with peroxide and peroxidase and DA-67. The measurement cartridge 100 is moved to the optical region to measure color development through light emission and light reception in the measurement region 113 of the reagent vessel 110 and the HbA1c is measured therefrom.

When the albumin creatinine ratio (ACR) is measured by measuring the microalbumine and creatinine present in the urine in one reagent vessel 110 using the measurement cartridge 100, It is measured by immuno-turbidimetry and creatinine is measured by the Jaffe method. Since the Jaffe method proceeds in an alkaline state, it is preferable to measure microalbumin first and then measure creatinine. An antibody selectively binding to micro albumin is introduced into the latex particle (latex particle) by introducing into the first-1-1 drying reagent receiving section 131-1 of the reagent bar 130, Sodium hydroxide (NaOH) is introduced into the second reagent storage portion 132-2 by drying and introduced into the second reagent storage portion 132-2 by drying sodium picrate. The reagent rod 130 equipped with the dried reagent is mounted on the housing.

2, the measurement cartridge 100 is mounted on the rotating body 230, the capillary module 120 is detached from the housing 140 to collect a urine sample, and then the urine sample is mounted on the housing 140. The sample inlet 121-1 of the capillary 121 penetrates through the sealing film 111 of the reagent vessel 110 and flows into the inside of the reagent vessel 110 by the pressing pressure in the process of mounting the reagent vessel 110 to the housing 140. [ Or the sample inlet 121-1 of the capillary 121 may be introduced into the reagent vessel 110 by using a separate pressing device provided in the measuring device 200. [ When the sample inlet 121-1 of the capillary tube 121 flows into the reagent vessel 110, the measuring instrument 200 rotates the rotating body 230 to rotate the urine sample flowing into the capillary tube 121 by centrifugal force Elute with liquid reagent. When the urine sample is eluted with the liquid reagent, the measuring device 200 rotates the rotating body 230 to the left and right to allow the sample to be completely dispersed in the liquid reagent.

When the dispersion is completed, the measuring device 200 rotates the rotating body 230 to move the measuring cartridge 100 to the optical area, and measures color, turbidity, etc. of the liquid sample into which the urine sample is introduced. The pressure of the reagent rod 130 is applied to the reagent vessel 110 to flow in the reagent vessel 110 and the latex particles having the antibody immobilized thereon are dispersed in the liquid reagent. The dispersed latex particles bind to the microalbumin present in the liquid reagent and cause immuno-agglutination, thereby increasing the turbidity of the liquid reagent. After the reaction for a predetermined time, the reagent vessel 110 is moved to the optical region to measure the turbidity. After the microallumin measurement is completed, the 2-1 drying reagent receiving portion 132-1 and the 2-2 drying reagent receiving portion 132-2 of the reagent bar 130 are flowed into the reagent container 110 Sodium hydroxide and picrates are dissolved in liquid reagents. When sodium hydroxide is dissolved in a liquid reagent, the pH changes to alkaline and the color reaction occurs with the creatinine present in the picric acid and urine samples. After the reaction for a certain period of time, the reagent container is moved to the optical region to measure color development by creatinine.

Hereinafter, another embodiment of the measurement cartridge 100 will be described. Since the basic structure of the reagent vessel 110, the capillary tube module 120, the reagent rod 130, and the housing 140 is the same, the same reference numerals will be used for the description, I will explain.

FIG. 10 is a perspective view of a measurement cartridge according to another embodiment, and FIG. 11 is a sectional view of a measurement cartridge according to another embodiment. As shown in FIGS. 10 and 11, the measurement cartridge 100 includes a reagent container 110, a capillary module 120, a reagent rod 130, and a housing 140. The reagent vessel 110 may include a particle receiving portion 112 in which the particles are received and the capillary module 120 and the reagent rod 130 may be integrally formed with the housing 140. 10 and 11, the capillary module 120 may be a cover for the housing 140. [ And the reagent rod 130 may be coupled through the upper portion or the lower portion of the housing 140. In one embodiment, a barcode 150 may be formed on one side of the housing 140. The barcode 150 may include a Lot NO., A measurement item, a shelf life, calibration curve information, and the like. The measurement cartridge 100 is different in that the capillary tube 121 and the reagent bar 130 pass through the sealing film 111 of the reagent vessel 110 when the capillary module 120 is pressurized, ).

FIG. 12 is a perspective view of a capillary module according to another embodiment, and FIG. 13 is a cross-sectional perspective view of a capillary module according to another embodiment. The capillary module 120 shown in FIGS. 12 and 13 is only slightly different in shape from the capillary module 120 shown in FIGS. Therefore, redundant description is omitted.

14 is a perspective view of a reagent rod according to another embodiment. The reagent rod 130 may include a lower drying reagent receiving portion 131 and an upper drying reagent receiving portion 132 provided on the same surface. The lower drying reagent receiving portion 131 may include a 1-1 drying reagent receiving portion 131-1 and a 1-2 drying reagent receiving portion 131-2, May include the 2-1 drying reagent receiving portion 132-1 and the 2-2 drying reagent receiving portion 132-2. A rupture part 133 for rupturing the sealing film 111 is formed on the lower part of the reagent rod 130 and a dehumidifying agent receiving part 136 for receiving a dehumidifying agent may be formed on the upper part. The reagent rod 130 may further include a solution blocking portion 134 between the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132.

Further, the reagent bar 130 may further include a reagent bar sealing film 138. The reagent rod sealing film 138 seals at least a portion of the reagent rod, and includes a lower drying reagent receiving portion 131 and an upper drying reagent receiving portion 132. Also, the reagent rod sealing film 138 can be sealed together with the dehumidifying agent receiving portion 136 as well. An air passage 134-1 capable of moving air is provided in a part of the solution blocking portion 134 in order to keep the humidity of the drying reagent receiving portions 131 and 132 low while being sealed by the reagent rod sealing film 138. [ Can be formed. The dehumidifying agent accommodating portion 136 and the drying reagent accommodating portions 131 and 132 communicate with each other through the air passage 134-1.

According to one aspect, the reagent rod seal film 138 may extend from the reagent rod 130 and the end of the extended portion may be attached to the housing 140. In one embodiment, it may be attached to the outer wall of the housing 140. This is so that the reagent rod sealing film 138 is automatically peeled off when the reagent rod 130 is introduced into the reagent vessel 110. Or the tip of the elongated portion of the reagent bar sealing film 138 may be attached to the reagent vessel 110. The reagent rod sealing film 138 is automatically peeled off when the reagent rod 130 is introduced into the reagent vessel 110. As another example, the reagent rod sealing film 138 may be directly peeled off by the user. Meanwhile, the assembly guiding portion 137 is a guiding portion when the reagent bar 130 is assembled to the housing 140.

15 is a reference diagram for explaining the operation of the measurement cartridge according to another embodiment. 15A shows a state in which the housing 140 including the capillary module 120 and the reagent bar 130 is mounted from above the reagent vessel 110. FIG. At this time, both the capillary tube 121 and the reagent rod 130 of the capillary module 120 are located above the sealing film 111 of the reagent vessel 110. When the primary pressure is applied to the housing 140 in this state, the housing 140 moves downward as shown in FIG. 9 (b). The capillary 121 of the capillary module 120 and the reagent rod 130 pass through the sealing film 111 and flow into the reagent vessel 110. In FIG. 15 (b), only the reagent rod sealing film 138 at the lower drying reagent receiving portion 131 can be peeled off by adjusting the pressing depth. 15 (c), when the secondary pressure is applied to the housing 140, the reagent rod 130 is further moved downward. As a result, the reagent rod sealing film (138) is also peeled off. That is, the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132 may be sequentially exposed. Of course, it is also possible to expose the lower drying reagent receiving portion 131 and the upper drying reagent receiving portion 132 at a time by controlling the pressing depth.

16 is a reference view for explaining the operation of the measurement cartridge according to another embodiment. 16 (a) shows a state in which the housing 140 is mounted from above the reagent vessel 110. FIG. At this time, only the reagent rod 130 is mounted on the housing 140, and the capillary module 120 is not mounted. When the primary pressure is applied to the housing 140 in this state, the housing 140 moves downward as shown in FIG. 16 (b). Therefore, the reagent bar 130 passes through the sealing film 111 and flows into the reagent container 110. In FIG. 16 (b), only the reagent rod sealing film 138 at the lower drying reagent receiving portion 131 can be peeled off by adjusting the pressing depth. Next, when the capillary module 120 is mounted on the housing 140, the capillary module 120 passes through the sealing film 111 and flows into the reagent container 110 as shown in FIG. 16 (c). When the secondary pressure is applied to the housing 140 in this state, the reagent rod 130 moves further downward as shown in (d) of FIG. 16, The film 138 is also peeled off.

The present invention has been described with reference to the preferred embodiments. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. Therefore, the disclosed embodiments should be considered in an illustrative rather than a restrictive sense. The scope of the present invention is defined by the appended claims rather than by the foregoing description, and all differences within the scope of equivalents thereof should be construed as being included in the present invention.

100: Measurement cartridge 110: Reagent container
111: sealing film 112: particle receiving portion
120: capillary module 121: capillary tube
121-1: Sample inlet 121-2: Air outlet
122-1: First sample recognition electrode 122-2: Second sample recognition electrode
130: reagent rod 131: lower drying reagent accommodating portion
132: upper drying reagent accommodating portion 133: rupture portion
134: solution blocking portion 140: housing
200: Measuring instrument

Claims (1)

A measurement cartridge; And
And a measuring device for measuring the analyte present in the sample of the measurement cartridge, the measurement cartridge being mounted,
The measuring cartridge is:
A reagent vessel which receives the liquid reagent and whose upper portion is sealed with a sealing film,
A capillary module located on the upper side of the reagent vessel and including a capillary for collecting the sample by capillary phenomenon, the capillary being introduced into the reagent vessel by rupturing the contact portion to the sealing film by the applied pressure, and
And a reagent bar which is located on the upper side of the reagent container and includes a plurality of dry reagent accommodating portions in which the drying reagent is accommodated and which ruptures the contact portion with the sealing film by the applied pressure and flows into the reagent container.

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