WO2004005919A1 - Device for quantitative analysis of biological materials - Google Patents
Device for quantitative analysis of biological materials Download PDFInfo
- Publication number
- WO2004005919A1 WO2004005919A1 PCT/KR2003/001280 KR0301280W WO2004005919A1 WO 2004005919 A1 WO2004005919 A1 WO 2004005919A1 KR 0301280 W KR0301280 W KR 0301280W WO 2004005919 A1 WO2004005919 A1 WO 2004005919A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- test strip
- photometric
- socket
- electrochemical
- electrode
- Prior art date
Links
- 239000012620 biological material Substances 0.000 title abstract description 3
- 238000004445 quantitative analysis Methods 0.000 title abstract description 3
- 238000012360 testing method Methods 0.000 claims abstract description 145
- 239000013077 target material Substances 0.000 claims abstract description 37
- 238000004458 analytical method Methods 0.000 claims abstract description 36
- 238000000840 electrochemical analysis Methods 0.000 claims abstract description 36
- 238000000034 method Methods 0.000 claims abstract description 28
- 238000002848 electrochemical method Methods 0.000 claims abstract description 21
- 238000006243 chemical reaction Methods 0.000 description 21
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 20
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 18
- 239000008103 glucose Substances 0.000 description 18
- 238000012545 processing Methods 0.000 description 17
- 239000003153 chemical reaction reagent Substances 0.000 description 14
- 238000003780 insertion Methods 0.000 description 13
- 230000037431 insertion Effects 0.000 description 13
- 235000012000 cholesterol Nutrition 0.000 description 8
- 239000000463 material Substances 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000000758 substrate Substances 0.000 description 5
- 238000005259 measurement Methods 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000009585 enzyme analysis Methods 0.000 description 3
- 238000000059 patterning Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 238000000151 deposition Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000004973 liquid crystal related substance Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000011806 microball Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000033116 oxidation-reduction process Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 238000005375 photometry Methods 0.000 description 1
- 238000005240 physical vapour deposition Methods 0.000 description 1
- 238000006479 redox reaction Methods 0.000 description 1
- 238000007650 screen-printing Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/8483—Investigating reagent band
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
Definitions
- This invention relates to a device for quantitatively analyzing biochemical components (analytes), particularly to a device, which is used together with a test strip, for quantitatively analyzing biochemical components in aqueous fluids, particularly whole blood, according to the reaction result between the reagent attached to the test strip and the biochemical components.
- This invention is useful in quantitatively analyzing biochemical components such as glucose, cholesterol, lactate, and so forth, selectively.
- biosensors utilizing enzyme analysis are used most widely in hospital and clinical laboratories because they are easy to apply, superior in measurement sensitivity, and allow rapid acquisition of test result.
- the enzyme analysis applied in biosensor can be broadly divided into a photometric method and an electrochemical method.
- the photometric method is described in U.S. Pat. No. 4,935,346, and the electrochemical method is described in U.S. Pat. No. 5,997,817.
- Fig. la is a schematic view of a conventional device using the photometric method
- Fig, lb is a schematic view of a test strip used with the device of Fig. la.
- the light-emitting element 104 such as a light-emitting diode (LED)
- the light-detecting element 106 are installed below the bottom surface of the mounting part 102 on which test strip 120 is mounted.
- a reagent reacting to biochemical components, especially material which is a target for analysis (target material) is fixed in the reaction region 122 of the test strip 120.
- the user provides information about target material to the device 100 by handling of buttons 108a, 108b.
- the color of the reaction region 122 varies gradually.
- the color variation of the reaction region 122 is measured as the degree that light emitted from the light-emitting element 104 is detected at the light-detecting element 106 after being reflected from the reaction region 122.
- the measurement result is analyzed by a built-in analysis algorithm (not shown) and displayed on a monitor, such as a liquid crystal display (hereinafter referred to as "LCD").
- LCD liquid crystal display
- Those photometric biosensors have been developed over various biochemical components because those can be easily embodied. However, the measuring time of the photometric biosensors is longer than that of the electrochemical biosensors. Also, since the photometric biosensors have generally measurement errors caused by the turbidity of the biochemical components, it is sometimes very difficult to analyze significant biochemical components using the photometric biosensors. Moreover, it is difficult to discriminate whether a test strip is installed in a photometric biosensor. Therefore, the electrochemical biosensors have been widely used recently. In an electrochemical biosensor, an electrochemical system is made on a nonconduclive substrate by screen printing or physical vapor deposition, and a reagent is fixed at a specific region (reaction region) on the electrochemical system. In measuring biochemical components, a predetermined level of voltage is applied to the electrochemical system, and a sample including the biochemical components is introduced at the reaction region.
- Fig. 2a is a schematic view of a conventional device using the electrochemical method
- Fig. 2b is a schematic view of the electrochemical test strip used with the device of Fig. 2a.
- the device 200 using the electrochemical method has a socket (not shown) electrically connected with the electrodes of the test strip 220.
- the electrodes 222 and 224 of the test strip 220 are connected with the terminals formed in the socket of the device 200, when the test strip 220 is inserted into the device 200 through the insertion hole 204.
- the mounting part 202 supports the test strip 220, which is physically weak.
- the device 200 After a user turns on the device 200 by handling the buttons 206a and 206b, the device 200 receives information about target material to be analyzed trough the user's additional handling of the buttons 206a and 206b.
- the test strip 220 is formed by depositing the reference electrode 222 and the working electrode 224 on the insulating substrate 221, and fixing reagent 226 across the reference electrode 222 and the working electrode 224.
- the oxidation-reduction (redox) reaction between the target material and the reagent 226 occurs.
- a capillary is formed on the reagent 226 by depositing another insulating substrate (not shown) on the insulating substrate 221 in order that the target material permeates appropriately into the entire reagent 226.
- the reaction on the test strip 220 between the reagent 226 and the target material allows current to flow in the working electrode 224. Since the density of the target material determines the intensity of the flowing current, an analysis algorithm calculates the density of the target material by measuring the value of the flowing current. The density is displayed on the LCD 208.
- the electrochemical biosensors are easy to use, and superior in measurement accuracy. Also, the measuring time of the electrochemical biosensors is generally shorter than that of the photometric biosensors. Moreover, the electrochemical biosensors can generally identify easily whether the test strip is mounted on the device. However, the electrochemical biosensors have a defect that those can be applied only a few biochemical components, because those are not developed over various biochemical components compared with the photometric biosensors.
- a biosensor utilizing enzyme analysis comprises a test strip and a device (meter).
- a reagent reacting with target material is fixed.
- the device has a processing unit according to an analysis method, it can analyze the reaction result on the test strip with a photometrical or an electrochemical method, and display the result in a form that a user can utilize. Because the reagent, which is fixed to the test strip, is decided according to target material, the test strip is exclusively used for the target material.
- a device can be used for various biochemical components if it has a processing unit that can handle various biochemical components and if it can selectively operate the processing unit according to target material.
- a button is generally used to inform the device of information about target material.
- the button is inconvenient to use.
- a code chip is developed to overcome this problem.
- the code chip has an advantage that it can inform the device of much information including target material.
- the manufacturing cost of the code chip is really very expensive in the market.
- An object of the present invention which is proposed to solve these problems, is to provide biochemical components measuring device that can realize electrochemical method and photometric method in one system for analyzing biochemical components.
- Another object of the present invention is to provide biochemical components measuring device that is easy to use and inexpensive.
- the present invention provides a biochemical components measuring device that has both a processing unit for analyzing biochemical components with a photometrical method and a processing unit for analyzing biochemical components with an electrochemical method.
- the device may has separately a socket for mounting a photometric test strip and a socket for mounting an electrochemical test strip, or has a socket for mounting both types of test strip.
- the photometric test strip according to the present invention may have a recognition electrode formed at a specific position determined by target material and analysis method, on the test strip.
- plural terminals for the recognition electrode are installed in the socket for photometric method.
- the number of the variable positions of the recognition electrode determines the number of the terminals for the recognition electrode.
- a built-in switch for discerning whether the photometric test strip in which a recognition electrode is not formed, is mounted or not may be installed in the socket for photometric method of the biochemical components measuring device.
- the electrochemical test strip according to the present invention may have a recognition electrode formed at the specific position determined by target material and analysis method. In this case, in order to identify the position of the recognition electrode, plural terminals for the recognition electrode are installed in the socket for electrochemical method.
- photometric method and electrochemical method are embodied in a device according the present invention, a user can use all tire advantages of the two methods. In other words, for some materials to which electrochemical method can be applicable, a user can perform the analysis of high accuracy by using the electrochemical method, and perform analysis for other various materials by using the photometric method.
- the device according to the present invention can identify target material and analysis method by checking the position of the recognition electrode. After identifying whether the mounted test strip is for photometric method or electrochemical method, the device carries out the corresponding processing routine. Therefore, the device does not need to manipulate a button to provide information about target material and analysis method to the device. Consequently, the device according to the invention is very convenient to use.
- the recognition electrode according to the present invention is merely an electrode formed at a specific position on the test strip. Therefore, compared with the conventional manufacturing process, there is substantially no need of air additional process in manufacturing a test strip. Moreover, it is very advantageous that two measuring methods can be used not through two separate systems, but through only one system.
- Fig. 1 shows a conventional device and a test strip using the photometric method.
- Fig. 2 shows a conventional device and a test strip using the electrochemical method.
- Fig. 3 is a schematic view and a block diagram of the device according to an embodiment of the invention.
- Fig. 4 is a schematic view of the device according to another embodiment of the invention.
- Fig. 5 shows an exemplary test strip according to the invention.
- Fig. 6 shows an exemplary socket of the device according to the invention.
- Fig. 7 shows a second exemplary socket of the device according to the invention.
- Fig. 8 shows a third exemplary socket of the device according to the invention.
- Fig. 9 shows a fourth exemplary socket of the device according to the invention.
- Fig. 10 shows a flow chart explaining the control method of the device according to the invention.
- Fig. 3 a is a schematic view of the device according to an embodiment of the invention.
- the device 300 has both a mounting part 302 for mounting a photometric test strip and a mounting part 304 for mounting an electrochemical test strip.
- the light-emitting element 306 and the light-detecting element 308 are installed in the mounting pail 302.
- the electrochemical test strip installed in the mounting part 304 is electrically connected with a built-in socket (not shown) through the insertion hole 310.
- the buttons 312a and 312b Through the manipulation of the buttons 312a and 312b, the device 300 is turned on or off and one of various function modes is selected.
- the analysis result from the device 300 is generally displayed on LCD 314.
- the biochemical components that can be analyzed with an electrochemical method can be analyzed by mounting an electrochemical test strip on the mounting part 304.
- the biochemical components that a photometric method should be applied to can be analyzed by mounting a photometric test strip on the mounting part 302. If the device 300 is used, a user can selectively use a photometric method and an electrochemical method in merely one device. Therefore, it is possible to analyze various biochemical components and to analyze some biochemical components more accurately.
- Fig. 3b is a block diagram of the device 300 shown in Fig. 3a.
- the device 300 has both the mounting part 302 for mounting a photometric test strip and the mounting part 304 for mounting an electrochemical test strip.
- the light-emitting element 306 and the light-detecting element 308 are installed in the mounting part 302 as shown in Fig. 3a.
- the socket 316 that is electrically connected with the electrodes of an electrochemical test strip adjoins the mounting part 304.
- the controller 318 controls all the operations of the device 300.
- the analyzer 320 analyzes biochemical components according to a predetermined photometric method, by using the results detected from the photometric test strip mounted in the mounting part 302 through the light-emitting element 306 and the light-detecting element 308. And the analyzer 322 analyzes biochemical components according to a predetermined electrochemical method, by using the results detected from the electrochemical test strip mounted in the mounting part 304 through the socket 316.
- the analyzer 320 performing a photometric analysis and the analyzer 322 performing an electrochemical analysis appear to be physically separated.
- the measuring device stores both a photometric analyzing algorithm and an electrochemical analyzing algorithm in one memory unit (not shown).
- the photometric analyzing algorithm is read from the memory unit and performed.
- the electrochemical analyzing algorithm is read from the memory unit and performed.
- the controller 318 controls the execution of the analysis algorithms.
- Fig. 4 is a schematic view of the device according to another embodiment of the invention.
- the device 400 has the mounting part 402 for mounting both a photometric test snip and an electrochemical test strip selectively.
- the others are the same as that of the device 300 shown in Fig. 3. Since the device 300 shown in Fig. 3 has two mounting parts, a user should discriminate mounting parts according to analysis method. However, the device 400 shown in Fig. 4 has just one mounting part. Thus, because there is no need to discriminate mounting parts according to analysis method, the device is easy to use and can be manufactured more compactly.
- Fig. 5 is a schematic view of an exemplary test strip according to the invention.
- Fig. 5a is an electrochemical test strip for measuring glucose
- Fig. 5b is an electrochemical test strip for measuring cholesterol.
- Fig. 5c is a photometric test strip for measuring glucose
- Fig. 5d is a photometric test strip for measuring cholesterol.
- the electrochemical test strips 500 and 520 include a reference electrode 502, a working electrode 504, and reagent 506 attached across the reference electrode 502 and the working electrode 504, as previously described referring to Fig. 2b.
- the photometric test strips 540 and 560 include a reaction region 542, as previously described referring to Fig. lb.
- the recognition electrodes 510, 530, 550 and 570 are formed at a specific position of the upper part on the test strip 500, 520, 540 and 560 respectively.
- the recognition electrodes 510, 530, 550 and 570 indicate what material can be analyzed using the test strip, and whether the test strip is for the photometric method or the electrochemical method.
- the recognition electrodes 510, 530, 550 and 570 provide the measuring device about whether a test strip is inserted or not.
- the recognition electrodes 510, 530, 550 and 570 are discriminated by their positions formed on the test strips 500, 520, 540 and 560, respectively.
- the position of the recognition electrode 510 indicates that the test strip 500 is an electrochemical test strip for measuring glucose.
- the position of the recognition electrode 530 is formed on a slight right side as compared with the recognition electrode 510.
- the recognition electrode 530 indicates that the test strip 520 is an electrochemical test strip for measuring cholesterol.
- the position of the recognition electrode 550 indicates that the test strip 540 is a photometric test strip for measuring glucose.
- the recognition electrode 550 is formed on a slight right side as compared with the recognition electrode 530.
- the test strip 560 shown in Fig. 5d is a photometric test strip for measuring cholesterol.
- the recognition electrode 570 is formed on a slight right side as compared with the recognition electrode 550.
- the recognition electrodes of this embodiment are classified into four classes, according to the position. However, it is possible to make the recognition electrodes having a great variety of information by narrowing the width of the recognition electrodes and/or arranging the recognition electrodes two-dimensionally on the test strip. Also, although the test strips shown in Fig. 5a and 5b correspond to a two-electrode system, the invention is applicable to a three-electrode system similarly.
- Fig. 6 shows an exemplary socket of the measuring device according to the invention. In the socket part 600 shown in Fig. 6, the terminal 602 is electrically connected with the reference electrode 502 of the electrochemical test strips 500, 520 shown in Fig. 5a and 5b. The terminal 604 is electrically connected with the working electrode 504.
- the terminals 606a-606d is electrically connected with the recognition electrodes 510, 530, 550, and 570 respectively.
- the recognition electrode 510 is electrically connected with the terminal 606a of the socket 600, and the device identifies that the electrochemical test strip for measuring glucose is inserted.
- the recognition electrode 570 is electrically connected with the terminal 606d of the socket 600, and the device identifies that the photometric test strip for measuring cholesterol is inserted.
- the measuring device can identify analysis method and target material of the test strip through the position of the terminal that is electrically connected with the recognition electrode of the inserted test strip.
- the conventional photometric test strip does not have the reference electrode 222 and the working electrode 224 differently from the electrochemical test strip shown in Fig. 2b. Only the reagent is fixed on the reaction region 122 as shown in Fig. lb. Therefore, in case that a photometric test strip is mounted, the device has a difficulty in identifying the insertion of a test strip. However, if a photometric test strip has a recognition electrode 550 and 570 as shown in Fig. 5c and Fig. 5d, the device can easily identify the insertion of the photometric test strip 540 and 560 by checking electrical connection between the terminals 606a-606d of the embedded socket 600 and the recognition electrodes 550 and 570 of the test strips 540 and 560.
- Fig. 7 shows another exemplary socket of the device according to the invention.
- the socket 700 has only the terminals 702a-702d connected with the recognition electrode of a test strip, and does not have a reference electrode and a working electrode differently from the socket 600 shown in Fig. 6. Therefore, the socket 700 is used only for a photometric test strip on which a recognition electrode is formed.
- the recognition electrode 510 is electrically connected with the terminal 702a, and the device identifies that the inserted test strip is an electrochemical test strip for measuring glucose and display this fact on the LCD 314 (shown in Fig. 3a).
- the recognition electrode 550 is electrically connected with the terminal 702c and the device identifies that the inserted test strip is a photometric test strip for measuring glucose. And then, the device reads the appropriate analysis algorithm from the memory and analyzes the reaction result of the test strip 540. In other words, the device can identify the insertion of a test strip, the analysis method, and the target material of the inserted test strip through the socket 700.
- Fig. 8 shows the third exemplary socket of the device according to the invention.
- the socket 800 has only the micro-switch 802 and does not have a terminal for a recognition electrode. Therefore, the socket 800 is used only for the conventional photometric test strip on which no recognition electrode is formed. Since the socket 800 does not have a terminal for a recognition electrode differently from the socket 600 and 700 shown respectively in Fig. 6 and Fig. 7, the device can identify merely whether a test strip is inserted or not through the socket 800.
- the micro-ball 804 is pushed up by the insertion of a test strip, the micro-switch 802 generates a signal that indicates the insertion of a test strip.
- a recognition electrode can be patterned at the same time with the reference electrode and the working electrode.
- the conventional photometric test strip does not require such a patterning process, so the patterning process for forming a recognition electrode must be added in manufacturing a photometric test strip.
- the socket 800 shown in Fig. 8 is useful to the device for analyzing only one anaiyte with a photometric method, because the socket 800 can inform the measuring device only whether a test strip is inserted or not, without any information regarding target material.
- Fig. 9 is the fourth exemplary socket of the device according to the invention.
- the socket 900 has the reference electrode 902, the working electrode 904, the recognition electrodes 906a-906d, and the micro-switch 908. Therefore, the socket 900 can be used for not only the electrochemical/photometric test strip with a recognition electrode, but also the photometric test strip without a recognition electrode.
- the micro-switch 908 the device can identify the insertion of a photometric test strip without a recognition electrode. And in case of the photometric test strip with a recognition electrode, through the recognition electrode, the device can be informed of the target material, the analysis method, the insertion of a test strip, and so forth.
- Fig. 10 shows a flow chart for explaining the control method of the device according to this invention.
- the device starts the initial state (step 1002), displays an icon indicating whether a test strip is inserted or not on LCD, and then checks the insertion of a test strip (step 1004). Then, when a test strip is inserted, the device rings a buzzer and identifies the position or the existence of the recognition electrode patterned on the inserted test strip so as to discriminate the analysis method (steps 1008 and 1010). If the inserted test strip is electrochemical one, the device drives the unit for causing a redox reaction in the test strip (step 1012).
- the device drives the unit for sensing the color change of the reaction region (step 1014). If the inserted test strip is neither photometric one nor electrochemical one, the device shows an error message on LCD (step 1015) and waits for the insertion of a new test strip (steps 1032 and 1034).
- the device identifies the target material to be analyzed from the position of the recognition electrode (steps 1016, 1018, 1020 and 1022), and then executes the corresponding analysis routine (steps 1024, 1026, 1028 and 1030). For example, if the inserted test strip is electrochemical one for measuring glucose, the device executes a processing routine for an electrochemical glucose strip (step 1024). When a test strip is removed after the execution of a processing routine and a predetermined time lapses without the insertion of a new test strip, the device is automatically turned off If a new test strip is inserted, the device rings a buzzer and re-executes the step of identifying the type of a test strip (steps 1032, 1034, 1006, 1008 and 1010).
- the device checks whether a memory button is pressed as well as whether a test strip is inserted. If the memory button is pressed, it may further fulfill the step of reading the value stored in the memory unit of the device, such as EEPROM (electrically erasable and programmable read only memory).
- the device rings buzzer and is automatically turned off (steps 1032, 1034, 1036, 1038, 1040 and 1042).
- the device re-executes the processing routine from step 1004.
- the processing routine for an electrochemical glucose strip at step 1024 is executed concretely through the following steps.
- the device displays the icon representing the target material is glucose on LCD, and then blinks the icon that instructs the user to apply a sample, such as blood, into the reaction region of a test strip.
- a sample is applied into a test strip
- a predetermined time for example, 8 seconds
- the voltage of about 0.3V is impressed between the reference electrode and the working electrode on the inserted test strip during a predetermined time (for example, 3 seconds).
- the device measures the electric current flowing in the working electrode and converts the value of the measured current into glucose level by using the relation table stored in the memory of the device.
- the processing routine for an electrochemical cholesterol strip at step 1026 is the same as the processing routine at step 1024, except that the relation between the measured current and the cholesterol level is different from that of the processing routine at step 1024.
- the processing routine for a photometric glucose strip at step 1028 is executed as follows. Firstly, the device displays the icon representing the target material is glucose on LCD, and blinks the icon that instructs the user to apply a sample into the reaction region on the inserted test strip. A sample is applied to the test strip with the test strip off the device or with the test strip inserted into the device. The device checks whether a sample is applied by using a light-emitting element such as LED and a light-detecting element such as a photo detector. When a sample is applied, the device waits till the intensity of light reflected from the reaction region is stabilized. When the reaction is stabilized, the device converts the intensity of the reflected light into the glucose level, stores this level in EEPROM and displays it on LCD.
- the processing routine for a photometric cholesterol strip at step 1030 is the same as the processing routine at step 1028, except that the relationship between the intensity of the reflected light and the cholesterol level is different from that of the processing routine at step 1028.
- the device can perform the analysis of high accuracy for some materials to which the electrochemical method can be applicable, and perform analysis for the other various materials by using the photometric method.
- the device can automatically identify the type of a test strip (namely, the analysis method) and the target material, without an additional operation of a button, by using the recognition electrode of the test strip and the terminals for the recognition electrode in the socket of the device.
- the test strip according to the invention can be manufactured more inexpensively than the conventional one because the recognition electrode is merely an electrode formed on the surface of a test strip differently from the code chip.
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Abstract
Description
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003240040A AU2003240040A1 (en) | 2002-07-05 | 2003-06-30 | Device for quantitative analysis of biological materials |
EP03733605A EP1532440A4 (en) | 2002-07-05 | 2003-06-30 | Device for quantitative analysis of biological materials |
US10/520,555 US20060099703A1 (en) | 2002-07-05 | 2003-06-30 | Device for quantitative analysis of biological materials |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020020039072A KR100540849B1 (en) | 2002-07-05 | 2002-07-05 | A device for analyzing quantitatively material of a living creature |
KR10-2002-0039072 | 2002-07-05 |
Publications (1)
Publication Number | Publication Date |
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WO2004005919A1 true WO2004005919A1 (en) | 2004-01-15 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/KR2003/001280 WO2004005919A1 (en) | 2002-07-05 | 2003-06-30 | Device for quantitative analysis of biological materials |
Country Status (6)
Country | Link |
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US (1) | US20060099703A1 (en) |
EP (1) | EP1532440A4 (en) |
KR (1) | KR100540849B1 (en) |
CN (1) | CN1666103A (en) |
AU (1) | AU2003240040A1 (en) |
WO (1) | WO2004005919A1 (en) |
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US8545774B2 (en) | 2004-12-15 | 2013-10-01 | Roche Diagnostics Operations, Inc. | Electrical connection system for an electrochemical analysis system |
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- 2003-06-30 US US10/520,555 patent/US20060099703A1/en not_active Abandoned
- 2003-06-30 AU AU2003240040A patent/AU2003240040A1/en not_active Abandoned
- 2003-06-30 WO PCT/KR2003/001280 patent/WO2004005919A1/en not_active Application Discontinuation
- 2003-06-30 EP EP03733605A patent/EP1532440A4/en not_active Withdrawn
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1672364A1 (en) * | 2004-12-15 | 2006-06-21 | F. Hoffmann-La Roche AG | Analytical system for analysis of a liquid sample by means of a test element. |
US8545774B2 (en) | 2004-12-15 | 2013-10-01 | Roche Diagnostics Operations, Inc. | Electrical connection system for an electrochemical analysis system |
EP1917525A1 (en) * | 2005-06-28 | 2008-05-07 | Jae Chern Yoo | BlO DRIVE APPARATUS, AND ASSAY METHOD USING THE SAME |
JP2008544296A (en) * | 2005-06-28 | 2008-12-04 | シェーン ユウ、ジャエ | Biodrive device and analysis method using the same |
EP1917525A4 (en) * | 2005-06-28 | 2011-05-25 | Samsung Electronics Co Ltd | BlO DRIVE APPARATUS, AND ASSAY METHOD USING THE SAME |
JP4940446B2 (en) * | 2005-06-28 | 2012-05-30 | サムスン エレクトロニクス カンパニー リミテッド | Biodrive device and analysis method using the same |
US9279818B2 (en) | 2005-06-28 | 2016-03-08 | Samsung Electronics Co., Ltd. | Bio drive apparatus, and assay method using the same |
Also Published As
Publication number | Publication date |
---|---|
EP1532440A4 (en) | 2008-07-23 |
CN1666103A (en) | 2005-09-07 |
EP1532440A1 (en) | 2005-05-25 |
KR20040004739A (en) | 2004-01-14 |
KR100540849B1 (en) | 2006-01-10 |
US20060099703A1 (en) | 2006-05-11 |
AU2003240040A1 (en) | 2004-01-23 |
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