WO2011152238A1 - 尿分析方法、その装置、前記分析方法に用いられるプログラム、およびその記憶媒体 - Google Patents
尿分析方法、その装置、前記分析方法に用いられるプログラム、およびその記憶媒体 Download PDFInfo
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- WO2011152238A1 WO2011152238A1 PCT/JP2011/061753 JP2011061753W WO2011152238A1 WO 2011152238 A1 WO2011152238 A1 WO 2011152238A1 JP 2011061753 W JP2011061753 W JP 2011061753W WO 2011152238 A1 WO2011152238 A1 WO 2011152238A1
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- 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
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- 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
- G01N33/493—Physical analysis of biological material of liquid biological material urine
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N2035/00891—Displaying information to the operator
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
- G01N35/04—Details of the conveyor system
- G01N2035/046—General conveyor features
- G01N2035/0465—Loading or unloading the conveyor
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- 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
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/274—Calibration, base line adjustment, drift correction
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
- Y10T436/145555—Hetero-N
Definitions
- the present invention relates to a technique that analyzes urine using a reagent and can be used, for example, for urinalysis in a health checkup.
- Patent Document 1 As a conventional example of a method for analyzing urine, there is a method described in Patent Document 1.
- the concentration of a specific component in urine is obtained using a test paper coated with a reagent.
- the reagent develops color by causing a reaction with a specific component in urine, and the degree of color development corresponds to the concentration of the specific component.
- the color development degree of the reagent as an optical value using an optical device, it is possible to obtain the concentration of a specific component in urine based on this value.
- the color tone of the urine itself is also examined using an optical device in a state where the urine is not in contact with the reagent.
- the color development state of the reagent may be affected by the color of urine.
- the color of urine is examined, it is possible to correct the value when obtaining the concentration of the specific component based on the degree of color development of the reagent.
- the analysis result may not correspond to the actual content due to the influence of the drug.
- the azo coupling method is often used.
- an azo dye is produced by a diazo reagent reacting with bilirubin under acidic conditions (diazo coupling reaction).
- this reaction of azo dye formation is not unique to bilirubin and may occur even when the subject is receiving drugs such as iobenzamic acid, etodolac, or epalrestat. There is.
- the present invention has been conceived under the circumstances as described above, and when the urinary component shows false positive or false negative, or when there is such a possibility, the fact is accurately confirmed. It is an object of the present invention to provide a urine analysis method, an analysis apparatus, a program used for the urine analysis method, and a storage medium for the program, which can obtain a highly reliable test result.
- the present invention takes the following technical means.
- the urine analysis method provided by the first aspect of the present invention includes a first determination step of determining whether the specific component is positive or negative based on a color reaction between the specific component in urine and the reagent.
- Urine analysis method comprising: obtaining data of light absorption characteristics of the urine itself with respect to light in a predetermined wavelength range, wherein the value of the light absorption characteristics data is within a predetermined range, and the first When the determination result in the determination step is one of positive and negative in advance, the determination result is changed to false positive or false negative, or it is determined that there is a possibility of false positive or false negative It is characterized by further comprising two determination steps.
- the urine is a predetermined colorless or yellow color
- the specific component in the urine is bilirubin
- the value of the light absorption characteristic data is within the predetermined range
- the determination result in the first determination step is positive for bilirubin
- the second determination step it is determined that there is a possibility of changing the positive to a false positive or a false positive.
- the light absorption characteristic data is data indicating the light absorption characteristic of the urine with respect to light having a wavelength of about 525 nm and a wavelength of about 470 nm.
- the absorbance per 10 mm of the optical path length is A2
- the relationship between the two expressions A1 ⁇ 0.08 and A2 ⁇ 0.5 is established, the light absorption characteristic is determined in the second determination step.
- the light absorption characteristic is determined in the second determination step.
- the light absorption characteristic data is a calculated value B calculated by the following equation.
- B (A4-A5) / (A3-A5) (where A3, A4, and A5 are the absorbances of the urine with respect to light at wavelengths near 525 nm, 470 nm, and 635 nm, respectively)
- the value of the light absorption characteristic data is within the predetermined range in the second determination step. It is judged.
- the urine analysis method when the relationship of B ⁇ 5.30 is not established, it is further determined whether or not the relationship of A6 ⁇ 0.54 is established, and A6 ⁇ 0.54. In the second determination step, it is determined that the value of the light absorption characteristic data is within the predetermined range.
- A6 is the absorbance of the urine with respect to light in the vicinity of a wavelength of 470 nm, and is the absorbance per 10 mm of the optical path length.
- the urine analysis method according to the present invention further includes a step of detecting when a predetermined abnormal color develops in the color reaction.
- the analyzer provided by the second aspect of the present invention is capable of making a first determination on whether a specific component is positive or negative based on a color reaction between a specific component in urine and a reagent. And an optical measuring means capable of obtaining light absorption characteristic data with respect to light in a predetermined wavelength range of the urine itself, wherein the value of the light absorption characteristic data is in a predetermined range. And when the result of the first determination is a predetermined one of positive and negative, the determination means changes the result of the first determination to false positive or false negative, Alternatively, the second judgment that there is a possibility of false positive or false negative is made.
- the analyzer when the urine is a predetermined colorless or yellow color, it is determined in the second determination that the value of the light absorption characteristic data is within the predetermined range.
- the analyzer when determining whether the bilirubin as a specific component in the urine is positive or negative, has a value of the light absorption characteristic data within the predetermined range, and When the result of the first determination is positive for bilirubin, the determination means is configured to change the positive to a false positive or to be a false positive in the second determination. ing.
- the light absorption characteristic data is data indicating the light absorption characteristic of the urine with respect to light having a wavelength of about 525 nm and a wavelength of about 470 nm.
- the absorbance per 10 mm of the optical path length is A2
- the relationship between the two expressions A1 ⁇ 0.08 and A2 ⁇ 0.5 is satisfied, in the second judgment, The data value is assumed to be within the predetermined range.
- the light absorption characteristic data is a calculated value B calculated by the following equation.
- B (A4-A5) / (A3-A5) (where A3, A4, and A5 are the absorbances of the urine with respect to light at wavelengths near 525 nm, 470 nm, and 635 nm, respectively)
- the analyzer according to the present invention is configured to determine whether or not B ⁇ 5.30 is satisfied.
- the value of the light absorption characteristic data is determined to be within the predetermined range in the second determination.
- the analyzer when the relationship of B ⁇ 5.30 is not established, it is further determined whether or not the relationship of A6 ⁇ 0.54 is established, and A6 ⁇ 0.54 is satisfied.
- the relationship in the second determination, the value of the light absorption characteristic data is assumed to be within the predetermined range. (However, A6 is the absorbance of the urine with respect to light in the vicinity of a wavelength of 470 nm, and is the absorbance per 10 mm of the optical path length.)
- the analyzer according to the present invention is configured to be able to output data for recognizing the result of the second determination using a data output means.
- the analyzer according to the present invention is configured to detect that when a predetermined abnormal color is generated in the color reaction.
- the program provided by the third aspect of the present invention provides a determination means capable of performing a first determination on whether a specific component is positive or negative based on a color reaction between a specific component in urine and a reagent. And an optical measuring means capable of obtaining light absorption characteristic data for light in a predetermined wavelength region of the urine itself, and a program for causing the determination means of the analyzer to perform data processing, When the value of the light absorption characteristic data is within a predetermined range and the determination result in the first determination step is one of positive and negative, the determination result is false positive or false. It is characterized in that it contains data for causing the determination means to execute a second determination that there is a possibility of false negative or false negative.
- the storage medium provided by the fourth aspect of the present invention stores the program provided by the third aspect of the present invention.
- FIG. 5 is a VV cross-sectional view of FIG. 3.
- FIG. 1 to 5 show an example of an analyzer to which the present invention is applied.
- the analyzer AN of the present embodiment is for performing an analysis process on the urine U stored in the container 30 and is transported to the front surface of the analyzer body 1.
- the apparatus 2 is assembled.
- the transport device 2 is for transporting the rack 3 that holds the container 30 upright on a fixed path.
- the transport device 2 can have the same configuration as a conventionally known transport device (for example, the transport device described in Japanese Patent Application Laid-Open No. 2009-229233), and details of its specific structure are omitted. .
- the transport device 2 when the rack 3 is inserted into the predetermined start end area Sa, the rack 3 is subsequently transported sequentially in the directions indicated by the arrows N1 to N3, and finally reaches the predetermined end area Ea. It is supposed to be. In the process in which the rack 3 is conveyed in the direction of the arrow N2, an operation of collecting urine U from the container 30 is performed by a suction nozzle 50 described later.
- the analyzer AN includes a test strip supply device 4, a dispensing device 5, a control unit 6, an optical measurement unit 7 ⁇ / b> A for color reaction detection, and a urine color tone test.
- the optical measurement unit 7B, the operation unit 10, the printer 11, and the display unit 12 are provided.
- the test strip supply device 4 is for supplying a test strip 8 for urine analysis to a predetermined location P1 of the optical measuring unit 7A.
- the test strip supply apparatus 4 includes a hopper 40 that houses a plurality of test strips 8 and a rotating drum 41 for taking out the test strips 8 one by one from the hopper 40.
- the rotating drum 41 has a concave portion 41 a that allows only one test piece 8 to be fitted on the outer peripheral surface thereof.
- the test piece 8 fitted into the concave portion 41 a as the rotating drum 41 rotates is arranged outside the hopper 40. To the pair of guides 42. Thereafter, the test piece 8 is transferred to a predetermined location P1 by a transfer device (not shown).
- the dispensing device 5 is capable of collecting urine U from the container 30 using the suction nozzle 50 and dispensing (dropping) the collected urine U onto the test piece 8.
- the suction nozzle 50 is movable up and down and horizontally by a drive mechanism (not shown).
- the dispensing device 5 has a function of cleaning the suction nozzle 50, and includes a cleaning liquid tank 51 that stores cleaning liquid such as distilled water, syringe pumps 52 ⁇ / b> A and 52 ⁇ / b> B, a direction switching valve 53 such as a three-way valve, and a cleaning liquid tank 51.
- To the suction nozzle 50 are provided in series.
- the flow path 54 is configured using an appropriate tube.
- a negative pressure for sucking the urine U and a positive pressure for discharging the urine U can be generated in the suction nozzle 50.
- the cleaning liquid in the cleaning liquid tank 51 can be sent into the suction nozzle 50 to be cleaned.
- the optical measurement unit 7B for urine color tone inspection is provided in the middle of the flow path 54 of the dispensing device 5, and this will be described later.
- the optical measurement unit 7 ⁇ / b> A for color reaction detection includes a mounting table 70 for mounting a plurality of test pieces 8 and an optical measuring instrument 71.
- Each test piece 8 is provided with a plurality of reagent pads 80, and the urine U collected by the suction nozzle 50 is dispensed onto the reagent pads 80.
- the plurality of reagent pads 80 include a reagent that reacts with a predetermined component in the urine U and develops color to a degree corresponding to the concentration of the component.
- the reagent there are various components corresponding to the examination item of urine U. As described in the background art section, for example, a diazo reagent is used as the reagent for the bilirubin test.
- the optical measuring instrument 71 is movable in the X and Y directions, irradiates each reagent pad 80 with light in a predetermined wavelength range from a light source (not shown) after the urine U is spotted, and reflects the reflected light.
- Light is received by a light receiving element (not shown).
- the light reflectance of the reagent can be measured based on the amount of light received by the light receiving element. This light reflectance corresponds to the degree of color reaction (development degree) between the specific component of urine U and the reagent, and the presence or concentration (including semi-quantitative value) of the specific component in urine is based on this value. To be judged.
- the wavelength of main light is 565 nm or its vicinity
- the wavelength of reference light is 760 nm or its vicinity.
- the reference light is useful for reducing errors caused by the size of the test piece 8 and other variations.
- An example of an arithmetic expression for obtaining the reflectance will be described later.
- the optical measurement unit 7A is configured to appropriately detect abnormal color development when abnormal color development occurs after dispensing the urine U onto the reagent pad 80.
- the wavelength of the main light is 565 nm or its vicinity as described above
- the wavelength of the reference light is 500 nm or its vicinity. An expression for determining this abnormal color development will also be described later.
- the optical measurement unit 7B for urine color tone inspection is provided in the middle of the flow path 54, and the urine U sucked by the suction nozzle 50 is contained in a cell 75 described later of the optical measurement unit 7B. It is possible to flow in.
- the optical measurement unit 7B includes a transparent cylindrical cell 75 into which urine U flows, a light source 77 attached to a light shielding block 76 surrounding the cell 75, and two light receiving elements 78a and 78b. have.
- the light source 77 can emit light toward the cell 75.
- this light for example, light having a wavelength of 470 nm, 525 nm, 635 nm, or a total of three wavelengths in the vicinity thereof is used.
- the light receiving element 78a receives light transmitted through the urine U in the cell 75, and based on the amount of light received by the light receiving element 78a, absorbances A1 and A2 per predetermined optical path length of the urine U to be described later are obtained. These absorbances A1, A2, etc. are the absorbances of urine U itself that has not reacted with the reagent.
- the light receiving element 78b is for receiving light scattered and reflected by the urine U, and the turbidity of the urine U can be determined based on the amount of light received by the light receiving element 78b.
- the intensity of incident light on the solution may be used as I0 .
- Absorbance is proportional to the optical path length. Therefore, as will be described later, it is possible to convert the absorbance measured at a certain optical path length into the absorbance of another optical path length. As the absorbance, those per 10 mm optical path length are generally used.
- the printer 11 is for printing out the analysis result of the urine U and data of other predetermined items on a predetermined sheet, and corresponds to an example of the data output means in the present invention.
- the display unit 12 includes an image display screen such as a liquid crystal display panel, and performs screen display for guiding operation of the operation unit 10, for example.
- the analysis result of the urine U may be displayed on the display unit 12.
- the display unit 12 corresponds to a specific example of the data output means in the present invention.
- the control unit 6 is configured using a microcomputer, for example, and includes a storage unit 60.
- the control unit 6 corresponds to an example of a determination unit referred to in the present invention.
- the storage unit 60 stores a program and various data for performing operation control of each unit of the analyzer AN and various data processing. An example of a specific operation process of the control unit 6 will be described later.
- the transport device 2 is driven to transport the rack 3 along the above-described fixed path.
- the control unit 6 drives the dispensing device 5 and collects the urine U from the container 30 using the suction nozzle 50 ( S2).
- a part of the collected urine U is caused to flow into the cell 75 of the optical measurement unit 7B for urine color tone inspection.
- the control unit 6 irradiates light from the light source 77 of the optical measurement unit 7B toward the urine U, and obtains the absorbances A1 and A2 of the urine U with respect to light in two wavelength ranges from the transmitted light amount (S3).
- the aforementioned absorbance A1 is, for example, the absorbance of urine U with respect to light having a wavelength of 525 nm or in the vicinity thereof, and is the absorbance per 10 mm of the optical path length.
- the absorbance value of the optical path length of 1.8 mm obtained by using the cell 75 is (10/1). .8), the absorbance A1 converted as the absorbance per 10 mm of the optical path length can be obtained.
- the absorbance A2 is, for example, the absorbance of urine U with respect to light having a wavelength of 470 nm or in the vicinity thereof, and is also converted into the absorbance per 10 mm of the optical path length.
- absorbances A1 and A2 are used for determination of false positive for bilirubin, as will be described later.
- required using the cell 75 can also be converted into the light absorbency per other optical path length like 5 mm, 15 mm, and 20 mm, for example.
- FIG. 9 shows the relationship between the absorption spectrum of bilirubin itself contained in urine and the measurement wavelengths of absorbances A1 and A2.
- the measurement wavelength of the absorbance A1 is, for example, a wavelength of 525 nm or the vicinity thereof.
- the measurement wavelength of the absorbance A ⁇ b> 1 matches the wavelength at the base of the absorption of bilirubin.
- the measurement wavelength of the absorbance A1 is preferably selected from 515 nm to 575 nm (wavelength region W1).
- the measurement wavelength of the absorbance A2 is, for example, 470 nm or a wavelength in the vicinity thereof.
- the measurement wavelength of the absorbance A2 coincides with the wavelength of the main absorption part of bilirubin.
- the measurement wavelength of the absorbance A2 is preferably selected from 400 nm to 480 nm (wavelength region W2).
- the urine U collected by the suction nozzle 50 is spotted on the reagent pad 80 for the bilirubin test of the test piece 8, and then this spot is irradiated with two wavelengths of light sequentially.
- the light reflectance R of the wearing part is measured (S4).
- R (r1 / r2) / (r3 / r4)
- the control unit 6 determines whether the bilirubin is positive or negative based on the data of the predetermined calibration curve stored in the storage unit 60 and the reflectance R. (S5). Preferably, in the case of positive, ranking of positive (1+), (2+), (3+), etc. is also performed according to the bilirubin concentration.
- the control unit 6 When the result of the first determination described above is positive for bilirubin (S6: YES), the control unit 6 performs a second determination as to whether or not the false positive or the possibility is high. In this second determination, it is determined whether or not the following expressions 2 and 3 are satisfied for the absorbances A1 and A2 of the urine U obtained in step S3 (S7).
- the numerical value shown by Formula 2 and Formula 3 is a numerical value per 10 mm of optical path length, and can be suitably changed according to the optical path length by which an absorbance is measured or converted.
- S7: YES the control unit 6 determines that there is a false positive or that possibility is high (S8).
- the inventors of the present invention implemented the analysis method using an analysis device having the same structure as the analysis device AN, and verified this. Then, out of a total of 85 false positive samples in which the result of the first determination is positive for bilirubin and negative by the retest by the ictotest, a total of 69 samples are determined to be false positive by the second determination. I was able to. From this, it can be understood that according to the analysis method, the reliability of the analysis result is high. In addition, when the reliability of the analysis result is increased as described above, there is an advantage that the number of urine retests can be reduced and the efficiency of the analysis process can be improved.
- the control unit 6 determines whether or not an abnormal color is generated on the reagent pad 80 on which the urine U is spotted (S10). This determination is made using the following equation (4).
- R ′ in Equation 4 is the light reflectance at the spot where the urine U is spotted, and is obtained by Equation 5.
- R ′ > 1.30 Formula 4
- R ′ (r1 / r5) / (r3 / r6) Equation 5
- r5 500 nm wavelength reflected light intensity of the reagent pad portion for detecting bilirubin
- r6 500 nm wavelength reflected light intensity of the reference reagent pad portion r1, r3: the same as r1 and r3 in Formula 1 If Expression 4 is satisfied, it is determined that there is abnormal coloring (S10: YES). When abnormal coloring has occurred, there is a high possibility that the result of the first determination is inaccurate.
- the control unit 6 prints the determination result on a predetermined sheet using the printer 11 (S9).
- a symbol or the like for recognizing that is also printed.
- a report 9 as shown in FIG. 7 is created.
- data D10 for identifying a subject, data D11 of inspection items, and data D12 of inspection results are printed out. If it is determined that bilirubin is false positive or highly likely, data D13 indicating that is printed out corresponding to the item of bilirubin (BIL).
- the data D13 is displayed using a symbol “*”, but other symbols, characters, and designs can be used.
- FIG. 8 shows another example of a report printed by the printer 11 of the analyzer AN.
- the same reference numerals are given to the same data as the data of the report 9 described in FIG. 7, and the description thereof is omitted here.
- the data D14 when it is determined that bilirubin is false positive or highly likely, the data D14 indicating that is replaced with the data of the test result in the item column of the test result of bilirubin.
- the data D14 is displayed using characters “FALSE-POSITIVE”, but other symbols, characters, and designs can be used.
- data indicating that bilirubin is false positive or highly likely and the data of the test result can be written in the item column of the test result of bilirubin.
- step S10 if it is determined in step S10 that abnormal coloration has occurred, information indicating that is printed in correspondence with the bilirubin item of the report 9.
- the inspector can accurately detect that there is a suspicion in the test result of bilirubin and there is a need for a retest.
- the information is a symbol, a character, a design, or the like that can be distinguished from information indicating a false positive.
- FIG. 10 the steps denoted by the same numbers as those in FIG. 6 perform the same or similar processing as the steps shown in FIG.
- FIG. 10 the difference between FIG. 10 and FIG. 6 is as follows. That is, in FIG. 10, steps S3 and S7 in FIG. 6 are deleted, and steps S11, S12, S13, and S14 are added. In the following, the added steps and the steps related thereto will be mainly described, and detailed description of the other steps will be omitted.
- the control unit 6 drives the dispensing device 5 and collects urine U from the container 30 using the suction nozzle 50 (S2). In this case, a part of the collected urine U is caused to flow into the cell 75 of the optical measurement unit 7B for urine color tone inspection.
- the control unit 6 irradiates light from the light source 77 of the optical measurement unit 7B toward the urine U, and obtains absorbances A3, A4, and A5 of the urine U with respect to light in three types of wavelength ranges from the amount of transmitted light.
- the control unit 6 calculates the calculated value B using Equation 6 using the absorbances A3, A4, and A5 (S11).
- B (A4-A5) / (A3-A5) Equation 6
- the absorbance A3 is, for example, the absorbance of urine U with respect to light having a wavelength of 525 nm or in the vicinity thereof.
- the absorbance A4 is, for example, the absorbance of urine U with respect to light having a wavelength of 470 nm or the vicinity thereof.
- the absorbance A5 is, for example, the absorbance of urine U with respect to light having a wavelength of 635 nm or in the vicinity thereof.
- the absorbances A3, A4, and A5 are measured as absorbances with an optical path length of 1.8 mm, for example, when the inner diameter of the cell 75 shown in FIG. 5 is 1.8 mm.
- the absorbances A3, A4, and A5 may be converted as absorbances per other optical path length such as 5 mm, 10 mm, 15 mm, and 20 mm.
- the absorbance converted to the absorbance per 10 mm of the optical path length is obtained by multiplying the absorbance value of the optical path length of 1.8 mm obtained by using the cell 75 by the value of (10 / 1.8). It is possible.
- the calculated value B calculated from these absorbances A3, A4, and A5 is used for determination of false positive for bilirubin, as will be described later.
- the measurement wavelength of the absorbance A3 is, for example, 525 nm or a wavelength in the vicinity thereof. As shown in FIG. 9, the measurement wavelength of the absorbance A3 coincides with the wavelength at the base of bilirubin absorption. Therefore, specifically, the measurement wavelength of the absorbance A3 is preferably selected from 515 nm to 575 nm (wavelength region W1), similar to the absorbance A1 described above.
- the measurement wavelength of the absorbance A4 is, for example, 470 nm or a wavelength in the vicinity thereof. The measurement wavelength of the absorbance A4 coincides with the wavelength of the main absorption part of bilirubin.
- the measurement wavelength of the absorbance A4 is preferably selected from 400 nm to 480 nm (wavelength region W2) as in the case of A2.
- the measurement wavelength of the absorbance A5 is, for example, 635 nm or a wavelength in the vicinity thereof.
- the measurement wavelength of the absorbance A5 coincides with the wavelength of the portion where bilirubin does not absorb.
- the measurement wavelength of the absorbance A5 is preferably selected from 625 nm to 780 nm (wavelength region W3).
- the absorbance A6 is calculated based on the absorbance A4 (S12).
- This absorbance A6 also corresponds to an example of the light absorption characteristic data referred to in the present invention.
- the absorbance A6 is the absorbance of the urine with respect to light having a wavelength of 470 nm or in the vicinity thereof, and is the absorbance per 10 mm of the optical path length.
- the absorbance A6 is obtained by converting the absorbance A4 of the urine U with respect to light having the wavelength of 470 nm or the vicinity thereof into the absorbance per 10 mm of the optical path length.
- this absorbance A4 value can be used as it is as the absorbance A6.
- the absorbance A6 may be converted as absorbance per other optical path length such as 5 mm, 15 mm, and 20 mm. Further, the absorbance A6 may be measured separately from the absorbance A4.
- the urine U collected by the suction nozzle 50 is spotted on the reagent pad 80 for the bilirubin test of the test piece 8, and then two wavelengths are deposited on this spotted portion.
- the light reflectance R of the spotted portion is measured by sequentially irradiating the light (S4).
- the control unit 6 determines whether the bilirubin is positive or negative based on the data of the predetermined calibration curve stored in the storage unit 60 and the reflectance R. (S5).
- the control unit 6 When the result of the first determination described above is positive for bilirubin (S6: YES), the control unit 6 performs a second determination as to whether or not the false positive or the possibility is high. In this second determination, it is determined whether or not Expression 7 holds for the calculated value B obtained in step S11 (S13). B ⁇ 5.30 Expression 7 When the above-described Expression 7 is established (S13: YES), the control unit 6 determines that there is a false positive or that possibility is high (S8).
- the control unit 6 additionally determines whether Expression 8 is further satisfied for the absorbance A6 (S14).
- the numerical value shown by Formula 8 is a numerical value per 10 mm of optical path length, and can be suitably changed according to the optical path length by which an absorbance is measured or converted. A6 ⁇ 0.54 (8)
- the control unit 6 determines that there is a false positive or high possibility in the second determination (S8).
- Formula 7 is for precisely separating false-positive urine from urine whose first determination result is bilirubin-positive. As described above, all of urine having a predetermined transparent or yellow color tone is negative (false positive). Similar to Equations 2 and 3, Equation 7 is also an equation for determining whether the color tone of the urine U is a predetermined transparent or yellow color. It can be determined that the color tone of U is a predetermined transparent color or yellow color. Therefore, when the result of the first determination is positive for bilirubin and Equation 7 is satisfied, it is finally possible to determine that the bilirubin is false positive or that the possibility is high. Therefore, the reliability of the test result of bilirubin by the analysis method can be increased.
- Expression 8 is an expression for additionally determining whether or not a false positive occurs when Expression 7 is not satisfied. If this equation 8 holds, even if the result of the first determination is bilirubin positive and urine U does not hold equation 7, it is finally determined that the bilirubin false positive or that possibility is high. Is possible. Therefore, the reliability of the test result of bilirubin by the analysis method can be made higher.
- the inventors of the present invention collected urine U having a transparent or yellow color tone, implemented the analysis method using an analyzer having the same structure as the analyzer AN, and verified this. Then, by performing the determination using Expression 7, a total of 87 samples out of a total of 88 samples that are positive for bilirubin and negative by retesting by the ictotest are second samples. It was possible to determine that the result was false positive. Furthermore, by performing an additional determination using Expression 8, it was possible to determine that a total of 88 samples out of the total of 88 false positive samples were false positives by the second determination.
- the reliability of the analysis result is high.
- the reliability of the analysis result is increased as described above, there is an advantage that the number of urine retests can be reduced and the efficiency of the analysis process can be improved.
- control is performed.
- the unit 6 determines whether or not an abnormal color is generated on the reagent pad 80 on which the urine U is spotted (S10).
- control unit 6 prints the determination result on a predetermined sheet using the printer 11 as described in the flowchart of FIG. 6 (S9).
- the present invention is not limited to the contents of the above-described embodiment.
- an expression different from Expression 2, Expression 3, Expression 7, and Expression 8 can be used as a condition for determining bilirubin positive as a false positive.
- “data of light absorption characteristics with respect to light in a predetermined wavelength range of urine” may use simple light transmittance values other than absorbance, and light reflectance also indicates light absorption characteristics. Therefore, it can be used.
- the result of the first determination is positive for bilirubin, it is basically determined that this is a false positive when the color of urine is a predetermined colorless or yellow color. is there. Therefore, for example, a method of determining the color tone of urine by irradiating light on a wide wavelength range and analyzing the spectrum of the transmitted light, and determining whether it is false positive based on the determination result It is also possible to adopt.
- the bilirubin test has been described as a representative example, but the present invention can also be applied to test items other than bilirubin (for example, urobilinogen). Further, the present invention can be applied not only to false positive determination but also to false negative determination. The present invention can be applied not only to a comparatively large analyzer equipped with a container transport device, but also to a small analyzer that does not include such a transport device.
- the optical measurement unit 7B for urine color tone inspection provided in the analyzer AN is used to measure the absorbance of urine, but the absorbance used for the determination of false positive or false negative. It is also possible to separately provide an optical measurement unit for measuring.
- “light absorption characteristic data for light in a predetermined wavelength region of urine” is acquired using light in a wavelength region near 525 nm, 470 nm, or 635 nm. It is also possible to use light in the region.
- AN analyzer U urine 6 control unit (judgment means) 7A Optical measurement unit for color reaction detection 7B Optical measurement unit for urine color tone inspection (optical measurement means) 8 Test piece 11 Printer (data output means) 12 Display (data output means) 80 reagent pad
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Abstract
Description
B=(A4-A5)/(A3-A5)(ただし、A3、A4、およびA5は、それぞれ波長525nm付近、波長470nm付近、および波長635nm付近の光に対する前記尿の吸光度である。)
B=(A4-A5)/(A3-A5)(ただし、A3、A4、およびA5は、それぞれ波長525nm付近、波長470nm付近、および波長635nm付近の光に対する前記尿の吸光度である。)
R=(r1/r2)/(r3/r4) ・・・式1
r1:ビリルビン検出用の試薬パッド部分の565nm波長の反射光強度
r2:ビリルビン検出用の試薬パッド部分の760nm波長の反射光強度
r3:リファレンス用の試薬パッド部分の565nm波長の反射光強度
r4:リファレンス用の試薬パッド部分の760nm波長の反射光強度
A1<0.08 ・・・式2
A2<0.5 ・・・式3
制御部6は、前記した式2,式3がともに成立する場合には(S7:YES)、偽陽性またはその可能性が高いものと判断する(S8)。
R’>1.30 ・・・式4
R’=(r1/r5)/(r3/r6) ・・・式5
r5:ビリルビン検出用の試薬パッド部分の500nm波長の反射光強度
r6:リファレンス用の試薬パッド部分の500nm波長の反射光強度
r1,r3:式1のr1,r3と同じ
制御部6は、前記の式4が成立する場合には、異常発色があるものと判断する(S10:YES)。異常発色が生じている場合、先の第1の判断の結果が不正確である可能性は高い。
B=(A4-A5)/(A3-A5) ・・・式6
B<5.30 ・・・式7
制御部6は、前記した式7が成立する場合には(S13:YES)、偽陽性またはその可能性が高いものと判断する(S8)。
A6<0.54 ・・・式8
制御部6は、式8が成立する場合に(S14:YES)、第2の判断において、偽陽性またはその可能性が高いものと判断する(S8)。
U 尿
6 制御部(判断手段)
7A 呈色反応検知用の光学測定部
7B 尿色調検査用の光学測定部(光学測定手段)
8 試験片
11 プリンタ(データ出力手段)
12 表示部(データ出力手段)
80 試薬パッド
Claims (23)
- 尿中の特定成分と試薬との呈色反応に基づいて、前記特定成分の陽性または陰性の区別を判断する第1の判断ステップと、
前記尿自体の所定波長域の光に対する吸光特性のデータを求めるステップと、
を有する、尿分析方法であって、
前記吸光特性のデータの値が所定の範囲内にあり、かつ前記第1の判断ステップにおける判断結果が陽性および陰性のうちの予め定められた一方であるときに、前記判断結果を偽陽性もしくは偽陰性に改め、または偽陽性もしくは偽陰性の可能性があるものと判断する第2の判断ステップを、さらに有していることを特徴とする、尿分析方法。 - 請求項1に記載の尿分析方法であって、
前記尿が所定の無色系または黄色系であるときに、前記第2の判断ステップにおいて、前記吸光特性のデータの値が前記所定の範囲内にあると判断する、尿分析方法。 - 請求項1または2に記載の尿分析方法であって、
前記尿中の特定成分は、ビリルビンであり、
前記吸光特性のデータの値が前記所定の範囲内にあり、かつ前記第1の判断ステップにおける判断結果がビリルビンの陽性であるときには、前記第2の判断ステップにおいて、前記陽性を偽陽性に改め、または偽陽性の可能性があるものと判断する、尿分析方法。 - 請求項3に記載の尿分析方法であって、
前記吸光特性のデータは、波長525nm付近および波長470nm付近のそれぞれの光に対する前記尿の吸光特性を示すデータである、尿分析方法。 - 請求項4に記載の尿分析方法であって、
波長525nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度をA1とし、
波長470nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度をA2とした場合において、
A1<0.08
A2<0.5
の2つの式の関係がともに成立する場合には、前記第2の判断ステップにおいて、前記吸光特性のデータの値が前記所定の範囲内にあるものと判断する、尿分析方法。 - 請求項3に記載の尿分析方法であって、
前記吸光特性のデータは、下記の式により計算される計算値Bである、尿分析方法。
B=(A4-A5)/(A3-A5)
(ただし、A3、A4、およびA5は、それぞれ波長525nm付近、波長470nm付近、および波長635nm付近の光に対する前記尿の吸光度である。) - 請求項6に記載の尿分析方法であって、
B<5.30の関係が成立するか否かを判定する、尿分析方法。 - 請求項7に記載の尿分析方法であって、
B<5.30の関係が成立する場合には、前記第2の判断ステップにおいて、前記吸光特性のデータの値が前記所定の範囲内にあるものと判断する、尿分析方法。 - 請求項7に記載の尿分析方法であって、
B<5.30の関係が成立しない場合には、更にA6<0.54の関係が成立するか否かを判定し、A6<0.54の関係が成立する場合に、前記第2の判断ステップにおいて、前記吸光特性のデータの値が前記所定の範囲内にあるものと判断する、尿分析方法。
(ただし、A6は、波長470nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度である。) - 請求項1ないし9のいずれかに記載の尿分析方法であって、
前記呈色反応において、所定の異常発色が生じたときに、その旨を検出するステップをさらに有している、尿分析方法。 - 尿中の特定成分と試薬との呈色反応に基づいて、前記特定成分の陽性または陰性の区別についての第1の判断が可能な判断手段と、
前記尿自体の所定波長域の光に対する吸光特性のデータを求めることが可能な光学測定手段と、
を備えている、分析装置であって、
前記吸光特性のデータの値が所定の範囲内にあり、かつ前記第1の判断の結果が陽性および陰性のうちの予め定められた一方であるときに、前記判断手段は、前記第1の判断の結果を偽陽性もしくは偽陰性に改め、または偽陽性もしくは偽陰性の可能性があるとの第2の判断を行なうように構成されていることを特徴とする、分析装置。 - 請求項11に記載の分析装置であって、
前記尿が所定の無色系または黄色系であるときには、前記第2の判断において、前記吸光特性のデータの値が前記所定の範囲内にあると判断されるように構成されている、分析装置。 - 請求項11または12に記載の分析装置であって、
前記尿中の特定成分としてのビリルビンの陽性または陰性の区別を判断する場合において、
前記吸光特性のデータの値が前記所定の範囲内にあり、かつ前記第1の判断の結果がビリルビンの陽性であるときには、前記判断手段は、前記第2の判断において、前記陽性を偽陽性に改め、または偽陽性の可能性があるものとされるように構成されている、分析装置。 - 請求項13に記載の分析装置であって、
前記吸光特性のデータは、波長525nm付近および波長470nm付近のそれぞれの光に対する前記尿の吸光特性を示すデータである、分析装置。 - 請求項14に記載の分析装置であって、
波長525nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度をA1とし、
波長470nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度をA2とした場合において、
A1<0.08
A2<0.5
の2つの式の関係がともに成立する場合には、前記第2の判断において、前記吸光特性のデータの値が前記所定の範囲内にあるものとされる、分析装置。 - 請求項13に記載の分析装置であって、
前記吸光特性のデータは、下記の式により計算される計算値Bである、分析装置。
B=(A4-A5)/(A3-A5)
(ただし、A3、A4、およびA5は、それぞれ波長525nm付近、波長470nm付近、および波長635nm付近の光に対する前記尿の吸光度である。) - 請求項16に記載の分析装置であって、
B<5.30が成立するか否かの判定を行うように構成されている、分析装置。 - 請求項17に記載の分析装置であって、
B<5.30の関係が成立する場合には、前記第2の判断において、前記吸光特性のデータの値が前記所定の範囲内にあるものとされる、分析装置。 - 請求項17に記載の分析装置であって、
B<5.30の関係が成立しない場合には、更にA6<0.54の関係が成立するか否かが判定され、A6<0.54の関係が成立する場合に、前記第2の判断において、前記吸光特性のデータの値が前記所定の範囲内にあるものとされる、分析装置。
(ただし、A6は、波長470nm付近の光に対する前記尿の吸光度であって、光路長10mm当たりの吸光度である。) - 請求項11ないし19のいずれかに記載の分析装置であって、
前記第2の判断の結果を認識させるためのデータを、データ出力手段を用いて出力することが可能な構成とされている、分析装置。 - 請求項11ないし20のいずれかに記載の分析装置であって、
前記呈色反応において、所定の異常発色が生じたときに、その旨が検出されるように構成されている、分析装置。 - 尿中の特定成分と試薬との呈色反応に基づいて、前記特定成分の陽性または陰性の区別についての第1の判断が可能な判断手段と、
前記尿自体の所定波長域の光に対する吸光特性のデータを求めることが可能な光学測定手段と、
を備えている分析装置の前記判断手段にデータ処理を行なわせるためのプログラムであって、
前記吸光特性のデータの値が所定の範囲内にあり、かつ前記第1の判断ステップにおける判断結果が陽性および陰性のうちの予め定められた一方であるときに、前記判断結果を偽陽性もしくは偽陰性に改め、または偽陽性もしくは偽陰性の可能性があるとの第2の判断を、前記判断手段に実行させるためのデータを含んでいることを特徴とする、プログラム。 - 請求項22に記載のプログラムを記憶していることを特徴とする、記憶媒体。
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JP2015057585A (ja) * | 2013-09-16 | 2015-03-26 | 株式会社テクノメデイカ | 呈色反応を用いた定性分析における尿中ケトン体の偽陽性反応判定方法及び同判定方法を用いた定性分析装置 |
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WO2014126995A1 (en) | 2013-02-14 | 2014-08-21 | Siemens Healthcare Diagnostics Inc. | Reduction of false positive on reagent test devices |
JP2016510417A (ja) * | 2013-02-14 | 2016-04-07 | シーメンス・ヘルスケア・ダイアグノスティックス・インコーポレーテッドSiemens Healthcare Diagnostics Inc. | 試薬検査装置での偽陽性を低減する装置 |
EP2956575A4 (en) * | 2013-02-14 | 2017-03-01 | Siemens Healthcare Diagnostics Inc. | Reduction of false positive on reagent test devices |
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JP2015057587A (ja) * | 2013-09-16 | 2015-03-26 | 株式会社テクノメデイカ | 呈色反応を用いた定性分析における尿中ウロビリノーゲンの偽陽性反応判定方法及び同判定方法を用いた定性分析装置 |
JP2015057585A (ja) * | 2013-09-16 | 2015-03-26 | 株式会社テクノメデイカ | 呈色反応を用いた定性分析における尿中ケトン体の偽陽性反応判定方法及び同判定方法を用いた定性分析装置 |
Also Published As
Publication number | Publication date |
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JP5770724B2 (ja) | 2015-08-26 |
EP2579035A1 (en) | 2013-04-10 |
CN102918393A (zh) | 2013-02-06 |
JPWO2011152238A1 (ja) | 2013-07-25 |
CN102918393B (zh) | 2014-11-05 |
US20130071939A1 (en) | 2013-03-21 |
EP2579035A4 (en) | 2016-03-02 |
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