JPH04109148A - Analyzer - Google Patents

Abstract

PURPOSE:To prevent the error of the evaluation based on the inspection result by judging the reliability of the measured result of a reagent layer related to a reagent from the measured result of the preset reagent. CONSTITUTION:When a test tool 4 is mounted on a tray face 30 and a switch 91 is turned on, a tray 3 is moved into a device main body 2. When the preset color reaction time for each reagent layer 41 elapses, a signal is sent to a constant-current controller 8, and a drive current is applied to a luminous source 51 for emission. The reflected light is fed to a light receiving element 52, and the color intensity of each reagent layer 41 is converted an electric signal as the reflected light intensity. The output of the element 52 is inputted to a microcomputer 6 via an A/D converter 12. Each input value from the element 52 is compared with the calibration curve data stored in advance, whether it is negative or positive is judged, or the content in urine is calculated. The color intensity of the reagent layer 41 is compared with the calibration curve data to calculate the content. Ascorbic acid and the pH value are evaluated, if they are normal values, the measured result is outputted.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to an analyzer for analyzing and measuring components of a specimen such as urine using a test device.

<Conventional technology> Conventionally, for example, when detecting components in urine, a test device has been used that is equipped with a reagent layer that changes color when it comes into contact with each component of the urine. The presence or absence and amount of the component is determined by the determination. As a method for determining the color intensity of such a reagent layer, a method is used in which the reagent layer is set in an analyzer and the color intensity is determined optically.

On the other hand, the reagents constituting each reagent layer are affected by other components and elements of the detection component, such as the concentration of ascorbic acid and the p)l value, and the color reaction with the substance to be detected is affected. Therefore, the color intensity may not be able to accurately indicate the amount or presence of the substance.

For example, when measuring the amount of sugar in a sample, the coloring principle of the reagent layer is as shown in the formula below.
It is decomposed into gluconic acid and hydrogen peroxide by an enzyme called D), and this hydrogen peroxide is decomposed into water and oxygen atoms by an enzyme called peroxidase (POD), and this oxygen atom reacts with a chromogen (color former). It becomes a pigment.

GOD Glucose + O8 --- gluconic acid decaH,O.

GOG Oxygen atoms decomposed from hydrogen oxide cannot react with the chromogen, and the reagent layer may give a false negative. Also,
Ascorbic acid exerts a similar effect on the reaction of hemoglobin with reagents.

Furthermore, tetrabromophenol blue (hereinafter referred to as rTBPBJ) is used to detect proteins in a sample. When TBPB is dissolved in water, it dissociates and shows a blue color, and when the pH of the solution is low, dissociation is suppressed and the solution becomes colorless. On the other hand, in an aqueous solution with a low pH, protein is positively charged and forms an ion bear with TBPB, which prevents dissociation from being suppressed, and TBPB turns blue. Since the discoloration range of TBPB is at pH 3 to 4, the pH of the test paper is maintained at 3 by containing a buffer in the test paper, and the presence or absence of protein is detected.

However, if the pH of the urine exceeds 8, the buffering agent in the test strip loses its pH-maintaining effect, and the pH of the test strip approaches 4, causing it to turn blue even in the absence of protein.

In such a case, there is a high possibility that the judgment obtained by setting the test device in the analyzer will be incorrect, and as a result, the test results may be evaluated incorrectly, which is a problem.

<Problems to be Solved by the Invention> An object of the present invention is to provide an analytical device that does not make mistakes in evaluation based on test results when measuring the color intensity of a reagent layer of a test device.

<Means for Solving the Problems> Such objects are achieved by the present invention described in (1) and (2) below.

(1) In an analyzer that measures the color intensity of two or more types of reagent layers that develop color upon contact with sample components, the reliability of the measurement results of related reagent layers based on the measurement results of a predetermined reagent layer An analysis device characterized by having a function of determining.

(2) The analyzer according to (1) above, which has a function of displaying or warning when there is doubt about the reliability of the measurement result of the related reagent layer.

<Function> The analyzer measures the color intensity of two or more colored reagent layers. Based on the measurement results of a given reagent layer,
The reliability of the measurement result of the reagent layer of a specimen related to the specimen detected by the reagent layer is determined.

If there is any doubt about the reliability, a notification to that effect is provided to prevent incorrect judgments by the measurer.

To give a more specific example, when the predetermined reagent layer detects ascorbic acid, the reliability of the coloring reaction of the reagent layer, such as glucose, may be determined based on the amount of ascorbic acid. I can do it. Similarly, if the predetermined reagent layer is for detecting pl, then p
Depending on the value of H, for example, the reliability of the color reaction of the reagent layer such as protein can be determined.

<Embodiments> Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

FIG. 2 is a partial perspective view of the analyzer. In the illustrated example, the analyzer 1 is in a standby state with the tray 3 coming out from inside the main body 2 of the analyzer 1.

A test device 4 in contact with a specimen is placed on the tray 3. The tray 3 on which the test device 4 is placed moves into the apparatus main body 2, and the test device 4 placed on the tray surface 30 is conveyed to the measurement section 5 within the apparatus main body 2.

On the other hand, the test device 4 includes a strip-shaped support 40 and reagent layers 4 arranged on the support 40 at equal intervals from one end of the support 40.
It is composed of 1.

The test device 4 of this embodiment uses urine as a specimen. As the material of the support 40, for example, materials having a certain degree of rigidity such as plastics such as polystyrene, polyethylene terephthalate, polyvinyl chloride, polyvinyl acetate, polypropylene, celluloid, ceramics, and metals are used. As the layer 41, reagents for detecting, for example, glucose, hemoglobin, protein, ascorbic acid, pH, etc. in urine are used.

In this embodiment, five reagent layers 41 are arranged.
Here, an example of the detailed composition of each reagent layer 41 will be described below.

Glucose reagent layer (first solution) Glucose oxidase 300g Peroxidase 50g Quen M
1g trisodium citrate
7g tartrazine
O, 1g Sodium alginate 0.5g
This is dissolved in water 1001 to obtain a first liquid, and a filter paper is impregnated with this first liquid, and then dried in an oven at 40°C for 50 minutes.

(Second liquid) Obtained by dissolving 2.5 g of o-tolidine in 100+aj of acetone, impregnating the dried filter paper, and drying in an oven for 40'' Cl2O minutes.

Hemoglobin reagent layer (first solution) 2,5-dimethylhexane-2,5-dihydroperoxide 0.4 g p-)luenesulfone-N-diethylamide (stabilizer) 5 g Sodium dioctyl sulfosuccinate 1.5 g solution in 100 mj of ethanol .

(Second liquid) Acrylamide 10 g Polyethylene glycol 4000 10 g Citric acid
1g trisodium citrate
A solution of 9 g in 100 ml of water.

(3rd liquid) o-tolidine 1.2g 3-aminoquinoline 0.5g benzene 100
Solution according to m1.

Starting with the first liquid, each liquid is impregnated into a filter paper and dried in an oven repeatedly. Regarding the drying temperature and time, the first liquid and the third liquid were dried at 40°C for 20 minutes, and the second liquid was dried at 40°C for 50 minutes.

Protein reagent layer T B P B 40 mg
Obtained by impregnating a filter paper with an aqueous solution of 20 mg of polyvinylpyrrolidone, 10 g of citric acid, 4 g of trisodium citrate and 100 μl of water, and drying in an oven at 40° C. for 50 minutes.

Ascorbic acid reagent layer 2.6-dichlorophenol/indophenol 50mg Methyl orange 20mgKH, PO40,
A filter paper is impregnated with an aqueous solution of 08 g Na m HP O4 1.34 g of 901 in water and dried in an oven at 40° C. for 50 minutes.

A pH reagent layer is obtained by impregnating a filter paper with a solution of 2 mg of methyl red, 20 mg of bromothymol blue, and 6 g of polyvinyl birodrine in 100 ml of ethanol, and then drying it in an oven at 40° C. for 50 minutes.

As already mentioned, the composition explained above is just an example.
The test device 4 may have a reagent layer made of other composition components.

As a method for measuring the coloring intensity of the reagent layer 41 of the test device 4 as described above, in this embodiment, in the measuring section 5, light from a light source is reflected by the reagent layer 41, and the reflected light is measured. method, but other methods can also be used.

FIG. 3 is a block diagram of the measurement control system provided within the main body 2 of the apparatus.

As shown in FIG. 3, the specific configuration of the measuring section 5 is as follows.
It consists of a light emitting source 51 that emits light at an angle of 45 degrees with respect to the surface of the reagent layer 41, and a light receiving element 52 provided at right angles to the surface of the reagent layer 41. The color intensity of the reagent layer 41 is determined based on the light intensity. In the apparatus of this embodiment, the measuring section 5 including the light emitting source 51 and the light receiving element 52 is configured as a photometric array provided at a position corresponding to each reagent layer 41. At this time, the photometric array measures each reagent layer 41 at a predetermined color reaction time. When the measurement is completed, the tray 3 moves again and returns to the standby position. Inside the device main body 2, a micro combinator 6 is installed as a control means.
is provided. A constant current control section 8 that serves as a power source for the display section 7 and the light emitting source 51 is connected to the output side of the microcomputer 6. The display unit 7 includes a print output unit 72 that prints the measurement results for each component on a sheet 71 such as roll paper based on the output signal from the microcomputer 6, and a display that displays status and operation instructions. It consists of 73.

On the other hand, the constant current control unit 8 controls the power transmission to the light emitting source 51 based on the output signal from the microcomputer 6.

Further, an operating section 9 provided toward the outside of the device main body 2 is connected to the microcomputer 6 .
Further, the reference numeral 10 in the figure indicates a power source.

An output signal indicating the coloring intensity from the light receiving element 52 constituting the measuring section 5 is amplified by the amplifier 11, and the amplified signal indicating the coloring intensity is sent via the A/D converter 12.
It is input to the microcomputer 6.

FIG. 1 is a flowchart showing the operating procedure of the microcomputer 6. As shown in FIG. The operation of the measurement control system configured as described above will be explained based on FIG. 1.

When the power switch 101 of the apparatus main body 2 is turned on, an internal check is performed within the apparatus main body 2, and if there is a problem such as the sheet 71 being cut, an error message is displayed on the display 73 of the display section 7. If there is no abnormality,
The tray 3 is moved to the standby position, and a standby sign is displayed on the display 73 of the display section 7. When the test device 4 is placed on the tray surface 30 and the start switch 91 is turned on, the tray 3 moves into the apparatus main body 2. Then, when a predetermined color reaction time for each reagent layer 41 has elapsed, a signal is sent to the constant current controller 8, and a driving current is applied to the light emitting source 51 to cause it to emit light.

The light emitted from the light emitting source 510 causes reflected light to enter the light receiving element 52, and the coloring intensity of each reagent layer 41 is converted into an electric signal as the reflected light intensity.

The output of the light receiving element 52 is transmitted to the amplifier 11 and the A/D converter 12.
The signal is input to the microcomputer 6 via the .

Each input value from the light receiving element 52 is first compared with pre-stored calibration curve data to determine whether it is negative or positive, or to calculate the content in urine. The content can be calculated by comparing the color intensity of the reagent layer 41 and the calibration curve data.

Next, the values of ascorbic acid and pH are evaluated, and if the values are normal, the measurement results are output. Figure 4a shows
FIG. 7 is a plan view of a sheet 71 punched out from the apparatus main body 2, showing an example of output results when the ascorbic acid and pH values are normal.

On the other hand, as mentioned above, if the ascorbic acid and pH values are above the preset reference values, the color reaction of the reagent is judged to be unreliable, and glucose, hemoglobin, and protein A predetermined mark 74 is printed after or simultaneously with printing the measurement results.

Furthermore, to explain this point in detail, when a reagent having the composition described above is used as a reagent in the reagent layer 41 of the test device 4,
Ascorbic acid in urine is about 10-25 mg/di,
Alternatively, if the glucose content is higher than that, the color reaction of the glucose reagent layer shows a false negative reaction even if the urine is originally positive. In addition, the color reaction of the hemoglobin reagent layer indicates that 10 to 25 mg of ascorbic acid is present in the urine.
When it is contained at a ratio of about /dl or more, a false positive reaction similar to that of the glucose reagent layer occurs.

On the other hand, when the pH of urine reaches about 8, a false positive reaction occurs even if the urine is originally negative. Therefore, these values are stored in advance for each measurement item, and each measurement item is compared and evaluated, and the measurement results of the predetermined items (ascorbic acid and pH in this example) are determined based on these values. For those that have reached the target, a mark 74 is printed at the same time to inform the measurer of the possibility of an erroneous determination.

Figure 4b shows items with unreliable measurement results marked 7.
4 is printed, and the output sheet 7
1 is a plan view of FIG.

As a means to notify that measurement results are unreliable,
An alarm may be displayed on the display 73 (or an alarm lamp may be provided and lit or blinking).
If there is a single item that can determine the reliability of the measurement results,
It is also possible to use an auditory notification means such as a buzzer.

When the output of the measurement results is completed, the tray 3 returns to the standby position, the test tool 4 is removed, and the test tool 4 is placed in a standby position for the next measurement. The standby sign is displayed again on the display 73 of the display unit 7.

Furthermore, the correlation between the content of ascorbic acid and the color intensity of the reagent layer is memorized in advance, and the measurement results of glucose and hemoglobin are corrected and displayed based on the color intensity of the ascorbic acid reagent layer. It is also possible. In this case, a mark 74 may be printed to notify that it is a correction value.

The embodiments described above are intended for test devices that use urine as a sample, but they can also be used for test devices that use other samples such as blood. Furthermore, the measurement means is not limited to optical measurement, but can also be used in analysis devices using other means, such as devices that measure based on changes in the electrical properties of a reagent layer.

<Effects of the Invention> As explained above, according to the present invention, the reliability of the measurement results of the analyzer is improved, and erroneous determinations are reduced by accurately understanding the sample components.

[Brief explanation of the drawing]

FIG. 1 is a flowchart showing the operation of the control means provided within the main body of the apparatus of the present invention. FIG. 2 is a partial perspective view of the analyzer. FIG. 3 is a block diagram of a measurement control system provided within the main body of the apparatus of the present invention. Figure 4 is a plan view of the printed and outputted sheet.
Fig. 4a shows a case where the measurement result is reliable, and Fig. 4b shows a state where marks are printed on items where the measurement result is unreliable. Explanation of symbols 1...Analyzer 2...Device body 3...Tray 30...Tray surface 4...Test device 40...Support 41...Reagent layer 5...Measurement part 51... Light emitting source 52... Light receiving element 6... Control means 7... Display section 71... Sheet 72... Print output section 73... Display 74... Mark 8... Constant current control section 9...Operation section 10...Power source 11...Amplifier 12...A/D converter Patent applicant Terumo Corporation Company representative
Person Patent Attorney Yo Ishii - Same
Patent Attorney Increase 1) Tatsuya FIG, 2 FIG, 4a FIG, 4b

Claims (2)

[Claims] (1) In an analyzer that measures the color intensity of two or more types of reagent layers that develop color upon contact with sample components, the reliability of the measurement results of related reagent layers based on the measurement results of a predetermined reagent layer An analysis device characterized by having a function of determining. (2) The analyzer according to claim 1, which has a function of displaying or warning when there is doubt about the reliability of the measurement result of the related reagent layer.