JP2002040022A - Test paper analytical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a test jig analytical device capable of measuring easily, for example, in the state where a test jig is placed on a cup, similarly to conventional visual determination, and being utilized smoothly in bedside medical examination or regional medical examination. SOLUTION: A test body component analytical device of a measuring test jig has a measuring part equipped with a detector for measuring reflected light and a control part installed separately or integrally with the measuring part. In the device, a test jig reading part facing to the measuring test jig is installed in the measuring part, and an operation part for comparing the difference of measured values caused by fluctuation of the distance between the measuring test jig and the detector in each measurement with a reference and correcting it is installed in the control part, and the measuring part is formed movably by manual operation.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test device analyzer capable of accurately measuring a sample component simply by making a test device reading unit face a test device to be measured. The present invention relates to a test tool analyzer that can be freely moved manually (manually) and can be measured directly at a bedside or the like.

[0002]

2. Description of the Related Art When measuring the concentration of components in a blood sample such as urine, blood, plasma, serum, etc. using a test device in which a test paper strip having a reagent layer is provided on a support such as a plastic strip, a conventional reagent is used. It has been performed by observing the degree of coloration of the layer visually or by an optical analyzer using a reflectometer.

As such an apparatus, for example, Japanese Patent Laid-Open
The apparatus described in Japanese Patent Application Laid-Open No. 0-31011 and Japanese Patent Application Laid-Open No. 8-43387 are exemplified.

[0004] Such a conventional device is so large that it cannot be easily carried around, and it is necessary to hold the test device in a test device reading section of the device. This is because the distance from the detector for each measurement can be made constant by holding the test tool at a fixed position.

[0005]

However, it is convenient to collect urine at the bedside and measure it on the spot in the case of a sick person after surgery or a bedridden sick person. It could not be used for this purpose, because it was not possible to move the test paper and measure it against the test paper.

[0006] In addition, urinalysis in regional examinations is very late in terms of mechanization, and there are still many visual judgments at present. The reason is that when measuring with the device, it is necessary to collate the subject, the sample, and the data, and the test takes time, but visually, dip the test equipment in the urine cup in front of the person and place it on the cup This is because the result can be understood by waiting for 10 to 30 seconds, so that about 10 persons can perform the test simultaneously and in parallel, and can perform the test efficiently.

[0007] The present invention has been made in view of such a point, and can be easily measured, for example, in a state where a test tool is placed on a cup, as in the case of conventional visual judgment, and the bedside It is an object of the present invention to provide a test tool analyzer that can be used for medical examinations and regional medical examinations without any trouble.

[0008]

In order to achieve the above object, the present invention provides a measuring unit having a detector for measuring reflected light, and a control unit provided separately or integrally with the measuring unit. In the sample component analyzer for a measurement test device having a measurement device, the measurement unit is provided with a test device reading unit facing the measurement test device, and the measurement caused by a change in the distance between the measurement test device and the detector for each measurement. An arithmetic unit for correcting the difference between the values compared to the standard is provided in the control unit, and the measuring unit is configured to be manually movable.

Here, the fact that the measuring unit can be moved manually means that the measuring unit can be moved alone (manually) as a single unit or as a whole. In addition, the variation in the distance between the test device and the detector means that not only the distance from the detector but also the inclination in the vertical or horizontal direction,
The meaning includes a change in distance due to a twist or the like.

[0010] In short, the present invention has a feature that the measuring unit can be moved manually, and the resulting variation in the distance between the test tool and the detector can be corrected as compared with the standard. It is. Conventionally, there has been no known analyzer that can move the measuring unit manually so as to face the test device, and no idea has been known.

[0011]

Next, an embodiment of the present invention will be described.

As a test device used in the present invention, a urine test device, an immunochromatographic test device, a biochemical substance detection test device (sugar, pregnancy, etc.), a dry chemistry leaf film, and the like can be used. It is preferred to do so.

As the light source, an LED, a fluorescent lamp, a tungsten lamp or the like can be used. However, since the device can be downsized and the generation of heat can be suppressed,
In particular, it is preferable to use an LED. It is also preferable to use a small fluorescent lamp because the size of the apparatus can be reduced.

The left side of FIG. 1 is a schematic sectional view showing an example of the measuring unit (detection module) 6 of the present invention. The lower end of the detection module 6 is formed in a step, and the recessed portion of the step is a test tool. The reading unit 16 is provided. The test tool reading unit 16 may be a recess instead of a step. Also, it may be flat.

The measuring test tool 4 is located close to the test tool reading section 16, and the calibration plate 1 is held in a protruding portion 17 at the lower end of the detection module 6.

As shown in FIG. 1, a test strip 4 for measurement is arranged such that a test strip 4 (eight pieces) of an item to be measured and the eight test strips 5 are vertically sandwiched between elongated plastic strips 18 as shown in FIG. And white standard pieces 2 and 2 provided in the above.

As shown in FIG. 1, the calibration plate 1 includes a colored standard piece (eight pieces) 3 and a white standard piece 2 which are colored in a color (a color that frequently occurs) of the test paper piece 5 of the item to be measured. , 2. The test strip 5 and the colored standard strip 3 correspond to the same items.

The white standard piece 2 comprises a plastic piece 18
If it has a standard role, it does not need to be provided as a white standard piece. In short, it is only necessary that a white standard part is provided. However, in order to measure more accurately, it is better to detect the image as a predetermined shape image. Therefore, as shown in FIG.
8 is good.

A plurality of white standard pieces 2 are preferably provided so as to sandwich the test piece. In particular, as shown in FIG. 1, the white standard pieces 2 are preferably provided outside the test pieces 5 at both ends. Correction can also be made by providing a white standard piece in only one place and measuring the reflected light at two points in the white standard piece, but to measure more accurately,
It is preferable to provide two or more white standard pieces and detect the white standard pieces as an image.

The white standard piece 2 is formed of a material that completely repels a blood sample such as urine or blood, blood plasma, serum, or the like, or of a material that completely repels a urine or blood sample. It is preferable to select a material whose reflected light does not change before and after immersion in urine or the like, such as a material whose surface is coated.
This is because, when urine or the like adheres, reflected light from the white standard piece 2 of the calibration plate for each measurement clearly differs greatly. The white standard piece 2 of the measurement test tool and the white standard piece 2 of the calibration plate are formed of the same material, and emit the same reflected light signal.

As shown in FIGS. 1 and 2, above the calibration plate 1 and the measuring test tool 4, a measuring optical system, that is, a lens system 9, a detector 10, and light sources 7, 7 are arranged. . The lens system may use a plurality of lenses or may have an aperture on the lens. Note that a lens is not always necessary.

The lens system 9 has a function of forming images of the white standard piece 2 and the colored standard piece 3 of the calibration plate 1 and the white standard piece 2 and the test paper piece 5 of the measuring test tool 4 on the detection surface of the detector. The detector 10 calculates the amounts of light reflected from the white standard piece 2 and the colored standard piece 3 of the calibration test paper 1 and the white standard piece 2 and the test paper piece 5 of the measuring test tool 4 into R, G, and B. It has a function of measuring separately.

As the detector 10, any sensor having a light receiving element may be used. For example, a photocell, an image sensor, and a CCD sensor can be used.

Since the photocell can only correct the black-and-white degree (brightness), if abnormal coloring occurs, it is impossible to distinguish between normal coloring and abnormal coloring, so that the color information (hue, saturation,
It is preferable to use a color image sensor or a color CCD sensor that can also correct the brightness. In order to obtain accurate data, it is preferable to use a CCD sensor, especially a color CCD sensor.

On the ceiling above the light source 7, a diffusion plate 8 is provided. By providing the diffusion plate 8 as described above, the light from the light source can be uniformly and uniformly irradiated on the calibration plate 1 and the measurement test tool 4, and accurate measurement can be performed.

FIG. 3 is a block diagram showing an embodiment of the apparatus according to the present invention, which comprises a stabilized power supply 11 for stabilizing the light source output of the detection module 6 and a control unit (body module). The unit includes an example composed of a signal extraction (amplification) / A / D conversion circuit 12, a memory (including a signal storage memory and a reference value storage memory) 13, an operation unit 14, and a result output unit 15. Show.

Signal extraction (amplification) A / D conversion circuit 12
Has a role of converting an analog value corresponding to the measured light amount into a digital value and storing the digital value in a memory location of the signal storage memory 13 determined in advance according to the signal type.
In addition, the amplification in parentheses means that it is not necessary to exist.

The reference value storage memory stores a colored standard strip 3 colored in a color that the test strip 5 of the item to be measured is colored.
The reflected light of the calibration plate 1 having a white light and a white standard piece 2 is measured at a predetermined distance from the detector 10, and is similarly stored separately for each standard piece into R, G, and B. is there.

The calculation unit 14 calculates the correction of the measuring optical system and the correction of the measuring object using the data in the signal storage memory and the reference value storage memory, and performs rank determination for each measurement item.

The result of the rank determination obtained in this way is displayed on a liquid crystal display (LCD) of the result output unit 15 and can be printed by a printer.

FIG. 4 shows another embodiment of the present invention, in which the present invention is applied to a micro urine test piece.

That is, in the multi-item urine test device 5 'of the test device 4, micro urine test paper strips of all items for one sample are provided in a range which can be wet by a single drip of urine. The size of the micro urine test paper is generally such that the diameter of the micro urine test piece or the length between the opposing sides is equal to 0.
It has a size of 5 to 2.5 mm.

In the above embodiment, a total of nine multi-item urine test strips (not shown) are fixed vertically and horizontally on a multi-item urine test device 5 'having a size of 1 cm ² .

The light source 7 is formed in the same manner as the embodiment shown in FIGS. 1 and 2 except that a ring-shaped light source 7 is used. As a light source, a shape similar to the object to be measured is
It is preferable because irradiation can be performed uniformly. The micro urine test paper strip is formed in a ring shape because the outer shape of the arrangement is substantially square. In the embodiment shown in FIG. 1, since a stick-shaped test device arranged in a straight line is used, a straight tube light source is used.

The calibration plate 1 is formed such that a colored standard plate 3 provided with a colored standard piece is vertically sandwiched between white standard pieces 2 and 2.
The test device 4 is configured such that a multi-item urine test device 5 ′ is vertically sandwiched between white standard pieces 2 and 2. Similarly to the micro urine test strip provided on the multi-item urine test device 5 ', nine colored standard strips (not shown) are immobilized at the same positions as the micro urine test strip. Have been. For more accurate measurement, the white standard pieces 2, 2
It is preferable that the multi-item urine test device 5 'is sandwiched between left and right.
In this way, the inclination of the urine test device 4 in the left-right direction can be corrected more accurately.

FIG. 5 shows a specific example of the present invention. A measuring section (leader section) is formed in a bar code reader type, and a control section (main body section) 2 is connected by a lead wire 19.
3 shows an example of the connection. The test tool reading section 16 is formed in a concave portion, and can be measured only by touching the test tool 4 on the cup 20 from above. In FIG. 5, reference numeral 21 denotes a display unit, and reference numeral 22 denotes a printer. In addition, lead wire 19
Alternatively, data exchange between the measurement unit and the control unit may be performed using wireless communication means such as infrared communication means.

In the present invention, the test device reading section and the measurement test device can be measured even if they are separated from each other. If a certain amount of light that can be used as data is obtained from the white standard piece and the test paper piece formed opposite to the measurement test tool, and if these can be imaged on the detector as those having a certain shape, measurement is possible. is there. When the measurement can be performed in this manner, a beep sound or another sound generated when reading with a barcode reader may be generated, or a display may be formed on the display unit 21.

Next, the operation of the arithmetic unit 14 of the above embodiment will be described. The calculation unit 14 performs (A) measurement optical system correction (B) measurement target correction (C) reflectance calculation for each measurement item (D) rank determination for each measurement item. The correction of (A) includes correction of a white standard plate (correction 1) and the correction of a colored standard piece (correction 2). The correction of (B) includes correction of a white standard plate (correction 3) and a test piece. (Correction 4). Hereinafter, each will be described.

The reference value is obtained by measuring the reflected light of the calibration plate 1 having the colored standard piece 3 and the white standard piece 2 which are colored to the color of the test paper piece 5 of the item to be measured by the detector ( The measured value at a predetermined distance from 10 (using a color CCD sensor) is stored in a reference value storage memory. In this case, the reflected light signals of the white standard pieces above and below the calibration plate were stored in the same manner. (A) Measurement optical system correction: Corrects the fluctuation due to the measurement optical system.

(Correction 1) White standard piece correction: The measured values of the upper and lower white standard pieces on the calibration plate are corrected. The correction coefficients of the (upper) white standard piece and the (lower) white standard piece are calculated by the following equations. In the equation, the correction 1 (upper) coefficient represents the correction coefficient of the (upper) white standard piece, and the correction 2 (lower) coefficient represents the correction coefficient of the (lower) white standard piece. This correction corrects the fluctuation of the output intensity of the light source and the fluctuation of the detection sensitivity of the detector.

Correction 1 (upper) coefficient = calibration plate white standard piece (upper) reference value / calibration plate white standard piece (upper) measured value Correction 1 (lower) coefficient = calibration plate white standard piece (lower) reference value / calibration In this example, the upper and lower reference values of the white standard piece are:
The same value was set.

(Correction 2) Colored standard piece correction: For each of the colored standard pieces (n = 2 to n = 9 in FIG. 6) of the calibration plate,
The measured values of R, G, and B are corrected. The respective correction coefficients of R, G, and B of the colored standard pieces 2 to 9 are obtained by the following equations. In the formula, n represents 2 to 9, and m represents R, G or B. This correction corrects the fluctuation of the emission wavelength of the light source and the fluctuation of the detection wavelength characteristic of the detector.

Correction 2 nm coefficient = nm reference value of calibration plate coloring standard piece / (measured value of calibration plate coloring standard piece × A) In the above formula, A represents the following meaning.

When correction 1 (upper) coefficient ≧ correction 1 (lower) coefficient A = correction 1 (lower) coefficient + (correction 1 (upper) coefficient−correction 1
(Lower coefficient) × (10−n / 10−1) When correction 1 (upper) coefficient ≦ correction 1 (lower) coefficient A = correction 1 (upper) coefficient + (correction 1 (lower) coefficient−correction 1
(Top) Coefficient) × (n-1 / 10-1) (B) Correction of measurement target: White standard piece and test piece of test paper for measurement are corrected.

(Correction 3) White standard piece correction: The measured values of the upper and lower white standard pieces of the measurement test paper are corrected. The correction coefficients of the (upper) white standard piece and the (lower) white standard piece are calculated by the following equations. In the formula, the correction 3 (upper) coefficient represents the correction coefficient of the (upper) white standard piece, and the correction 3 (lower) coefficient is (lower)
Represents the correction coefficient of the white standard piece. This correction corrects the vertical distance between the test paper and the measuring unit and the horizontal twist.

Correction 3 (upper) coefficient = reference value of test paper white standard piece (upper) reference value / (measurement test paper white standard piece (upper) measured value × correction 1 (upper) coefficient) Correction 3 (lower) coefficient = White standard piece for measurement (lower) reference value /
(Measurement test paper white standard piece (bottom) measured value x correction 1 (bottom)
Coefficient) The standard value of the test paper white standard (upper) and the standard value of the test paper white standard (lower) are the reference value of the calibration plate white standard (upper) and the reference value of the calibration plate white lower (lower), respectively. Reference values were used.

(Correction 4) Test piece correction: For each of the test pieces (n = 2 to 9 in FIG. 6) of the test paper for measurement, R,
The measured values of G and B are corrected. By the following formula,
The respective correction coefficients of R, G and B of the test pieces n = 2 to 9 are obtained. In the formula, n and m represent the above-mentioned meaning.

Correction value of nm for test piece of test paper = measured value of nm for test paper piece for measurement × correction 2 nm coefficient × B In the above formula, B represents the following meaning.

When correction 3 (upper) coefficient ≧ correction 3 (lower) coefficient B = correction 3 (lower) coefficient + (correction 3 (upper) coefficient−correction 3
(Lower coefficient) × (10−n / 10−1) When correction 3 (upper) coefficient ≦ correction 3 (lower) coefficient B = correction 3 (upper) coefficient + (correction 3 (lower) coefficient−correction 3
(Upper) coefficient) × (n−1 / 10−1) In the formula, n and m represent the above-mentioned meaning. C) Calculation of reflectance for each measurement item Using the nm correction value of the test strip for measurement obtained as described above and the reference value of the calibration plate white standard piece (upper), the reflectance for each measurement item by the following formula: Is calculated.

Reflectance of test paper strip nm for measurement = (correction value of test paper strip for measurement / reference value of white standard piece for calibration plate (upper)) × 100 In the formula, n and m represent the above-mentioned meanings. (D) Rank determination for each measurement item For example, it is determined whether or not the following expression is within the range of thm (k) ≦ nm test piece reflectance <thm (k + 1).

In the equation, th represents a threshold value for rank determination, and is a value predetermined for each measurement item and each rank.
k represents, for example, a rank number from 1 to 10, and n and m represent the above-mentioned meaning.

In the present invention, although the measurement accuracy is slightly lowered, the correction can be made by using only one of the calibration plate and the reference value stored in the reference value storage memory as a standard. In this case, except that the correction of the colored standard piece is not performed,
It can be carried out in the same manner as described above.

That is, a correction coefficient was determined so that the standard white standard piece and the white standard piece of the measuring test tool coincided with each other, and a straight line was obtained from the correction coefficients of the two white standard pieces of the measuring test tool thus obtained. , The correction coefficient for each test strip is similarly determined from this straight line, and the correction coefficient may be multiplied by the measured value of each test strip.

In the above embodiment, since a urine test device is used as a test device, the measurement is performed with the test device reading section brought close to the test device, but blood samples such as blood, plasma, and serum are dropped. When the measurement is performed using a so-called blood component measurement test device (for example, a dry chemistry leaf film or the like) in which the result of the reaction is measured from the side opposite to the dropping surface, for example, as shown in FIG. In addition, the target measurement can be performed by bringing the test device reading unit close to the lower surface of the test device. When plasma, serum, or the like is used as a sample, a test device for measuring blood components or a urine test device may be used for measurement from above.

According to the present invention, since the measuring section can be freely moved and the measuring section only has to be opposed to the measuring test device, the measurement can be immediately performed anywhere on the spot. This is an excellent function not found at all in the conventional test device analyzer.

In the analyzer according to the present invention, the measuring section and the control section may be integrated or separate. However, if they are connected as separate bodies by, for example, lead wires, the control section can be carried in a pocket. This is very convenient because the measurement can be performed only by facing the measuring unit to the test device for measurement.

[0057]

As described above, according to the present invention, there is provided a conventional test device analyzing apparatus of this kind, in which measurement can be performed manually (manually) and measurement can be performed only by facing the test device for measurement. By adopting a configuration that cannot be seen at all, bedside examinations, which were difficult with conventional analyzers, can be performed easily, and regional examinations and the like can be performed without visual inspection, making it easy and accurate. And the advantage is extremely large.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing one embodiment of a measuring section of the present invention, and a plan view showing one embodiment of a calibration plate and a measuring test device.

FIG. 2 is a plan view showing an internal state of a measurement unit of the present invention.

FIG. 3 is a block diagram showing one embodiment of the device of the present invention.

FIG. 4 is a cross-sectional view showing another embodiment of the measuring section of the present invention, and a plan view showing another embodiment of the calibration plate and the measuring test tool.

FIG. 5 is a perspective view showing one embodiment of the device of the present invention.

FIG. 6 is a plan view showing a calibration plate (measurement test device).

FIG. 7 is a sectional view showing another embodiment of the measuring section of the present invention.

[Explanation of symbols]

1 ······························································································· Multi-item urine test 5 ″ ……………………………………………………………………………………………………………………………… ····································································· Detector 11 Stabilized power supply 12 Signal extraction (amplification) A / D conversion circuit 13 Memory (signal storage memory, reference value storage memory) 14. Operation unit 15 Result output unit 16 Test device reading unit 17 Inside the protruding portion 18 Plastic piece 19 Lead wire 20 Cup 21 Display Unit 22 Printer 23 Control unit (Main unit)

 ──────────────────────────────────────────────────の Continued on the front page (72) Inventor Haruki Oishi 6-1 Takada-cho, Amagasaki-shi, Hyogo Wako Pure Chemical Industries, Ltd. Osaka Research Laboratory F-term (reference) 2G045 AA01 AA15 CB03 FA11 FB17 FB18 GC11 JA02 2G054 AA07 EA05 FA33 GE06 JA05 JA08

Claims (15)

[Claims] 1. A sample component analyzer for a measurement test tool, comprising: a measuring section having a detector for measuring reflected light; and a control section provided separately or integrally with the measuring section. A test device reading unit provided to face the measurement test device, and a calculation unit that corrects a difference between measured values caused by a change in the distance between the measurement test device and the detector for each measurement in comparison with a standard, A test tool analyzer provided in a control unit, wherein the measurement unit is configured to be manually movable. 2. The analyzer according to claim 1, wherein the test device to be measured is a urine test device. 3. The analyzer according to claim 1, wherein the test device for measuring is a blood component measuring device. 4. The analyzer according to claim 2, wherein the measuring section and the control section are separated from each other, and both are connected by a lead wire. 5. The test device according to claim 1, wherein the test device has a test strip of an item to be measured and a white standard portion, and the white standard portion corrects a measured value of the test strip. The analyzer according to any one of claims 1 to 4, which has a standard role. 6. A second standard by providing a calibration plate having a colored standard piece colored in a color of the test paper strip and a white standard portion at a predetermined position from the detector, or The reference values stored in the reference value storage memory provided in the control unit are the third standard or the second standard, based on the reflected light signals from the colored standard pieces and the white standard unit of the plate. The analyzer according to any one of claims 1 to 5, wherein the measurement value of the test strip is corrected so that the reflected light of the white standard part of the standard and the first standard becomes the same. 7. The white standard part is a white standard piece, the measuring test device is such that the white standard piece is opposed via the test paper piece, and the calibration plate is that the white standard piece is the colored standard piece. The test piece for measurement and the white standard pieces of the calibration plate, and the test paper piece and the colored standard piece are opposed to each other via a piece, and are positioned so as to face each other at an interval. Analysis equipment. 8. A third standard divided by a second standard for each white standard piece so that the reflected light of the second standard white standard piece matches the third standard. Is calculated, and a second correction coefficient for each colored standard piece is calculated from the slope of a straight line connecting the correction coefficients of the white standard pieces, and the second correction coefficient is a measured value of each colored standard piece. Multiplied by
The value obtained by dividing the reference value of the colored standard piece by the obtained value is used as a third correction coefficient, and the optical system is corrected to the reference value by multiplying the measured value of each test paper piece by the third correction coefficient. The analyzer according to claim 7. 9. The measured value of the reflected light of each of the opposing white standard pieces of the measuring test tool is multiplied by the first correction coefficient, and the reference value of the third standard white standard piece is divided by this. Using the value as a fourth correction coefficient, a fifth correction coefficient for each colored standard piece is calculated from the slope of a straight line connecting each of the fourth correction coefficients, and the fifth correction coefficient is measured for each test strip. 9. The analyzer according to claim 8, wherein the variation of the optical system and the distance is corrected by multiplying the value. 10. The analyzer according to claim 8, wherein the measured values of the opposing white standard pieces of the third standard are measured and stored under the same condition. 11. A white standard part of the test device for measurement so that reflected light does not change before and after immersion in a urine or blood sample.
The analyzer according to any one of claims 5 to 9, wherein the urine or blood sample is formed of a material that repels almost completely. 12. The analyzer according to claim 1, wherein the measuring section includes a lens system, a detector, and a light source as a measuring optical system. 13. The analyzer according to claim 12, wherein said detector is a sensor having a light receiving element. 14. The analyzer according to claim 13, wherein the sensor having the light receiving element is a photocell, an image sensor, or a CCD sensor. 15. A measurable sound or sound when a white standard piece formed opposite to the measuring test device is recognized as having a constant light amount usable as data and having a constant shape. The analyzer according to any one of claims 7 to 14, wherein the analyzer is formed so as to display a display.