JP2018036187A - Test kit for specimen inspection device and method of calibrating specimen inspection device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To realize a test kit for specimen inspection devices that has a unified fusion color and is easy to adjust and carry, and which is usable for a long time and has stability.SOLUTION: The test kit includes a pigment whose maximum absorption wavelength is on the order of 480 nm, a pigment whose maximum absorption wavelength is on the order of 620 nm, and a milk fat agent. A bench mark 603 is formed on a storage container 502, and it is possible to remove a cap 601 from the storage container 502, add water to the storage container 502, and prepare a usable sample as a solute 604 accommodated at the bottom of the storage container 502 dissolves in water. As the pigment whose maximum absorption wavelength is on the order of 480 nm there is orange G (CHNNaOS). As the pigment whose maximum absorption wavelength is on the order of 620 nm there is amido black 10B (CHNNaOS). As the milk fat agent there is Intraripid 20%.SELECTED DRAWING: Figure 6

Description

  The present invention relates to a test kit for a sample testing apparatus used for performance evaluation of a detection apparatus that detects a component color with high accuracy for a biological sample composed of a plurality of components, and a calibration method for the sample testing apparatus.

  2. Description of the Related Art Conventionally, techniques for analyzing components constituting a biological sample using the biological sample have been provided. In this technique, a dedicated container is prepared, and a biological sample collected from a patient is processed in the container. For example, when the sample is blood, the collected blood is put into a blood collection tube in which a separating agent is stored in advance. Thereafter, the blood collection tube is centrifuged to separate blood into blood clot and serum, and serum, which is a component necessary for analysis, is extracted.

  In recent years, test items that can be measured using serum have been diversified. As a result, the number of automatic analyzers is increasing, and the increase in the number of specimens is also remarkable. In response to this situation, there is an increasing demand for a system (automatic processing) that is performed before a biological sample is put into the automatic analyzer and a system that automatically performs a sample transport process to the automatic analyzer.

  As an example of pre-processing, there is processing for detecting the type of serum and the amount of liquid. If the serum has a color different from normal (light yellow), such as hemolysis (red), jaundice (dark yellow), or chyle (milky white), it may cause an error in an automatic analyzer that uses absorbance as the measurement principle. Become.

  Therefore, in the pretreatment stage, it is necessary to exclude specimens whose serum is hemolyzed, jaundice or chyle, and in particular in the case of hemolysis, it is necessary to request the doctor to collect blood again. As such a detection apparatus for discriminating a serum type, there is Patent Document 1.

  In Patent Document 1, in consideration of the influence of scattered light or the like by a label attached to a blood collection tube, the color information of the serum region is obtained using image data obtained by imaging a blood collection clot containing serum or blood after centrifugation with a camera. Classify serotypes.

Japanese Patent Laid-Open No. 2015-014506

  By the way, in the detection apparatus as described in Patent Document 1, standard samples such as hemolysis (red), jaundice (dark yellow), and chyle (milky white) are used at the time of product evaluation and performance evaluation at the time of apparatus installation. Therefore, it is necessary to evaluate the performance of the inspection apparatus in the sample inspection apparatus.

  In general, serum from horses, etc., as the base, hemoglobin for hemolysis (red), free and conjugated bilirubin for jaundice (dark yellow), and milk fat such as intralipos for chyle (milky white) Is evaluated using a standard sample prepared by dissolving it at an appropriate concentration.

  However, the above-mentioned hemoglobin, free and conjugated bilirubin, etc. are biological samples, and since the concentration of hemoglobin etc. varies from production lot to production lot, a standard sample with a unified concentration and solution color should be used. It was very difficult to produce easily.

  In addition, standard samples such as hemolyzed (red) and jaundice (dark yellow) chyle (milky white) prepared using the above hemoglobin, free and conjugated bilirubin, intralipos, etc. are biological samples. In addition, it was necessary to handle with great care in carrying and management.

  And it is widely known that (ZZ) -bilirubin, which is a free bilirubin, absorbs 450 nm light that is a visible light region and undergoes a stereoisomerization reaction to (ZE) -bilirubin. For this reason, a standard sample of jaundice (dark yellow) prepared using free bilirubin changes in solution color with the progress of stereoisomerization reaction over time. It was difficult to use as a sample for a long time.

  Based on the above, standard samples such as hemolysis (red), jaundice (dark yellow), and chyle (milky white) prepared using biological samples such as hemoglobin, free and conjugated bilirubin, and intralipos It may be difficult to use it for performance evaluation.

  In addition, it is conceivable that a printed material having a similar color as a color sample of a serum species is placed in a blood collection bottle and measured by, for example, the detection apparatus in Patent Document 1, but multiple reflections that occur between the illumination on the camera side and the blood collection bowl In addition, it is difficult to measure the correct color information due to the influence of halation, etc.In addition, the position of the illumination reflection of the blood collection tube is not necessarily exactly the same for each measurement, so the repeated stability of the measured color information is lacking. It is known from the verification experiment.

  An object of the present invention is to realize a test kit for a specimen testing apparatus and a calibration method for the specimen testing apparatus that have a unified molten color, are easy to adjust and carry, can be used for a long time, and have stability. is there.

  In order to achieve the above object, the present invention is configured as follows.

In a test kit for an analyte testing device, a first dye having a maximum absorption wavelength of about 480 nm, a second dye having a maximum absorption wavelength of about 620 nm, a milk fat,
A storage container for mixing water with at least one of the first dye, the second dye, and the milk fat is used for calibration of the specimen testing apparatus.

  Further, a calibration method for a sample testing apparatus for calibrating a sample testing apparatus using the test kit for the sample testing apparatus, wherein at least one of the first dye, the second dye, and the milk fat preparation is used. Water and water are mixed in the storage container to produce an aqueous solution with a standardized solution color, and the aqueous solution contained in the storage container is irradiated with light from the light source of the specimen testing device and scattered from the aqueous solution. The captured light is captured by an imaging camera, the color information of the captured image is compared with the color information of the aqueous solution of the standardized solution color, and the imaging camera is calibrated according to the comparison result.

  According to the present invention, it is possible to realize a test kit for a specimen testing apparatus and a calibration method for a specimen testing apparatus that have a unified molten color, are easy to adjust and carry, can be used for a long time, and have stability. it can.

It is a schematic block diagram of the test | inspection apparatus in a sample test device. It is a figure explaining the relationship between the direction of the label affixed on the blood-collecting tube, and a camera. 3 is an operation flowchart of the sample check module shown in FIG. 1. It is a flowchart of the image processing shown in step S302 of FIG. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an external view of a test kit (sample kit) that can easily prepare standard samples of normal serum (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) in Example 1 of the present invention. . It is detailed explanatory drawing of the standard sample kit in Example 1 of this invention. It is a graph which shows the H value (hue) which measured the normal sample (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) standard sample by changing the illumination intensity of illumination. It is a graph which shows S value (saturation) which changed the illumination intensity of illumination, and measured the standard sample of normal sample (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white). It is a graph which shows V value (brightness) which changed the illumination intensity of illumination, and measured the standard sample of normal sample (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white). For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), change the blue / green ratio in the white balance ratio of the RGB color system in the image processing engine. It is a graph which shows H value (hue) measured in this way. For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), change the blue / green ratio in the white balance ratio of the RGB color system in the image processing engine. It is a graph which shows S value (saturation) measured by measuring. For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), change the blue / green ratio in the white balance ratio of the RGB color system in the image processing engine. It is a graph which shows V value (lightness) measured by measuring. For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), the red / green ratio of the white balance ratio of the RGB color system in the image processing engine is changed. It is a graph which shows H value (hue) measured in this way. For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), the red / green ratio of the white balance ratio of the RGB color system in the image processing engine is changed. It is a graph which shows S value (saturation) measured by measuring. For standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white), the red / green ratio of the white balance ratio of the RGB color system in the image processing engine is changed. It is a graph which shows V value (lightness) measured by measuring. It is a table | surface which shows the serum classification discriminate | determined by measuring the aqueous solution which added the amide black 10B aqueous solution to the aqueous solution which diluted saturated orange G aqueous solution ²ⁿ times with the sample check module. It is a table | surface which shows the serum classification discriminate | determined by measuring the aqueous solution which added Intralipid 20% to the aqueous solution which diluted the saturated orange G aqueous solution ²ⁿ times, with the sample check module. It is a graph which shows the H value (hue) of the aqueous solution which diluted saturated orange G aqueous solution ²ⁿ times. It is a graph which shows S value (saturation) of the aqueous solution which diluted the saturated orange G aqueous solution ²ⁿ times. It is a graph which shows V value (lightness) of the aqueous solution which diluted saturated orange G aqueous solution ²ⁿ times. It is a graph which shows the H value (hue) of the aqueous solution which added 0-40 microliters of amide black 10B aqueous solution to the aqueous solution which diluted the saturated orange G aqueous solution 256 times. It is a graph which shows S value (saturation) of the aqueous solution which added 0-40 microliters of amide black 10B aqueous solution to the aqueous solution which diluted the saturated orange G aqueous solution 256 times. It is a graph which shows V value (lightness) of the aqueous solution which added 0-40 microliters of amide black 10B aqueous solution to the aqueous solution which diluted saturated orange G aqueous solution 256 times. It is a graph which shows H value (hue) of the aqueous solution which added 0-300 microliters of Intralipid 20% to the aqueous solution which diluted saturated orange G aqueous solution 1024 times. It is a graph which shows S value (saturation) of the aqueous solution which added 0-300 microliters of Intralipid 20% to the aqueous solution which diluted saturated orange G aqueous solution 1024 times. It is a graph which shows the V value (lightness) of the aqueous solution which added 0-300 microliters of Intralipid 20% to the aqueous solution which diluted saturated orange G aqueous solution 1024 times.

  Embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Example 1
FIG. 1 is a schematic configuration diagram of a test apparatus (sample check module) in a sample test apparatus (sample analysis apparatus), and shows an example of a sample check module of a sample analysis apparatus that classifies serum types.

  The sample check module shown in FIG. 1 is provided in the sample pretreatment processing apparatus, and is used for determining the type of serum.

  In FIG. 1, the sample check module includes light sources (illuminations) 106a and 106b, light source drivers (illumination drivers) 107a and 107b, a camera (imaging camera) 101, an image processing engine (detection unit) 108, and a background plate. (Background part) 105, controller 109, input / output interface (input / output I / F) 110, and data bus 111 are provided.

  Light sources 106a and 106b, which are irradiation units, irradiate light on the upper front and lower front of the blood collection tube 102, respectively. As the light sources 106a and 106b, LED light sources or the like that are strong and have high directivity are used. The visible light having a wavelength range of approximately 400 nm to 700 nm is used. In order to drive the light sources 106a and 106b, light source drivers 107a and 107b such as a power source are used.

  By irradiating the front upper portion and the lower front portion of the blood collection tube 102 from above and below, the intensity distribution of the light hitting the blood collection tube 102 can be made uniform as compared with the case where one light source is used. By making the light intensity distribution uniform, the serum color information can be obtained more accurately. Also, the same between the light sources 106a and 106b and the camera (imaging unit) 101 in order to prevent the accuracy of the acquired serum color information from being lost due to reflected light such as halation by the light source of the illumination unit. A polarizing filter of a polarizing component may be used.

  The camera 101 captures a two-dimensional image of the entire blood collection tube 102. FIG. 2 is a diagram for explaining the relationship between the direction of the label 103 attached to the blood collection tube 102 and the camera 101. The relationship between the direction of the label 103 affixed to the camera 101 and the blood collection tube 102 can image the sample (detection target region 203) in the blood collection tube 102 from the gap of the label 102 as shown in FIG. State.

  At this time, the light emitted from the light sources 106 a and 106 b passes through the blood collection tube 102, a part of the wavelength is absorbed by the serum (detection target region) 104 in the blood collection tube 102, and a part of the light passes through the serum 104. . The transmitted light is transmitted through the blood collection tube 102 and scattered on the label 103 attached to the surface of the blood collection tube 102. The scattered light again passes through the blood collection tube 102, the serum 104, and the blood collection tube 102 in this order and enters the camera 101. The image processing engine 108 performs image processing such as serum region extraction processing from the image captured by the camera 101, and recognizes the position and color (color information) of the serum region.

  FIG. 3 is an operation flowchart of the sample check module shown in FIG. In FIG. 3, first, the entire blood collection tube 102 is imaged by the camera 101 (step S301). Next, the image processing engine 108 performs image processing on the image captured by the camera 101 (step S302). Further, information on the serum type detected by the image processing in step S302 is output (step S303), and the processing ends.

  FIG. 4 is a flowchart of the image processing shown in step S302 of FIG. In FIG. 4, first, the acquired image is converted from the RGB color system to the HSV color system (step S401). The HSV color system is known to be similar to the method of human perception of color, and is suitable for automating the recognition of serum types, which has been performed manually.

  Next, using the image converted into the HSV color system, the average value of the color of the serum region 104 that is the detection target region with the label 103 as the background is obtained as the serum color (step S402). The blood collection sputum image used for extracting the serum region 104 is a state in which the sample (detection target region 203) in the blood collection tube 102201 can be imaged from the gap between the label 103 and the label 103 as shown in FIG. And In addition, although the average value is calculated in the calculation of the color information, the present invention is not limited to this, and it is also conceivable to acquire the median value, variance, and the like.

  Next, the serum type is determined from the acquired color information (step S403), and the process ends.

  For the determination of the serum type, a threshold is used to determine normal serum (light yellow), hemolysis (red), jaundice (dark yellow), chyle (milky white), and the like. The threshold is set in advance according to the serum region with the label 103 as the background. The threshold value set in advance is compared with the color information of the acquired serum, and the serum type is determined.

  Similarly, it is also effective to have a serum type determination threshold in accordance with the serum region with the background plate 105 behind the blood collection tube 102 as the background.

  The threshold value for determining the serum type may be changed according to the type of blood collection tube 102, the light amounts of the light sources 106a and 106b, the setting value of the camera 101, and the like. Depending on the type of the blood collection tube 102, the wall material is different and the light transmittance is different. Therefore, even in the case of similar serum, the color in the image captured by the camera 101 may be different. For this reason, it is possible to more accurately discriminate the serum type by changing the region extraction threshold according to the type of blood collection tube.

  FIG. 5 shows a test kit (sample kit) that can easily prepare standard samples of normal serum (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) in Example 1 of the present invention. It is an external view, and a plurality of storage containers 502 are accommodated in an outer box 501 of a sample kit.

  In general, the degree of hemolysis is known to vary widely in serum color (red) depending on the hemoglobin concentration in the serum. As hemolysis samples, high hemolysis (dark red) kit and low hemolysis (Light red) It is good also as a kit.

  The sample kit includes a dye (first dye) having a maximum absorption wavelength around 480 nm (approximately 480 nm), a dye (second dye) having a maximum absorption wavelength around 620 nm (approximately 620 nm), and a milk fat agent. It is also possible to make a kit by dissolving a pigment containing lipase and a milk fat agent, but it is excellent in chemical stability in order to minimize color fluctuations due to changes in the components in the aqueous solution. It is desirable to use a non-aqueous substance, that is, a pigment and a milk fat agent in powder form as much as possible, and add water when used to make an aqueous solution.

  In addition, the sample kit includes a dye having a maximum absorption wavelength around 480 nm (approximately 480 nm) (first dye), a dye having a maximum absorption wavelength around 620 nm (approximately 620 nm), and milk fat. A storage container for storing an aqueous solution obtained by dissolving a pigment and a milk fat agent containing an agent, and a storage container for storing at least one of the first pigment, the second pigment, and the milk fat agent It can also comprise so that it may have both.

  FIG. 6 is a detailed explanatory diagram of a standard sample kit in Example 1 of the present invention. The storage container 502 includes a prismatic storage container as shown in FIG. 6 (a) and a test tube type storage container as shown in FIG. 6 (b), both of which use storage containers. Can do.

  As shown in FIGS. 6A and 6B, a mark line 603 indicating the amount of liquid contained is formed in the storage container 502 of the sample kit, and the cap 601 is removed from the storage container 502 according to the mark line 603 and stored. By simply adding water to the container 502, the solute 604 housed in the bottom of the storage container 502 is dissolved in water, and a usable sample can be prepared.

  In addition, since the solute 604 is stored in the storage container 502 in advance, it is not necessary to touch the pigment more than necessary, and there is no problem of accidentally coloring clothes or fingers with the pigment during work.

  As in the storage container shown in FIG. 6 (b), the same shape as the blood collection tube 102, or by making the blood collection tube 102 into the storage container 502 of the kit, it is prepared by adding water in accordance with the formed marked line 603. The prepared sample can be used immediately in the specimen check module.

  The sample kit according to Example 1 of the present invention is a kit for preparing 20 ml of serum having a sufficient volume even when serum prepared in a general blood collection tube is added.

  For this reason, sample storage containers 502 for normal serum (light yellow), high hemolysis (dark red), low hemolysis (light red), jaundice (dark yellow), and chyle (milky white) are provided. The target serum sample can be easily prepared by adding 20 ml of water, mixing with the solute 604 and completely dissolving. The water used for dissolution is preferably pure water or ion-exchanged water for the purpose of minimizing the entry of foreign substances (components) that may affect the color of the aqueous solution.

In the components included in the sample kit in Example 1 of the present invention, for example, Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) is a dye having a maximum absorption wavelength around 480 nm. An example of a dye having a maximum absorption wavelength around 620 nm is amide black 10B (C ₂₂ H ₁₄ N ₆ Na ₂ O ₉ S ₂ ). As a milk fat medicine, there is, for example, Intralipid (intralipid) 20%.

  Here, having the maximum absorption wavelength around 480 nm means having the maximum absorption wavelength at 465 nm to 505 nm, and having the maximum absorption wavelength around 620 nm means having the maximum absorption wavelength at 580 nm to 635 nm.

  A sample kit (test kit) of normal serum (light yellow) includes, for example, 0.625 mg of orange G as the solute 604, which is dissolved in 20 ml of water when used.

  Moreover, as a low hemolysis (light red) sample kit (test kit), for example, there is one that contains 10.0 mg of orange G as the solute 604 and dissolves in 20 ml of water at the time of use.

  Further, as a sample kit (test kit) for high hemolysis (dark red), for example, there is one containing 40.0 mg of orange G as the solute 604 and dissolving it in 20 ml of water at the time of use.

  Moreover, as a sample kit (test kit) for chyle (milky white), for example, there is one containing 0.625 mg of orange G as a solute 604 and 200 μl of Intralipid 20%, which is dissolved in 20 ml of water when used.

  Here, the storage state of the sample kit until the time of the chyle sample preparation is that Orange G and Intralipid 20% are not in physical contact with each other so that the chemical reaction does not proceed in the long term. It is desirable to store it in a separate container.

  In addition, as a sample kit (test kit) of jaundice (dark yellow), for example, there is a solute 604 containing 0.625 mg of orange G and 20 μg of amide black 10B, which dissolves in 20 ml of water when used. . It is desirable to store the orange G and amide black 10B in separate storage containers so that the chemical reaction does not proceed in the long term until the jaundice sample is prepared.

  In addition, when 20 μg of amide black 10B is contained as in this kit, the amount of amide black 10B is very small. Therefore, when the sample is prepared, the amide black 10B is affected by the wind pressure in the environment or the impact when the storage container is opened. The mass of can vary. In that case, for example, as a part of the kit, an amide black 10B aqueous solution (1.0 g / l) is prepared in an appropriate volume (for example, 100 ml) as a separate container, and a certain amount thereof is dispensed into a micropipette or the like. You can add as much as 20 μl using an instrument that can.

  By carrying out the procedure described above, the concentration and solution color according to the purpose can always be stably reproduced, and the normal sample (light yellow), hemolyzed (red), jaundice (with standardized concentration and solution color) Dark yellow) and chyle (milky white) standard samples can be easily prepared.

  By using the sample kit (test kit) according to the first embodiment of the present invention, it is possible to easily evaluate the performance of the inspection apparatus when the sample check module is shipped or when the apparatus is installed. Not only that, but by using the sample kit (test kit) of the present invention on a daily basis as an accuracy control sample for the serum discrimination performance of the specimen check module installed in a laboratory such as a hospital, accuracy control is easily performed. can do.

  Furthermore, in addition to the routine accuracy control, for example, when the location of the specimen check module is changed, the color information (HSV value) that has changed due to the influence of the room lighting in the laboratory is measured by measuring a standardized standard sample. ) Can be easily investigated. Here, as a procedure for correcting the variation of the color information (HSV value), the illuminance of the illuminations 106a and 106b and the white balance ratio of the RGB color system in the image processing engine 108 are changed to obtain the HSV required for the standard sample. Verification has shown that the values can be corrected.

  In FIGS. 7, 8 and 9, standard samples of normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) were measured by changing the illuminance of the illuminations 106a and 106b. It is a graph which shows H value (hue), S value (saturation), and V value (lightness).

  The vertical axis in FIG. 7 indicates the H value, the horizontal axis indicates the illuminance, the vertical axis in FIG. 8 indicates the S value (saturation), and the horizontal axis indicates the illuminance. Moreover, the vertical axis | shaft of FIG. 9 shows V value (brightness), and a horizontal axis shows illumination intensity.

  7, 8, and 9, a cross indicates a normal sample, a square indicates high hemolysis, a diamond indicates low hemolysis, a circle indicates jaundice, and a triangle indicates chyle.

  As shown in FIG. 7, FIG. 8, and FIG. 9, it can be seen that only the V value (brightness) in FIG. 9 monotonically increases in proportion to the illuminance in all normal samples, high hemolysis, low hemolysis, jaundice and chyle. It was.

  From this, it was found that only the V value (brightness) can be selectively varied by changing the illuminance of the illuminations 106a and 106b.

  10, 11, and 12 show normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) standard samples as white balance of the RGB color system in the image processing engine 108. It is a graph which each shows H value (hue), S value (saturation), and V value (lightness) measured by changing Blue / Green ratio among ratios.

  The vertical axis in FIG. 10 indicates the H value, the horizontal axis indicates the Blue / Green ratio, the vertical axis in FIG. 11 indicates the S value (saturation), and the horizontal axis indicates the Blue / Green ratio. In addition, the vertical axis in FIG. 12 indicates the V value (brightness), and the horizontal axis indicates the Blue / Green ratio.

  10 to 12, as in FIGS. 7 to 9, a cross indicates a normal sample, a square indicates high hemolysis, a diamond indicates low hemolysis, a circle indicates jaundice, and a triangle indicates chyle.

  From FIG. 10, FIG. 11 and FIG. 12, only the S value (saturation) shown in FIG. 11 monotonically decreases in all normal samples, high hemolysis, low hemolysis, jaundice and chyle in proportion to the Blue / Green ratio. I understood that. From this, it was found that only the S value (saturation) can be selectively varied by changing the Blue / Green ratio in the white balance ratio.

  13, 14, and 15 show normal samples (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) standard samples as white balance of the RGB color system in the image processing engine 108. It is a graph which each shows H value (hue), S value (saturation), and V value (lightness) measured by changing Red / Green ratio among ratios.

  The vertical axis in FIG. 13 indicates the H value, the horizontal axis indicates the Red / Green ratio, the vertical axis in FIG. 14 indicates the S value (saturation), and the horizontal axis indicates the Red / Green ratio. In addition, the vertical axis in FIG. 15 indicates the V value (brightness), and the horizontal axis indicates the Red / Green ratio.

  13 to 15, as in FIGS. 7 to 9, a cross indicates a normal sample, a square indicates high hemolysis, a diamond indicates low hemolysis, a circle indicates jaundice, and a triangle indicates chyle.

  13, 14, and 15, only the H value shown in FIG. 13 monotonically decreases in proportion to the Red / Green ratio, and only the V value shown in FIG. 15 monotonously increases in proportion to the Red / Green ratio. I understood that.

  Here, it is known from FIG. 9 that the V value (brightness) can be changed by the illuminance. For this reason, among the white balance ratios, the V value (lightness) can be made constant by changing the Red / Green ratio and the illuminance of the illuminations 106a and 106b, and the H value (hue) can be changed by changing the illuminance. Since it does not change but changes according to the Red / Green ratio, it was found that only the H value (hue) can be selectively changed.

  That is, each of the V value (lightness), S value (saturation), and H value (hue) can be selectively varied.

  For the above-described sample kits for normal serum, low hemolysis, high hemolysis, jaundice, and chyle, the illuminance, Blue / Green ratio, and Red / Green ratio of the inspection apparatus shown in FIG. , S value and V value are calculated. Since the H value, S value, and V value, which are color information of the sample kit, are known, the known H value, S value, and V value are compared with the H value, S value, and V value calculated by the inspection apparatus. Thus, the illuminance, the Blue / Green ratio, and the Red / Green ratio of the light source of the inspection apparatus can be calibrated.

  From the above, according to the sample kit (test kit) according to Example 1 of the present invention, the colors of normal sample (light yellow), hemolysis (red), jaundice (dark yellow), and chyle (milky white) are standardized, It is easy to adjust and carry, can be used for a long time, has stability, and reproduces the colors of the normal sample (light yellow), hemolyzed (red), jaundice (dark yellow), and chyle (milky white). Standard samples can be easily prepared.

  In addition, by using a sample whose prepared solution color is standardized, it is possible to easily manage the accuracy of the measurement color information (HSV value) of the inspection apparatus. In the unlikely event that the measurement color information (HSV value) fluctuates, it is possible to correctly adjust and correct the measurement color information by the inspection apparatus by using a sample whose solution color is standardized.

(Example 2)
Next, a second embodiment of the present invention will be described.

In the components contained in the sample kit (test kit) of the present invention, for example, orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) is a dye having a maximum absorption wavelength around 480 nm. An example of a dye having a maximum absorption wavelength around 620 nm is amide black 10B (C ₂₂ H ₁₄ N ₆ Na ₂ O ₉ S ₂ ). Moreover, as a milk fat agent, there exists Intraripid 20%, for example.

FIG. 16 shows an aqueous solution obtained by adding 0 to 40 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of an aqueous solution obtained by diluting 2 ⁿ (n = 3 to 12) times of a saturated orange G aqueous solution (50 g / l). FIG. 3 is a table showing serum types measured and discriminated by the sample check module shown in FIG. 1. FIG.

  In FIG. 16, 0 to 40 μl of amide black 10B aqueous solution (1.0 g / l) was added to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/8 to 1/32. Standard samples can be adjusted.

  A standard sample of low hemolysis was prepared by adding no amide black 10B aqueous solution (1.0 g / l) to 20 ml of a saturated orange G aqueous solution (50 g / l) diluted to 1/64 to 1/512. can do. A standard sample of low hemolysis can also be obtained by adding 10 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of a saturated orange G aqueous solution (50 g / l) diluted to 1/64, 1/128. Can be adjusted. A standard sample with low hemolysis can also be prepared by adding 20 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of an aqueous solution obtained by diluting saturated orange G aqueous solution (50 g / l) to 1/64. it can.

  A standard sample of jaundice is prepared by adding 10 μl of an amide black 10B aqueous solution (1.0 g / l) to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/256 to 1/2048. be able to. The standard sample of jaundice is also prepared by adding 20 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of aqueous solution obtained by diluting saturated orange G aqueous solution (50 g / l) to 1/128 to 1/512. can do. A standard sample with low hemolysis can also be obtained by adding 30 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of a saturated orange G aqueous solution (50 g / l) diluted to 1/64 to 1/512. Can be adjusted. A standard sample of jaundice is also prepared by adding 40 μl of amide black 10B aqueous solution (1.0 g / l) to 20 ml of aqueous solution obtained by diluting saturated orange G aqueous solution (50 g / l) to 1/64 to 1/256. can do.

  In addition, a normal standard sample is prepared by adding no amide black 10B aqueous solution (1.0 g / l) to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/1024 to 1/44096. be able to.

FIG. 17 shows the specimen check module shown in FIG. 1 in which an aqueous solution obtained by adding 0 to 300 μl of Intralipid 20% to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) 2 ⁿ (n = 9 to 12) times. It is a table | surface which shows the serum classification measured and discriminated in (1).

  In FIG. 17, a standard sample with low hemolysis can be prepared by adding 20% of Intralipid to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/512.

  A normal standard sample can be prepared by adding 20% of Intralipid to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/1024 to 1/44096. A normal standard sample can be prepared by adding 100 μl of Intralipid 20% to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/512 to 1/1024. A normal standard sample can be prepared by adding 200 μl of Intralipid 20% and 300 μl to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/512.

  Further, a standard sample of chyle can be prepared by adding 100 μl of Intralipid 20% to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/20. In addition, 200 μl of Intralipid 20% is added to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) to 1/1024, and a standard sample of chyle can be prepared by adding 300 μl.

  As shown in the tables of FIG. 16 and FIG. 17, a combination of Orange G, Amido Black 10B, and Intralipid 20% allows normal samples (light yellow), high hemolysis (dark red), and low hemolysis (light red). Standard samples of jaundice (dark yellow) and chyle (milky white) can be prepared.

  Also in Example 2, as shown in FIGS. 5 and 6, Orange G, Amido Black 10B, and Intralipid 20% are stored in the storage container 502, and the storage container 502 or other appropriate container is used. In accordance with the dilution ratio and addition amount shown in FIGS. 16 and 17, normal samples (light yellow), high hemolysis (dark red), low hemolysis (light red), jaundice (dark yellow) and chyle (milky white) standards A sample is prepared.

18, 19 and 20 show the H value (hue), S value (saturation), V of 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) 2 ⁿ (n = 3 to 12) times. It is a graph which shows a value (lightness), respectively.

  The vertical axis in FIG. 18 indicates the H value, the horizontal axis indicates the dilution ratio of the saturated orange G aqueous solution, the vertical axis in FIG. 19 indicates the S value (saturation), and the horizontal axis indicates the dilution ratio of the saturated orange G aqueous solution. Moreover, the vertical axis | shaft of FIG. 20 shows V value (brightness), and a horizontal axis shows the dilution rate of saturated orange G aqueous solution.

  18, 19, and 20, the S value (saturation) and V value (lightness) do not change greatly according to the concentration change of the saturated orange G aqueous solution, whereas the H value (hue) increases monotonously. I understood.

  21, 22, and 23 show the H value of an aqueous solution obtained by adding 0 to 40 μl of an amide black 10B aqueous solution (1.0 g / l) to 20 ml of an aqueous solution obtained by diluting a saturated orange G aqueous solution (50 g / l) 256 times. It is a graph which shows (hue), S value (saturation), and V value (lightness), respectively.

  The vertical axis in FIG. 21 indicates the H value, the horizontal axis indicates the amount (μl) of the amide black 10B aqueous solution (1.0 g / l), the vertical axis in FIG. 22 indicates the S value (saturation), and the horizontal axis indicates The addition amount (μl) of amide black 10B aqueous solution (1.0 g / l) is shown. Moreover, the vertical axis | shaft of FIG. 23 shows V value (brightness), and a horizontal axis shows the addition amount (microliter) of amide black 10B aqueous solution (1.0 g / l).

  From FIG. 21, FIG. 22 and FIG. 23, it can be seen that the H value (hue) and S value (saturation) do not change significantly according to the concentration of amide black 10B, whereas the V value (lightness) decreases monotonously. It was.

  24, 25 and 26 show the H value (hue) and S value (saturation) of an aqueous solution obtained by adding 0 to 300 μl of Intralipid 20% to 20 ml of an aqueous solution diluted 1024 times with a saturated orange G aqueous solution (50 g / l). And V values (lightness).

  The vertical axis of FIG. 24 shows the H value, the horizontal axis shows the addition amount (μl) of Intralipid 20%, the vertical axis of FIG. 25 shows the S value (saturation), and the horizontal axis shows the addition amount (μl) of Intralipid 20%. Show. Moreover, the vertical axis | shaft of FIG. 26 shows V value (brightness), and a horizontal axis shows the addition amount (microliter) of Intralipid 20%.

  From FIG. 24, FIG. 25 and FIG. 26, it was found that the H value (hue) and V value (brightness) did not change greatly, but the S value (saturation) increased monotonously according to the density of Intralipid 20%. .

  From the above, by combining Orange G aqueous solution, amide black 10B and Intralipid 20%, a standard sample of arbitrary color information (HSV value) can be freely prepared, and arbitrary color information (HSV value) of A sample kit (test kit) having a standard sample can be realized.

  In addition, by using the sample kit (test kit) according to Example 2 of the present invention, for example, depending on a hospital laboratory, if there is a color to be used as a quality control sample of the serum identification performance of the sample check module, A standard sample of color information (HSV value) can be freely reproduced and prepared by combining Orange G, Amido Black 10B, and Intralipid 20%.

  Intralipos can be used as a milk fat.

  As described above, according to the present invention, the melt color is unified, the adjustment and carrying are easy, the test kit for the specimen testing apparatus that can be used for a long time and has stability, and the calibration method for the specimen testing apparatus Can be realized.

  In addition, since the sample kit in the present invention is a solution, the influence of illumination reflection is smaller than that in the case of using a printed matter, and the repeated stability of measurement color information is excellent.

  DESCRIPTION OF SYMBOLS 101 ... Imaging part, 102 ... Blood collection tube, 103 ... Label, 104 ... Detection object area, 105 ... Background board, 106a, 106b ... Illumination, 107a, 107b ... Illumination Driver, 108 ... Image processing engine, 109 ... Controller, 110 ... Input / output interface, 111 ... Data bus, 201 ... Blood collection bottle, 203: Detection target area, 501 ... Sample kit Outer box, 502 ... storage container, 601 ... cap, 603 ... mark, 604 ... solute in the kit

Claims (15)

A first dye having a maximum absorption wavelength of about 480 nm;
A second dye having a maximum absorption wavelength of approximately 620 nm;
With milk fat,
A storage container for mixing water with at least one of the first pigment, the second pigment, and the milk fat;
A test kit for a specimen testing apparatus, characterized by being used for calibration of a specimen testing apparatus. The test kit for a specimen testing apparatus according to claim 1,
A test kit for a specimen testing apparatus, wherein the aqueous solution of the first dye, the second dye, and the milk fat agent reproduces colors of normal serum, low hemolysis, high hemolysis, chyle and jaundice. The test kit for a specimen testing apparatus according to claim 2,
The first dye, Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2) automatic analyzer test kit, which comprises a. The test kit for a specimen testing apparatus according to claim 2,
The test kit for a specimen testing apparatus, wherein the second dye contains amide black 10B (C ₂₂ H ₁₄ N ₆ Na ₂ O ₉ S ₂ ). The test kit for a specimen testing apparatus according to claim 2,
A test kit for a specimen testing apparatus, wherein the milk fat preparation contains intralipid or intralipos. The test kit for a specimen testing apparatus according to claim 2,
A storage container for accommodating a substantially 0.625mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2), a substantially 0.625mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2) A storage container for storing an aqueous solution dissolved in approximately 20 ml of water; and approximately 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) A test kit for a specimen testing apparatus, wherein an aqueous solution dissolved in 20 ml of water is used as a sample of the normal serum. The test kit for a specimen testing apparatus according to claim 2,
A storage container for accommodating a substantially 10.0mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2), a substantially 10.0mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2) A storage container for storing an aqueous solution dissolved in approximately 20 ml of water, and approximately 10.0 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) A test kit for a specimen testing apparatus, wherein an aqueous solution dissolved in 20 ml of water is used as the low hemolysis sample. The test kit for a specimen testing apparatus according to claim 2,
A storage container for accommodating a substantially 40.0mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2), a substantially 40.0mg Orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2) A storage container for storing an aqueous solution dissolved in approximately 20 ml of water; and approximately 40.0 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) A test kit for a specimen testing apparatus, wherein an aqueous solution dissolved in 20 ml of water is used as the high hemolysis sample. The test kit for a specimen testing apparatus according to claim 2,
A storage container containing approximately 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and approximately 200 μl of intralipid 20%, and approximately 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and a storage container containing an aqueous solution prepared by dissolving approximately 200 μl of intralipid 20% in approximately 20 ml of water, the approximately 0.625 mg of Orange G aqueous solution prepared by dissolving in water a substantially 20ml Intralipid 20% _{(C 16 H 10 N 2 Na} 2 O 7 S 2) and substantially 200μl is a sample testing apparatus characterized in that it is used as a sample of the chyle Test kit for. The test kit for a specimen testing apparatus according to claim 2,
A storage container containing approximately 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and approximately 20 μg of Amido Black 10B, and approximately 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and at least one storage container containing an aqueous solution obtained by dissolving approximately 20 μg of amide black 10B in approximately 20 ml of water, the approximately 0.625 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and an aqueous solution obtained by dissolving approximately 20 μg of amide black 10B in approximately 20 ml of water is used as a sample for the jaundice. The test kit for a specimen testing apparatus according to claim 2,
A storage container containing about 0.625 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and about 10.0 mg of Orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) A storage container for storing, a storage container for storing approximately 40.0 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ), and approximately 0.625 mg of orange G (C ₁₆ H ₁₀ N ₂ Na _2). O ₇ S ₂ ) and a storage container containing approximately 200 μl of intralipid 20%, approximately 0.625 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and approximately 20 μg of amide black 10B aqueous solution of Orange _G of the generally 0.625mg of _{(C 16 H 10 N 2 Na} 2 O 7 S 2) with water at approximately 20ml and a storage container for the above normal serum samples It is used as,
An aqueous solution obtained by dissolving approximately 10.0 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) in approximately 20 ml of water is used as the low hemolysis sample,
An aqueous solution obtained by dissolving approximately 40.0 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) in approximately 20 ml of water is used as the highly hemolyzed sample,
An aqueous solution prepared by dissolving approximately 0.625 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and approximately 200 μl of intralipid 20% in approximately 20 ml of water is used as the sample of the chyle.
An aqueous solution obtained by dissolving approximately 0.625 mg of orange G (C ₁₆ H ₁₀ N ₂ Na ₂ O ₇ S ₂ ) and approximately 20 μg of amide black 10B with approximately 20 ml of water is used as the sample of the jaundice. A test kit for specimen testing equipment. The test kit for a specimen testing apparatus according to claim 2,
The first dye is orange _{G (C 16 H 10 N 2} Na 2 O 7 S 2), said second dye is an amido black _{10B (C 22 H 14 N 6} Na 2 O 9 S 2) The milk fat is intralipid or intralipos, and a predetermined amount of the second dye is added to an aqueous solution obtained by diluting the first dye at a predetermined magnification to obtain normal serum, low hemolysis, high hemolysis, and Specimen test that reproduces the color of jaundice and reproduces the colors of normal serum, low hemolysis, and chyle by adding a predetermined amount of the above-mentioned fat to an aqueous solution in which the first dye is diluted at a predetermined magnification Equipment test kit. The test kit for a specimen testing apparatus according to any one of claims 6, 7, 8, 9, 10, 11, and 12,
A test kit for a specimen testing apparatus, wherein a mark indicating the amount of liquid contained is formed in the storage container. In the test kit for a specimen testing apparatus according to any one of claims 1 to 13,
The test kit for a specimen testing apparatus, wherein the approximately 480 nm is 465 nm to 505 nm, and the approximately 620 nm is 580 nm to 635 nm. A method for calibrating a sample testing apparatus for calibrating a sample testing apparatus using the test kit for a sample testing apparatus according to claim 1,
Mixing at least one of the first pigment, the second pigment and the milk fat and water with the storage container to produce an aqueous solution having a standardized solution color;
Irradiating the aqueous solution contained in the storage container with light from the light source of the specimen testing device,
Imaging the light scattered from the aqueous solution with an imaging camera,
Compare the color information of the captured image with the color information of the aqueous solution of the standardized solution color,
A calibration method for a specimen testing apparatus, wherein the imaging camera is calibrated according to a result of comparison.

Images