Patent Application
20120105470
The present invention relates to a display method, and a display device for displaying HbA1c measurement results.
A device for measuring hemoglobin A1c (HbA1c) based on separation analysis, such as, for example, HPLC (high performance liquid chromatography), as the measurement principle, often outputs a separation chromatogram together with an HbA1c value as measurement results. In the chromatogram, however, there are peaks other than the peak of HbA1c as a target object. Therefore, the HbA1c fraction (peak area) on the chromatogram is hatched sometimes so as to be more distinguishable from the other Hb fractions (Takuji MURAKAMI et al., “Development of Tosoh's fully automated glycohemoglobin analyzer HLC-723 G8 ”, TOSOH Research & Technology Review Vol. 50 (2006), pp. 69-72).
On the other hand, in Japan, new diagnostic criteria for diabetes were put into effect on Jul. 1, 2010, and the HbA1c value was added to diagnosis items. In other words, hereafter in clinical practices, the HbA1c value plays a role not only as a treatment marker for diabetes as conventionally but also as a diagnosis marker for diabetes.
Regarding the HbA1c value as a treatment marker for diabetes, comparison between a previously measured value and a currently measured value of the same has important implications for checking treatment effects and deciding a new treatment policy. On the other hand, regarding the HbA1c value as a diagnosis marker for diabetes, the focus is which category the value falls in, i.e., the diabetic type or the non-diabetic type, according to the Diagnostic Criteria for Diabetes. In clinical practices where many samples are measured, elimination of overlooking of diabetes-type samples is required.
The present invention provides a display method, a display device, and a display program for displaying HbA1c measurement results, which make it possible to prevent the overlooking of a sample exhibiting a predetermined HbA1c value different from a normal HbA1c value, for example, a sample exhibiting the diabetic type.
The present invention in one aspect relates to a method for displaying spectrum data as results of measurement of hemoglobin A1c (HbA1c) in a sample by separation analysis, the method including applying one of at least two different types of designs to a peak area for HbA1c in the spectrum data, according to the amount of HbA1c in the sample, or according to the amount of HbA1c and the amount of blood glucose in the sample.
The present invention in another aspect relates to a device including: a measurement section that measures hemoglobin A1c (HbA1c) in a sample by separation analysis and obtains a measured amount of HbA1c and spectrum data; a display data conversion section that applies one of at least two different types of designs to a peak area for HbA1c in the spectrum data according to the amount of HbA1c or according to the amount of HbA1c and the amount of blood glucose; and at least one of a display section that displays data obtained through the conversion, a printing section that prints out the data, and a transmission section that transmits the data.
The present invention in still another aspect relates to a non-transitory computer-readable recording medium storing a display program that causes a processor that displays an amount of hemoglobin A1c (HbA1c) and spectrum data obtained by measuring HbA1c in a sample by separation analysis to execute: a process of making access to a recording section that has preliminarily recorded correspondence relationship data indicating correspondence relationship between either the amount of HbA1c or the amount of HbA1c and the amount of blood glucose on one hand and a design on the other hand, and deciding a design corresponding to either the amount of HbA1c in the sample or the amount of HbA1c and the amount of blood glucose; a process of altering a design of a peak area for HbA1c in the spectrum data of the sample to the decided design; and a process of displaying, printing, or outputting to outside, the spectrum data having the alteration.
With the present invention, it is possible to prevent overlooking measurement results that should be noticed, such as in HbA1c measurement using separation analysis.
In the present specification, “hemoglobin A1c (HbA1c)” refers to hemoglobin having glucose bonded to an N terminal of a β chain thereof, which is one of protein components in erythrocytes, and unless otherwise provided, it refers to stable HbA1c (s-HbA1c). Examples of components other than the stable HbA1c that can be detected when blood or a blood-derived sample is analyzed by separation analysis include, but not limited to, hemoglobin A0 (HbA0), hemoglobin A1a (HbA1a), hemoglobin A1b (HbA1b), hemoglobin A2 (HbA2), hemoglobin S (HbS, sickle cell hemoglobin), hemoglobin F (HbF, fetal hemoglobin), hemoglobin M (HbM), hemoglobin C (HbC), hemoglobin D (HbD), hemoglobin E (HbE), met-hemoglobin, carbamoylated hemoglobin, acetylated hemoglobin, and unstable HbA1c (1-HbA1c).
In the present specification, the “sample” refers to a sample prepared from a sample material, or the sample material per se. Examples of the sample materials include biological samples containing components derived from living bodies. The sample material is preferably a material containing the above-described target object, such as a sample containing hemoglobin. Examples of the biological sample include, but not limited to, blood, blood-derived materials containing erythrocytes, saliva, and cerebrospinal fluid. Blood is, for example, blood sampled from a living body. The blood-derived material containing erythrocytes is, for example, a material that is separated or prepared from blood and contains erythrocytes, and examples of the same include a fraction of blood cells obtained by removing plasma, concentrate of blood cells, freeze-dried blood or blood cells, a hemolyzed sample obtained by hemolyzing whole blood, centrifuged blood, blood samples obtained through spontaneous sedimentation, and washed blood cells.
In the present specification, the “amount of HbA1c” refers to a concentration of HbA1c in a sample or blood, and from a viewpoint of practical application, it preferably refers to an HbA1c value. In the present specification, the “HbA1c value” refers to a ratio of HbA1c with respect to hemoglobin in a sample or blood (concentration of HbA1c/concentration of hemoglobin), and the unit thereof is %.
On the other hand, the HbA1c value (JDS value) used in Japan is characterized in that it has been standardized in Japan earlier than in other countries, but it has a problem in that it is about 0.4% lower than the HbA1c value used in many countries in the world (NGSP value). The Japan Diabetes Society therefore decided that a new HbA1c value obtained by adding 0.4% to the conventional HbA1c value expressed in the JDS value style is referred to as an international standard value, and the diabetes diagnosis is performed, with reference to the JDS value at the moment, and with reference to the international standard value after a date of implementation of the international standard value that will be made public later.
According to the new diagnostic criteria for diabetes revised on Jul. 1, 2010, diabetes is diagnosed into the following three categories based on the HbA1c value and the blood glucose value:
Diabetes is a group of disorders characterized by a chronic hyperglycemia state due to insufficient effect of insulin, which finally lead to death if sustainable hyperglycemia state continues for a long time and causes diabetic complications. Diabetes treatments focus on preventing complications from developing, and therapeutic intervention at an early stage of diabetes and continuous maintenance and control with suppression of increase of a blood glucose value has a great significance. Therefore, in order to start treatments for diabetes at an early stage, health checkup, medical tests on patients with suspected diabetes, etc. are particularly important.
The present invention focuses attention on an increase in the possibility that a sample to be classified as diabetes or a sample to be classified as suspected diabetes could be overlooked in clinical sites where the HbA1c value is used as a diagnosis marker for diabetes. The present invention is based on knowledge that such overlooking can be reduced easily by applying a different design to a peak area for HbA1c in a chromatogram displayed or printed for each measurement, depending on which type a sample measured belongs to, for example, the “diabetic type” and the “non-diabetic type”.
More specifically, the present invention in one aspect relates to a method for displaying spectrum data as a result of measurement of hemoglobin A1c (HbA1c) in a sample by separation analysis (hereinafter this method is referred to as “the display method of the present invention” also), the method including applying one of at least two different types of designs to a peak area for HbA1c in the spectrum data, according to the amount of HbA1c in the sample, or according to the amount of HbA1c and the amount of blood glucose in the sample.
With the display method of the present invention, it is possible to achieve an effect of, for example, reducing the overlooking of a sample that indicates an HbA1c value that should be noticed, in a clinical site where many samples are measured. It should be noted that the display method of the present invention does not include making a diagnosis with respect to an individual, for example, making a diagnosis for diabetes with respect to an individual who has provided a sample. The display method of the present invention relates to displaying a classification of a sample, and is able to provide a guideline or information for diagnosis carried out by a doctor. The display method of the present invention, however, is not limited to the purpose of diagnosis.
In the present specification, the “separation analysis” refers to a method that is for performing an analysis while individually separating a target object contained in a sample, and that is capable of performing separation analysis of HbA1c. Specific examples of the separation analysis include liquid chromatography, electrophoresis, gas chromatography, and electrochromatography. Liquid chromatography is, particularly, high performance liquid chromatography (HPLC), and, for example, cation exchange chromatography, anion exchange chromatography, partition chromatography, reversed-phase partition chromatography, or gel filtration chromatography. Examples of the electrophoresis include, particularly, capillary electrophoresis (CE), for example, capillary zone electrophoresis, capillary isoelectric focusing electrophoresis, capillary electrokinetic chromatography, and capillary gel electrophoresis.
In the present specification, “spectrum data” refer to a waveform graph representing a separation state of components including HbA1c in a sample. “Spectrum data” refer to a chromatogram when the separation analysis is chromatography, while the same refer to an electropherogram when the separation analysis is capillary electrophoresis. In the present specification, a “peak area for HbA1c” refers to an area occupied by HbA1c in spectrum data, i.e., an HbA1c fraction.
In the present specification, a “design” refers to a marking, a pattern, a color, and a combination thereof applied to a peak area for HbA1c when spectrum data are displayed or printed. Examples of the designs that can be applied to a peak area include a colorless and patternless one. Those skilled in the art are able to suitably select a combination of two or more types of designs that can be easily distinguished.
In an embodiment of the present invention, the type of the design applied to a peak area for HbA1c is altered with reference to the HbA1c value as the diagnostic criteria for diabetes. The HbA1c value as the diagnostic criteria for diabetes is, for example, the international standard value of not less than 6.5% (JDS value: not less than 6.1%), as described above. It should be noted that when the diagnostic criteria for diabetes are revised as to the aforementioned value, the value after the revision may be used as the reference value.
In still another embodiment of the present invention, the display may be switched with reference to the blood glucose value in addition to the HbA1c value, following the new diagnostic criteria for diabetes in Japan. In the present embodiment, two designs may be used as designs for the “diabetic type” and the “non-diabetic type” applied to one peak area for HbA1c. More specifically, if data fall under any one of the following conditions a) to c) as described above, the design for the “diabetic type” is applied to the peak area; and if data do not fall under any of the following conditions, the design for the “non-diabetic type” is applied to the peak area. Further, different designs may be applied as the “diabetic type” design, depending on which one of the following conditions a) to c) the data fall under.
Information on the blood glucose value is preferably based on one sample. The blood glucose value may be measured by a glucose measurement unit incorporated in a device for measuring the amount of HbA1c, or may be measured by a measurement device other than the device for measuring the amount of HbA1c.
The form of display in the display method of the present invention may be the same as the display by a conventional HbA1c measurement device, and examples of the same include printing by a printer, display by a display device or the like, and electrical output for communication or to an electronic medium. The form of display may be selected appropriately from these.
Next, a device of the present invention is explained.
The present invention in one aspect relates to a device that includes a measurement section that measures HbA1c in a sample by separation analysis and obtains a measured amount of HbA1c and spectrum data; a display data conversion section that applies one of at least two different types of designs to a peak area for HbA1c in the spectrum data according to the amount of HbA1c or according to the amount of HbA1c and an amount of blood glucose; and at least one of a display section that displays display data obtained through the conversion, a printing section that prints out the data, and a transmission section that transmits the data to outside. With the device of the present aspect, the measurement of HbA1c and the display by the display method of the present invention can be performed.
The device of the present aspect is explained with reference to an embodiment shown in
In the case where the blood glucose value is used by the conversion section 2, the measurement section 1 may include a blood glucose value measurement part (e.g., a glucose measurement unit). Alternatively, data measured by an external measurement device may be used. In such a case, the device 10 includes an I/O port such as a communication port, a keyboard, or a barcode reader, and a blood glucose value can be entered through the I/O port. The display section 3 may be a visual display means such as a liquid crystal display device, an organic electroluminescence display device, or a printer, or may be an electric output such as a communication port, an I/O port, or an electronic medium. The recording section 4 is not an essential component for the device of the present aspect, but it can record, for example, correspondence relationship data that indicate correspondence relationship between the amount of HbA1c and designs, and/or correspondence relationship between the amount of HbA1c and the blood glucose value on one hand and designs on the other hand.
A sample is measured by the HbA1c measurement part 11 of the measurement section 1, and measurement data are obtained. A chromatogram is created by the chromatogram creation part 12 using the measurement data, and an HbA1c value is calculated from the chromatogram by the HbA1c value calculation part 13. The chromatogram and the HbA1c value are recorded in the recording section 4. Further, a blood glucose value of the same sample is measured by the blood glucose value measurement part 14 and recorded in the recording section 4 as required. Next, the analysis part 21 of the conversion section 2 decides a design to be applied to a peak area for HbA1c, based on the HbA1c value obtained by the measurement section 1, and correspondence relationship data obtained by access to the recording section 4. The chromatogram conversion part 22 converts the chromatogram by applying the decided design to the peak area for HbA1c in the chromatogram obtained by the measurement section 1. The converted chromatogram is recorded in the recording section 4. The converted chromatogram is fed via the output part 23 to the display section 3. The display section 3 outputs the converted chromatogram to the display screen 31, the printing part 32, and/or the external output part 33. The display section 3 is capable of displaying, printing, or outputting to outside the recorded chromatogram after conversion, by making access to the recording section 4 as required.
The function of the conversion section 2 shown in
Therefore, the present invention in an aspect is a non-transitory computer-readable recording medium storing a display program that causes a processor that displays an amount of hemoglobin A1c (HbA1c) and spectrum data obtained by measuring HbA1c in a sample by separation analysis to execute: a process of making access to a recording section that has preliminarily recorded correspondence relationship data indicating correspondence relationship between either the amount of HbA1c or the amount of HbA1c and the amount of blood glucose on one hand and a design on the other hand, and deciding a design corresponding to either the amount of HbA1c in the sample or the amount of HbA1c and the amount of blood glucose; a process of altering a design of a peak area for HbA1c in the spectrum data of the sample to the decided design; and a process of displaying, printing, or outputting to outside, the spectrum data having the alteration.
The device 10 shown in
Therefore, the present invention in an aspect relates to a device that includes a reception section that obtains an amount of HbA1c and spectrum data as results of measurement of HbA1c in a sample by separation analysis; a display data conversion section that applies one of at least two different types of designs to a peak area for HbA1c in the spectrum data according to the amount of HbA1c or according to the amount of HbA1c and an amount of blood glucose; and at least one of a display section that displays display data obtained through the conversion, a printing section that prints out the data, and a transmission section that transmits the data to outside.
The present invention is useful in, for example, the fields of medical diagnostic equipment, clinical inspection equipment, etc.
The invention may be embodied in other forms without departing from the spirit or essential characteristics thereof. The embodiments disclosed in this application are to be considered in all respects as illustrative and not limiting. The scope of the invention is indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are intended to be embraced therein.
| Number | Date | Country | Kind |
|---|---|---|---|
| JP 2010-240856 | Oct 2010 | JP | national |
