Liquid chromatography device with quality control function

Abstract

To provide a liquid chromatography device that is suitable for monitoring a device state, using quality control data in a plurality of measurement modes.SOLUTION: A liquid chromatography device comprises: a storage unit that stores two or more measurement modes in which a main quantitative item is common; an input unit that is to select the measurement mode; a control unit that performs control of a measurement unit; a processing unit that implements a quantitative calculation; and a data storage unit that stores quantitative result data on a quality control sample, chromatogram, specimen identification information and measurement mode information. in which the liquid chromatography device has a display unit that defines the quantitative result data on the quality control sample as plot data, discriminates the plot data by an identifiable plot identifier for each measurement mode, and can display the quantitative result data on the quality control sample having common specimen identification information measured in the two or more measurement modes on a single graph area.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] The present invention relates to a liquid chromatography device. [Background technology]

[0002] In clinical testing using liquid chromatography, there is a demand for faster processing speeds through rapid measurement (Short mode) that is specialized for detecting and quantifying only the target components, as well as for obtaining more detailed information through precise measurement (Long mode) that slows down the processing speed to improve separation between target and non-target components, or between non-target components. In Long mode, separation performance is improved for incidental components that cannot be separated in Short mode by measures such as extending the measurement time, adding eluent species, changing the eluent mixture ratio, and slowing down the flow rate of the delivery pump.

[0003] When performing different measurement modes such as Short mode and Long mode, it was necessary to perform the measurement using different devices, or to use the same device and temporarily stop the measurement, switch the measurement mode, and then start the measurement again. As another example of operation, Patent Document 1 discloses a method for measuring the main components and associated components in a measurement sample without manually switching the measurement mode, and for switching measurement conditions according to whether associated components are detected or not even during the measurement.

[0004] Furthermore, with recent improvements in the processing power of the control unit of the device, it has become possible to perform quality control (QC) on the display unit of the device, as described in Non-Patent Document 1.

[0005] However, in a liquid chromatography device having multiple measurement modes, quality control must be performed in each measurement mode to ensure that the device, columns, and other consumables are in normal condition and that the measurement results are accurate. In addition, since quality control samples generally use multiple different concentrations, it was difficult to centrally manage quality control results for multiple measurement modes in a limited display area without switching screens. Furthermore, in a liquid chromatography device having multiple measurement modes, quality control by comparison between multiple measurement modes is required in addition to quality control in each measurement mode. For example, although quality control in one measurement mode meets the pass criteria and quality control in another measurement mode meets the pass criteria, a situation may occur in which the quality control should be judged as failing by setting a standard for the deviation between the measurement modes. In such a case, it is necessary to clearly and simply notify the user of the situation. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] JP 2015-127700 A [Non-patent literature]

[0007] [Non-Patent Document 1] Erba Lachema Hb-Vario Catalogs and Brochures<URL:https: / / www.erbalachema.com / en / products-and-solutions / diabetes-testing / hb-vario / > Summary of the Invention [Problem to be solved by the invention]

[0008] An object of the present invention is to provide a liquid chromatography apparatus suitable for monitoring the state of the apparatus by utilizing quality control data in a plurality of measurement modes. [Means for solving the problem]

[0009] According to one aspect of the present invention, the apparatus includes a storage unit that stores two or more measurement modes having a common main quantitative item, an input unit for selecting the measurement mode stored in the storage unit, a control unit that controls the measurement unit according to the selected measurement mode, a processing unit that performs quantitative calculations from the measurement results, and a data storage unit that stores at least all or any of the quantitative result data of the quality control sample, the chromatogram of the quality control sample, the specimen identification information of the quality control sample, and the measurement mode information when the quality control sample is measured, A liquid chromatography device is provided which has a display unit capable of displaying the quantitative result data of the quality control sample, which is plotted as data, distinguishing the plot data by plot markers that can be identified for each measurement mode, and displaying the quantitative result data of the quality control sample having common specimen identification information measured in two or more measurement modes in a single graph area.

[0010] The liquid chromatography device of the above aspect is provided with a display means for plotting quantitative values ​​of two or more measurement modes in the same graph area in a time series manner using plot indicators. Evaluation and judgment may be made based on the reference standard value and the control standard range, or the difference in quantitative values ​​between the measurement modes, and displayed on the graph using identifiers (flags, etc.). This allows for centralized display and management of quality control of multiple measurement modes, and also enables support for estimating the causes of variation.

[0011] In addition, the liquid chromatography device of the above aspect is provided with a display means for plotting the difference between the measurement modes in a time series manner in the same graph area using plot indicators. The difference may be evaluated and judged in accordance with the control standard range and displayed on the graph using identifiers (flags, etc.). This allows the quality control of multiple measurement modes to be displayed and managed in a unified manner, and also makes it possible to assist in estimating the cause of variation when different behavior is observed in the results between the measurement modes.

[0012] In addition, the liquid chromatography device of the above embodiment is provided with a display means for plotting the ratio between measurement modes in a time series manner in the same graph region using plot indicators. The ratio may be evaluated and judged in accordance with the control standard range and displayed on the graph using identifiers (flags, etc.). This allows the quality control of multiple measurement modes to be displayed and managed in a unified manner, and also makes it possible to assist in estimating the cause of variation when different behavior is observed in the results between measurement modes. Effect of the Invention

[0013] According to one aspect of the present invention, a liquid chromatography device can be provided that is capable of centrally displaying and managing quality control results of each measurement mode in quality control of liquid chromatography having two or more measurement modes with a common main measurement target. [Brief description of the drawings]

[0014] [Figure 1] FIG. 2 is a diagram of a measurement device in accordance with an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a configuration diagram of the measurement device shown in FIG. [Diagram 3] 2 is an example of a chromatogram of a sample from a healthy subject obtained by measurement in Short mode, which is one of the measurement modes stored in the measurement device shown in FIG. 1. [Figure 4] 2 is an example of a chromatogram of a sample containing abnormal HbE obtained by measurement in Long mode, which is one of the measurement modes stored in the measurement device shown in FIG. 1. [Diagram 5] 2 is an example of a chromatogram of a sample containing abnormal HbS obtained by measurement in Long mode, which is one of the measurement modes stored in the measurement device shown in FIG. 1. [Figure 6] 13 is a user interface screen for making a reservation for switching the measurement mode for a STAT port in order to perform a STAT (urgent sample) analysis, which is displayed on a display unit provided in the measurement device shown in FIG. 1. [Figure 7] FIG. 13 is a diagram showing one aspect of a quality control chart for the measurement results of a quality control sample, which is common specimen identification information. [Figure 8]FIG. 8 is a detailed view of the results of a quality control sample that is displayed when a plot on the graph of FIG. 7 is selected. [Figure 9] FIG. 13 is a diagram showing one aspect of a quality control chart for measurement results in multiple measurement modes of a quality control sample, which is common specimen identification information. [Figure 10] FIG. 13 is a diagram showing one aspect of a quality control chart using the difference between measurement results in two different measurement modes of a quality control sample, which is common specimen identification information. [Figure 11] FIG. 13 is a diagram showing one embodiment of a quality control chart using the ratio of measurement results in two different measurement modes of a quality control sample, which is common specimen identification information. [Figure 12] FIG. 1 shows one embodiment of a quality control chart in which the measurement results of patient samples obtained on that day are used as a population and their average values ​​are used. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS EXAMPLES

[0015] Hereinafter, the embodiments of the present invention will be described in detail with reference to the accompanying drawings, but the aspects of the present invention are not limited thereto. In the following description and drawings, the same reference numerals indicate the same or similar components, and therefore the description of the same or similar components will be omitted.

[0016] <Configuration of measuring device> The measuring device 1000 is an example of a blood hemoglobin analyzer that uses liquid chromatography as the measurement principle. The measurement target of the measuring device 1000 is not limited to hemoglobin, but may be lipoproteins, amino acids, catecholamines, vitamins, albumin, 1,5-anhydro-D-glucitol, creatinine, uric acid, etc., and the sample type is not limited to blood, but may be urine, cells, saliva, tears, feces, amniotic fluid, cerebrospinal fluid, or substances derived from these. An example of the configuration of the measuring device 1000 is shown in FIG. 2.

[0017] The measuring device 1000 is provided with a degassing unit 13 for degassing three kinds of eluents (10, 11, 12), a liquid delivery unit (liquid delivery plunger pump) 14 for delivering the eluents, and solenoid valve units (15, 16, 17) for switching the mixing ratio of the eluents, an autosampler unit 18 for injecting samples, an analytical column 19, and an absorptiometric detector 20. The temperature of the analytical column is controlled to a constant 25° C. by a column oven 21. The operation and temperature control of each of these units are controlled by a control / processing unit 22. The detection signal obtained from the absorptiometric detector is taken in by the control / processing unit 22, which creates chromatogram data from plot data of the detector signal, and outputs the chromatogram as part of the measurement result on a display unit 24. The control / processing unit 22 also performs noise processing, chromatogram waveform processing, peak identification processing, quantification, and the like. Various parameters such as column oven temperature control, pump flow rate, and solenoid valve switching program are stored in a storage unit 23. In liquid chromatography having a plurality of measurement modes, control parameters are preset, and a measurement mode in which at least one parameter differs from the measurement conditions is further set, and information on these measurement conditions is stored in the storage unit 23.

[0018] The measurement results, chromatograms, and various condition information including the measurement mode information are stored in the data storage unit 25 in the form of a database or the like. The control / processing unit 22 can be exemplified by a microcomputer or a personal computer, and the storage unit 23 and the data storage unit 25 may be a unit integrated with the control / processing unit, or may be a separate unit such as an external storage. The display unit 24 may be any display capable of displaying the quantitative results, but is preferably a liquid crystal display (LCD) capable of displaying a chromatogram, more preferably a touch panel LCD also serving as an input unit and an operation unit, and is more preferably integrated with the device as shown in FIG. 1. The measuring device 1000 is preferably a system in which these units, the processing / control unit, the storage unit, and the display unit are integrated into one device, for the purposes of miniaturizing the entire device, reducing the volume of the liquid delivery flow path, optimizing the entire system, and reducing costs.

[0019] Furthermore, the means for supplying samples to the autosampler is preferably a rack loader system that transports samples using a sample container rack on which sample containers are placed, and more preferably a rack loader system that is provided with a STAT port 26 on which emergency samples can be placed independently of the transport path of the rack loader 28.

[0020] The measuring device 1000 has two measuring modes, a short mode and a long mode, in its storage section, and the main measurement item in either measuring mode is HbA1c (hemoglobin A1c, s-A1c (stable A1c)), which is glycated hemoglobin. In the short mode, hemoglobin is fractionated into six peaks including A1a (31), A1b (32), HbF (33), L-A1c (unstable A1c) (34), HbA1c (35), and A0 (36), as shown in the chromatogram of a healthy subject sample in FIG. 3. Depending on the sample, it may be fractionated into six or more peaks. It takes 30 seconds per sample to obtain these fractions. On the other hand, in the Long mode, in addition to the six fractions separated by the Short mode, it is possible to separate the non-glycated or glycated peaks of the major abnormal hemoglobins (abnormal Hb), namely HbE, HbD, HbS, and HbC.

[0021] FIG. 4 shows an example of the results of measuring a sample containing HbE in the Long mode. The glycated peak of HbE (37) can be separated between HbA1c (35) and hemoglobin A0 (36). FIG. 5 shows an example of the results of measuring a sample containing HbS. The HbS peak (38) can be separated behind the hemoglobin A0 (36). Some of the samples containing abnormal Hb may interfere with the area of ​​non-glycated hemoglobin A0 when measured in the Short mode, and as a result, the HbA1c may not be quantified correctly. An example of the operation of the measuring device 1000 is a method in which a measurement is usually performed in the Short mode, and if the result indicates the presence of abnormal Hb, a retest is performed in the Long mode to confirm the presence of abnormal Hb and to accurately quantify the HbA1c concentration. The measurement time for each measurement in the Long mode was set to 50 seconds. In this explanation, two measurement modes will be used, however, the measurement device 1000 may be equipped with three or more measurement modes, and it is also possible to provide a measurement mode with an even greater number of fractions than the Long mode, for example.

[0022] <Measurement operation by switching measurement modes> The measurement mode can be switched by calling up another measurement mode information stored in the storage unit by operating the input unit while the measuring device is on standby, and the control unit changes the control of each unit according to the switched conditions. For example, the measurement mode can be selected when the device is started, but it is preferable that the measurement mode can be switched at any time while the measuring device is on standby for measurement, and more preferably for any sample even during measurement. Therefore, it is preferable that consumables and measurement reagents such as analytical columns and eluents are common between measurement modes to avoid replacement during measurement, and it is preferable that the analysis conditions can be changed by setting the gradient conditions that change the mixture ratio of multiple eluents and the collection and acquisition time of measurement results as different parameters between measurement modes. An example of a method for switching the measurement mode during measurement is to enable measurement mode selection for a sample provided in the STAT port 26.

[0023] Alternatively, the measurement mode can be switched by using the shape of the blood collection tube rack that stores the blood collection tubes, the rack barcode, the rack QR code (registered trademark), or the rack RFID tag. Furthermore, the measurement mode can be switched by recognizing whether the sample number obtained by the sample identification information reading unit 27 from the barcode, QR code (registered trademark), or RFID tag attached to the blood collection tube matches with a number registered in advance as a sample subject to measurement mode switching. Naturally, it is also possible to make it possible to switch the measurement mode in response to a request inquiry from a processing device external to the measuring device 1000.

[0024] FIG. 6 shows a user interface screen for reserving measurement mode switching for a STAT port. In the sample ID input field 41 for the sample for which STAT measurement is to be performed, the sample ID is entered by free input or by reading it with a handheld barcode reader, a QR code (registered trademark) reader, an RFID scanner, or the like. The measurement number display unit 42 can assign an individual number separate from the sample ID. For example, it is possible to manage the measurements for one day by consecutive serial numbers. The measurement mode selection unit 43 can specify a reservation by selecting under which measurement conditions the sample placed in the STAT port 26 (a sample introduction unit independent of the rack loader 28) to be measured next will be measured. The measurement mode can be selected by selecting a radio button, selecting from a drop-down list, or the like.

[0025] Furthermore, an interface may be provided that allows selection of the blood type in the specimen type designation unit 44 and selection of whether to calculate HbA1c (%) by removing the HbF peak from the total area in the quantitative condition selection unit 45, for example. By commanding measurement for STAT analysis after selecting these conditions, measurement under the designated conditions is executed by interrupting normal continuous measurement using the rack loader 28, and if the measurement mode designated for measurement by the STAT port is different from that for continuous measurement, the control / processing unit can automatically switch the measurement conditions at the start of the measurement, and when the measurement is completed, the original measurement conditions can be automatically switched back to continue the measurement of the specimen on the rack loader.

[0026] <Quality control samples and quality control measurements> Quality control samples are also called control samples. Quality control samples used in hemoglobin analyzers are made of blood, blood-derived components, or pseudo samples, and are lyophilized to ensure stability during storage and transportation. Alternatively, pooled samples made by mixing multiple blood samples at each facility are often used as quality control samples. These quality control samples are measured before daily measurements or for each measurement unit, and the condition of consumables such as the measuring device, analytical column, and eluent is judged to be satisfactory based on the measurement results of the quality control sample. More than one quality control sample is measured, and generally two or three samples with different concentrations are used for the measurement.

[0027] For example, when measuring HbA1c (%) using a hemoglobin analyzer, quality control samples are often prepared for a low concentration range of about 4.5-6.0%, a medium concentration range of about 6.0-9.0%, and a high concentration range of about 9.0% or more. Quality control methods include comparing the measurement results obtained from the measurement of these quality control samples with previous quantitative results or with specified values ​​set in advance by the manufacturer, etc., to confirm that there is no deviation. In addition, the peak shape in the chromatogram, the overall shape of the chromatogram, the peak area, the elution time (retention time), the half-width, the number of theoretical plates, etc. may be compared to confirm that there are no problems with the equipment, consumables, or the measurement environment.

[0028] In a chromatography device with multiple measurement modes, in an operation mode in which the measurement mode may be switched, quality control is required for each measurement mode. Although quality control samples are often used in common between measurement modes, the quality control of a chromatography device with multiple measurement modes involves a wide range of items to be controlled even if the main quantitative items are the same.

[0029] For quality control samples, a barcode, QR code (registered trademark), or RFID incorporating sample identification information such as a sample ID is attached to a sample container containing the quality control sample as a barcode label, QR code (registered trademark), or RFID tag, which is a sample identifier, in the same way as for a normal blood collection tube sample. By individually setting a sample ID for each quality control sample, quality control can be performed by setting the same sample ID even on different measurement dates. The sample identifier is linked to the chromatogram or quantitative result obtained by measurement by, for example, a barcode reader, a QR code (registered trademark), or an RFID scanner (sample identification information reading unit 27) of the sample loader, after the sample identification information incorporated in the sample identifier is read. The sample identifier is registered in advance as a quality control sample, and a match is simultaneously performed when the sample identifier is read, and the sample that matches can be determined as a quality control sample.

[0030] As an example of the operation of this embodiment, only when a sample is determined to be a quality control sample, the sample is automatically measured in a different stored measurement mode in addition to the measurement in the preset measurement mode. This makes it possible to eliminate the trouble of re-measuring the quality control sample when switching the measurement mode to measure a clinical sample.

[0031] <Quality control screen> An example of the quality control display of this embodiment is shown in Figure 7. It is possible to graph the quality control result by dotting plot indicators in the quality control result graph display area 100, which has the measurement date on the horizontal axis and the quantitative value on the vertical axis, and it is also possible to connect the plot indicators with straight lines or curves.

[0032] The center of the vertical axis can be set to the average value of the measurement results or a known concentration. Also, a straight line showing the standard deviation width from the average value or known concentration can be set on the same graph. The deviation width can be set by specifying a value or a multiple of the standard deviation. In this embodiment, quality control samples having the same specimen ID measured in different measurement modes are shown on the same graph. To clarify which measurement mode the results were obtained from, the dot shape can be changed, the dot color can be changed, or the dots can be connected with a dashed or solid line to distinguish them.

[0033] In this embodiment, the device was operated in Short mode and Long mode using a quality control sample with a specimen ID set to 910001. The center of the vertical axis was set to 5.1%, which is a value previously set by the manufacturer as a reference standard value for HbA1c (%). Two levels of the control standard width were used, and the conditions were set to exceed ±0.2% and ±0.4%. This control standard width was displayed on the graph as a one-level line 102 (dashed line) and a two-level line 101 (solid line). As an example, the display area was set to an area from January 1 to January 9. In this embodiment, a warning identifier 103 is attached to the result plot indicator that deviates from the control standard width. In addition, the quality control sample is measured, and the control standard width is verified at the time of obtaining the results, and when there is a deviation, the measurement can be stopped due to an error or a warning message can be displayed on the screen to alert the measurer.

[0034] Furthermore, by tapping or otherwise operating the plots on the graph, detailed results for that result can be popped up. Figure 8 shows the pop-up screen that appears when the plot indicator 104 is tapped. The pop-up screen can display a chromatogram 120 of the quality control sample and measurement conditions 121, and also allows reference to a list 122 of measurement results other than HbA1c. It is also possible to provide a QC comment field 123 that can display information about deviations from the quality control standard range, and a detailed results button 124 that guides the user to detailed results to reference information such as the lot of consumables used and the person who performed the measurement.

[0035] The lot of the quality control sample, the replacement of the column, the replacement of the eluent, the replacement of the line filter, or the implementation of calibration may affect the results of the quality control sample depending on the situation. In this embodiment, a warning identifier (105, 106) can be added to the plot of the results of the quality control sample measured on the day the consumables were replaced, and a warning identifier 107 indicating that it is the day the calibration was performed can be added. A flag identifier 108 can also be added to the plot data of the quality control results in which part of the measurement results falls under a preset flag condition (for example, the total area is smaller than a certain threshold) and displayed together. This makes it easy to distinguish between the replacement of consumables, the flag condition, and the trend changes in the quality control sample results. In addition, the display range of the horizontal axis or the standard control width can be set on a pop-up window screen that pops up by touching the display setting button 109.

[0036] The plots and graph lines of the measurement modes can be confirmed in the graph legend 110, and the target quality control ID can be confirmed in the quality control ID display 111. In addition, the average value, standard deviation, multiple value of the standard deviation, coefficient of variation, etc. of each measurement mode can also be displayed together in the statistical information display section 112 as statistical information within the display range.

[0037] In another aspect of the quality control display of this embodiment shown in Fig. 9, in addition to the control standard range of the quality control sample, a standard for the difference between the measurement modes is set. A deviation of more than ±0.3% in the difference in HbA1c value between the measurement conditions of short mode and long mode is set as another control standard range. The results of each quality control sample in short mode and long mode measured on January 4th do not deviate from the control standard range in each measurement, but since the difference between the two measurement modes is 0.4%, an inter-measurement mode difference warning identifier 130 is assigned.

[0038] Another example of the quality control display of this embodiment is shown in Figure 10. The graph is drawn with the measurement date on the horizontal axis and the difference in the quantitative results of the two measurement modes (Long mode result - Short mode result) on the vertical axis.

[0039] Another example of the quality control display of this embodiment is shown in Figure 11. The graph is drawn with the measurement date on the horizontal axis and the ratio of the quantitative results of the two measurement modes (Long mode result ÷ Short mode result) on the vertical axis.

[0040] In this way, by visualizing the differences and ratio trends in the quantitative results of the two measurement modes, it is possible to quickly and easily detect changes in the equipment or measurement environment that may affect the measurement results.

[0041] FIG. 12 shows another example of the quality control display of this embodiment. In this embodiment, the measurement results of the patient samples obtained on that day without using the quality control sample are used as a population, and the average value is calculated, and the measurement date is plotted on the horizontal axis and the average value is plotted on the vertical axis. When the population is always at least a certain number in a testing center or a large hospital, the distribution forms a distribution that is roughly close to the average distribution in the facility. In that case, the change in the average value or standard deviation may indicate the state of the device rather than the fluctuation of the patient population. In particular, when the distributions and statistics of multiple measurement modes are compared and the same trend is formed between the measurement modes, it is highly likely that the state of the device can be considered as the main factor. It is also possible to display a regression curve or a moving average line as an index showing the trend. This makes it possible to perform highly reliable quality control even without using a quality control sample. [Explanation of symbols]

[0042] 10, 11, 12: Eluent 13. Deaeration unit 14... Liquid delivery unit (liquid delivery pump) 15, 16, 17: Solenoid valve 18. Sampling unit 19. Analytical column 20....Absorptiometry detector 21. Column oven 22 Control / processing section 23 Storage section 24 Input and display section 25 Data storage section 26 STAT port 27... Sample identification information reader 28 Rack loader 31 A1a peak 32 A1b peak 33 HbF peak 34. Peak L-A1c 35 HbA1c peak 36 A0 peak 37 Glycated HbE peak 38 HbS peak 41. Sample ID input field 42 Measurement number display section 43 Measurement mode selection section 44... Sample type designation section 45 Quantitative condition selection section 100...Quality control result graph display area 101, 102...Accuracy control standard width 103 Quality control reference range deviation identifier 104... Plot Indicator 105, 106, 107... Attention Identifier 108...Flag Identifier 109 Display setting button 110...Graph Legend 111...Quality control ID display 112...Statistics information display 120...Quality control sample chromatogram 121... Measurement conditions 122···Results list 123···QC Comment section 124...Detailed Results Button 130 Measurement mode difference warning identifier 1000...Analyzer

Claims

1. A storage unit for storing two or more measurement modes having a common main quantitative item; an input unit for selecting the measurement mode stored in the storage unit; A control unit that controls the measurement unit in accordance with the selected measurement mode; A processing unit that performs quantitative calculations from the measurement results; a data storage unit for storing all or any of the quantitative result data of the quality control sample, the chromatogram of the quality control sample, the specimen identification information of the quality control sample, and the measurement mode information at the time of measuring the quality control sample; The quantitative result data of the quality control sample is plotted as data, The plot data is classified by a plot indicator that can be identified for each measurement mode; A liquid chromatography apparatus having a display unit capable of displaying, in one graph area, quantitative result data of the quality control sample having common specimen identification information measured in two or more measurement modes.

2. A display unit capable of displaying quantitative result data of the quality control sample having common specimen identification information measured in two or more measurement modes in a single graph area in chronological order using plot indicators.

2. The liquid chromatography device of claim 1.

3. The sample identification code is read, and when the code matches with the sample identification code registered in advance as a quality control sample, a control unit controls the sample in the sample container having the code to perform a plurality of measurements using two or more measurement modes selected from two or more measurement modes stored in the storage unit. The liquid chromatography device according to claim 1 or 2.

4. When at least one of the following items is carried out between the last quality control sample measurement and the start of the next quality control sample measurement: a change in the quality control sample lot, a change in reagent, a change in column, or a change in calibration conditions. A user interface is provided, which is characterized in that a recognition character is added to a plot marker during measurement of the quality control sample or the plot marker is changed. The liquid chromatography device according to claim 1 or 2.

5. The present invention is provided with a user interface that, when at least any or all of the quantitative result values ​​of a quality control sample having common specimen identification information measured in two or more measurement modes having a common main quantitative item deviates from a preset range, assigns a recognition character to the plot marker or changes the plot marker. The liquid chromatography device according to claim 1 or 2.

6. A liquid chromatography apparatus as described in any one of claims 1 to 5, having a display unit capable of displaying the ratio or difference between the quantitative results of any two measurement modes as plot data in a single graph area for quantitative control samples having common specimen identification information measured in two or more measurement modes in which the main quantitative item is common.

7. The present invention is provided with a user interface that, with respect to quantitative result data of a quality control sample having common specimen identification information measured in two or more measurement modes in which the main quantitative item is common, when the ratio or difference between each quantitative result of any two measurement modes deviates from a preset range, adds a recognition character to the plot indicator or changes the plot indicator. The liquid chromatography device of claim 6.

8. The liquid chromatography apparatus according to claim 1 , wherein the main quantitative item is HbA1c.

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