JPH07311191A - Method and apparatus for measuring glycosylated hemoglobin - Google Patents

Abstract

PURPOSE:To continue the measurement even upon failure of any measuring part, while shortening the measuring time, by separating a pretreatment section for conditioning a specimen in a sample cup from a plurality of parts for measuring the concentration of glycosylated hemoglobin in the specimen. CONSTITUTION:The measuring apparatus comprises a rack supply/discharge station 1, a pretreatment section 2, first and second measuring sections 3, 4, and a transfer section 5. The rack 6 is loaded with a plurality of blood sampling pipes 7 and the bloods sampled from patients are stored therein. The rack 6 is introduced from a rack introducing section 1a and discharged from a rack discharging section 1c after the blood is sampled at a sampling position A. At the pretreatment section 2, the blood is sampled into a sample cup 18 and subjected to thermal hemolytic dilution to prepare a specimen and then the rack 25 loaded with a sample cup 18 is transferred to any one of the measuring sections 3, 4. The measuring sections 3, 4 measure the concentration of glycosylated hemoglobin of specimen in the sample cup 18 by liquid chromatography.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a glycated hemoglobin measuring and measuring apparatus using liquid chromatography, and in particular, it prepares a sample by hemolyzing and diluting a blood sample to measure the unstable glycated hemoglobin in the sample. The present invention relates to a method and an apparatus for measuring glycohemoglobin that can eliminate the influence and measure the stable glycohemoglobin concentration.

[0002]

Glycohemoglobin (HbA ₁ ) has a structure in which glucose, glucose 6-phosphate and the like are covalently bonded to hemoglobin Hb. Hemoglobin Hb
The proportion of glycated hemoglobin HbA ₁ in it is called the hemoglobin A _1c value (%), which has become an important test item for diabetes.

The above-mentioned glycohemoglobin HbA _1c accounts for about 4 to 6% of total hemoglobin in Hb, but increases 2 to 3 times in healthy subjects in diabetic patients with poor glycemic control. Therefore, by measuring the hemoglobin A _1c value in blood, a powerful index in the diagnosis of diabetes can be obtained.

However, glycohemoglobin HbA ₁ has stable HbA _1c and unstable HbA _1c .
Among these, unstable HbA _1c is greatly affected by the blood glucose state during blood collection. Therefore, the unstable HbA _1c is removed,
A method for measuring stable HbA _1c has been developed and evaluated.

An example of a method for automatically measuring glycated hemoglobin by removing the unstable HbA _1c as described above is disclosed in JP-A-1-97857. The measuring method disclosed in the above-mentioned prior art proposes a method of measuring the stable HbA _1c using high performance liquid chromatography. In this method, first, in the sampling section, a blood sample (whole blood sample or blood cell sample) is sucked and collected from a sample container such as a blood collection tube by a sampling nozzle. Next, the blood sample collected from the sampling nozzle is transferred to the dilution / dispensing tank, and the hemolytic diluent is also discharged to the dilution / dispensing tank to dilute the blood sample by hemolysis to obtain a sample. After that, the sample in the dilution / dispensing tank is guided to the sample loop of the sample injection valve using the sample suction nozzle, and the sample is guided from the sample loop to the measurement unit by switching the sample injection valve. In this measurement method, the hemolytic dilution contains an unstable HbA _1c removal reagent, and the unstable HbA _1c is removed by heating the sample for a certain period of time in the sample loop.

Therefore, in the method described in the above-mentioned prior art,
The following pretreatment steps must be carried out for each measurement. That is, a step of collecting a blood sample from a blood collection tube with a sampling nozzle, a step of injecting the collected blood sample into a dilute dispensing tank, a step of adding a hemolytic diluent to the diluting dispensing tank, and a sample aspirating nozzle Step of guiding the sample to the sample loop of the sample injection valve Step of incubating the sample in the sample loop Step of cleaning the dilution dispensing tank Step of switching the sample injection valve and introducing the sample in the sample loop to the column of the measurement section Sample injection valve Process of switching the sample to the original state Process of cleaning the sample loop

[0007]

In the measurement of glycated hemoglobin, there is a strong demand for shortening the measurement time. That is, since it is desired to use the measurement result for medical treatment in the outpatient clinic of the hospital, it is strongly demanded that the measurement result be obtained in a short time, and in order to improve the measurement efficiency, the measurement per unit time per measurement device is required. It is strongly desired to increase the number of times.

However, in the above-mentioned conventional method for measuring glycohemoglobin, in order to remove unstable HbA _1c , it was necessary to incubate in a warmed sample loop for a certain period of time. Therefore, it has been an obstacle to shortening the measurement time.

Since the steps of collecting a blood sample, preparing a sample by hemolyzing and diluting the blood sample, removing unstable HbA _1c , and measuring glycohemoglobin in the sample are performed in series, The measurement time was determined by the total time required for the process. Therefore, unstable Hb
In order to reliably remove A _1c , it was very difficult to further shorten the measurement time.

Further, when a trouble occurs in the measuring section, there is a problem that the measurement cannot be continued. That is, when trouble occurs in the measurement unit,
The measurement could not be continued without repair work such as column replacement. Therefore, for example, if the measuring device is configured to automatically stop when a trouble occurs in the measuring unit, and if the pressure in the separation column rises excessively during unattended continuous night operation, it will automatically stop. become.
As a result, the collected blood sample was deteriorated and could no longer be used for measurement.

The object of the present invention is to solve the above-mentioned problems of the conventional method for measuring glycohemoglobin, to shorten the measuring time, and to continue the measurement even when a failure occurs in the measuring section. It is an object of the present invention to provide an enabling method and measuring apparatus for glycated hemoglobin.

[0012]

The invention according to claim 1 is a method for measuring glycated hemoglobin by liquid chromatography, wherein a blood sample is collected in a sample cup in a pretreatment section and is hemolyzed. The sample is prepared by, and the sample cup is conveyed from the pretreatment unit to any one of a plurality of measuring units by the conveying unit, and the glycohemoglobin concentration of the sample in the sample cup is measured by the measuring unit. A method for measuring glycated hemoglobin, comprising each step of measuring by liquid chromatography.

In the method for measuring glycated hemoglobin, preferably, as described in claim 2, the transport means is provided with a warming portion to heat the sample during transportation, whereby unstable glycated hemoglobin is more likely to be contained. Effectively removed.

The invention according to claim 3 is an apparatus for measuring glycated hemoglobin by liquid chromatography, wherein a blood sample is sampled in a sample cup and hemolyzed and diluted to prepare a sample. A pretreatment unit for measuring a plurality of measurement units for measuring the glycohemoglobin concentration of the sample in the sample cup, and transporting the sample cup from the pretreatment unit to one of the measurement units. A measuring device for glycated hemoglobin, comprising:

In the glycated hemoglobin measuring apparatus, preferably, the transport means is provided with a warming section, and the specimen is warmed by the warming section, and unstable glycated hemoglobin is obtained. Are effectively removed.

[0016]

The method for measuring glycated hemoglobin according to claim 1 and the apparatus for measuring glycated hemoglobin according to claim 3 are characterized in that the pretreatment unit and the plurality of measuring units are separated as described above. . That is, the pretreatment unit for preparing the sample in the sample cup and the plurality of measurement units for measuring the glycohemoglobin concentration in the sample are separated, and the sample cup is separated from the pretreatment unit to one of the plurality of measurement units. It is characterized in that it is configured so as to be transported to the measuring section of 1.

Therefore, in continuously measuring the glycated hemoglobin concentration, the sample is transported from the pretreatment unit according to the time required for the measurement (separation) in the measuring unit (liquid chromatography) to obtain the total glycated hemoglobin concentration. The measurement time can be shortened.

That is, in the conventional method for measuring glycated hemoglobin, the steps of performing pretreatment, removing unstable glycated hemoglobin, and measuring the glycated hemoglobin concentration by liquid chromatography are carried out in series. Therefore, if the measurement in the measurement unit is not completed, the next pretreatment and measurement will not be performed.Therefore, the total measurement time will be the time required for pretreatment, the time required for measurement of unstable glycohemoglobin, and the measurement. It was not possible to reduce the total time required. On the contrary,
In the measuring method and the measuring apparatus of the present invention, a plurality of measuring units are provided, and the preprocessing unit and the measuring unit are separated, so that before the measurement in one measuring unit is finished, the other measuring unit is finished. Glycohemoglobin can be measured in. Therefore, when continuously analyzing a large number of samples, the total measurement time can be significantly shortened.

Further, in the inventions according to the first and third aspects, the sample is prepared in the sample cup, and the sample in the sample cup is supplied to the measuring section for measurement. Therefore, simplification of the device can be achieved. Also, by selecting the transport time in the transport means,
Unstable glycohemoglobin can be removed during transport. In particular, as described in claims 2 and 4, the unstable hemoglobin can be removed more effectively by providing the heating means in the transfer means and heating the sample during the transfer.

[0020]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be clarified by describing the measuring method and measuring apparatus for glycated hemoglobin of the embodiments with reference to the drawings.

FIG. 1 is a schematic configuration diagram showing a measuring apparatus for glycated hemoglobin according to an embodiment of the present invention. The measuring apparatus for glycated hemoglobin of the present embodiment is a rack supply /
It has an ejection station 1, a pretreatment unit 2, first and second measuring units 3 and 4, and a carrying unit 5 as a carrying means.
The rack supply / discharge station 1 constitutes a part for supplying the rack shown in FIGS. 2A and 2B to the measuring apparatus of this embodiment or discharging the rack from the measuring apparatus of this embodiment.

As shown in FIGS. 2A and 2B, the rack 6 is configured to mount a plurality of blood collection tubes 7, and the rack 6 is mounted with the plurality of blood collection tubes 7. It is hung. A blood sample collected from a patient or the like is stored in the blood collection tube 7. The blood sample may be either a whole blood sample or a blood cell sample.

The rack 6 is supplied from the rack introduction section 1a of the rack supply / discharge station 1 and moved to the sampling position shown by the arrow A in FIG. This sampling position A
Are located near the preprocessing unit 2. At the sample collection position A, the blood sample in the blood collection tube 7 is sampled, and the pretreatment described below is performed in the pretreatment unit 2. After the blood sample is collected, the rack 6 is moved to the rack discharge section 1c of the rack supply / discharge station 1 and discharged. The specific structure of the rack supply / discharge station 1 can be configured by using an appropriate transfer means such as a belt conveyor, or is not limited to the one that linearly transfers the rack 6 such as a belt conveyor. Instead, it may be configured by a transfer device that can transfer the rack 6 in a curved shape.

The pretreatment unit 2 is arranged in the vicinity of the blood sample collecting position A, and the pretreatment unit 2 collects the blood sample in the blood collection tube 7 to prepare a sample. The operation of the preprocessing unit 2 will be described with reference to FIG.

In FIG. 3, the pretreatment unit 2 includes a nozzle 8
Is provided. The nozzle 8 is configured to be capable of sucking and discharging the liquid sample, and is configured to be moved between the positions A to C in FIG. The nozzle 8 can be moved between positions A to C by connecting an appropriate drive source such as an air cylinder to the nozzle 8.

The nozzle 8 is constructed so that it can move not only between positions A to C, but also up and down at each position. The nozzle 8 is heated by the flow path 11 to the heating unit 9
Are linked to. In the heating unit 9, a loop-shaped flow path 1
0 is provided. Further, a hemolytic washing liquid container 12, a first pump P1 and a second pump P2 are connected to the warming section 9 on the side opposite to the flow path 11. That is, as is clear from FIG. 3, the flow passage 13 is extended in the hemolytic wash liquid container 12 in which the hemolytic wash liquid 12a is stored, and the flow passage 13 is connected to the first pump P1. Road 14,
It is connected via the first valve V1. Further, the valve V1 is connected to the second valve V2 via the flow path 15. On the other hand, the second pump P2 is connected to the second valve V2 via the flow path 16. Further, the second valve V2 is connected to the above-mentioned heating unit 9 via the flow path 17.

Each of the valves V1 and V2 has three ports, and is constructed so that it can be switched between two states in which two ports are connected. Valve V
1 and V2 can be configured by appropriate valves such as conventionally known three-way valves.

The first and second pumps P1 and P2 are
The pumps are provided to suck the hemolyzed lavage fluid and the blood sample, respectively, and can be constituted by an appropriate pump such as a conventionally known roller pump.

As the hemolytic wash solution 12a stored in the hemolytic wash solution container 12, a conventionally known hemolytic wash solution can be used, and an appropriate solution that can hemolyze blood cells and dilute a blood sample can be used. Can be used.

Further, in FIG. 3, below the nozzle positions B and C, the sample cup 18 and the cleaning tank 1 are provided, respectively.
9 are arranged. The sample cup 18 can be constituted by an appropriate container having a bottomed cylindrical shape or a rectangular tube shape, and a plurality of the sample cups 18 are mounted on a rack similar to the rack 6 shown in FIG. In FIG. 3, only the cross section of one sample cup 18 is schematically shown.

Further, the washing tank 19 is composed of a container having an appropriate shape, and the washing tank 19 is provided for discharging the hemolyzed washing solution after washing the flow paths and valves V1, V2, etc. in the pretreatment section. In the cleaning tank 19, the flow path 2 is provided.
0 is extended, and the flow path 20 is connected to the drain container 22 via the valve V3. The opening of the drain container 22 is closed by a stopper, and the stopper is
The pipe 23 is inserted. The pipe 23 is connected to the air pump 24. Therefore, by operating the air pump 24, the waste liquid of the hemolytic washing liquid in the washing tank 19 is discharged into the drain container 22.

Next, the operation of the pretreatment section will be described with reference to FIG. 4 showing the states of the nozzle 8, the valves V1 to V3, and the pumps P1 and P2. Note that nozzle positions A to C in FIG. 4 correspond to the nozzle positions A to C shown in FIG. 3, respectively, and indicate the position of the nozzle 8. Also,
The symbol of the state of the valve V1 indicates that the flow paths 13 and 14 are connected (for example, step 1 described later) or the flow paths 14 and 15 are connected. Regarding the symbol of the valve V2, the state in which the flow paths 16 and 17 are connected (for example, step 1) or the flow path 1 is used.
The state where 5 and 16 are connected (for example, the state of step 3) is shown. Further, the downward or upward arrows indicating the states of the pumps P1 and P2 indicate the state in which the pump is feeding or sucking downward or upward as shown in FIG. Furthermore, in FIG. 4, the H solution represents a hemolytic wash solution.

First, in step 1, the nozzle 8 is positioned at the nozzle position A. At this time, the valve V1 connects the flow paths 13 and 14, and the hemolytic washing liquid 12a is sucked toward the pump P1 by the pump P1. On the other hand, the valve V2 connects the channels 16 and 17, and the blood sample 7a in the blood collection tube 7 is sucked from the nozzle 8 by the pump P2.

Next, in step 2, the nozzle 8 is moved to the position B, the liquid feeding direction of the pump P2 is reversed, and the blood sample is discharged from the nozzle 8 into the sample cup 18.

Next, in step 3, the valve V1 connects the flow paths 14 and 15, and the valve V2 connects the flow paths 15 and 17.
Are connected, the direction of the pump P1 is reversed, and the hemolytic wash solution is discharged from the nozzle 8 into the sample cup 18, whereby the blood sample is hemolyzed and diluted with the hemolytic wash solution, and the sample is prepared. It

Further, in step 4, the nozzle 8 is moved to the position C, the valve V1 connects the flow passages 13 and 14, and the hemolysis solution is introduced into the flow passage 14 by the pump P1. However, in step 5, the state of the valve V1 is switched, the hemolytic washing liquid is sent to the nozzle 8, the nozzle 8 is washed with the hemolytic washing liquid, and the hemolytic washing liquid is discharged to the washing tank 19.

Further, in step 6, the valve V3
Is opened, and the cleaning liquid discharged to the cleaning tank 19 is flow path 2
It is discharged via 0. Next, in step 7, the valves V1 and V2 are switched to the state of step 1 and the valve V3 is closed. In this way, the standby state is set, and thereafter, by returning to step 1, the next sample preparation is performed.

The above-mentioned heating unit 9 is used for the hemolytic washing liquid 1.
It is provided to heat 2a, and has a loop-shaped channel 10 of a predetermined length and a heater arranged around the channel 10. As described above, by providing the heating unit 9, the hemolytic washing liquid 12a can be heated and the unstable glycohemoglobin HbA _1c can be efficiently removed in a short time.

In the sample cup 18, the amount of sample required for measurement in the measuring section described later is prepared, but in this embodiment, the amount of sample required for at least three measurements is prepared. . For example, 1.5 μL of sample is 3
When diluted to 00 times, 450 μL of sample can be obtained. However, when 100 μL is used for one measurement, the dead volume in which the sample cannot be collected is about 10 in the measurement part.
When the volume is 0 μL, the measurement can be performed 3 times.

Returning to FIG. 1, the specimen is prepared in the sample cup 18 as described above, and the operation in the pretreatment unit 2 is completed. This sample cup 18 is a rack 25
It is mounted on multiple books. The rack 25 is placed on the transport unit 5, and is moved by the transport unit 5 in the direction of arrow D shown in the figure. That is, the rack 25 moves on the transport unit 5 by the arrow D
It is conveyed along the direction and is conveyed to a position in the vicinity of any of the measuring units 3 and 4. In this case, in the middle of the transport unit 5,
A sample cup heating unit 26 is provided.

The sample cup heating section 26 is constructed by disposing an appropriate heater around the transport section 5,
As a result, the unstable glycohemoglobin HbA _1c can be more effectively removed during transportation. However, the sample cup heating unit 26 may not be provided in particular, and the unstable glycohemoglobin HbA _1c may be removed by adjusting the transport time in the transport unit 5.

The rack 25 is carried by the carrying section 5 and carried to the vicinity of either the first measuring section 3 or the second measuring section 4. The selection of the first transport unit 3 and the second transport unit 4 can be performed by a control device (not shown). In the present embodiment, two transport paths 5b and 5c are branched and provided on the measurement section side of the transport section 5, and the first measurement section 3 and the other transport path 5c are provided on one transport path 5b side.
The second measuring unit 4 is arranged on the side.

Next, the configuration and operation of the first and second measuring units 3 and 4 will be described with reference to FIGS. 5 and 6. In FIG. 5, a nozzle 28 is provided in the measuring section. The nozzle 28 is provided for sucking a sample or a cleaning liquid, and is configured to move between a position D and a position E shown in the drawing. In addition, the nozzle 28
Are configured to be movable up and down at positions D and E, respectively. The movement of the nozzle 28 between the positions D and E and the vertical movement can be appropriately configured by an air cylinder or the like (not shown).

The nozzle 28 is connected to a sample injection valve 30 via a flow path 29. The sample injection valve 30
In the present embodiment, it is configured by a 6-way valve, and is configured so as to be able to take a state in which each port is connected by a solid line a shown in the figure and a state in which 6 ports are connected by a broken line b. Has been done. A valve 32 is connected to the sample injection valve 30 via a flow path 31, and a cleaning liquid container 34 is connected to the valve 32 via a flow path 33. A cleaning liquid 34a is stored in the cleaning liquid container 34. A pump P3 is connected to the valve 32 via a flow path 35. The pump P3 is configured by an appropriate pump such as a roller pump, and is provided to guide the sample and the cleaning liquid through the flow path. The valve 32 has the flow path 3 described above.
1, 33, and 35, and are connected to the flow path 31 and the flow path 35.
And the flow path 33 and the flow path 35 are connected to each other.

Further, at one port of the sample injection valve 30, a column 36 for liquid chromatography is used as the flow path 3.
It is connected via 7. In addition, the flow path 38 is the column 3
A flow path for guiding the waste liquid from 6 to the sample injection valve 30.

A sample loop 39 is connected to the sample injection valve 30. The sample loop 39 is
It is provided to guide the sample, and 2 of the sample injection valve
It is configured to connect two ports.

A cleaning tank 40 is arranged below the nozzle 28 at the position E. The cleaning tank 40 contains the cleaning liquid 3
The cleaning tank 40 is provided to discharge 4a, and the cleaning tank 40 has the same flow passage 41 as the cleaning tank 19 shown in FIG.
A valve III is connected via a valve, and a waste liquid container and a pump are connected to the lower end of the valve III as in the case below the valve V3 shown in FIG.

Next, the operation of the measuring section will be described with reference to FIG. FIG. 6 shows the position of the nozzle 28, the state of the flow path of the sample injection valve 30 (valve I), the state of the valve 32 (valve II), and the valve II in the measuring section shown in FIG.
It is a figure which shows the state of I, and the drive direction of the pump P3 in each process.

First, in step 1, the nozzle 28 is located at the position D, and the tip of the nozzle 28 is introduced into the sample in the sample cup 18. Valves I to I
II is in the state shown in FIG. 6, that is, the valve 30 (valve I) is in the state a, and the valve 32 is the flow path 35.
Is connected to the flow path 31, and the valve III is closed. Further, the pump P3 is driven so as to suck the sample in the sample cup 18, as indicated by the downward arrow in the figure. Therefore, the sample is sucked by the nozzle 28 and guided to the sample loop 37.

Next, in step 2, the valve 30 (valve I) is switched to the state of b, and the sample loop 3
The sample held in 9 is injected into the column 36.
In step 3, the nozzle 28 is moved to the position E, the valve 30 (valve I) is switched to the state a, and the driving direction of the pump P3 is switched as shown by the upward arrow in FIG. As a result, the residual liquid of the sample remains in the cleaning tank 4.
It is discharged to 0.

In step 4, the valve 32 is switched, the flow passage 33 and the flow passage 35 are connected, and the pump P3
The liquid feeding / sucking direction of is switched as shown by the downward arrow in the figure. As a result, the cleaning liquid 34a is sucked.

Next, in step 5, the valve 32 (valve II) is switched, and the liquid feeding direction of the pump P3 is switched, whereby the cleaning liquid guided to the flow path 35 is supplied to the nozzle 28 and the nozzle 28 is turned on. To be washed.

Next, in step 6, the valve III
Is opened, and the cleaning liquid discharged from the cleaning tank 40 is discharged from the cleaning tank 40. Next, in step 7,
The valve 30 (valve I) is set to the state a, and the valve 32
Is connected to the flow path 31 and the flow path 35, and the valve III is closed to enter the standby state.

Next, returning to step 1, the next measurement is performed. As described above, in the measurement unit, the sample in the sample cup is supplied to the column provided in the measurement unit,
The concentration of glycated hemoglobin is measured by the column based on liquid chromatography.

The measurement of HbA _{1c on} the column is
It is carried out in the same manner as the measurement of glycohemoglobin using conventional liquid chromatography. Returning to FIG. 1, in the measuring apparatus and the measuring method of the present embodiment, the conveying paths 5b and 5c branched to the measuring section side of the conveying section 5 are configured,
The first measuring unit 3 is provided in each of the transport paths 5b and 5c.
And the second measuring unit 4 is configured. Therefore, the control device (not shown) can transport the rack 25 to the transport path 5b provided with the measuring unit 3 and the measuring unit 3 can perform the measurement. When the measurement is not completed in the measurement unit 3, the rack 25 can be transported to the transport path 5c side and the measurement can be performed in the measurement unit 4. That is, since it has a plurality of measurement units 3 and 4, it is possible to measure a new sample even when the measurement in the measurement unit 3 or 4 is not completed.

In the above embodiment, as shown in FIG. 1, branch conveying paths 5b and 5c are provided in the conveying path 5, and the measuring section 3 is arranged in the conveying path 5b and the measuring section is arranged along the conveying path 5c. However, in the measuring apparatus and the measuring method of the present invention, the arrangement of the plurality of measuring units can be changed appropriately.

For example, as shown in FIG. 7, a plurality of measuring units 3 and 4 are arranged in parallel, and the conveying paths 5d to 5d are provided on both sides of each of them.
5f may be arranged in parallel so that a sample can be collected from the sample cup mounted on the rack 25 on any of the transport paths 5d to 5f. That is, in the modified example shown in FIG. 7, in the measurement unit 1, the sample in the sample cup mounted on the rack 25 on the transport paths 5d to 5f can be collected and measured, and similarly in the measurement unit 4. Can also collect and measure the specimen in the sample cup 18 mounted on the rack 25 that is transported on the transport paths 5d to 5f.

Of the transport paths 5d to 5f shown in FIG. 7, for example, the transport path 5f may be used as a reinspection transport path. That is, in the case where the rack discharge station 41 is provided on the downstream side of the transport paths 5d to 5f and configured to discharge the rack 25 mounted with the sample cup whose measurement has been completed, the rack discharge station 41
A transport path 5f is provided so as to return to the transport path 5, and the transport path 5f is provided.
The rack 25 may be supplied to the rack 25 and the sample in the sample cup mounted on the rack 25 transported on the transport path 5f may be inspected again.

Further, as in the modified example shown in FIG. 8, in the transport path 5, in order to facilitate the suction of the stopper from the sample cup in the vicinity of the measuring parts 3 and 4, a sampling station 5g is provided in the transport path 5. , 5h may be provided to facilitate the aspiration of the sample. That is, the sampling stations 5g and 5h are configured so that the rack 25 can be moved toward and away from the measuring units 3 and 4 on the side of the measuring units 3 and 4 on the transport path 5, thereby performing sampling. It is possible to facilitate the suction of the sample from the cup 18.

The configuration of each of the transport paths 5 shown in FIGS. 7 and 8 described above can be configured by combining conventionally known belt conveyors or by combining other appropriate transporting means.

Next, the effect of shortening the measurement time in the method for measuring glycohemoglobin of the present invention will be described with reference to the schematic block diagram of FIG. As described above, in the method for measuring glycohemoglobin of the present invention, sample cups (rack) are assigned to a plurality of measuring sections to shorten the measuring time as a whole. In this case, the control unit 51 allocates the sample cup to the measurement unit. The control unit 51 is electrically connected to the pretreatment unit 2 and the plurality of measurement units described above, and controls to which measurement unit the rack existing in the transport unit is transported.

Further, as described above, in the measuring method of this embodiment, the blood sample stored in the blood collection tube 7 is injected into the sample cup 18 to prepare a sample. Therefore, it is necessary to manage the correspondence between the blood sample 7a and the specimen 18a. For such management, the transport rack 6 is provided with the identification number ID1 and the sample cup is stored in accordance with the identification number ID1. The identification number ID2 is also given to the rack 25 on which 18 is mounted, and the relationship between the blood sample and the sample can be managed by the correspondence relationship between the two. In this case, a bar code is attached to each blood collection tube 7, and the bar code is read by a bar code reading means (not shown).
The correspondence relationship between the identification numbers ID1 and ID2 can be stored in the control unit and the correspondence relationship can be managed.

Alternatively, when the barcode is not attached to the blood collection tube 7, the blood collection tube 7 is numbered in order from the start of measurement based on the positional relationship between the rack 6 and the blood collection tube 7, and the number n of the blood collection tube 7 is set. , The rack identification numbers ID1 and ID2 described above
The correspondence relationship with may be managed.

In the present invention, the measurement time is shortened by allocating the rack 25 to a plurality of measuring sections. This will be described more specifically. For example, when the pretreatment time in the pretreatment unit 2 is 30 seconds, the pretreatment can be performed 120 times in 1 hour. On the other hand, if the processing time in the measurement unit is 3 minutes, one measurement unit can measure 20 times per hour. Therefore, in the conventional measuring method and measuring apparatus, since only one measuring unit 7 is provided and the measuring unit of the pre-processing unit is connected in series, if the processing time of the measuring unit is 3 minutes. ,
Only 20 samples could be processed in one hour.

On the other hand, in the present invention, since a plurality of measuring units are provided, for example, if six measuring units are provided, the preprocessed sample can be sequentially assigned to each measuring unit. It is possible to measure 120 specimens per hour. In addition, when the measurement processing time in the measuring unit is 2 minutes, it is possible to reduce the same time by providing four measuring units.
It is possible to measure 120 specimens per hour.

Table 1 below shows the number of measuring sections as described above, the processing time in the measuring sections, and the sample processing capacity (number of sample measurements) per hour.

[0067]

[Table 1]

As is clear from Table 1, by using the measuring device and the measuring method of this embodiment, it is possible to assign sample cups to a plurality of measuring parts and perform the measurement.
It can be seen that the measurement time can be significantly shortened.

Further, in the case where a plurality of measuring units are provided, if a trouble occurs in any of the measuring units, the rack on which the sample cup is mounted can be transported to another measuring unit. , The measurement can be continued.

Further, when an abnormality occurs in the measurement result in any of the measuring units, the rack is moved so that the same sample is re-inspected in another measuring unit, so that the sample is surely re-inspected. be able to.

[0071]

As described above, in the method and apparatus for measuring glycated hemoglobin of the present invention, the preparation of the sample in the pretreatment section and the measurement of glycated hemoglobin concentration by liquid chromatography in the measurement section are separated. , And since a plurality of measuring units are provided, even if the length of time required for separation in the measuring unit is longer than the pretreatment time, by allocating the sample cups to the plurality of measuring units, The measurement time as a whole can be significantly shortened. Therefore, the concentration of glycated hemoglobin can be measured easily and quickly, so that the measurement result can be easily used for diagnosis in, for example, an outpatient clinic of a hospital.

Further, in the conventional method for measuring glycohemoglobin, it was necessary to incubate the specimen for a certain period of time in order to remove the unstable HbA _1c , but in the present invention,
Unstable glycohemoglobin H when transported in the transport section
Since bA _1c can be reliably removed, in particular, in the inventions described in claims 2 and 4, since the specimen is heated in the transport section,
The unstable HbA _1c is removed more efficiently. Therefore, the concentration of stable HbA _1c can be measured quickly and reliably.

[Brief description of drawings]

FIG. 1 is a schematic configuration diagram for explaining a measuring apparatus for glycated hemoglobin according to an embodiment of the present invention.

2A and 2B are a plan view and a side view showing a rack on which a blood collection tube is mounted.

FIG. 3 is a schematic configuration diagram for explaining a configuration of a preprocessing unit in the embodiment.

FIG. 4 is a schematic diagram for explaining a process in a pretreatment unit.

FIG. 5 is a schematic configuration diagram for explaining a configuration of a measurement unit.

FIG. 6 is a schematic diagram for explaining a process in a measurement unit.

FIG. 7 is a schematic plan view for explaining a modified example of the arrangement method of the transport unit and the measurement unit.

FIG. 8 is a schematic plan view for explaining a modified example in which a transport station is provided with a sampling station.

FIG. 9 is a schematic block diagram of the measuring apparatus of the present invention.

[Explanation of symbols]

 2 ... Pre-treatment part 3, 4 ... Measuring part 5 ... Conveying part 7 ... Blood collection tube 8 ... Nozzle 18 ... Sample cup 25 ... Rack mounting sample cup 36 ... Column

Claims (4)

[Claims] 1. A method for measuring glycated hemoglobin by liquid chromatography, which comprises collecting a blood sample in a sample cup in a pretreatment section, and diluting hemolyzed to prepare a sample, and carrying out the pretreatment by a conveying means. Section to convey the sample cup to any one of a plurality of measuring sections, comprising each step of measuring the glycohemoglobin concentration of the sample in the sample cup by liquid chromatography in the measuring section, glycohemoglobin Measuring method. 2. The method for measuring glycated hemoglobin according to claim 1, wherein a warming portion is provided in the carrying means to warm the specimen in the sample cup during the carrying. 3. An apparatus for measuring glycated hemoglobin by liquid chromatography, comprising a pretreatment unit for preparing a sample by collecting a blood sample in a sample cup and diluting by hemolysis. A plurality of measurement units for measuring the glycohemoglobin concentration of the sample in the cup, and a transport means for transporting the sample cup from the pretreatment unit to any one of the plurality of measurement units. An apparatus for measuring glycated hemoglobin characterized by: 4. The measuring apparatus for glycated hemoglobin according to claim 3, wherein the transporting unit has a heating unit for heating the sample.