JPS6388461A - Biochemical automatic analyser - Google Patents

Abstract

PURPOSE:To always stably measure an item to be analyzed after change-over, by automatically washing a measuring flow passage in the optimum washing process preliminarily selected according to the combination of the analytical items in the first and second cycles. CONSTITUTION:A reaction line 3 has a large number of reaction containers 2 capable of being continuously recirculatingly moved, and a specimen supply apparatus 4 for supplying a specimen to each of the reaction containers 2, a reaction reagent supply apparatus 5 for supplying the reaction reagent of a predetermined analytical item and a pure water and detergent supply apparatus for washing a flow cell are provided to said reaction line 3. A liquid mixture of a specimen and a reaction reagent is prepared to be distributed to each of the reaction containers 2 and supplied to a flow cell 62 from said container 2 through a suction nozzle 61, and a photometric apparatus 6 measures the optical density of the liquid mixture in the flow cell 62. Then, in the optimum washing process preliminarily selected according to the combination of the analytical item in the first cycle and that in the second cycle, the measuring flow passage containing the flow cell 62 is automatically washed.

Description

DETAILED DESCRIPTION OF THE INVENTION (a) Field of Industrial Application This invention relates to an automatic biochemical analyzer. More specifically, it is a multi-item automatic analyzer used in clinical and other fields, and uses two circulating reaction lines.
The present invention relates to an automatic biochemical analyzer that performs switching analysis every cycle.

(b) Conventional technology Conventionally, a multi-item automatic analyzer used in the field of biochemistry has a 2-T type, which has a large number of reaction vessels.

one reaction line that can continuously circulate the samples; and a means for dispensing the sample into the reaction vessel.1. A means for dispensing a reaction reagent for a predetermined analysis item, a means for dispensing pure water and a detergent for flow cell cleaning gj, and a means for dispensing a reaction reagent for a predetermined analysis item, a means for dispensing a pure water and a detergent for flow cell cleaning gj, and a means for dispensing a mixed solution of a sample and a reaction reagent from a reaction container into which the mixed solution is dispensed and prepared, and then transferring the mixed solution to the flow cell via a suction nozzle. Predetermined items are measured for each reaction container in the first cycle in which the supply measurement flow path, the photometry unit that measures the optical density of the mixed liquid in the flow cell, and the reaction line circulate, and after one cycle, these reaction container groups are used. In the second cycle, items different from those in the first cycle are switched and analyzed.

An apparatus is known that includes a nostem control section that controls the above-mentioned reaction line, a sample dispensing means, a reaction reagent dispensing means, and a photometry section. The device consists of one circulation of the reaction line (first
There is a limit to the number of items that can be automatically analyzed depending on the
When measuring more items than this limit, change the reaction line to 2.
Measurement is performed by cycling (second cycle), and for this purpose, the control section changes the control in the first cycle and the control in the second cycle of the reaction line by replacing programs on a floppy disk, etc. (or by using the same program). It is configured so that switching can be performed using the same reaction vessel and the same flow cell.

In the above device, cleaning is performed using a fixed amount of cleaning solution (pure water and/or detergent solution) each time the device switches from analysis in the first cycle to analysis in the second cycle, regardless of the combination of items to be analyzed. It was configured to carry out the process.

(c) Problems to be solved by the invention However, depending on the combination of items that are switched and analyzed in the same reaction vessel and the same flow cell, the reagents or samples used during the analysis in the first cycle may remain even after washing. As a result, the measured values analyzed in that cycle may be observed to increase or decrease, and the measured values may be interpreted as being those of the patient. There was a risk of making an incorrect diagnosis. This is a problem, and even if studies were conducted from various angles to elucidate the cause, in the end the cause could not be elucidated, resulting in a wasted effort and time.

The present invention was made in view of the above situation, and in particular, it provides a cleaning process that can always stably measure the items to be analyzed after switching in an automatic analyzer that switches and analyzes multiple items in the same reaction vessel and same flow cell. The purpose is to provide an automatic biochemical analyzer equipped with the following.

(d) Means for Solving the Problems Thus, according to the present invention, one reaction line that has a large number of reaction vessels and can continuously circulate them, a means for dispensing a sample into the reaction vessels, Dispensing means for dispensing reaction reagents for predetermined analysis items, dispensing means for dispensing pure water and detergent for washing the flow cell, and dispensing the mixed solution of the sample and reaction reagent from the reaction container into which the mixed solution has been dispensed into the flow cell via the suction nozzle. After measuring predetermined items for each reaction vessel in the first cycle in which the supply measurement flow path, the photometry unit that measures the optical density of the mixed liquid in the flow cell, and the reaction line circulate, 1st in 2 cycles
It is equipped with a nostem control section that controls the reaction line, the sample dispensing means, the reaction reagent dispensing means, and the photometry section so that items different from the cycle can be switched and analyzed. Before cycle measurement, the measurement channel including the flow cell is washed with (i) a reagent blank solution and (i1) a process of washing with pure water and/or detergent solution and a reagent blank solution, depending on the combination of measurement items to be changed. A 1U system capable of sequentially dispensing pure water, detergent, and/or reagent blank solution into a reaction vessel and supplying it to a measurement channel in order to subject it to an optimal cleaning process selected from the following processes.
11. An automatic biochemical analyzer is provided which includes a constant flow path cleaning control section.

The apparatus of the present invention is capable of switching and analyzing multiple measurement items using the same reaction vessel and the same measurement cell over the first cycle and the second cycle. The method is characterized in that the measurement channel including the flow cell is automatically cleaned by an optimal cleaning process that is preselected in accordance with the combination with the analysis items (hereinafter referred to as the next analysis items) in the second cycle.

The above-mentioned cleaning process involves dispensing a fixed amount of cleaning liquid into a predetermined number of reaction vessels based on a preselected combination or order of cleaning liquids or groups of cleaning liquids, and sequentially dispensing a certain amount of cleaning liquid into a predetermined number of reaction vessels according to the order in which these reaction vessels are moved. This operation consists of suctioning the washing liquid in each reaction container into the measurement cell.

Examples of the cleaning liquid used in the above-mentioned cleaning step include pure water, detergent liquid, and reagent blank liquids for the next analysis items.

In this invention, the optimal cleaning process refers to a cleaning solution or a combination thereof that has the effect of removing residual samples, reagents, etc. used in the measurement of the preceding analysis item without substantially affecting the measured value of the next measurement item. Among the combinations, it is the one that can be used in the least amount, that is, the one that can be cleaned in the shortest amount of time. Although the above-mentioned minimum time is determined by the number and order of dispensing of the washing liquid used, it is preferable that the reagent blank liquid for the next analysis item is used as the final washing liquid of the washing step (that is, co-washed). Examples of the above combinations include pure water -> washing with a reagent blank solution for the next analysis item, pure water - detergent - pure water - washing with a reagent blank solution for the primary analysis item, washing with only the reagent blank solution for the next analysis item, etc. can be mentioned.

The cleaning unit control unit used in the present invention has a storage unit that stores in advance the selection and dispensing order and number of cleaning liquids, and controls each of the cleaning liquid dispensing means according to the procedure set in the storage unit. .

In the apparatus of the present invention, the analysis items to be combined in the first cycle and the second cycle include, for example, (GOT
and LDH), (ALB and TCHO).

(ALP and TG), (GLU and UA), etc.

(E) Effect According to the present invention, a cleaning solution consisting of pure water, detergent, and/or reagent blank solution is added to the reaction vessels moving on the reaction line after the predetermined items are measured in the first cycle. The cleaning liquid group is sequentially dispensed in a preset dispensing order and number of times, and as the reaction line moves 7, the cleaning liquid in the reaction container that is transferred is sequentially sucked into the measurement channel including the flow cell. After being washed, it is switched to a second cycle for analysis.

The present invention will be described in detail below with reference to Examples, but the present invention is not limited thereby.

(F) Embodiment FIG. 1 is an explanatory diagram of the configuration of an embodiment of the apparatus of the present invention. In the figure, the biochemical automatic analyzer (i) includes a large number of reaction vessels (2)... and a reaction line (3) that allows these reaction vessels to be circulated in the direction of the arrow (a) by a drive unit (not shown). ), a sample supply device (4) equipped with an autosampler (41) and a sample dispenser (42), and a reagent pressure (not shown) and reagent dispenser equipped with a large number of reagents corresponding to the intended analysis items. A reagent supply device (
5), a photometer (6) equipped with a flow cell (62) connected to the test liquid suction nozzle (61), and a pipe connected to a pure water supply tank (not shown) and a detergent supply tank (71). A nozzle (72
) is equipped with a detergent supply device (not shown), a nozzle for suctioning and discharging reactive gastric fluid (8 nozzles, a tap water cleaning nozzle, a water cleaning nozzle, 7 nozzles, a drainer, etc.). a cleaning device (9), a reaction vessel drying device (i0), a temperature controller (i11), an input section (i2) for inputting the operating procedures of each of the above devices, and a storage section (i2) for storing the input procedures. i3
) and a control ff1J (J5) which has a built-in microcomputer and is equipped with a recording section (i4) for controlling the operation of each of the devices according to the input procedure described above.

In the storage unit of the control unit, the operating procedure for measuring the preceding analysis item in the first cycle of the reaction line is sequentially stored in one program, and the operating procedure for measuring the next analysis item in the second cycle of the reaction line is stored in sequence. Stored on another program. Then, the cleaning process when switching between the first cycle and the second cycle is stored in yet another program. This cleaning process program includes pure water and detergent solution, depending on the combined analysis items, in order to remove the test liquid for the preceding analysis item and perform it in the minimum amount of time without affecting the measurement of the next analysis item. , the number and order of dispensing of the optimal cleaning solution or group of cleaning solutions selected from each reagent are stored in the input device.

The control section of this device instructs the pure water or detergent supply device and the reagent dispensing device to perform a dispensing operation, and also instructs the photometry section to perform a suction operation, in order to carry out the optimum cleaning process from the first cycle to the second cycle.

In the Sho Chemical automatic analyzer configured as above,
Specimen: Nescol-X A, detergent solution: 3% Cleano 99K was set to be measured by immunoturbidimetry, 60 TTT (thymol turbidity test: preliminary analysis item) samples were measured in the first cycle, and β in the second cycle. -Lip(β-
Riboprotein (next analysis item) was set to measure each of 60 samples, and the results were examined.

As a cleaning process when switching from the preceding analysis item measurement to the next analysis item measurement, (a) β-Lip reagent alone (blank solution) was dispensed 8 times, and this dispensing operation was repeated 3 times (hereinafter referred to as 8 Times ×
3), (b) Pure water injection 6 times - (β-Lip reagent blank solution 1
(c) 6 pure water injections → 20 detergent injections - 10 pure water injections → β-Lip reagent blank liquid injection (8+6) times. Furthermore, the reproducibility (d) was measured using a new reaction vessel at the time of switching, and the results shown in FIG. 2 were obtained.

From the above results, the cleaning step (a) is undesirable because significant drift occurs, and the cleaning step (c) is undesirable because no drift occurs but the measured value decreases. On the other hand, the washing process (mouth) is shown to be preferable because similar data to that obtained during reproducibility measurement is obtained.Furthermore, the analysis time in case (b) is about 15 minutes. It has been shown that the (near) cleaning step is the optimal cleaning step in terms of cleaning effectiveness and analysis time.

On the other hand, if the preceding analysis item is β-Lip and the next analysis item is TTT, the best method is to add detergent dispensing in the middle to the above method (b) based on the experimental results (omitted). It was a cleaning process.

Next, as a combination of (preceding analysis item and next analysis item), (GOT and LDH), (ALB and T Cklo), (
ALP and TG), (GLU and tJA), the results were carried out using only the reagent blank solution for each analysis item as in (a) above instead of the regular washing solution [Table 1]. Got the results.

[Table 1] Washing with reagent blank solution for next analysis item The above results show that the reagent blank solution for the next analysis item in each combination is the optimal cleaning solution.

(G) Effects of the Invention According to the present invention, when switching analysis items to be combined in the first cycle and the second cycle, the photometry flow path and the measurement cell section are cleaned by an optimal cleaning process, resulting in stable T. This measurement value can be obtained.

Furthermore, since the amount of cleaning liquid used for cleaning is appropriately selected, waste of high α reagents and the like can be prevented and costs can be saved. Cleaning operations such as cleaning solution selection and dispensing are automated, eliminating the need for complicated operations and reducing the time required for switching analysis, allowing effective use of time.

[Brief explanation of the drawing]

Fig. 1 is an explanatory diagram of the configuration of one embodiment of the device of the present invention;
The figure is a graph showing the influence of various cleaning steps on the measurement value α of β-Lip when performing switching analysis between TTT and β-Ljp. (2)...Reaction container, (3)...Reaction line, (4)...Specimen supply device, (5)...
...Reagent supply device, (6) ...Photometer, (9) ...Cleaning device, (i2) ...
・Human resources department, (i3)...Storage department, (i4
)...Recording unit, (61)...Test liquid suction nozzle, (62)...Flowal, (71)...Detergent supply tank, (72) )...Pure water or 1= is the detergent supply nozzle. --One band trip- 14 miles to Figure 2 4 villages ζ

Claims (1)

[Claims] 1. One reaction line that has a large number of reaction vessels and can continuously circulate them, a means for dispensing a sample into the reaction vessels, a means for dispensing a reaction reagent for a predetermined analysis item, and a means for cleaning a flow cell. A means for dispensing pure water and detergent, a measurement flow path for supplying the mixture from the reaction container into which the sample and reaction reagent mixture has been dispensed to the flow cell via a suction nozzle, and measuring the optical density of the mixture in the flow cell. After measuring a predetermined item for each reaction container in the first cycle in which the photometering section and the reaction line circulate, the reaction container group is used to switch and analyze items different from the first cycle in the second cycle. The above reaction line, sample dispensing means,
It is equipped with a system control section that controls the reaction reagent dispensing means and the photometry section, and after the first cycle measurement is completed and the second cycle
Before cycle measurement, the above measurement flow path including the flow cell is
Depending on the combination of measurement items to be switched, the optimal cleaning process is selected from (i) cleaning with reagent blank solution and (ii) cleaning with pure water and/or detergent solution and reagent blank solution. An automatic biochemical analyzer comprising a measurement channel cleaning control unit that can sequentially dispense and prepare water, detergent, and/or reagent blank solution into a reaction container and supply it to a measurement channel.