JP5372723B2 - Automatic analyzer - Google Patents

Abstract

Disclosed is an automatic analysis device provided with a pretreatment mechanism, wherein rapid automatic retesting is possible and consumption of a source specimen and treatment liquid can be suppressed. The automatic analysis device is provided with: a source specimen container for accommodating a source specimen; a pretreatment container for pretreating the source specimen dispensed from the source specimen container; a source specimen dispensing mechanism for dispensing the source specimen to the pretreatment container; a reaction container for analyzing a pretreated specimen dispensed from the pretreatment container; a pretreated specimen dispensing mechanism for dispensing the pretreated specimen to the reaction container; and a control unit for controlling the dispensing of the source specimen from the source specimen container to the pretreatment container performed by the source specimen dispensing mechanism, in accordance with information about the type of specimen and/or whether or not automatic retesting has been set.

Description

  The present invention relates to an automatic analyzer that analyzes components of biological samples such as blood and urine, and more particularly to an automatic analyzer that includes a pretreatment mechanism that performs pretreatment such as dilution on a specimen.

  A biochemical (colorimetric) analyzer that automatically analyzes components contained in biological samples such as blood and urine, and measures the color change of the reaction solution using a photometer and analyzes the components There is an immunoanalyzer that measures a label attached to a substance that specifically binds (directly or indirectly) to a component to be analyzed using a photodetection element such as a photomultiplier tube. In any analyzer, the detector has a limited measurable concentration range (dynamic range). For this reason, there is an “automatic re-examination” function that automatically performs re-measurement when the concentration of the component to be measured is outside the measurable concentration range, even if the operator does not give an instruction. There are some that measure the sample by setting it to invalid.

  In this case, an automatic analyzer that dispenses a sample directly from an original sample (parent sample) can perform automatic reexamination if the sample is again dispensed from the original sample container. In an automatic analyzer equipped with a mechanism for pretreatment such as dilution, there is a case where the original sample is not already present after being transported to another analyzer, and only the sample that has been pretreated remains on the device. is assumed. When there is a margin in the amount of the pre-processed sample, the pre-processed sample may be re-dispensed from the pre-processing container at the time of automatic re-examination.

JP-A-8-194004

  However, if there is a shortage of pre-treated samples at the time of re-examination, the sample cannot be automatically re-examined. Therefore, the device again dispenses the original sample into the pre-treatment container and performs the re-examination through the pre-treatment step. Need arises. When such a situation occurs, there is a concern that the output of the re-examination result of the pretreated specimen will be delayed due to the second pretreatment step.

  On the other hand, if an excessive amount of pretreated specimens is prepared in the first pretreatment step, the shortage of pretreated specimens at the time of retesting will be resolved, but the consumption of the original specimen and pretreatment liquid will increase, and patient This is not practical because it leads to an increase in the burden of running and an increase in running costs.

  An object of the present invention is to provide an automatic analyzer that can perform rapid automatic reexamination and can suppress consumption of the original sample and the pretreatment liquid in an automatic analyzer having a pretreatment mechanism.

In order to suppress the consumption of the original sample and the pretreatment liquid and reduce the occurrence of the shortage of the pretreated sample at the time of automatic retesting, the automatic analyzer is provided with the following functions.
1. Based on at least one of the information on the presence / absence of automatic retest setting and the type of specimen, the original specimen dispensing from the specimen container to the pretreatment container by the original specimen dispensing mechanism is controlled.
In 2.1,
a) For samples that may be subject to automatic re-examination, the effective amount that can be used for dispensing into reaction vessels among pre-treated samples, the amount of pre-treated sample that is used in the first analysis, and the first analysis that is used The original sample dispensing is controlled based on the preprocessed sample amount to be used and the predicted amount of the preprocessed sample used in the retest analysis calculated based on the predetermined automatic retest preliminary ratio.
b) For samples that are not subject to automatic re-examination, based on the effective amount that can be used for dispensing into pre-treated samples and the amount of pre-treated sample used in the first analysis, Control notes.
In 3.1 and 2, when automatic reexamination is set, when the type of specimen is a general specimen that has never been analyzed (initial specimen), the manual reexamination specimen, standard solution, For any of the quality control samples, the dispensing amount of the original sample is controlled based on (Equation 2).
In 4.1 to 3, in accordance with the order of dispensing the preprocessed sample by the preprocessed sample dispensing mechanism, the dispensing of the preprocessed sample into the reaction container is performed for each single dispensing of the preprocessed sample. Determine whether or not the effective amount that can be used for the injection has been exceeded, and if the effective amount is exceeded, the original sample dispensing mechanism uses the original sample dispensing mechanism to further adjust the pretreated sample in the pretreatment container. Control original sample dispensing.
5. As the above-mentioned automatic re-examination reserve ratio, a value aggregated from past apparatus use results or an arbitrarily input value is used.

  In an automatic analyzer equipped with a pretreatment mechanism, it is possible to suppress consumption of the original sample and the pretreatment liquid and reduce the occurrence of a shortage of pretreated samples during automatic retesting.

It is a block diagram of the automatic analyzer concerning embodiment of this invention. It is a judgment formula selection flow according to the presence / absence of automatic retest of the automatic analyzer according to the embodiment of the present invention and the type of specimen. It is the determination flow of the automatic analyzer concerning embodiment of this invention. It is an automatic re-examination preliminary | backup ratio input screen of the automatic analyzer concerning embodiment of this invention. It is a screen which totals and displays an automatic retest preliminary | backup ratio from the apparatus use condition in the past fixed period of the automatic analyzer concerning embodiment of this invention. It is a screen which totals and displays an automatic re-examination preliminary | backup ratio from the apparatus use condition in the past specific day of the automatic analyzer concerning embodiment of this invention. It is a screen which totals and displays an automatic reexamination preliminary | backup ratio from the apparatus use condition in the past specific time slot | zone of the automatic analyzer concerning embodiment of this invention. It is a screen which inputs an automatic re-examination preliminary | backup rate for every kind of pre-processing of the automatic analyzer concerning embodiment of this invention. It is a screen which inputs an automatic retest preliminary | backup rate for every sample classification of the automatic analyzer concerning embodiment of this invention.

  Embodiments of the present invention will be described below with reference to the drawings.

  First, an outline of the automatic analyzer will be described with reference to FIG.

  The automatic analyzer is divided into a sample erection unit, a pretreatment unit, and a reaction unit. In the sample erection unit, samples such as serum and urine collected in the sample container 1 are erected on the sample disk 2, and the sample is dispensed from the sample container 1 to the pretreatment container 8 by the original sample dispensing mechanism 7. The pretreatment container 8 is arranged on the circumference of the pretreatment unit 3 in the pretreatment unit, and the pretreatment container 8 in which the sample is dispensed by the original sample dispensing mechanism 7 is rotated by the pretreatment unit 3. By doing so, it moves to the pretreatment liquid dispensing position, and the pretreatment liquid dispensing mechanism 9 discharges the pretreatment liquid. Further, when the pretreatment unit 3 rotates, the pretreatment container 8 from which the pretreatment liquid has been discharged moves to the agitation position, and is agitated by the rotation of the agitation bar of the pretreated specimen agitation mechanism 10. The stirred preprocessed specimen moves to the preprocessed specimen dispensing position by the rotation of the pretreatment section 3 and is discharged to the reaction container 12 by the pretreated specimen dispensing mechanism 11. The reaction container 12 is arranged on the circumference of the reaction disk 6 in the reaction section, and the reaction container 12 into which the pretreated specimen is dispensed moves to the reagent addition position by rotating the reaction disk 6. The reagent is added from the reagent container 4 set on the reagent disk 5 by the reagent dispensing mechanism 13. The reaction vessel 12 to which the reagent has been added moves to the stirring position when the reaction disk 6 rotates, and is stirred when the reaction vessel stirring mechanism 16 rotates. The reaction vessel 12 containing the reaction solution passes through the optical axis of the photometer 14 at regular intervals by the rotation of the reaction disk 6, and the absorbance is measured each time. The concentration of the target component in the reaction solution is calculated from the measured absorbance, and the result is output. The pretreatment container 8 and the reaction container 12 after use are washed by the pretreatment container washing mechanism 15 and the reaction container washing mechanism 17 and used for the next measurement.

  When the sample dispensed in the sample container 1 is dispensed into the pretreatment container 8 by the original sample dispensing mechanism 7, the original sample dispensing mechanism 7 is controlled in accordance with the presence / absence of automatic retest and the type of sample.

Of the pretreated samples in the pretreatment container 8, the effective amount (≡A) that can be used for dispensing into the reaction container is a value obtained by subtracting the dead volume of the pretreatment container from the pretreated sample amount. . Also,
a) For samples that may be re-examined, the amount of pre-processed sample used in the first analysis that is known (assuming ≡B) and the amount of pre-processed sample used in the first analysis because it is unknown The sum of the predicted values of pre-processed sample amounts (identified as ≡C) used in the re-analysis calculated based on the predetermined automatic re-test preliminary ratio is the predicted value of the amount used as the pre-processed samples.
b) For samples that are unlikely to be re-examined, the pre-processed sample amount B used in the known initial analysis is the amount used as the pre-processed sample.

  The sample that may be re-examined in a) is the initial analysis of the patient sample when the automatic re-examination function is effective. In this case, a pre-processed sample is created in consideration of the reserve amount for re-examination. b) In the analysis of specimens that are not likely to be re-examined, that is, when the automatic re-examination function is disabled, the initial analysis of patient specimens, manual re-examination specimens, standard solutions, and quality control samples, take into account the reserve amount for re-examination. You don't have to. The pretreated sample amount B used in the first analysis is pretreated at the time of this dispensing in addition to the pretreated sample that is actually dispensed into the reaction container 12 by the pretreated sample dispensing mechanism 11. In the case of an automatic analyzer that sucks extra preprocessed sample dummies to prevent thinning of the sample, the preprocessed sample dummy amount is included.

  Here, there are two methods for controlling the original specimen dispensing mechanism 7. The first is a method in which the amount of the pretreated sample to be prepared is changed according to the amounts obtained in the above a) and b), and the original sample amount and the pretreatment liquid amount according to the necessary pretreated sample amount. To control the dispensing volume. The second is a method of changing the number of pretreated samples to be prepared according to the amounts obtained in the above a) and b), and whether or not the effective amount A that can be used for dispensing into the reaction container has been exceeded. According to the order of dispensing the pretreated samples by the pretreated sample dispensing mechanism 11, one item is determined at a time, and when this effective amount A is exceeded, the pretreated sample is additionally prepared in the pretreatment container 8. The original specimen dispensing from the specimen container 1 to the pretreatment container 8 by the original specimen dispensing mechanism 7 is controlled.

  Hereinafter, an example of a method of mainly changing the number of pre-processed specimens will be described. However, the logic of whether the case of a) or b) depends on the presence / absence of automatic re-examination and the type of specimen, The setting of the automatic retest preliminary ratio is the same as the method of changing the pretreated sample amount. FIG. 2 shows a flow for selecting a judgment formula to be used for control according to the presence / absence of automatic retest and the type of specimen. When automatic re-examination is enabled, when the sample type is the first sample (Equation 1), when manual re-examination sample, standard solution, quality control sample is used (Equation 2), when automatic re-examination is disabled, regardless of the type of sample (Equation 2) 2) Whether or not the condition is satisfied is determined item by item in accordance with the dispensing order of the pretreated sample by the pretreated sample dispensing mechanism 11, and if (Equation 1) or (Equation 2) is not satisfied, The original specimen dispensing from the specimen container 1 to the pretreatment container 8 by the original specimen dispensing mechanism 7 is controlled so that the pretreated specimen is additionally prepared in the processing container 8.

(Formula 1)
Pre-treated sample usage amount ≦ (Pre-treated sample effective amount−2 × Pre-treated sample dummy amount) / {1+ (Automatic re-examination preliminary rate / 100)}
Pre-treated sample use amount = total pre-treated sample dispensing amount + pre-treated sample dummy amount x dummy switching count Pre-treated sample effective amount = original sample dispensing amount + pre-treatment liquid dispensing amount-pre-treatment container Dead volume

(Formula 2)
Pre-processed sample use amount ≦ Pre-processed sample effective amount−Pre-processed sample dummy amount Here, [Pre-processed sample effective amount] is the above-mentioned A, [Pre-processed sample use amount + Pre-processed sample dummy] Amount] corresponds to B described above, and [(automatic retest preliminary ratio / 100) × (pretreated sample use amount + pretreated sample dummy amount)] corresponds to C described above. The terms in (Formula 1) and (Formula 2) will be described below.

Total pretreated sample dispensed amount: The total amount of sample dispensed by the preprocessed sample dispensing mechanism 11 up to the nth test in determining the nth test item.
Dummy amount: An extra amount that is a preprocessed sample held in the preprocessed sample dispensing mechanism 11 and is not used for measurement.
Number of times of dummy switching: The number of times the dummy held in the preprocessed sample dispensing mechanism 11 is discarded and the dummy is held again during the dispensing of the preprocessed sample.
Original sample dispensing amount: The amount of original sample dispensed from the sample container 1 to the pretreatment container 8 by the original sample dispensing mechanism 7.
Pretreatment liquid dispensing amount: Pretreatment liquid amount dispensed into the pretreatment container 8 by the pretreatment liquid dispensing mechanism 9.
Dead volume: Extra amount not used for measurement in the pretreatment container 8.
Automatic re-examination reserve ratio: Percentage of the pre-processed sample amount that is expected to be used at the time of re-examination against the pre-processed sample amount used for the measurement in the first test.

  The determination flow will be described with reference to FIG. Judgment is started from the first test for pre-processed samples for which N tests are requested per sample. In the determination of the I test, the total amount of the pretreated sample dispensed amount from the first to the I test is calculated, and the determination is made using (Expression 1) or (Expression 2) selected according to the flow of FIG. If the determination result is I <N and OK, the process proceeds to the determination for the (I + 1) th test. On the other hand, in the case of NG, it is determined that the preprocessed specimen prepared first is insufficient, and it is determined that the preparation of the preprocessed specimen for one pretreatment container 8 is additionally necessary. Also, I is reset to 1, and the determination for the remaining items is resumed from the M test that is NG. This flow is repeated, and the determination ends when I = N and OK is reached. Following the above flow, the original sample is dispensed by the original sample dispensing mechanism 7 from the sample container 1 to the required number of pretreatment containers 8.

  Next, input of the automatic retest preliminary ratio will be described with reference to FIG. The operator inputs the automatic retest preliminary ratio (%) for general samples and emergency samples, and presses the registration button. The apparatus performs the determination according to (Equation 1) using the registered automatic re-examination preliminary ratio.

  Next, the function of counting and displaying the automatic retest preliminary ratio from the apparatus usage status in the past fixed period will be described with reference to FIG. The operator designates a period to be totaled and presses a totaling start button. First, the apparatus extracts specimens that have been subjected to automatic reexamination during a specified period, and divides them into two groups: general specimens and emergency specimens. Next, for each sample group, the ratio of the total sample amount dispensed in the retest inspection to the total sample amount dispensed from the pretreatment container 8 to the reaction container 12 in the initial inspection is calculated, and the average value thereof is calculated. , Maximum value, Minimum value are displayed on the screen. The operator confirms each displayed value, selects a value to be adopted for each of the general sample and the emergency sample, and presses the registration button. By this series of operations, the automatic re-examination reserve rate is aggregated from the device usage status in the past fixed period, and the automatic re-examination reserve rate designated by the operator from the total value is used for the determination of (Equation 1). Can do.

  Next, the function of counting and displaying the automatic re-examination preliminary ratio from the device usage status on a specific day in the past will be described with reference to FIG. The operator designates a period and day of the week to be totaled and presses a totaling start button. First, the apparatus extracts the specimens subject to automatic reexamination during the designated period and day of the week, and divides them into two groups: general specimens and emergency specimens. Next, for each sample group, the ratio of the total sample amount dispensed in the retest inspection to the total sample amount dispensed from the pretreatment container 8 to the reaction container 12 in the initial inspection is calculated, and the average value thereof is calculated. , Maximum value, Minimum value are displayed on the screen. The operator confirms each displayed value, selects a value to be adopted for each of the general sample and the emergency sample, and presses the registration button. By this series of operations, the automatic re-examination reserve ratio is totaled from the device usage status in the past fixed period and a specific day of the week, and the automatic re-examination reserve ratio designated by the operator from the total value is used. It can be used for determination.

  Next, the function of counting and displaying the automatic re-examination preliminary ratio from the apparatus usage status in a specific past time zone will be described with reference to FIG. The operator designates a period and a time zone to be totaled, and presses a totaling start button. First, the apparatus extracts the specimens subject to automatic reexamination during the designated period and time zone, and divides them into two groups: general specimens and emergency specimens. Next, for each sample group, the ratio of the total sample amount dispensed in the retest inspection to the total sample amount dispensed from the pretreatment container 8 to the reaction container 12 in the initial inspection is calculated, and the average value thereof is calculated. , Maximum value, Minimum value are displayed on the screen. The operator confirms each displayed value, selects a value to be adopted for each of the general sample and the emergency sample, and presses the registration button. By this series of operations, the automatic retest reserve rate is totaled from the device usage status in the past fixed period and specific time zone, and the automatic retest reserve rate specified by the operator from the total value is used (Formula 1) It can be used for determination.

  Next, a function capable of setting an automatic retest preliminary ratio for each type of pretreatment liquid will be described. The pretreatment liquid is not limited to one type, and a plurality of pretreatment liquids can be installed in the apparatus depending on the application. The function of changing the automatic retest preliminary ratio for each type of pretreatment liquid will be described with reference to FIG. The operator inputs an automatic retest preliminary ratio for each type of pretreatment liquid and presses a registration button. The apparatus makes a determination according to (Equation 1) using the automatic retest preliminary ratio registered for each pretreatment liquid.

  Next, a function for changing the automatic retest preliminary ratio according to the specimen type will be described. Specimen type refers to the origin of the specimen such as serum, urine, plasma, and cerebrospinal fluid. The function of changing the automatic retest preliminary ratio according to the specimen type will be described with reference to FIG. The operator inputs an automatic retest preliminary ratio for each sample type for each general sample and emergency sample, and presses the registration button. The apparatus performs the determination according to (Equation 1) using the automatic retest preliminary ratio registered for each specimen type.

DESCRIPTION OF SYMBOLS 1 Sample container 2 Sample disk 3 Pretreatment part 4 Reagent container 5 Reagent disk 6 Reaction disk 7 Original sample dispensing mechanism 8 Pretreatment container 9 Pretreatment liquid dispensing mechanism 10 Pretreated specimen stirring mechanism 11 Pretreated specimen dispensing Mechanism 12 Reaction container 13 Reagent dispensing mechanism 14 Photometer 15 Pretreatment container cleaning mechanism 16 Reaction container stirring mechanism 17 Reaction container cleaning mechanism

Claims (9)

An original sample container for storing the original sample, a pretreatment container for preprocessing the original sample dispensed from the original sample container, an original sample dispensing mechanism for dispensing the original sample into the pretreatment container, In an automatic analyzer equipped with a reaction container for analyzing a pretreated sample dispensed from a pretreatment container, and a pretreated sample dispensing mechanism for dispensing the pretreated sample into the reaction container,
Provided with a control mechanism for controlling the amount of the original sample dispensed from the original sample container to the pretreatment container by the original sample dispensing mechanism based on information on at least one of automatic retest setting and sample type ,
For samples that may be subject to automatic re-examination, the effective amount that can be used for dispensing into reaction vessels among pre-processed samples, the amount of pre-processed sample that is used in the first analysis, and before use in the first analysis A control mechanism that controls the dispensing of the original sample based on the predicted amount of the pre-processed sample used in the re-analysis calculated based on the processed sample amount and a predetermined automatic re-examination preliminary rate,
A setting mechanism for setting the automatic re-examination reserve ratio,
An automatic analyzer comprising a calculation mechanism for automatically calculating the automatic re-examination reserve ratio based on past apparatus usage results . The automatic analyzer according to claim 1, wherein
For samples that are not subject to automatic retesting, dispense the original sample based on the effective amount of pretreated sample that can be used for dispensing into the reaction vessel and the amount of pretreated sample that will be used in the first analysis. An automatic analyzer characterized by comprising a control mechanism for controlling the motor. The automatic analyzer according to claim 1 , wherein
When automatic re-examination is set, when the original sample type is a general sample that has never been analyzed, a control mechanism is provided for controlling the dispensing amount of the original sample based on (Equation 1) Automatic analyzer characterized by
(Formula 1)
Pre-treated sample use amount ≦ (Pre-treated sample effective amount−2 × Pre-treated sample dummy amount) / {1+ (Automatic re-examination preliminary rate / 100)}
Pre-treated sample use amount = total pre-treated sample dispensing amount + pre-treated sample dummy amount × dummy switching number Pre-treated sample effective amount = original sample dispensing amount + pre-treatment liquid dispensing amount−pre-treatment container Dead volume The automatic analyzer according to claim 2 ,
When the type of the original sample is any one of a manual retest sample, a standard solution, and a quality control sample, an automatic is provided, which includes a control mechanism for controlling the dispensing amount of the original sample based on (Equation 2) Analysis equipment.
(Formula 2)
Pre-treated sample usage ≤ Pre-treated sample effective amount-Pre-treated sample dummy amount In the automatic analyzer of Claims 1-4 ,
For each dispensing of the pre-treated sample by the pre-treated sample dispensing mechanism, it is determined whether or not the effective amount that can be used for dispensing into the reaction container exceeds the pre-treated sample, and the effective amount is determined. An automatic analyzer comprising a control mechanism for controlling the original sample dispensing by the original sample dispensing mechanism so as to additionally adjust the pretreated sample in the pretreatment container when exceeding. The automatic analyzer according to claim 1 , wherein
An automatic analyzer capable of setting an automatic retest preliminary ratio for each type of pretreatment liquid as means for setting the automatic retest preliminary ratio. The automatic analyzer according to claim 1 , wherein
An automatic analyzer capable of setting an automatic retest preliminary ratio for each specimen type as means for setting the automatic retest preliminary ratio. The automatic analyzer according to claim 1 , wherein
An automatic analyzer comprising a display mechanism for displaying the automatic re-examination preliminary ratio calculated by the calculation mechanism. The automatic analyzer according to claim 1 , wherein
The automatic analyzer is characterized in that the calculation mechanism has a function of individually calculating the automatic re-examination preliminary rate for every fixed period.

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