JP2008122333A - Automatic analyzer and method for same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To accurately analyze a component concentration in a range from a low concentration to a high concentration regardless of an increase or a decrease in the quantity of a specimen. <P>SOLUTION: A reagent blank of an analytical curve constant is corrected in response to the increase or the decrease in the quantity of the specimen. A concentration of an analyzed item is calculated based on the reagent blank correction value Eb', the analytical curve constant K<SB>10</SB>and absorbance data Ex of a reaction liquid. As a result, an automatic analyzer and its method are constituted, and can accurately analyze the component concentration in the range from the low concentration to the high concentration regardless of the increase or the decrease in the quantity of the specimen. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an automatic analyzer for calculating a concentration for each analysis item of a component of a sample sample collected from a subject such as a general patient, and a method thereof, for example, a sample according to a normal standard test or retest of a sample sample. The present invention relates to an automatic analyzer and method for increasing or decreasing the amount of a specimen of a sample.

The automatic analyzer analyzes a component contained in a body fluid of a specimen sample such as blood or urine collected from a subject such as a general patient. In this analysis, a specimen sample and a reagent collected from a specimen are dispensed and mixed in a reaction tube, and the absorbance of the transmitted light is measured by irradiating the mixture with light. Calculate the concentration of each component. This component concentration is calculated using a calibration curve Q1 for _each analysis item such as glucose (urine), for example, as shown in FIG. The calibration curve Q ₁ is set by the reagent blank value BLK ₁ and the calibrator C _{1 for} each analysis item, and has a calibration curve constant (factor: slope) K ₁ . When the absorbance a is measured by irradiating light to the mixed solution of the sample sample and the reagent, the component concentration d ₁ is calculated from the absorbance a ₁ using the calibration curve Q ₁ . The component concentration d ₁ is printed out, for example, report.

  When analyzing the concentration of the component of the sample sample by the automatic analyzer, after analyzing the concentration of the sample sample using the sample sample of the standard sample amount in a normal standard test, the concentration of the component of the analysis result is, for example, If the concentration value is much larger or smaller than the predicted concentration value, the specimen sample is retested. In this re-examination, the sample amount of the standard sample amount is increased or decreased according to the concentration value of the component of the analysis result, for example, the sample sample is decreased if the component concentration is significantly large, and Increase the sample and retest.

For example calibration curve Q ₁ shown in FIG. 9 is created by using a test sample of a standard amount of specimen. The analysis item when analyzing component concentration general patient, are those wide linear range of the calibration curve Q _1, and the reference value range is in the low concentration side. When analyzing component concentration of such analysis items by the calibration curve Q _1, it is necessary to analyze in different amounts the amount of analyte sample and the standard sample volume. For example, the amount of the specimen sample is to be reduced from the standard specimen amount.

On the other hand, the standard specimen amount of a general patient is increased in order to increase the sensitivity of component concentration analysis in the reference value range. Calibration constants K ₁ calibration curve Q ₁ by increasing the sample volume becomes larger for example calibration constant K _2, and the calibration curve Q _2. This increases the sensitivity of component concentration analysis.

However, the reagent blank value BLK are both the same value of the calibration curve Q _1, a calibration curve Q _2, for example, may be a "0", but the reagent blank of reagent blank values BLK calibration curve to Q ₁ calibration curve Q ₂ If the value is higher than the value BLK, the component concentration cannot be calculated accurately. That is, calibration curve Q ₁ represents linear range is wide, the reference value range is in a high concentration from a low density. On the other hand, the calibration curve Q ₂ has a linearity range narrower than the calibration curve Q ₁ , the reference value range is on the low concentration side, and the reference value range peaks on the low concentration side of the calibration curve Q ₁ . Accurate component concentration analysis is not possible. For example, if the calibration curve Q ₁ is used, the component concentration can be analyzed up to, for example, d ₁₀ , but if the calibration curve Q ₂ is used, it is possible to analyze only up to the component concentration d ₂₀ lower than the component concentration d ₁₀ . For this reason, it is necessary to analyze the component concentration for each of a plurality of analysis items separately for high concentration and low concentration. However, the analysis work becomes very inefficient. The analysis of the component concentration for each analysis item separately for the high concentration and the low concentration is the same in the retest.

As a technique related to the automatic analyzer, there is, for example, Patent Document 1. This Patent Document 1 describes a memory unit in which data of a used sample amount (V0) required for a general patient and a used sample amount (V1) required for a small amount of sample patient are written in advance for each analysis measurement item, and requested measurement. The data input device of the analysis request form including the items, whether the patient is a general patient or a small sample patient, and whether the patient is a general patient or a small sample patient based on the input analysis request form data and the read data of the memory unit When a sample dispenser that identifies and identifies the identified sample volume and dispenses it to the reaction tube, and a small amount of sample items are identified, the reagent blank correction value is calculated by the ratio of V0 / V1, and the correction is performed. It is disclosed that it has a small sample item calculation means that calculates the concentration based on the value and the calibration curve constant calculated by the sample amount used by general patients.
Japanese Patent No. 2535891

  An object of the present invention is to provide an automatic analyzer capable of analyzing a component concentration with high accuracy in a measurement range from a low concentration to a high concentration regardless of an increase or decrease in the amount of a specimen sample, and a method therefor.

  The automatic analyzer according to claim 1 of the present invention enables an increase or decrease in the amount of the sample of the sample sample for each of a plurality of analysis items with respect to the sample sample collected from the subject, and according to the sample sample and the analysis item In an automatic analyzer that generates a reaction liquid from the reagent and calculates the concentration of the analysis item based on the absorbance data of the reaction liquid and the calibration curve constant corresponding to the reagent, according to the increase or decrease of the sample amount of the sample sample Correction means for correcting the reagent blank of the calibration curve constant, and concentration calculation means for calculating the concentration of the analysis item based on the correction value of the reagent blank corrected by the correction means, the calibration curve constant, and the absorbance data of the reaction solution It has.

  The automatic analysis method according to claim 8 of the present invention enables the increase or decrease of the sample amount of the sample sample for each of a plurality of analysis items with respect to the sample sample collected from the subject, and according to the sample sample and the analysis item In an automatic analysis method that generates a reaction solution from a reagent and calculates the concentration of an analysis item based on the absorbance data of the reaction solution and a calibration curve constant according to the reagent, depending on whether the sample amount of the sample is increased or decreased The reagent blank of the calibration curve constant is corrected, and the concentration of the analysis item is calculated based on the corrected value of the corrected reagent blank, the calibration curve constant, and the absorbance data of the reaction solution.

  ADVANTAGE OF THE INVENTION According to this invention, the automatic analyzer which can analyze a component density | concentration with high precision in the measurement range from a low density | concentration to a high density | concentration irrespective of the increase or decrease of a sample sample and its method can be provided.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
FIG. 1 shows a configuration diagram of an automatic analyzer. The analysis unit 1 includes a reagent store 2, a disk sampler 3, and a reaction mechanism 4. In the reagent storage 2, a plurality of reagent bottles 6 are stored in an annular reagent rack 5. Each of the plurality of reagent bottles 6 contains a reagent for each of a plurality of analysis items. The reagent storage 2 is rotated by a drive unit (not shown).
The disk sampler 3 is formed in a disc shape and is provided with a plurality of sample containers 7. In these sample containers 7, specimen samples such as blood and urine collected from a subject such as a general patient are accommodated. The disk sampler 3 is rotationally moved by a drive unit (not shown).

  The reaction mechanism 4 includes a reaction chamber reagent chamber 8 formed in an annular shape, and an annular reaction disk 9 provided on the outer peripheral side of the reagent chamber 8 and concentrically with the reagent chamber 8. In the reagent storage 8, a plurality of reagent bottles 11 are stored in an annular reagent rack 10. Each reagent bottle 11 accommodates each reagent for each of a plurality of analysis items. A plurality of reaction vessels 12 are provided on the reaction disk 9. In each of these reaction containers 12, a specimen sample and a reagent are injected and mixed to generate a reaction solution.

  A first reagent dispensing arm 13 is provided close to the reagent storage 2. The first reagent dispensing arm 13 is provided with a first reagent dispensing probe 14. The first reagent dispensing arm 13 moves the first reagent dispensing probe 14 between the suction position of the reagent bottle 6 in the reagent storage 2 and the discharge position of the reagent bottle 11 in the reaction mechanism 4. The first reagent dispensing probe 14 aspirates each reagent contained in each reagent bottle 6 and discharges this reagent to the reagent bottle 11 of the reagent rack 10.

  A sample dispensing arm 15 is provided close to the disc sampler 3. The sample dispensing arm 15 is provided with a sample dispensing probe 16. The sample dispensing arm 15 moves the sample dispensing probe 16 between the suction position of the sample container 7 in the disk sampler 3 and the discharge position of the reaction container 12 in the reaction mechanism 4. The sample dispensing probe 16 sucks the specimen sample stored in the specimen container 7 of the disk sampler 3 and discharges the specimen sample to the reaction container 12 of the reaction disk 9.

  A second reagent dispensing arm 17 is provided close to the reaction disk 9. The second reagent dispensing arm 17 is provided with a second reagent dispensing probe 18. The second reagent dispensing arm 17 moves the second reagent dispensing probe 18 between the suction position of the reagent bottle 11 in the reagent rack 10 and the discharge position of the reaction container 12 in the reaction disk 9. The second reagent dispensing probe 18 sucks the reagent stored in the reagent bottle 11 of the reagent rack 10 and discharges the reagent into the sample specimen stored in the reaction container 12 of the reaction disk 9.

A stirring unit 19 is provided on the outer peripheral side of the reaction disk 9. The stirring unit 19 stirs the specimen sample and the reagent injected into the reaction container 12. A cleaning unit 20 is provided on the outer peripheral side of the reaction disk 9. The cleaning unit 20 cleans the reaction vessel 12.
The photometric unit 21 irradiates the mixed liquid of the specimen sample and the reagent injected into the reaction container 12 with light, receives the light transmitted through the mixed liquid, and outputs a measurement signal of the absorbance of the mixed liquid.

  The software control center (SCC) 30 controls the operation of the analysis unit 1 and inputs a measurement signal output from the photometry unit 21 to calculate the concentration of an analysis item such as glucose (urine). The software control center 30 has a main control unit 31 composed of a CPU. An inspection data storage unit 32, an analysis item storage unit 33, a program memory 34, a notification unit 35, and an operation unit 36 are connected to the main control unit 31. In addition, the main control unit 31 issues commands to the analysis control unit 37, the data input unit 38, the calibration unit 39, the reagent blank correction unit 40, and the concentration calculation unit 41 to control operations.

  The analysis control unit 37 rotates and moves the reagent storage 2 and controls the movement of the first reagent dispensing arm 13 to move the first reagent dispensing probe 14 to the aspirating position of the reagent bottle 6 in the reagent storage 2. Here, the first reagent dispensing probe 14 is aspirated to aspirate the reagent contained in the reagent bottle 6. Next, the analysis control unit 37 controls the movement of the first reagent dispensing arm 13 to move the first reagent dispensing probe 14 to the discharge position of the reagent bottle 11 in the reaction mechanism 4. The reagent dispensing probe 14 is discharged to discharge the reagent to the reagent bottle 11 of the reagent rack 10.

  The analysis control unit 37 rotates and moves the disk sampler 3 and controls the movement of the sample dispensing arm 15 to move the sample dispensing probe 16 to the suction position of the sample container 7 in the disk sampler 3, where the sample dispensing is performed. The probe 16 is aspirated to aspirate the specimen sample stored in the sample container 7. Next, the analysis control unit 37 controls the movement of the sample dispensing arm 15 to move the sample dispensing probe 16 to the discharge position of the reaction container 12 in the reaction mechanism 4, and here causes the sample dispensing probe 16 to discharge. The specimen sample is discharged into the reaction container 12 of the reaction disk 9.

  The analysis control unit 37 rotates and moves the reagent storage 8 and the reaction disk 9 in the reaction mechanism 4 and controls the movement of the second reagent dispensing arm 17 to move the second reagent dispensing probe 18 in the reagent rack 10. The reagent bottle 11 is moved to the aspiration position, and the second reagent dispensing probe 18 is aspirated here to aspirate the reagent contained in the reagent bottle 11 of the reagent rack 10. Next, the analysis control unit 37 controls the movement of the second reagent dispensing arm 17 to move the second reagent dispensing probe 18 to the discharge position of the reaction container 12 in the reaction disk 9, where The reagent dispensing probe 18 is discharged to discharge the reagent into the sample specimen stored in the reaction container 12 of the reaction disk 9.

  The second reagent dispensing probe 18 moves to the suction position of the reagent bottle 11 in the reagent rack 10 to suck the reagent, and then the second reagent dispensing probe 18 moves to the reaction container 12 in the reaction disk 9. It moves to the discharge position, discharges the reagent into the sample specimen accommodated in the reaction container 12 of the reaction disk 9, and thereafter, one cycle is taken until the second reagent dispensing probe 18 returns to the original position.

The analysis control unit 37 controls the operation of the stirring unit 19 and stirs the specimen sample and the reagent injected into the reaction container 12. The analysis control unit 37 controls the operation of the cleaning unit 20 and cleans the reaction vessel 12.
The data input unit 38 receives the measurement signal of the absorbance of the mixed solution in the reaction vessel 12 output from the photometry unit 21 and converts it into a digital measurement signal.

The test data storage unit 32 includes information on identification numbers of specimen samples such as blood and urine collected from a subject such as a general patient, information on a plurality of analysis items that require analysis on the specimen samples, Information relating to examination of the specimen sample such as information relating to standard examination and re-examination is stored. In the re-inspection, information regarding a plurality of re-inspections such as re-inspection “1”, re-inspection “2”,.
The analysis item storage unit 33 includes information on a plurality of analysis items that need to be analyzed for a specimen sample, information on the reagent such as the name and amount of each reagent used for each analysis item, and a standard test. Information on parameters of analysis items such as a standard sample amount that is sometimes necessary and a standard sample amount that is necessary at the time of retesting is stored.

  The program memory 34 stores an automatic analysis program in advance. This automatic analysis program makes it possible to increase or decrease the amount of a sample sample for each of a plurality of analysis items with respect to a sample sample collected from a sample, and generate a reaction liquid from the sample sample and a reagent corresponding to the analysis item. When calculating the concentration of the analysis item based on the absorbance data of the reaction solution and the calibration curve constant according to the reagent, the reagent blank of the calibration curve constant is corrected according to the increase or decrease of the sample amount of the sample sample, The concentration of the analysis item is calculated based on the corrected value of the corrected reagent blank, the calibration curve constant, and the absorbance data of the reaction solution.

The calibration unit 39 irradiates light to the reaction container 12 containing the sample sample and the reagent of the standard sample amount, receives the transmitted light, and outputs the measurement signal output from the photometry unit 21 as the data input unit 38. uptake from creating a standard test calibration curve Q _10, such as shown in FIG. 2 on the basis of the measurement signal. The calibration curve _{Q 10} is set by a reagent blank value _{BLK 10} and calibrator _{C 10} for each analysis item, calibration curve constant (factor: _slope) having a _{K 10.} The calibration unit 39 stores information on the created calibration curve Q _{10 in} , for example, the analysis item storage unit 33.

The reagent blank correction unit 40 and the concentration calculation unit 41 operate when the main control unit 31 executes an automatic analysis program stored in the program memory 34 in advance. That is, the reagent blank correction unit 40 corrects the reagent blank value BLK ₁₀ of the calibration curve constant K ₁₀ according to the increase or decrease of the sample amount of the sample sample. The specimen amount of the specimen sample is set as a standard specimen quantity or a retest specimen quantity necessary for retesting for each of a plurality of analysis items. However, the reagent blank correction unit 40 corrects the reagent blank value BLK ₁₀ of the calibration curve constant K ₁₀ according to the increase or decrease of the retest sample amount necessary for the retest.
Specifically, the reagent blank correction unit 40 obtains a ratio (Vbt / Vxt) between the reaction liquid volume Vbt of the reagent blank and the reaction liquid volume Vxt of the sample sample increased or decreased by the standard test or retest, and this ratio ( (Vbt / Vxt) multiplied by the absorbance data Eb of the reagent blank to give a reagent blank correction value Eb ′,
Eb ′ = (Vbt / Vxt) × Eb (1)
Is calculated. The reagent blank reaction liquid amount Vbt is a liquid volume obtained by mixing a preset sample and reagent. The reaction liquid amount Vxt of the sample sample increased or decreased by the standard test or the retest is a liquid volume obtained by mixing the sample sample and the reagent.

Movement amount when the reagent blank correction value Eb ', in response to increase or decrease the specimen sample as shown in FIG. 3, by which to translate calibration curve Q ₁₀ in the drawing of FIG. 3 without changing the calibration constant K ₁₀ It corresponds to. Calibration curve _{Q 10} will 'calibration curve _{Q 10} by correcting the' reagent blank correction value Eb.
The absorbance data Eb of the reagent blank value BLK ₁₀ is obtained based on a measurement signal output from the photometric unit 21 by irradiating light to the reaction vessel 12 containing water, receiving the transmitted light, for example. . The reagent blank value BLK ₁₀ is “0” when calculated using, for example, water.
The reagent blank correction unit 40 calculates a reagent blank correction value Eb ′ for each calibration curve for each analysis item and for each standard test or retest.

Concentration calculator 41 calculates the concentration Cx of analysis items based on the absorbance data Ex the reagent blank correction value Eb 'to a standard curve constant K ₁₀ which is corrected by a reagent blank correction unit 40 reaction. Specifically, the concentration calculation unit 41 obtains a difference (Ex−Eb ′) between the absorbance data Ex of the reaction solution and the reagent blank correction value Eb ′, and calculates the difference (Ex−Eb ′) and the calibration curve constant K ₁₀ . Multiply component concentration Cx
Cx = Df × K ₁₀ × (Ex−Eb ′) (2)
Is calculated. Df is a theoretical coefficient (dilution factor coefficient) for correcting the volume (correcting the difference in the dilution rate due to the difference in the amount of the sample according to the amount of the reagent blank).

The component concentration Cx is also expressed by the following equation.
Cx = {[(Cs−Cb) / (Es−Eb)] × (Ex−Eb ′) + Cb} × Df (3)
Here, Cs represents the displayed value of the standard sample, Cb represents the concentration of the reagent blank, and Es represents the absorbance data of the standard sample.

The concentration calculation unit 41 calculates each component concentration Cx of each analysis item for each analysis item and for each standard inspection or reexamination.
The notification unit 35 notifies the component concentration Cx calculated by the concentration calculation unit 41, and includes a printing unit 42 and a display unit 43. The printing unit 42 includes, for example, a printer, and prints and outputs the component concentration Cx on a recording medium such as printing paper in a report form.
The display unit 43 includes, for example, a liquid crystal display, and displays and outputs the component concentration Cx on the display screen of the liquid crystal display in a report form. In addition, the display unit 43 selects the contents operated on the operation unit 36, for example, whether a standard test or a retest is performed for each specimen sample, and displays analysis items required from a plurality of analysis items. Displays a setting screen such as selection.

The operation unit 36 includes, for example, a keyboard, a mouse, a button, a touch key panel, etc., and selects whether a standard test or a retest is performed for each specimen sample, and a required analysis item from a plurality of analysis items. and selecting, setting and the like calibration curve to Q ₁ each analysis item, operations and setting of the reagent blank value BLK ₁ and calibrator C ₁ in the calibration curve to Q ₁ each analysis item is performed.

When the operation unit 36 uses a touch key panel for the display unit 43, the operation unit 36 and the display unit 43 can be integrated. FIG. 4 shows an example of the standard / reexamination and analysis item setting screen 50 displayed on the display screen of the display unit 43. The setting screen 50 includes a selection setting touch button 51 for the standard test, selection selection touch buttons 52 and 53 for the retests “1” and “2”, and selection settings for each analysis item such as glucose (urine). Touch buttons 54 to 56 are displayed. When the selection setting touch button 51 of the standard inspection, the selection setting touch buttons 52 and 53 of the reexamination “1” and “2”, and the selection setting touch buttons 54 to 56 are respectively touched, the display color changes, for example. To indicate that it has been selected. In the reexamination “1” and “2”, for example, calibration curves having different reagent blank values BLK ₁ and calibration curve constants K ₁₀ are set.

The display unit 43 can display the following setting screens. FIG. 5 shows an example of the standard sample amount / retest sample amount setting screen 57 displayed on the display screen of the display unit 43 in the standard / retest. In this setting screen 57, for example, a standard sample amount setting field 59, a retesting “1” setting field 60, and a retesting “2” setting field 61 are displayed.
FIG. 6 shows an example of the reagent blank / calibrator sample amount setting screen 62. The setting screen 62 includes columns 63 for setting the name and concentration of each sample sample, and columns 64 for setting the sample amount of each sample sample.
FIG. 7 shows an example of the calibration curve display screen 65. This is the calibration curve screen 65, for example, a calibration curve Q ₁₀ corresponding to the analysis item is displayed.

Next, the analysis operation of the apparatus configured as described above will be described according to the automatic analysis flowchart shown in FIG.
On the display screen of the display unit 43, a standard / reexamination and analysis item setting screen 50 as shown in FIG. 4 is displayed. When the selection setting touch button 51 for the standard test and the selection setting touch button 54 for the analysis item necessary for the test of the specimen are touched on the setting screen 50, the selection setting touch button 51, the selection setting touch button 54, Indicates that the display color has been changed and selected.

  Further, a standard sample amount / retest sample amount setting screen 57 as shown in FIG. 5 is displayed on the display screen of the display unit 43. In this setting screen 57, for example, the standard sample amount of the analysis item necessary for the test of the sample is set in the standard sample amount setting column 59, and the retest of the same analysis item is performed in the setting column 60 of the retest “1”, for example The amount of the retest sample necessary for the test is set.

  The display screen of the display unit 43 displays a reagent blank / calibrator sample amount setting screen 62 as shown in FIG. In the setting screen 62, the name and concentration of the sample are set in the column 63, and the sample amount of the sample is set in the column 64. In these reagent blanks / calibrators, for example, water is set as the specimen sample.

On the other hand, the calibration unit 39 irradiates light to the reaction container 12 containing the sample sample and the reagent of the standard sample amount, receives the transmitted light, and inputs the measurement signal output from the photometry unit 21 as data. uptake from part 38, a calibration curve Q ₁₀ standard test, as shown in FIG. 2 on the basis of the measurement signal. The calibration curve _{Q 10} is set by a reagent blank value _{BLK 10} and calibrator _{C 10} for each analysis item, calibration curve constant (factor: _slope) having a _{K 10.} The calibration unit 39 stores information on the created calibration curve Q _{10 in} , for example, the analysis item storage unit 33.

  In step # 1, the main control unit 31 determines whether the standard inspection or the re-inspection. In the standard / re-examination and analysis item setting screen 50 shown in FIG. 4, for example, the standard examination selection setting touch button 51 is touched, so the main control unit 31 determines that it is a standard examination.

  Next, the main control unit 31 issues a command to the analysis control unit 37 to operate the analysis unit 1. In this analysis unit 1, the reagent storage 2 rotates, and at the same time, the first reagent dispensing arm 13 moves to move the first reagent dispensing probe 14 to the aspirating position of the reagent bottle 6 in the reagent storage 2. Let Here, the first reagent dispensing probe 14 performs a suction operation to suck the reagent contained in the reagent bottle 6. Next, the first reagent dispensing arm 13 moves to move the first reagent dispensing probe 14 to the discharge position of the reagent bottle 11 in the reaction mechanism 4. Here, the first reagent dispensing probe 14 discharges and discharges the reagent to the reagent bottle 11 of the reagent rack 10.

  The disk sampler 3 rotates. At the same time, the sample dispensing arm 15 moves to move the sample dispensing probe 16 to the suction position of the sample container 7 in the disk sampler 3. Here, the sample dispensing probe 16 performs the suction operation to suck the specimen sample stored in the sample container 7. Next, the sample dispensing arm 15 moves to move the sample dispensing probe 16 to the discharge position of the reaction vessel 12 in the reaction mechanism 4. Here, the sample dispensing probe 16 discharges and discharges the specimen sample to the reaction container 12 of the reaction disk 9.

  The reagent storage 8 and the reaction disk 9 in the reaction mechanism 4 each rotate. The second reagent dispensing arm 17 moves to move the second reagent dispensing probe 18 to the aspirating position of the reagent bottle 11 in the reagent rack 10. Here, the second reagent dispensing probe 18 performs a suction operation to suck the reagent stored in the reagent bottle 11 of the reagent rack 10. Next, the second reagent dispensing arm 17 moves to move the second reagent dispensing probe 18 to the discharge position of the reaction container 12 in the reaction disk 9. Here, the second reagent dispensing probe 18 discharges the reagent into the sample specimen stored in the reaction container 12 of the reaction disk 9.

Next, the stirring unit 19 stirs the specimen sample and the reagent injected into the reaction container 12.
Next, the photometric unit 21 irradiates the mixed liquid of the specimen sample and the reagent injected into the reaction container 12 with light, receives the light transmitted through the mixed liquid, and outputs a measurement signal of the absorbance of the mixed liquid. To do. The data input unit 38 receives the measurement signal of the absorbance of the mixed solution in the reaction vessel 12 output from the photometry unit 21 and converts it into a digital measurement signal.

The specimen amount of the specimen sample is set as a standard specimen quantity or a retest specimen quantity necessary for retesting for each of a plurality of analysis items. Reagent blank correction unit 40, in step # 2, corrects the reagent blank value BLK ₁₀ of the calibration curve constants K ₁₀ in accordance with the increase or decrease of the sample volume of the analyte sample. That is, the reagent blank correction unit 40 obtains a ratio (Vbt / Vxt) between the reaction liquid volume Vbt of the reagent blank and the reaction liquid volume Vxt of the sample sample increased or decreased according to the above equation (1), and this ratio (Vbt / Vxt) and the reagent blank absorbance data Eb are multiplied to calculate a reagent blank correction value Eb ′.
This reagent blank correction value Eb ′ corresponds to, for example, a calibration curve Q ₁₀ without changing the calibration curve constant K ₁₀ as shown in FIG. 3, for example, in accordance with the retest volume that has been increased from the standard volume at the time of the retest. Corresponds to the amount of movement when translating on the drawing of FIG. If the sample amount is a standard sample amount required for a general standard test, the reagent blank correction value Eb ′ is substantially “0”. However, the reagent blank correction value Eb ′ is a value corresponding to the increase or decrease of the sample amount.

Next, in step # 3, the concentration calculation unit 41 obtains a difference (Ex−Eb ′) between the absorbance data Ex of the reaction solution and the reagent blank correction value Eb ′ according to the above equation (2), and this difference (Ex -Eb ') and by multiplying the calibration curve constant _{K 10} for calculating the component concentrations Cx.
Next, the printing unit 42 in the notification unit 35 prints and outputs the component concentration Cx calculated by the concentration calculation unit 41 on a recording medium such as a printing paper in a report form. The display unit 43 displays and outputs the concentration Cx on a display screen of a liquid crystal display, for example, in a report form.

According to the embodiment described above, by correcting the reagent blank calibration curve constants depending on the increase or decrease of the sample volume of the analyte sample, and the reagent blank correction value Eb 'to a standard curve constant K ₁₀ reaction The component concentration Cx of the analysis item is calculated based on the absorbance data Ex. Thereby, the component concentration Cx can be analyzed with high accuracy in the measurement range from the low concentration to the high concentration regardless of the increase or decrease of the specimen sample. It is corrected calibration curve Q ₁₀ using a reagent blank correction value Eb ', provides centralized single calibration curve Q ₁₀ in accordance with the analysis items regardless of increase or decrease of the sample volume of the analyte sample, the reduction of reagent costs I can plan. In this case, for example, glucose (urine) calibration curve Q ₁₀ different analysis items such is not limited to the reagents used for the analytical item glucose (urine) or the like, applied to the calibration curve of each reagent to be used for all analysis items it can. Therefore, centralize each calibration curve Q ₁₀ in accordance with all the analysis items, thereby reducing the reagent costs.

Further, the specimen by 'calculates the reagent blank correction value Eb' reagent blank correction value Eb depending on sample amount of increase or decrease of the test sample to translate calibration curve Q ₁₀ using, for example, at the time of reinspection Since the calibration curve Q ₁₀ 'corresponding to the increase or decrease of the amount is calculated, there is no need to newly measure the reagent blank value when the sample amount of the sample is increased or decreased, and for the high concentration and the low concentration It is not necessary to analyze the component concentration for each analysis item separately. Thereby, the component concentration Cx can be analyzed efficiently.

  For the reexamination, for example, reexaminations “1”, “2”, etc. having different calibration curves can be set. For each calibration curve set for each of these retests “1” and “2”, the reagent blank correction value Eb ′ is easily calculated according to the increase or decrease of the sample amount of the sample sample, and the component concentration in the retest Can be analyzed.

Note that the present invention is not limited to the above-described embodiment as it is, and can be embodied by modifying the constituent elements without departing from the scope of the invention in the implementation stage. In addition, various inventions can be formed by appropriately combining a plurality of components disclosed in the embodiment. For example, some components may be deleted from all the components shown in the embodiment. Furthermore, constituent elements over different embodiments may be appropriately combined.
For example, although the calibration curve Q _{10 and the} like have been described as straight lines in the above-described embodiment, the present invention is not limited to this, and the calibration curve Q _{10 and the} like can also be applied to a calibration curve including a curve connecting multiple points. Such a multi-point calibration curve may be moved in parallel while maintaining the curvature of the curve using the reagent blank correction value Eb ′.

The block diagram which shows one Embodiment of the automatic analyzer which concerns on this invention. The figure which shows the calibration curve produced by the calibration part in the same apparatus. The figure which shows the reagent blank correction value calculated by the reagent blank correction | amendment part in the same apparatus. The figure which shows an example of the setting screen of the test | inspection and analysis item displayed on the display screen of the display part in the same apparatus. The figure which shows an example of the setting screen of the standard specimen quantity / retest specimen quantity in the standard / retest displayed on the display screen of the display part in the same apparatus. The figure which shows an example of the setting screen of the sample amount of the reagent blank / calibrator displayed on the display screen of the display part in the same apparatus. An example of a calibration curve display screen displayed on the display screen of the display unit in the apparatus is shown. The automatic analysis flowchart in the same apparatus. The figure which shows calculation of the density | concentration using the calibration curve in a standard test | inspection and a reexamination.

Explanation of symbols

  1: analysis unit, 2: reagent storage, 3: disk sampler, 4: reaction mechanism, 5: reagent rack, 6: reagent bottle, 7: sample container, 8: reagent storage, 9: reaction disk, 10: reagent rack, 11: Reagent bottle, 12: Reaction vessel, 13: First reagent dispensing arm, 14: First reagent dispensing probe, 15: Sample dispensing arm, 16: Sample dispensing probe, 17: Second reagent Dispensing arm, 18: second reagent dispensing probe, 19: stirring unit, 20: washing unit, 21: photometric unit, 30: software control center (SCC), 31: main control unit, 32: test data storage Unit 33: analysis item storage unit 34: program memory 35: notification unit 36: operation unit 37: analysis control unit 38: data input unit 39: calibration unit 40: reagent blank correction unit 4 : Density calculation section, 42: printing section, 43: display section, 50: standard / reexamination and analysis item setting screen, 51: standard inspection selection setting touch button, 52, 53: reexamination selection setting touch buttons 54 to 56: Analysis item selection setting touch buttons, 57: Standard sample amount / retest sample amount setting screen, 59: Standard sample amount setting column, 60: Retest “1” setting column, 61: Re Test "2" setting field, 62: Reagent blank / calibrator sample amount setting screen, 63: Column for setting the sample name and its concentration, 64: Column for setting the sample amount of the sample 65: Calibration curve display screen.

Claims (10)

Enabling an increase or decrease in the sample amount of the sample sample for each of a plurality of analysis items with respect to the sample sample collected from the subject, generating a reaction liquid from the sample sample and the reagent according to the analysis item, In the automatic analyzer that calculates the concentration of the analysis item based on the absorbance data of the reaction solution and the calibration curve constant according to the reagent,
Correction means for correcting the reagent blank of the calibration curve constant according to the increase or decrease of the sample amount of the sample sample;
A concentration calculating means for calculating the concentration of the analysis item based on the correction value of the reagent blank corrected by the correcting means, the calibration curve constant, and the absorbance data of the reaction solution;
An automatic analyzer characterized by comprising: The sample amount of the sample sample is set to a standard sample amount or a retest sample amount necessary for retesting for each of the plurality of analysis items,
The correction means corrects the reagent blank of the calibration curve constant according to the increase or decrease of either the standard sample amount or the retest sample amount required for the retest.
The automatic analyzer according to claim 1.   The correction means obtains a ratio between the amount of the reaction solution in the reagent blank and the amount of the reaction solution in the sample sample that has been increased or decreased, and multiplies the ratio by the absorbance data of the reagent blank to obtain the reagent blank. The automatic analyzer according to claim 1, wherein a correction value is calculated.   2. The automatic analysis according to claim 1, wherein the correction unit corrects the reagent blank having the calibration curve constant in accordance with the sample amount of the sample sample even in a standard test or a retest for the sample sample. apparatus.   The automatic analyzer according to claim 1, wherein the correction unit calculates the reagent blank correction value for each analysis item and for each standard test or retest.   2. The concentration calculating unit calculates a difference between the absorbance data of the reaction solution and the reagent blank correction value, and calculates the concentration by multiplying the difference by the calibration curve constant. The automatic analyzer described.   The automatic analyzer according to claim 1, wherein the concentration calculation unit calculates the concentration for each analysis item and for each standard inspection or re-inspection.   The automatic analyzer according to claim 1, further comprising an informing unit for informing the concentration calculated by the concentration calculating unit.   An operation unit is provided that performs at least selection of whether the standard test or the retest is performed for each specimen sample and selection of the analysis item required from the plurality of analysis items. The automatic analyzer according to claim 1. Enabling an increase or decrease in the sample amount of the sample sample for each of a plurality of analysis items with respect to the sample sample collected from the subject, generating a reaction liquid from the sample sample and the reagent according to the analysis item, In the automatic analysis method for calculating the concentration of the analysis item based on the absorbance data of the reaction solution and the calibration curve constant corresponding to the reagent,
The reagent blank of the calibration curve constant is corrected according to the increase or decrease of the sample amount of the sample sample,
Calculate the concentration of the analysis item based on the corrected correction value of the reagent blank, the calibration curve constant, and the absorbance data of the reaction solution,
An automatic analysis method characterized by that.

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