JPH11258242A - Method for processing measured data in automatic analyzer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for processing measured data in an automatic analyzer whereby analyzed data of high reliability can be obtained at all times, and a large quantity of loss of labor and time for analyzing abnormal analysis data and waste of a sample and a reagent, etc., due to reinspection can be effectively prevented. SOLUTION: In analyzing a desired measurement item of a sample by an automatic analyzing apparatus of a total reaction process photometry system, a first photometric point and a second photometric point related to a specific photometric point corresponding to the measurement item are set beforehand. A fluctuation acceptable range is operated on the basis of measured data of the specific photometric point. The fluctuation acceptable range and measured data at the first photometric point are compared. A required measurement data is selected from the measured data at each of the specific photometric point, first photometric point and second photometric point on the basis of the comparison result. The desired measurement item of the sample is analyzed on the basis of the selected required measurement data.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analyzer used in the field of clinical testing, and more particularly to a method of sequentially dispensing samples and reagents to each reaction vessel while sequentially transferring a plurality of reaction vessels. The present invention relates to a method for processing measured data in an automatic analyzer of a whole reaction process photometric system in which a liquid in a reaction vessel is photometrically measured at regular time intervals.

[0002]

2. Description of the Related Art In recent years, in an automatic analyzer used for chemical analysis of components such as serum in hospitals and the like, a plurality of reaction vessels are sequentially transferred while a sample is dispensed into each reaction vessel, and a reagent is dispensed. Perform dispensing, stirring, photometry and washing,
It is common to use a reaction vessel repeatedly. In addition, as an automatic analyzer that repeatedly uses the reaction vessel as described above, a photometric cuvette capable of direct photometry is used as a reaction vessel, and from a predetermined timing before the reaction is started for each photometric cuvette, before the reaction is started and before washing. Until a predetermined timing, each time the photometric cuvette passes through the photometric section, the liquid in the photometric cuvette is photometrically measured through the photometric cuvette, the sequential absorbance data is captured, and a plurality of the captured absorbance data are included. There is a method that employs an all-reaction process photometric method in which analysis is performed using absorbance data at a specific photometric point preset according to a measurement item.

According to the automatic analyzer of the whole reaction process photometric method, since the reaction vessel and the absorbance photometric cuvette are also used, it is not necessary to aspirate the liquid in the reaction vessel to a photometric section such as a flow cell. There are advantages that the amounts of samples and reagents can be reduced, and that the analytical processing ability can be improved. In addition, since many photometric points can be taken for each photometric cuvette over a long period of time, analysis by rate response can be easily performed, and check logic such as prozone for setting the reliability of analytical data is set. Also has the advantage of being advantageous.

[0004]

However, in the above-mentioned conventional automatic analyzer of the whole reaction process photometric method, for example, when performing the analysis by the end point method using the absorbance at the end of the reaction, a plurality of photometric cuvettes are required. One or two specific photometric points are set in advance for each measurement item from among the photometric points, and the absorbance data at the specific photometric point (when there are two specific photometric points, the average of the two absorbance data is used). Value) only, the analysis of the corresponding measurement item, that is, the concentration is calculated. For this reason, at the time of photometry at the set specific photometry point, if a random defect such as the appearance of bubbles in the test solution in the photometry cuvette occurs, analysis data of an abnormal value is output even in a normal value. Or, conversely, analysis data of a normal value may be actually output even for an abnormal value.

[0005] Such abnormalities in the analysis data are examined in detail by comparing the measurement items, comparing with the previous measurement value by re-examination, or outputting the absorbance data at a plurality of photometry points including the specific photometry point. By doing
Although it can be analyzed to some extent, in this case there is a problem that it takes a lot of labor and time, and especially when it is output as normal value analysis data, it does not notice that it is abnormal data , May be directly reported as analysis data. In addition, when performing a retest, there is a problem that samples and reagents are wasted.

The present invention has been made in view of such conventional problems, and it is possible to always obtain highly reliable analysis data. Therefore, a great deal of labor and labor are required for analyzing abnormal analysis data. It is an object of the present invention to provide a method for processing measurement data in an automatic analyzer that can effectively prevent time loss and waste of samples and reagents due to retests.

[0007]

SUMMARY OF THE INVENTION In order to achieve the above object, the present invention provides an automatic analyzer of a total reaction process photometry system, which processes measurement data at successive photometry points obtained for each reaction vessel. In analyzing a desired measurement item of the sample dispensed into the reaction container, the vicinity of the specific photometry point in relation to the specific photometry point for obtaining measurement data necessary for analysis corresponding to the measurement item A first photometry point including at least the photometry point of the above, and a second photometry point including at least a photometry point near the first photometry point are set in advance, and the measurement data is obtained based on the measurement data of the specific photometry point. Is calculated, and based on a comparison between the fluctuation allowable range and the measurement data at the first photometry point,
The specific photometry point, the first photometry point, and the second
The required measurement data is selected from the respective measurement data at the photometric points of (a) and (b), and the desired measurement items of the sample are analyzed based on the selected required measurement data.

[0008]

FIG. 1 shows the configuration of an example of an automatic analyzer for implementing a measurement data processing method according to the present invention. This automatic analyzer has a turntable 2 in which a plurality of reaction vessels 1 as photometric cuvettes are held at equal intervals on the same circumference. The first reagent (R) is added to each reaction vessel 1 while rotating clockwise and counterclockwise by a predetermined step in each cycle so as to rotate clockwise (360 ° -1 reaction vessel).
1) dispensing the sample and the second reagent (R2) sequentially,
The liquid in the reaction vessel 1 after the dispensing of the first reagent is directly measured at predetermined time intervals with light of a predetermined wavelength through the reaction vessel 1 by a total reaction process photometry method, and the sequential absorbance data is taken in for analysis. At the same time, the reaction vessel 1 after the analysis is washed and used repeatedly.

For this reason, the first reagent dispensing section 3, the stirring section 4, the photometric section 5, the sample dispensing section 6, and the second A reagent dispensing section 7 and a washing section 8 are provided. First reagent dispensing section 3 first dispenses a first reagent mainly containing a buffer solution into each reaction vessel 1, and then agitating section 4 And stir. For the reaction container 1 into which the first reagent has been dispensed, every time it is positioned at the photometric unit 5 at a fixed time interval, the light having the wavelength corresponding to the test component is measured through the reaction container 1 while the next measurement is performed. Then, in the sample dispensing section 6, a sample such as serum is dispensed from the sample cup 12 held on the sample table 11 by the sample dispenser 13, and then the mixture is stirred by the stirring section 4.

Next, in the second reagent dispensing section 7, from among the plurality of reagent tanks 16 containing second reagents which react with different test components set on the reagent table 15, The second reagent corresponding to the component is dispensed by the reagent dispenser 17 and then reacted by stirring in the stirring unit 4. After a predetermined reaction time has elapsed, the reaction vessel 1 is washed in the washing section 8 to prepare for the next analysis.

The operation of each unit described above is controlled by the arithmetic and control unit 21 according to a predetermined sequence. Also, the photometer 5
The sequential photometric data of each reaction vessel 1 at
The components are converted into absorbances, respectively, and are subjected to quantitative analysis of the test components in each sample based on the absorbance data. The analysis results are printed out on the input / output unit 22 or displayed on a display.

Hereinafter, as an embodiment of the present invention, a case where a measurement item by an end point method is analyzed will be described. In the analysis by the end point method by the automatic analyzer shown in FIG. 1, the specific photometric points for obtaining the absorbance data used for the concentration calculation according to the measurement items are classified as follows, for example. Group A: The specific photometry point is the final photometry point. Group B: The specific photometry point is the photometry point immediately before the final photometry point. Group C: The specific photometry point is two photometry points before the final photometry point.

Therefore, in this embodiment, the arithmetic control unit 2
1, a first photometry point and a second photometry point are set in advance for each group. For the first and second photometry points, for example, for the group A, two photometry points before the specific photometry point are set as a first photometry point, and two photometry points before the specific photometry point are set as a second photometry point. For the group B, one photometry point before and after the specific photometry point is set as the first photometry point, and the two previous photometry points are set for the second photometry point. For the group C, the specific photometry point is set. One photometry point before and after the first photometry point,
Further, one photometry point before and after each is set as a second photometry point.

In analyzing the measurement items by the end point method as described above, first, the arithmetic and control unit 21 based on the absorbance data at the specific photometry point.
Calculates the allowable range. The variation allowable range is set by adding or subtracting a variation value calculated using the constant k for the measurement item to the absorbance data at the specific photometry point. Here, the constant k is an allowable range of the variation of the concentration value of the item. For example, in the case of albumin, 0.2 g / dl is set to 0.2, and the constant k is calculated by calculating the concentration value from the absorbance data. Is divided by the calibration coefficient (gradient of the calibration curve), and the allowable range of the variation of the item is converted into the absorbance. The allowable range of the absorbance is 1/3 (the standard deviation) of the theoretical value of 1/4.
SD is set as a fluctuation allowable range. That is, absorbance data at a specific photometry point ± (constant k / calibration coefficient) / 4 × 3
Is calculated to obtain a variation allowable range. Therefore, assuming that the calibration coefficient of albumin is 7, the fluctuation value is 0.2
Since /7/4×3=0.02 Abs (absorbance), ± 0.02 is added to the absorbance data at the specific photometry point to set the fluctuation allowable range.

Next, as shown in FIG. 2, when the measurement item is the group A, when the absorbance data at the two first photometry points before the specific photometry point are the groups B and C, respectively. Is the first of each one before and after the specific photometry point
It is determined whether or not the respective absorbance data at the photometry points of the above are within the fluctuation allowable range. Here, FIG.
As shown in Case 1, when the two absorbance data at the first photometry point fall within the allowable fluctuation range, three absorbance data at the first photometry point and the absorbance data at the specific photometry point are used. An average value of the two absorbance data is calculated, and the average value is calculated as the absorbance for concentration calculation to calculate the concentration of the measurement item.

On the other hand, in each of the groups A, B and C, the two absorbance data at the first photometry point deviate from the allowable fluctuation range in the same direction as shown in case 2 of FIG. If so, the average value of the two absorbance data at the first photometry point that does not include the absorbance data at the specific photometry point is calculated, and the average value is used as the absorbance for the concentration calculation to calculate the concentration of the measurement item.

Further, in each of the groups A, B and C, as shown in case 3 of FIG. 2, two absorbance data at the first photometry point deviate from the allowable fluctuation range in opposite directions. In the case, for the group A and the group B, from the total of five absorbance data including the two absorbance data at the previous two second photometry points, for the group C, one second photometry point before and after each of the two second photometry points Calculate the average value of the three absorbance data excluding the maximum and minimum absorbance data from the total of five absorbance data including the two absorbance data in, and use the average value as the absorbance for the concentration calculation to determine the concentration of the measurement item. Is calculated.

Similarly, in each of the groups A, B, and C, one of the two absorbance data at the first photometry point has a variation allowable range as shown in case 4 of FIG. If it is out of the range, for the group A and the group B, a total of five pieces of absorbance data including the two absorbance data at the previous two second photometry points are used. From a total of five absorbance data including two absorbance data at two photometric points, calculate the average value of three absorbance data excluding the maximum and minimum absorbance data, respectively, and use the average value as the absorbance for concentration calculation. Calculate the concentration of the measurement item.

FIG. 3 is a flowchart showing the above processing in the group C, and the detailed description thereof will be omitted because it is duplicated.

In order to obtain the certainty of the analysis result,
In each of the groups A, B and C, case 2 in FIG.
If the absorbance data was processed at ~ 4, preferably
A message or a warning is displayed on the input / output unit 22, and coded characters are printed together with the analysis result.

The present invention is not limited to the above-described embodiment, but can be variously modified or modified. For example, in the above-described embodiment, the first photometry point and the second photometry point are set in relation to the specific photometry point after the reaction, with respect to the measurement items by the endpoint method. In the rate method, when the absorbance data at the specific photometric point before the start of the reaction, for example, before dispensing the second reagent in the automatic analyzer of FIG. Similarly, the first photometry point and the second photometry point can be set to obtain required absorbance data. Further, the number of the first photometry point and the second photometry point related to the specific photometry point is not limited to two, and can be set to an arbitrary number.

Also, the allowable range of the concentration value used for calculating the allowable range of the absorbance can be set by using a variation coefficient (CV) instead of the constant k. in this case,
First, the density value is calculated based on the absorbance data at the specific photometry point and the calibration coefficient, and then the allowable range SD is calculated from the calculated coefficient of variation of the allowable range of the density value. The allowable range SD obtained in this way is used instead of the constant k in the above equation to automatically calculate and set the allowable change range of the absorbance. The constant k, the calibration coefficient, or the variation coefficient used to determine the variation value with respect to the absorbance data at such a specific photometry point is desirably experimentally verified in consideration of the functional error of each analyzer. .

[0023]

According to the present invention, when a desired measurement item of a sample is analyzed by the automatic analyzer of the whole reaction process photometry method, the first measurement point near the specific photometry point corresponding to the measurement item is analyzed. And a second photometry point in the vicinity of the first photometry point are set in advance, and a variation allowable range of the measurement data is calculated based on the measurement data of the specific photometry point. And then, based on the comparison result, select required measurement data from the respective measurement data of the specific photometry point, the first photometry point, and the second photometry point, and select the selected measurement data. Since the desired measurement item of the sample is analyzed based on the required measurement data, highly reliable analysis data can always be obtained. Therefore, it is possible to effectively prevent enormous labor and time loss for analyzing abnormal analysis data, and waste of samples and reagents due to reinspection.

[Brief description of the drawings]

FIG. 1 is a diagram showing a configuration of an example of an automatic analyzer that implements a measurement data processing method according to the present invention.

FIG. 2 is a view for explaining an embodiment of a measurement data processing method by the automatic analyzer shown in FIG. 1;

FIG. 3 is a flowchart of one embodiment of the measurement data processing method shown in FIG. 2;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Reaction container 2 Turntable 3 1st reagent dispensing part 4 Stirring part 5 Photometry part 6 Sample dispensing part 7 2nd reagent dispensing part 8 Washing part 11 Sample table 12 Sample cup 13 Sample dispenser 15 Reagent table 16 Reagent Tank 17 Reagent dispenser 21 Operation control unit 22 Input / output unit

Claims (1)

[Claims] 1. An automatic analyzer of the whole reaction process photometry system processes measurement data at successive photometry points obtained for each reaction vessel, and performs desired measurement of a sample dispensed into the reaction vessel. In analyzing the item, a first photometry point including at least a photometry point in the vicinity of the specific photometry point in association with a specific photometry point for obtaining measurement data required for analysis corresponding to the measurement item, A second photometry point including at least a photometry point in the vicinity of the first photometry point is set in advance, and a variation allowable range of the measurement data is calculated based on the measurement data of the specific photometry point. Based on a comparison with measurement data at one photometry point, the specific photometry point;
A required measurement data is selected from the respective measurement data of the first photometry point and the second photometry point, and a desired measurement item of the sample is analyzed based on the selected required measurement data. Measurement data processing method in an automatic analyzer.