JP4474260B2 - Automatic analyzer proportionality confirmation reagent kit - Google Patents

Description

  The present invention relates to a container for enclosing a reagent for confirming the proportionality of a photometer of an automatic analyzer that performs qualitative / quantitative analysis of biological samples such as blood and urine, and a reagent kit using the container.

  Also in the field of biochemical clinical examinations in which qualitative and quantitative analysis of biological samples such as blood and urine is performed, in recent years, it has been required to ensure the reliability of analysis results based on standards such as GLP, GMP, and ISO. In order to ensure reliability (so that the same analysis result can be obtained using any analysis device of any manufacturer), it is essential to maintain and manage the absolute performance of the device.

  Although there are several items necessary for maintaining the performance of the automatic analyzer, the present invention relates to maintaining the proportionality of absorbance.

  In automatic analyzers, in order to check the degree of proportionality of absorbance at the measurement wavelength near the maximum absorption wavelength of the spectrum, standard samples with different concentrations at multiple wavelengths are dispensed into the reaction vessel. It is necessary to measure with a photometer.

  An example of the automatic analyzer is described in Patent Document 1.

JP-A-8-54402

  Usually, in an automatic analyzer, a standard sample is put in a sample container and set on a sample disk. The sample dispensing probe sucks a predetermined amount of sample from the sample container and discharges it to the reaction container. The sample dispensing probe has a relatively small maximum suction amount to ensure dispensing accuracy. On the other hand, since a standard sample for confirming the proportionality of absorbance requires a certain amount for measurement, the necessary amount cannot be dispensed into the reaction container by one dispensing of the sample dispensing probe. . Further, in a general automatic analyzer, it is not possible to perform control such that a sample is dispensed into the same reaction container from the same sample container a plurality of times. Therefore, at present, as for the standard sample for confirming the proportionality of the photometer, the operator dispenses a necessary amount of the standard sample into the reaction vessel by hand. However, skilled techniques are required to accurately dispense the required amount of standard sample. From the above situation, the fact is that the proportionality confirmation is requested to the service department of the device manufacturer.

  However, in order to confirm the proportionality, it is costly to periodically request the equipment manufacturer's service department to perform measurement, and there is a concern that the proportionality confirmation test cannot be performed so frequently in practice. In addition, it is originally desirable to be able to check the performance of your own automated analyzer yourself.

  An object of the present invention is to provide a reagent kit that allows a user of an average technical level to easily perform a proportionality confirmation test.

  In order to solve the above problems, in the present invention, a standard sample is sealed in a container that can dispense a standard sample into a reaction container using a reagent dispensing probe that can dispense a larger amount than a sample dispensing probe, A reagent kit prepared in advance for each measurement wavelength and dilution series was provided.

  Specifically, the container for sealing the standard sample was modified with a sample cup used in the automatic analyzer and provided with a lid. By setting this container at the mouth of the reagent bottle on the reagent disk, the reagent dispensing probe can dispense a necessary amount of standard reagent into the reaction container. In this method, after dispensing a standard reagent once, measurement with a spectrometer is possible, and a rapid proportionality confirmation test is possible.

  Also, set the sample cup filled with the standard reagent on the sample disk, set the reagent bottle containing the diluted standard reagent on the reagent disk, and dispense the standard reagent into the reaction container with the sample dispensing probe. In addition, the diluent may be dispensed into the same reaction vessel using a reagent dispensing probe. Although this method requires two dispensings, since a proportionality test can be performed in the same steps as a normal sample analysis, analysis can be performed without setting special test conditions.

  It is desirable to set the proportionality confirmation sample in a special box that clearly indicates the measurement wavelength and dilution series.

  According to the present invention, the proportionality confirmation work corresponding to the standards of GLP, GMP, and ISO can be easily performed by the apparatus user himself.

The procedure of the conventional proportionality confirmation test is as follows.
1. Prepare a sample solution for confirmation of proportionality.
Use a spectrophotometer to check the proportionality of the sample prepared in 2.1. The absorbance is adjusted to around 3.5 Abs in the dilution series 10/10.
After confirming the proportionality in 3.2, prepare for confirmation of the proportionality of absorbance in the automatic analyzer.
4). Remove the reaction vessel cleaning mechanism and wipe the water in the reaction vessel with a cotton swab.
5). To eliminate the effects of sample probes, reagent probes, stirrers, etc., remove them or stop them from operating.
6). Set the reaction container from which water has been removed, and install the reaction container cleaning mechanism.
7). Measure the cell blank.
8). Dispensing the proportionality confirmation sample into the cell is done manually, and the device is operated normally and put into place.
9. Measure absorbance (single wavelength measurement) with the cell blank measurement function.

  Such an operation is quite complicated and difficult to perform unless it is a skilled serviceman of the device manufacturer.

Furthermore, the supply form of the proportionality confirmation sample has the following problems.
(1) Reagents for confirming the proportionality of each wavelength of the photometer of the automatic analyzer are prepared and supplied to the user. However, the amount supplied is not in accordance with the amount actually used. Absent . This is caused by the fact that there is no suitable container at the time of supply, and the container is packed and supplied in a commercially available container with a lid. As a result, the reagent is being supplied in excess from the amount of reagent actually used (approximately 200 μl).
(2) Although the reagent to be supplied is packed in a box for each measurement wavelength, for example, the display wavelength 570
nm and 600 nm cannot be distinguished from each other in appearance. Proportionality cannot be confirmed if neglected during use.
(3) When a reagent packed in a container is shipped, since there is no dedicated box for the reagent, it cannot be put in the order of dilution system when packing the reagent, and the filling is put in the gap and shipped. However, this may cause liquid leakage during transportation.
(4) Since the reagent packaging is not in the order of dilution series, there is a possibility that the reagent is dispensed incorrectly when using the reagent, or that a reagent other than the measurement wavelength is inserted.

According to the present invention, it is possible to omit complicated operations such as the following (1) to (3) when confirming the proportionality of the photometer.
(1) A sample solution for confirming proportionality is prepared.
(2) Using a spectrophotometer, check the proportionality of the sample prepared in (1). The absorbance is adjusted to around 3.5 Abs in the dilution series 10/10.
(3) After confirming the proportionality in (2), perform steps 1) to 3) below to prepare for confirmation of the proportionality of absorbance in the automatic analyzer.
1) Remove the reaction vessel cleaning mechanism and wipe off the water in the reaction vessel with a cotton swab.
2) Remove or stop the sample probe, reagent probe, stirrer, etc., so that they are not affected.
3) Set the reaction vessel from which water has been removed, and attach the reaction vessel cleaning mechanism.

According to the present invention,
Since it is used in a sample cup, it eliminates the need for reagent dispensing (reducing work time). Because it is used in a sample cup, there is no need to ask a procedure such as dispensing into a reaction vessel.

  By omitting the dispensing operation, it is possible to avoid contamination that may occur when the reagent is dispensed for each dilution series.

  By reducing the size of the reagent bottle, the cost of reagent preparation can be reduced, and the amount of waste can be reduced.

  Transportation costs can be reduced by downsizing the reagent supply form.

By adopting a dedicated transport and storage container for the reagent kit, it is possible to avoid an error in the order of adding dilution series and an error in display wavelength.
Etc. can be obtained.

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

  As shown in FIG. 1, a container filled with a reagent for a proportionality test having a predetermined concentration is arranged at a sample container installation position on a sample disk (sample disk). On the reagent disk, a reagent bottle containing a diluent for diluting the reagent for the proportionality test and allowing the liquid to enter the reaction container so as to allow measurement with a photometer is disposed. The amount of liquid that can be dispensed by the sample dispensing probe from the sample container on the sample disk is about several tens of microliters, while the optimal amount of liquid that can be analyzed with a photometer is 100 microliters or more. Therefore, the measurement by the spectrometer cannot be performed only by dispensing the reagent for the proportionality test from the sample container to the reaction container. Therefore, it is necessary to add a diluent.

  Even in the analysis of a general specimen (sample), the reagent is added after the sample is dispensed and measurement is performed with a spectrometer. Therefore, it is not necessary to set special test conditions for the proportionality test.

What is required for a sealable container containing a reagent having a predetermined concentration is as follows.
1. The shape must be placed on the sample disc.
2. Assuming transportation, no liquid leakage should occur.
3. The lid cannot be removed easily.
4). The lid can be easily removed during use.

  Therefore, the container is as shown in FIGS. The details are as follows.

  Since the above-mentioned 1 is required, the container for storing the reagent is common.

For lids, emphasis was placed on sealing and sealing to prevent liquid leakage and contamination. As a container lid, in order to increase the adhesion between the container and the lid, a fine groove was provided on the inside of the lid as shown in FIG. As in FIG. 2, a groove was formed on the inside of the lid, and a handle was attached to the lid to facilitate attachment and detachment (FIG. 3). As shown in FIG. 4, the container and the lid were integrated so that they could be attached and detached with a single touch. As shown in FIG. 5, the container was grooved and the cap was screwed to simplify opening and closing. The container shown in FIGS. 2 to 5 can be reused by closing the lid after use. Also, as shown in FIG. 6, the use of a vapor deposition film provides the best sealing and sealing properties. The difficulty is that it is a single-use type.

  In addition, as shown in FIG. 7, by preparing a box for storing a sealable container containing a reagent having a predetermined concentration, it is possible to make the standard smaller than the current transportation mode and stand on the user side. As a way of viewing, each sample is neat when the box is opened, and visual confirmation is easy, so that it is easy to use.

  Moreover, you may set a sample cup as shown to FIGS. 2-6 in the opening | mouth of a reagent bottle. Since the reagent dispensing probe can dispense hundreds of microliters of reagent, measurement with a spectrometer can be performed by one dispensing without diluting with a diluent. In this case, it is necessary to omit the sample dispensing step into the reaction vessel, and it is necessary to set analysis conditions different from the analysis routine for general samples. In that case, separate from general sample analysis conditions, set the analysis conditions for the proportionality test in advance, and select software from the menu so that the set analysis conditions can be selected and set for the proportionality test. If you make it, you can respond.

The perspective view which showed the setting position of the reagent for proportionality confirmation. The perspective view of a container. A fine groove is made inside the sample cap to increase the adhesion to the container. Affix a label indicating the type of sample. Labels are applied in the same manner from FIG. 4 to FIG. The perspective view of a container. A handle is attached to the cap of the type shown in FIG. 2 to facilitate opening and closing of the cap. The perspective view of a container. The sample cap and lid were integrated. The perspective view of a container. The container was grooved and a screw-type cap was used. The container perspective view. A deposited film was used as a cap. Storage and transport box top view. A hole was removed to hold the container, and a hole was similarly removed for the analytical reagent.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 1 ... Reaction disk, 2 ... Reagent discharge position, 3 ... Reaction container for direct photometry, 4 ... Reaction container washing | cleaning mechanism, 5 ... Light beam, 6 ... Light source lamp, 7 ... Stirring mechanism, 8 ... Reagent probe, 9 ... Reagent disk, DESCRIPTION OF SYMBOLS 10 ... Sample disk, 11 ... Sample probe, 12 ... Sample cup, 13 ... Reagent bottle, 14 ... Lid, 15 ... Sample container, 16 ... Label which shows sample classification.

Claims (8)

A container that has a lid that can seal the contained reagent and that can be installed at the opening of the reagent bottle on the reagent disk of the automatic analyzer,
In a state in which a proportionality confirmation reagent for confirming the proportionality diluted to a predetermined concentration is accommodated in advance, the arrangement location is defined and set for each wavelength and dilution series used for measurement ,
In addition, it is possible to aspirate the proportionality confirmation reagent in an amount necessary for the proportionality test from the container installed at the opening of the reagent bottle on the reagent disk by one dispensing of the reagent dispensing probe. A proportionality confirmation reagent kit.   The proportionality confirmation reagent kit according to claim 1, wherein the lid part can be attached and detached by hand.   3. The proportionality confirmation reagent kit according to claim 2, wherein the lid portion includes a groove in at least a part of a contact surface between the lid portion and the container.   4. The proportionality confirmation reagent kit according to claim 3, wherein the lid part includes a handle part for pulling.   3. The proportionality confirmation reagent kit according to claim 2, wherein the lid portion includes a connecting portion so as not to be separated from the container.   3. The proportionality confirmation reagent kit according to claim 2, wherein the lid part includes a screw part that can be opened and closed by rotating.   2. The proportionality confirmation reagent kit according to claim 1, wherein the lid portion is an aluminum vapor deposition film. In the automatic analyzer which uses the kit in any one of Claims 1-7,
A storage unit that stores general analysis conditions using the reagent contained in the reagent bottle and analysis conditions for proportionality confirmation using the proportionality confirmation reagent;
An automatic analyzer comprising: a display unit configured to display a screen for setting which analysis condition to be executed among the analysis conditions stored in the storage unit.

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