JPH08271529A - Reagent supply method and reagent case - Google Patents

Abstract

PURPOSE: To obtain a method for supplying a reagent accurately and stably to an automatic analyzer with high reproducibility. CONSTITUTION: In an automatic analyzer 1 for determining specified components in a specimen by causing reaction of a specimen and a reagent in a reaction case 7 and subjecting a reaction liquid thus produced to photometry through a photometer 10, a reagent case 3 is set in a reagent stocker 2 and connected with a rubber plug and a tube 5 thus feeding the reagent through a perfectly enclosed system.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a container and method for supplying reagents to an automatic analyzer used in clinical tests such as biochemical analysis and immunological analysis.

[0002]

2. Description of the Related Art As the analytical methods for clinical tests are simplified and the reagents are improved, clinical test reagents tend to be supplied in the form of kits in which reagents can be conveniently prepared and used. With the spread of this kit of reagents,
Reagents are often stored in liquid form, and obtaining the stability of the reagent during the period of storage and use is also a major issue for clinical diagnostic reagents. Various studies have been attempted in order to obtain this stability, and preservatives have been added to suppress the generation of bacteria, and buffers etc. have been used to stabilize the pH and the deterioration of enzymes due to the oxidation of reagents. There is.

However, such stabilization of the reagent has a considerable influence on the automation of the test. The reagent in the conventional automatic analyzer is stored in a bottle-shaped reagent container 12 having a mouth portion 13 as shown in FIG. 4, and when the reagent container 12 is set in the reagent cooler 2, the lid of the mouth portion 13 of the reagent container 12 is opened. The tube 5 is inserted from and the reagent is sucked and collected. For this reason, the container is always open, so that (1) propagation of bacteria, (2) deterioration of unstable enzymes and substrates, (3) contamination of foreign substances such as dust, (4) gas in the air However, there are problems such as a change in pH due to the dissolution of the reagent in the reagent, and an influence on other reagents due to evaporation of the buffer component in the reagent into the air.

In order to solve these problems, in order to accurately and reproducibly use the reagent set in the automatic analyzer, conventionally, a preservative is added to the propagation of the bacteria of (1),
The unstable enzyme and the deterioration of the substrate of (2) have been dealt with by a method of adding an enzyme excessively or using a thermostable enzyme. However, the addition of preservatives to reagents prepared from several types of chemicals has many problems, including the fact that they do not affect each other, and the cost of adding enzymes excessively. Is the current situation. Also, above (3) to (5)
The stabilization problem with respect to is a problem that occurs because the reagent supply method is performed in an open system, and no improvement has been performed yet.

[0005]

SUMMARY OF THE INVENTION The present invention solves the problem of reagent stabilization in order to prevent the reagent from being oxidized or deteriorated.
By filling the liquid reagent in a flexible sealed container with almost no oxygen gas, and supplying the reagent into the reaction container in a state where it is completely closed to the outside air, it is possible to protect the external environment. This was done to supply an unanalyzed, accurate, and reproducible reagent to an automated analyzer.

[0006]

The present invention provides an automatic analyzer for quantifying a specific component in a sample by reacting a sample with a reagent in a reaction container and measuring the resulting reaction solution with a photometer.
A gist of a reagent supply method is characterized in that a reagent container containing a reagent is connected to the inside of the reaction container in a completely closed system. Further, the present invention provides a reagent supply method for an automatic analyzer in which a reagent container containing a reagent is connected to the inside of a reaction container in a completely closed system, and comprises a flexible sealed container having an outlet and a hanging portion. It is a gist to provide a characteristic reagent container.

[0007]

When the reagent container of the present invention is used to supply the reagent to the automatic analyzer, the reagent can be dispensed into the reaction container in a state of being completely closed to the outside air.

[0008]

Embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a perspective view showing a main part of an automatic analyzer in which the reagent container of the present invention is used, FIG. 2 is a plan view of a reagent container according to an embodiment of the present invention, and FIG. 3 is an embodiment of the present invention. It is sectional drawing of the connection part of the extraction port of a reagent container and tube which concerns on an example.

The automatic analyzer 1 contains a reagent cool box 2 for containing a reagent container 3, a dispensing device 4 for sucking a reagent from the reagent container 3 and supplying it from a reagent nozzle 9 to a reaction container 7, and a sample. A sample container 6, a reaction container 7 for reacting a reagent with a sample, a pipetter 11 for sucking the sample from the sample container 6 and dispensing it into the reaction container 7, a stirring unit 8 for mixing the sample with the reagent, and a photometer for photometry. It consists of 10. In the reagent cooler 2, the reagent container 3 is stored at a constant temperature. A reagent for sample measurement is hermetically stored in the reagent container 3.

The reagent container 3 is made of a synthetic resin and has a flexible seal in which a take-out port 31 for filling and sucking the reagent and a hanging part 32 for fixing the reagent in the reagent cooler 2 are integrally formed. It is a container. As a molding method, a method of stacking two sheets of synthetic resin and heat-sealing the periphery to form a bag, a method of blow molding, or the like is used. As the material, a thermoplastic resin such as polyvinyl chloride, ethylene acetic acid copolymer, polypropylene or polyethylene is used. Considering the eluate in the reagent solution, it is preferable to use a polyolefin-based material such as polypropylene or polyethylene. However, when the liquid reagent is very easily oxidized and the gas barrier property of the container is desired, it is also preferable to coat or laminate a resin having a high gas barrier property such as polyvinylidene chloride or ethylene vinyl alcohol copolymer.

As a method of filling the reagent into the reagent container 3, oxygen gas is hardly present. For example, it is preferable to fill in a reduced pressure state where there is almost no air, or to fill with an inert gas such as nitrogen.

The outlet 31 and the tube 5 may be connected to each other as long as they can be fitted and connected in a liquid-tight manner without liquid leakage after the fitting. For example, as shown in FIG. 3A, the outlet 31 is provided with a rubber stopper 311 as a sealing member, the end of the tube 5 is provided with a puncture needle 51 as a communication means, and the reagent container 3 is attached to the reagent cooler 2. At some time, the puncture needle 51 may be inserted into the rubber stopper 311 up to the locking portion 52, or the closing body 312 may be inserted into the slit 313 of the rubber stopper 311 as shown in FIG. Closure body 3 with cylinder 53
12 may be pressed, and a thin portion 314 for closing the outlet 31 may be provided as in (c), and the puncture needle 51 at the end of the tube 5 may be connected to the septum 54 by connecting. Etc.

The material of the tube 5 is polyvinyl chloride, ethylene vinyl acetate copolymer, polypropylene,
Polyethylene, fluorine-based resin, silicone-based resin and the like are available, and like the reagent container 3, a material with less elution is preferable.

The following are the results showing the effect of the reagent supply method of the present invention. As a comparative example, the closed reagent container 3 used in the present invention and a conventional open container 12 are filled with 500 ml each of total protein measuring reagents, and 100 ml of sterilized glucose-peptone (GP) medium is put in this. It was This and the fungus in the dish (Aspergillus sp. Rhizopus
sp) and yeast (Candida sp) were allowed to coexist in the reagent cooler 2. The day when the bacteria were put in the reagent cooler 2 was set as day 0, and 1 ml of the medium was taken out from each container every day.
Table 1 shows the results obtained by inoculating the sterilized agar medium in a clean bench, culturing the cells at 25 ° C for 3 days, and measuring the number of bacteria generated in 1 ml, and converting the number into 500 ml of the reagent. Show.

[0015]

[Table 1] From the results shown in Table 1, no generation of bacteria was observed at the time when the measurement was performed using the closed system reagent container 3, but from the second day when the measurement was performed at the conventional open system reagent container 12. Bacterial growth was confirmed.

500 reagents for measuring total protein are placed in the closed reagent container 3 used in the present invention and the conventional open reagent container 12.
Table 2 shows changes in the pH of the reagent when the reagents were filled in each ml and set in the reagent cooler 2 at the same time.

[0017]

[Table 2] From the results in Table 2, in the measurement using the conventional open type reagent container 12, the pH value of the reagent decreases after 2 weeks, but in the case of using the closed type reagent container 3 of the present invention, the pH value decreases.
There was no change in the value.

500 reagents for measuring total protein are placed in the closed reagent container 3 used in the present invention and the conventional open reagent container 12.
It was filled by ml. This is an automatic analyzer (Hitachi 7150)
Table 3 shows the results of measuring the total amount of protein in the same serum using the same after storage for a certain period of time.

[0019]

[Table 3] From the results of Table 3, in the Example, the measurement was performed with a constant value with good reproducibility, but in the Comparative Example, the deterioration of the reagent progressed after 2 weeks, and the measured value rapidly decreased, and the measured value was accurately measured. Not reproduced.

From the above results, it can be seen that in an open reagent container, the reagent comes into contact with the outside air, so that the reagent becomes unstable, which impairs the accuracy of the measurement result.

[0021]

EFFECTS OF THE INVENTION Since the present invention has the above-mentioned structure, it is accurate and has good reproducibility without the bacteria and the like in the conventional reagent container 12 growing and the enzyme in the reagent becoming unstable. A stable reagent can be supplied. Therefore, it is not necessary to add an unnecessary drug for the measurement, and there is no need to study the influence on the measurement system or the reagent, so that the production can be performed at low cost.

[Brief description of drawings]

FIG. 1 is an explanatory diagram showing a main part of an automatic analyzer according to the present invention.

FIG. 2 is a plan view showing an example of a reagent container according to the present invention.

FIG. 3 is an explanatory view showing an example of a connecting portion between a take-out port of a reagent container and a tube according to the present invention.

FIG. 4 is a perspective view showing an example of a conventional reagent container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Automatic analyzer 2 Reagent cold storage 3 Reagent container 31 Outlet 311 Rubber stopper 312 Closing body 313 Slit 314 Thin-walled part 32 Hanging part 4 Distributor 5 Tube 51 Puncture needle 52 Locking part 53 Communication cylinder 54 Partition wall 6 Sample container 7 Reaction container 8 Stirring part 9 Reagent nozzle 10 Photometer 11 Pipettor 12 Reagent container 13 Mouth

Claims (2)

[Claims] 1. In an automatic analyzer for reacting a sample with a reagent in a reaction container and measuring the resulting reaction solution with a photometer to quantify a specific component in the sample, the reagent container containing the reagent is a completely closed system. A method for supplying a reagent, characterized in that it is connected to the inside of the reaction vessel with. 2. A reagent supply method for an automatic analyzer in which a reagent container for containing a reagent is connected to the inside of a reaction container in a completely closed system, and comprises a flexible sealed container having an outlet and a hanging portion. A reagent container characterized by: