Containers and kits for the determination of cell functions, and method for the determination thereof

Abstract

An object is to obtain a container for measurement of cell functions which is simplified in operation, less risky and capable of measuring the cell functions very accurately. A container for measurement of cell functions, for use in the determination of a physiologically active substance produced by blood cells, is constituted such that an amount of material capable of inducing production of the physiologically active substance, when extracted by collecting water of a volume equal to a liquid volume to be subjected to measurement, is controlled at a level insufficient to induce production of the physiologically active substance from the blood cells. A container for measurement of cell functions in which a material capable of inducing production of a physiologically active substance in blood when contacted with the blood is accommodated in such a condition as being contactable with blood, and in which an amount of the material capable of inducing production of the physiologically active substance in the container before use is limited to a level insufficient to influence a measured value of the physiologically active substance.

Description

[0001] The present invention relates to a container for measurement of cell functions involved in immune and inflammatory reactions, a kit for measurement of the cell functions and a method for measuring the cell functions, and more particularly to a container for measurement of cell functions which is carried out through determination of physiologically active substances, such as cytokines, produced by blood cells including granulocytes, monocytes, macrophages, lymphocytes or the like, for example, kit and method for such a measurement of cell functions.DESCRIPTION OF PRIOR ART[0002] Leukocytes, such as granulocytes, monocytes, macrophages and lymphocytes, play various rolls in diversified bioprotective reactions including immune and inflammatory reactions in blood or respective organs. It is known that these cells exhibit important functions in a variety of morbidities including infectious diseases; inflammatory diseases such as hepatitis and nephritis; immune.cndot.allergic disea...

AI Technical Summary

Problems solved by technology

However, the conventional testing methods have required such specialized techniques as separation and culture of cells, microscopic measurement or the like, to consequently necessitate time-consuming measurements, RI facilities and expensive equipments.

However, the above-described methods for measurement of cell functions which have been conventionally carried out at hospital examining rooms or centers, as well as the methods disclosed in the gazettes of the above-listed laid-open patents, have the following problems.

This carries a risk for an examining person to acquire various infectious diseases, such as hepatitis and AIDS, when the person contacts the blood.

Also, there is a possibility that various bacteria or dusts are accidentally incorporated into a specimen blood during such operations.

There exists another risk of adversely affecting the measurement results when those contaminants or operations physically stimulate the cells in blood without necessity.

Since even a very slight amount of endotoxin can induce production of TNF.alpha. or IL-1.beta. from leukocytes, it was impossible to obtain reliable measurement results when, for example, entry of a slight amount of dusts during a manufacturing process or contamination through employed cleaning water resulted in incorporation of a small amount of endotoxin in the above-described blood collecting equipment or reactor.

However, there exists no general standard for endotoxin contents in anticoagulant, other than a guideline given by "Endotoxin testing method" in the dispensatory of 13th revised Japanese Pharmacopeia, which, for anticoagulants employed as an injection drug, officially sets 5 EU/Kg as a standard for a specification of minimal pyrogenic dose to a rabbit.

Accordingly, if anticoagulants are contaminated with endotoxin, and if the contents of such endotoxin are in a sufficient level to cause production of the physiologically active substances, it would become impossible to carry out precise measurements of various physiologically active substances in blood, of functions of blood cells, and of surface antigens of blood cells.

Also, the amount of the material capabl

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