Blood test container

Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter

Reexamination Certificate

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Details

C422S067000, C422S105000, C436S063000, C436S068000, C436S069000

Reexamination Certificate

active

06793885

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a blood test container for use in clinical examinations or testing of human and animals, and more particularly to a blood test container by which a whole procedure starting from blood collection and ending with measurement of blood components can be carried out with the use of a single container.
BACKGROUND ART
The blood component testing as heretofore practiced in clinical examinations and the like is accomplished according to the following procedure. First, blood is collected by using an injector or a vacuum blood-collecting tube. Next, the blood either transferred into a test tube or introduced into the blood-collecting tube is centrifuged to separate serum or plasma and solid matter. Subsequently, the serum or plasma separated is distributed into separately-prepared test containers for measurements.
An equipment for carrying out such measurements is commercially available, for example, under the product name “ORTHO HCV.AB QUICKPACK” from Orthoclinical Diagnostics Co., Ltd. With the use of this testing equipment, HCV antigen screening test can be performed, for example, after serum or plasma is dripped on a reagent of the testing equipment such as by a dropping pipet.
However, the aforementioned conventional test method has required a tester to remove a cover from the blood-collecting tube and distribute the blood into metering cups during the blood collection and measurement. Thus, several opportunities have existed for the tester to contact the blood. This has imposed a risk for the tester to acquire infectious HIV, hepatitis and the like.
It is an object of the present invention to provide a blood test container and a blood test method which can facilitate the practice of a series of procedures starting from blood collection and ending with measurement of various blood components while reducing the chance for the tester to contact the blood.
DISCLOSURE OF THE INVENTION
The blood test container according to the present invention includes a bottom-closed tubular container and a blood test reagent fixedly accommodated in the tubular container.
For the blood test container according to the present invention which secures the test reagent within the bottom-closed blood test container, (1) the blood or its component (referring to serum or plasma previously separated from the blood) is introduced into the tubular container where it is allowed to contact the blood test reagent, or alternatively, (2) the blood is introduced into the tubular container and subsequently centrifuged so that the separated blood component, such as serum or plasma, is allowed to contact the blood test reagent. Therefore, a series of procedures from collection till measurement of the blood can be carried out without the occurrence for a tester to contact the blood.
The blood test reagent may be secured onto an inner face of the tubular container, either directly or indirectly with the aid of other supplemental members. Alternatively, the blood test reagent may be secured onto an outer surface of an inner tubular container, a second tubular container, a tubular member or the like, accommodated within the tubular container.
The “securement of the test reagent onto the inner face or “securement onto the outer face”, as used in describing the present invention, is not limited to the configurations whereby the test reagent is literally secured onto the inner or outer face, and encompasses configurations whereby a liquid-form test reagent is located in contact with the inner or outer face and configuration whereby a powder-form test reagent is located in contact with the inner or outer face. Illustrating typical examples of such configurations of the blood test container, the liquid- or powder-form test reagent is located between the tubular container and any one of the inner tubular container, second tubular container and tubular member accommodated within the tubular container to contact therewith.
In accordance with the invention, the blood test container according to the present invention further includes a contact control structure effective to normally prevent the contact of blood introduced in the container with the test reagent and, when centrifuged, allow a blood component to successfully contact the test reagent. In the invention, the contact control structure operates such that it initially prevents the blood introduced into the tubular container from contacting the test reagent but, when centrifuged, permits the separated blood component to contact the test reagent.
In accordance with the invention, the aforementioned contact control structure includes an inner container portion extending along an inner face toward a bottom of said tubular container and perforated at its bottom to have a hole, and a solid member accommodated in the inner container portion for closing the hole and configured to fall down through the hole when centrifuged. Also, the blood test reagent is provided onto an inner face of the tubular container and/or an outer face of the inner container portion. Due to the presence of the solid member which closes the bottom hole of the inner container portion, the blood, when introduced into the tubular container, is initially retained to stay within the tubular container. As centrifuging is subsequently applied, the solid member is caused to fall down and the blood starts to build up in the bottom of the tubular container. After centrifugation, the separated serum or plasma is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member accommodated in the tubular container and an annular member radially extending between the outer face of the tubular member and the inner face of the tubular container to contact therewith. The annular member is positioned to initially locate below the test reagent. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the tubular member. This construction permits the blood when introduced into the tubular member to flow through the bottom opening of the tubular member into the bottom of the tubular container. However, the annular member blocks the blood which is accordingly prevented from reaching to contact with the test reagent. When centrifuged, the blood in the tubular member is forced to move downward and then upward along the circumferential surface of the tubular member, whereby the annular member is pushed upward. Also, the blood, when centrifuged, is separated into serum or plasma and solid matter and the separated serum or plasma is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member accommodated in the tubular container and having a bottom end brought into contact with an interior bottom face of the tubular container, and a pressing means for pressing the tubular member against the interior bottom face of the tubular container so that the blood introduced into the tubular member is prevented from leaking therefrom but, when centrifuged, a component of the blood is permitted to leak therefrom. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the tubular member. Since the pressing means acts to press the bottom end of the tubular member against the interior bottom face of the tubular container, the blood is initially prevented from leaking to leave the tubular member. When centrifuged, the blood is caused to leak from the tubular member while separated into serum or plasma and solid matter. As a result, the serum or plasma separated is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member secured onto the inner face of the tubular container, and a solid member secured adjacent a bottom end of the tubular member for closing a bottom opening of the tubular member and adapted to fall through

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