JPH02141664A - Testing tool - Google Patents

Abstract

PURPOSE:To make it possible to detect the concn. of a component in a specimen accurately by providing a through hole in one surface of a test layer into which liquid to be analyzed is supplied, and providing an absorber layer having liquid absorbing ability. CONSTITUTION:A reaction detecting layer 2 on which gelatin solution incorporating reaction detecting agent is applied and dried is provided on a transparent carrier layer 1. A developing member layer 3 comprising blood developing knit is laminated. An excessive-detection absorbing material 4 comprising knitted material is laminated thereon. A through hole 5 for dropping specimen is provided in the material 4. The entire body is surrounded with a plastic frame 6. When a blood specimen is attached in the hole 5 in analysis, the excessive amount is absorbed with the absorbing material layer 4. A specified amount is supplied into the member layer 3. The specified amount is quickly penetrated into the detecting layer 2. The specimen reacts with the reaction detecting body, and coloration occurs. The coloration is detected with a light source having a specified wavelength from the side of 7 through the carrier layer 1. Thus the coloring density can be judged.

Description

[Detailed description of the invention] [Industrial application field] The present invention relates to a test device for detecting biological components.

In particular, the present invention relates to a test device that can appropriately analyze even an excess supply of body fluid for analyzing body fluid components.

[Prior art and problems to be solved by the invention] In the field of clinical testing, dry reagents containing a certain amount of necessary reagents are used as a means of detecting or quantifying specific components in body fluids such as urine or blood. The type of test piece is extensive. That is, a multilayer analysis piece (also referred to as a multilayer analysis element or multilayer analysis element) for quickly and simply quantifying a specific component in a liquid sample using a dry method is already known.
No. 888 (corresponding to U.S. Patent No. 3,992,158), JP-A-50-137192, JP-A-51-40191,
JP-A-52-3488, JP-A-52-131786, JP-A-53-131089, JP-A-54-2970
No. 0, JP-A No. 54-34298, JP-A No. 61-613
No. 47, U.S. No. 4110079, U.S. No. 413252
111 and other specifications and [C11nical Ch.
volume 24, pages 1335-1350 (
(1978) and others.

In most of these methods, simply supplying a specimen such as urine or blood onto the test sample using a well-flowing means reacts with a specific component in the specimen, and detects the resulting chemical or physical property change. In addition, although these do not require strict sample weighing, it is necessary to weigh the sample supplied to the test device in order to cause chemical changes and changes in physical properties depending on the content of specific components in the sample. It was necessary to keep the amount constant within a predetermined range. Conventionally, this method involves supplying the specimen to a test device using a collection device that can accurately collect a minute amount of specimen;
A method has been used in which an arbitrary amount of specimen is supplied to a test device, and after a certain period of time, excess specimen is removed by washing with water or using blotting paper.

However, these methods require highly specialized techniques when using a dedicated collection device, and are suitable for experts to perform on samples containing a large number of liquids. In addition, in the latter method, it is necessary to strictly determine the time period from supplying the sample to removing the excess sample, and the complicated operation also causes measurement errors.

The present invention has been made in consideration of the problems of the prior art, and aims to provide a test device that can supply any amount of specimen and does not require the subsequent removal of an excess amount of specimen. purpose. Furthermore, the present invention provides a test device that allows analysis tests to be performed without requiring strict sample amounts so that non-experts and even patients themselves can detect or quantify specific components of body fluids. The purpose is to provide

[Means for Solving the Problems] The gist of the present invention is to provide a test device for analyzing liquid components, which has a through hole on at least one side of a test layer to which a liquid to be analyzed is supplied. This test device is characterized by being provided with an absorbent layer capable of absorbing liquid. The absorbent layer is preferably made of a woven fabric, a knitted fabric, a nonwoven fabric, a paper wrapper, or a non-fibrous porous material that has been subjected to a wood-filtering treatment.

The test device for analyzing a specific component in a liquid sample (such as blood) according to the present invention includes a carrier and a carrier, which reacts with a characteristic component in the sample (body fluid, such as blood) and detects chemical changes therein. This structure has a reaction detection body (JR) for detecting the reaction and a sample supply body (layer) that supplies or develops a liquid sample to the reaction detection body, that is, a developing body (layer), and as a preceding stage of the sample supply body. In order to supply an appropriate amount of specimen, an excess specimen absorbing layer (layer) having the performance described below is provided. That is, an absorbent layer having a liquid absorption ability that absorbs an excess body fluid specimen is provided as a preliminary step to supplying or developing the specimen.

As an absorber that absorbs the excess amount of analyte,
Materials having appropriate absorbency such as woven fabrics, knitted fabrics, non-woven fabrics, paper wrappers, and non-fibrous porous materials can be used, and woven fabrics or knitted fabrics are particularly suitable.

These materials also have the following properties:
It is desirable that the material be made hydrophilic by chemical means such as impregnation with a surfactant or physical means such as Blaze 7 treatment, corona discharge treatment, and ultraviolet treatment.

[Operation] The present invention will be described in detail by taking as an example a case where a blood sample is dropped into an instrument-1 to perform a blood test.

For both tests, (1) a highly absorbent material such as paper or cloth was used as a reaction detector placed on a carrier to react with characteristic components in the sample (blood) and detect chemical changes; There are highly absorbent reactive carriers prepared by impregnating a carrier with a reaction reagent solution and drying them, and (2) reaction detectors prepared by coating a polymer solution containing a reaction reagent on a plastic carrier.

Regarding the latter (2), a specimen spreading material is further installed on the test device to supply the specimen over a wide range. Therefore, in conventional test devices, when a predetermined amount of blood is supplied to the test device, as shown in FIG. It spreads horizontally within the reactive carrier or specimen developing material layer 3°, and also permeates vertically through the highly absorbent reactive carrier or specimen developing material layer 3° of the test device. Reaction with the reagent contained in the reactive carrier layer 2° or the reactive detector layer of the device is started. At this time, as shown in the figure, the blood 9 that has been supplied becomes spherical at 3° above the layer 3', and the diffusion into the layer 3' does not proceed rapidly. However, it takes a long time to spread the sample in the lateral direction, and the reaction progresses until the amount of sample per unit area of the area where the sample is dropped becomes constant, resulting in measurement errors.

In contrast, in the present invention, as shown in FIG.
Excess amount of blood dropped into the absorbent body 4 is absorbed by the surrounding absorbent body 4. That is, at least the part 5 where blood is dripped.
By providing an absorbent layer 4 that absorbs excess blood around the area except for the blood droplets, the amount of blood per unit area of the area 5 where blood is dropped is made constant in a very short time, and the amount of blood in the spreading material layer 3 is kept constant. The signal diffused in concentration and supplied to the detector layer 2 is vague.
In other words, the amount of blood that contributes to the reaction in the sensing body 2 can be defined. Therefore, it is possible to quickly detect chemical changes depending on the amount of characteristic components in the specimen (blood).

The material of the liquid absorber used in the test specimen of the present invention is, for example, one having a structure having a liquid absorbing ability using materials such as cotton and chemical fibers. Specifically, a nylon/polyester knitted fabric can be used. Its liquid absorption capacity is such that it can absorb body fluids such as blood to some extent.

The structure of the liquid absorber used in the present invention preferably has through holes, as described below.
As shown in FIG. B, the location where the sample is to be dropped, that is, the position of the through hole 5, can be sensed with just the touch of a finger, and thereby the sample can be easily deposited. In addition, the size of the through hole depends on the physical properties of the body fluid sample applied to the test. In other words, the structure is capable of stabilizing the amount of sample per unit area of the part where the sample has been dropped in an extremely short time, and making it possible to keep the amount of sample that approaches the reaction in the reaction detection body constant as specified. belongs to. Furthermore, by adjusting the size of this through hole, the speed at which the liquid sample can be completely supplied to the reaction detection body can be adjusted.

Therefore, the structure of the test tube can be determined according to the ability of the reaction detector.

The relationship between the liquid absorber layer according to the present invention and the body fluid supplier is as follows:
Although various three-dimensional relationships can be considered, it is possible to construct a structure in which the liquid absorber is laminated on a part or all of the surface of the body fluid supply body (namely, the spreading layer). Alternatively, it may be of a type in which it is provided at an appropriate position next to the body fluid supply body so that excess liquid sample flows into it. Furthermore, it can also be provided in a suitable distribution state in the body fluid developing body.

Next, the test device according to the present invention is shown in FIG. 1A, and the structure of a conventional test device is shown in FIG. 1B for comparison.

In the structure of the test device according to the prior art (FIG. 1B), for example, a gelatin solution is coated on a polyethylene terephthalate transparent film (transparent carrier) 1 and dried.
A reaction detection Jl (blood cell filtration/reaction film) 2 is formed. Then, a knitted fabric is laminated thereon as a spreading member (blood spreading knit) 3 for uniformly spreading the specimen.

On the other hand, in the test device structure of the present invention, as shown in FIG. 1A, a reaction detection layer (blood cell filtration, reaction An excess sample absorbing material 4 made of a knitted fabric having a through-hole 5 for dripping a sample onto the developing member layer 3 made of a blood spreading knit.
(Vampire 22/G) is laminated. The whole is then surrounded and held in a plastic frame 6. For detection analysis, a blood sample is spotted on the four parts 5 from the top of FIG. 1A. Then, an excessive amount of blood is absorbed into the absorbent layer 4, but the developing layer 3 is supplied with a constant supply amount, and the detection W4
2 in a predetermined amount, where it reacts with the reaction detection body and develops a color. The color development is detected from the side indicated by 7 using a light source of a predetermined wavelength, and the color density is measured.

In this way, in the tests of the present invention, since the through hole 5 is located in the center of the absorber layer 4, the supplied liquid sample (blood, etc.) is distributed evenly from the surroundings to the absorber 4 around the through hole 5. absorbed into. However, in the structure shown in FIG. 1B, for example, the absorption occurs via the reagent layer or the developing member layer (3), so there are drawbacks such as the reaction progressing while passing through that layer. It was something.

Next, an analytical test using the test device according to the present invention will be explained based on the A-body side, but the present invention is not limited to the following explanation.

[Example] The reaction detection layer 2 contained glucose oxidase, peroxidase, L-aminoantipyrine, N-ethyl-N-(
Same as the test prepared with the structure shown in Figure 1A using gelatin containing 2-hydroxy-3-sulfopropyl)-m-toluidine as a reaction reagent and in which titanium dioxide powder was dispersed. The following experiment was conducted using a reagent and a test device fabricated with the structure shown in FIG. 1B having a reaction detection layer fabricated with the same configuration.

100 mg/drl and 3 Q Omg/d each
Blood containing glucose at a concentration of Q was calibrated using both the test of the invention and the conventional test. In this case, the following reaction occurs in the reaction detection body.

Glucose + Phylogen → (Glucose oxidase) → Gluconic acid + Hydrogen peroxide (HIOI) Hydrogen peroxide chromogen →
(Peroxidase)→Pigment water (umo) The dropping amount for this calibration was varied in the range of 10 to 40 μP, and each drop was added to the test device with the above structure, and the intensity of coloring was measured 2 minutes after dropping. , at a wavelength of 565 nm, was measured as the relative intensity of reflected light to that before coloration. fI
FIG. 2 shows a graph in which the four constant values are plotted against the varying amounts of dripping.

The results measured using the test device shown in FIG. 1A are shown by ○ and solid lines, and the results measured using the test device structure shown in FIG. 1B are shown by dotted lines and are used as comparative examples. Also, 100 mg/dl
Glucose concentration blood test result in I, 300 sg
/ dll glucose concentration blood test results are indicated by I.

As shown in the graph of Fig. 2, the test device of the present invention can detect a constant value without being affected by the drop amount, that is, the size of the sample, as shown by the solid line. , revealed.

[Effects of the Invention] The test of the present invention differs from conventional test specimens by providing an excess specimen absorber to supply a certain amount of body fluid, that is, specimen, to the reaction detection layer. To provide a test specimen that can accurately detect even when the amount of specimen is excessive; second, to provide a test device that can accurately detect the concentration of components in a specimen over a wide range without being constrained by the amount of specimen; Thirdly, it has a significant technical effect in that it provides a test that allows non-experts, such as patients, to easily analyze and detect their own body fluids using a fecal tube.

FIGS. 3A, 3B, and 3C are explanatory diagrams for explaining the present invention in detail.

[Explanation of symbols of main parts] 1. Transparent carrier 2. Reaction detection layer 3. Sample development layer 4. Excess analyte absorber 5　、、、、、Through hole

Claims (2)

[Claims] (1) A test device for analyzing liquid components, characterized in that at least one side of the test layer to which the liquid to be analyzed is supplied is provided with a through hole and an absorbent layer capable of absorbing the liquid. test equipment. (2) The test device according to claim 1, wherein the absorbent layer is made of a woven fabric, a knitted fabric, a nonwoven fabric, a rolled paper, or a non-fibrous porous material that has been subjected to a hydrophilic treatment.