JP3053494U - Inspection tool - Google Patents

Abstract

(57) [Summary] [Problems] The present invention can easily confirm that a sample has been sufficiently collected without confirming whether or not a liquid sample has come into direct contact with a sampling section, and can easily confirm that a sample has high uric acid. To provide an inspection tool which does not require re-examination even when uric acid is clogged on a control surface by urine and the control portion is not colored. A sample collection unit for collecting a sample, a chromatographic medium unit to which a sample collected by the sample collection unit moves, and a detection unit for detecting a substance to be detected in the sample moving through the chromatographic medium unit In the inspection tool comprising, the inspection tool has a first confirmation unit to confirm the movement of the sample,
An inspection tool having a second confirmation unit for confirming that the sample has passed through the detection unit as necessary.

Description

[Detailed description of the invention]

[0001]

[Industrial applications]

 The present invention relates to a test device, particularly for the purpose of diagnosing pregnancy, judging the presence or absence of fecal occult blood, and testing bacteria and viruses. It relates to an inspection tool that detects using the principle of.

[0002]

[Prior art]

 Conventionally, various analytical methods have been developed as methods for measuring trace substances contained in liquid samples in the field of medical diagnostics. In particular, immunoassays utilizing antigen-antibody reactions are widely used as high-sensitivity measurement methods, and trace substances are analyzed using instruments that apply this measurement principle in the field of clinical testing (Japanese Patent Application Laid-Open No. 47-18597). Gazette, JP-B-53-47518, etc.).

In general households, the importance of home health care has been advocated, the need for simple measurement using this immune reaction has increased, and the development of a simple measurement device for that purpose has been progressing. Above all, a number of so-called "sticks" have been proposed (for example, Japanese Patent Application Laid-Open (JP-A) Nos. 62-501034, 63-118657 and 64-463).

In this type of immunoassay test device, a first antibody labeled with an enzyme, a fluorescent substance, a dye, or the like is movably disposed on a chromatographic medium, and a second antibody is provided on a detection portion downstream thereof. Is most common. The test substance (antigen) in the sample moving on the chromatographic medium (chromatographic medium) by capillary flow moves to the detection section while reacting with the first antibody for labeling, and the second antibody-antigen-label in the detection section. Form a complex of the first antibody. Qualitative or quantitative analysis of the sample is performed by detecting or measuring the label immobilized on the detector.

However, this immunoassay test device does not include a control unit for determining whether or not the sample has spread to the detection unit. Therefore, it is not possible to determine whether the sample is an original negative in which the test substance itself does not exist in the sample, or whether the sample is not displayed because the sample did not pass through the detection unit. For this reason, there was a risk that a positive sample would be erroneously determined to be negative. In order to solve this problem, there has been proposed an inspection tool which serves as a control part by applying a coloring agent which develops a color when wetted with water as an indicator on the upper part of the detection part of the reaction layer or the spreading layer ( JP-A-4-353774). Although this color former does not vary and develops a color, there is a problem in that the presence or absence of color development must be confirmed within a limited time because the color former flows along with the sample as it passes through the sample solution. .

[0006] In order to solve this problem, the color changed when contacted with the liquid sample, and the changed color was held for a long time at the position where the indicator was fixed, and the liquid sample definitely passed the control unit; and An inspection tool has been proposed in which it is confirmed whether determination is possible, and an indicator indicating the end of the inspection is fixed on the control section (Japanese Patent Application Laid-Open No. Hei 6-239009 and Japanese Utility Model Application Laid-Open No. Hei 6-28735).

[0007]

[Problems to be solved by the invention]

 However, the above-mentioned inspection tool is casing with plastic or the like, and can see only the detection unit and / or the control unit on the chromatographic medium. Therefore, it is not possible to predict whether the sample can reach the detection unit within the specified time due to a shortage of the collected sample or an abnormal delay in the capillary flow movement. Despite the fact that adding a sample within the specified time resulted in the desired result and often eliminating the need for re-inspection, re-inspection was performed using a new inspection tool.

[0008] Even when the sample does pass through the detection unit and the reaction is completed, for example, when the sample is hyperuricuric acid, the coloration of the control unit is inhibited due to clogging of the control unit by uric acid, and the control is negative. May be determined. In this case, re-inspection had to be performed using a new inspection tool.

[0009] Accordingly, the present invention has been made in view of such a conventional problem. By observing the capillary flow upstream of the detection unit, a shortage of the sample or an abnormal delay of the capillary flow movement is achieved. The purpose of the present invention is to provide an inspection tool capable of detecting the flow rate and observing the capillary flow downstream of the detection section to avoid false recognition due to abnormal coloring of the control section, that is, to provide an inspection tool capable of reducing the frequency of re-inspection. And

[0010]

[Means for Solving the Problems]

 The present inventors have conducted intensive studies to solve the above problems, and as a result, by providing a first confirmation unit that can confirm the movement of the sample upstream of the sample collection unit, it is possible to prevent the occurrence of reaction failure due to insufficient sample, and By providing a second confirmation unit downstream of the detection unit in response to this, it was possible to detect abnormal coloring of the control unit, and it was found that complicated re-inspection could be reduced, and the present invention was reached.

[0011] The inspection tool of the present invention is a chromatographic inspection tool having at least a sample collection part for collecting a sample and a detection part for detecting the presence of a test substance in a sample that has flowed by capillary flow. It is characterized in that the inspection tool has a first confirmation unit for confirming the movement of the sample.

[0012] Further, the inspection tool of the present invention is characterized in that the inspection tool further includes a second confirmation unit that confirms that the sample has passed the detection unit.

[0013] Further, the inspection tool of the present invention is a chromatographic inspection tool having at least a sample collection part for collecting a sample and a detection part for detecting the presence of a test substance in a sample that has moved by capillary flow, The inspection tool has a second confirmation unit that confirms that the sample has passed through the detection unit.

[0014]

DESCRIPTION OF THE PREFERRED EMBODIMENTS According to the inspection tool of the present invention, a first confirmation unit is provided upstream of a detection unit on a chromatographic medium in which a sample collected by a sample collection unit moves by a capillary flow. Can easily be visually confirmed as passing through the first confirmation section, and as a result, a reaction failure due to insufficient sample can be prevented.

[0015] In addition, the test device of the present invention can provide a sample, for example, by providing a second confirmation unit downstream of the detection unit in addition to or separately from the first confirmation unit. Even in the case of hyperuricuric acid, it is easy to visually confirm that it has passed through the detection unit.As a result, even if the control unit is clogged, the test result can be easily determined, so that complicated retesting is required. Can be prevented.

[0016]

【Example】

 Hereinafter, embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited thereto.

FIG. 1 is a front view showing an embodiment of the inspection tool of the present invention. In FIG. 1, 1 indicates a test strip, 2 indicates a sample collection unit, 3 indicates a chromatographic medium, 4 indicates a first confirmation unit, 5 indicates a detection unit, 6 indicates a second confirmation unit, and 7 indicates a control unit.

The chromatographic medium 3 functions as a medium for transferring a sample containing an analyte to be analyzed by the action of capillary action or the like, and as long as it has such a function, its material is particularly There is no restriction.

Examples of such a material include filter paper, nitrocellulose, cellulose acetate, and the like. These may be used alone or in combination. Among these materials, filter paper and nitrocellulose are particularly preferred in that they can easily control the physical adsorption ability and development speed of antibodies and the like. The dimensions of the chromatographic medium 1 are not particularly limited, but are preferably, for example, 2 to 10 mm wide, 50 to 150 mm long, and 0.02 to 1 mm thick when used.

To protect the test strip 1, most of the chromatographic medium 3 may be covered by a cover member made of any material. In this case, it is preferable that the distal end of the sampling section 2 located at the upstream end of the chromatographic medium 3 is not covered with the cover member. With such a configuration, the sample can be arbitrarily applied by dipping or pouring the sample into the sample collecting section 2 at the time of analysis.

At least a portion of the cover member corresponding to the first confirmation unit 4, the detection unit 5, the second confirmation unit 6, and the control unit 7 is provided with an observation window or is formed of a transparent member. Alternatively, it is necessary to eliminate the cover member.

With the above configuration of the first confirmation unit 4, the sample collected by the sample collection unit 2 is moved to the first confirmation unit 4 through the chromatographic medium 3 by the capillary action of the chromatographic medium 1. The state can be easily checked visually, and as a result, the reaction failure due to the shortage of the liquid sample can be prevented. At this time, if a shortage of the liquid sample is confirmed, the sample collection unit 2 is immersed in the liquid sample again, or a retest is performed to visually check the state in which the liquid sample moves through the first confirmation unit 4. Confirm.

The moving state of the sample can be sufficiently confirmed by a change in color tone caused by impregnation of the chromatographic medium with water. However, a dye different from the labeled antibody is arranged upstream of the chromatographic medium, and the flow of the dye is visually observed. You may check with. The dye component is not particularly limited as long as it is a component that exhibits a desired color change, such as an ink for detecting wetting, a pH indicator, and a cobalt complex, but an ink for detecting wetting is particularly preferable.

The fact that the sample has reached the detection unit 5 is visually checked by means provided in the first checking unit 4, and then the presence or absence of the substance to be detected in the sample is determined by a known test means. By visually confirming the change, the presence or absence of the substance to be detected can be tested by the detection unit 5.

The appropriate substance to be detected that can be applied to the test device of the present invention can be appropriately selected from known substances as long as it has a specific binding interaction. Specific examples of those having this specific binding interaction are not limited to antigens / antibodies, but include enzymes / substrates, enzymes / inhibitors, DNA / complementary DNA, hormones / receptors, biotin / avidin and the like.

Samples applicable to the test device of the present invention include all forms of solutions and colloidal solutions, which are fluid samples, and are preferably biological fluid samples, such as blood, serum, urine, and fecal suspension. Turbidity, cerebrospinal fluid, saliva and the like. The substances to be detected contained in these samples include, for example, human chorionic gonadotropin (hCG), thyroid stimulating hormone (TSH), hormones such as insulin, thyroxine, estrogen, estradiol, CEA, AFP, Cancer markers such as fecal hemoglobin, viruses such as human immunodeficiency virus (HIV), human adult disease lymphocyte virus (ATLV), hepatitis B virus (HBV), IL-1, IL-2, IL-6, etc. Examples include drugs such as cytokines, theophylline, phenytoin, and valproic acid, various growth factors such as EGF and PDG, DNAs and RNAs of the virus, proteins related to inflammation such as CRP, bacteria and cells.

In the present invention, a second confirmation unit 6 for further confirming the movement of the sample may be provided between the detection unit 5 and the control unit 7 in addition to the first confirmation unit 4 if necessary. it can. The second confirmation unit 6 has a configuration substantially the same as that of the first confirmation unit 4, so that the state in which the sample is moved can be easily visually confirmed. In the present invention, only the second checking unit 6 may be provided without providing the first checking unit 4.

The arrival of the sample in the control section 7 is visually confirmed by means provided in the second confirmation section 6, and then the coloration of the control section 7 is visually confirmed. , The end of the reaction can be determined. In this case, the state in which the sample is moved by the second checking unit 6 can be easily visually checked even if the control unit 7 does not color when the sample is cleaved on the determination surface due to, for example, hyperuricuric acid. In addition, complicated reexamination can be omitted.

[0029]

[Effect of the invention]

 According to the present invention, by providing the first confirmation unit for observing the situation where the sample collected by the sample collection unit moves on the chromatographic medium, it is easy to visually check whether the sample can be expanded to the detection unit. A predictable test tool can be provided. Therefore, according to the inspection tool of the present invention, it is possible to easily determine whether the reaction is not established due to the shortage of the liquid sample, and it is possible to eliminate the need for complicated re-inspection by a simple treatment of adding the sample.

In addition, the present invention provides a method for controlling the occurrence of color abnormality in the control unit by providing a second confirmation unit downstream of the detection unit in addition to or separately from the first confirmation unit. Also, the present invention provides an inspection tool that can determine whether or not a sample has passed an inspection section. Therefore, according to the test device of the present invention, the test results can be accurately determined even if the control section is clogged by a high uric acid sample or the like, so that retesting can be reduced.

[Brief description of the drawings]

FIG. 1 is a front view of the inspection tool of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Test strip 2 Sampling part 3 Chromatography medium 4 First confirmation part 5 Detection part 6 Second confirmation part 7 Control part

Claims (3)

[Utility model registration claims] A sample collection unit for collecting at least a sample;
A chromatographic inspection tool having a detection unit for detecting the presence of a test substance in a sample that has flowed in a capillary flow, wherein the inspection tool has a first confirmation unit for confirming the movement of the sample. Inspection tool. 2. The inspection tool according to claim 1, further comprising a second confirmation unit that confirms that the sample has passed the detection unit. 3. A sampling section for collecting at least a sample,
A chromatographic inspection tool having a detection unit for detecting the presence of a test substance in a sample that has flowed in a capillary flow, having a second confirmation unit for confirming that the sample has passed the detection unit. An inspection tool characterized by the following.