JP3120085U - Immediate body fluid inspection / diagnosis device - Google Patents

Abstract

To provide a body fluid immediate test / diagnosis device capable of accurately collecting a small amount of blood and easily performing an HIV test using a fixed amount of test solution.
A blood collection tool having a transparent blood collection tool main body, an external diagnostic drug-containing test paper disposed inside the blood collection tool main body, and a liquid-absorbing liquid attached to the tip of the blood collection tool, and a blood collection tool And a developing solution container for storing a developing solution to be brought into contact with the absorbing liquid, and a tip of the blood collecting device main body of the blood collecting device is attached to the developing solution container. By inserting, the body fluid that sucks the body fluid or the like into contact with the developing solution stored in the developing solution container, and pushes the sucked liquid into the blood collection device main body by the protrusion of the developing solution container Immediate inspection / diagnostic device.
[Selection] Figure 1

Description

  The present invention relates to a body fluid immediate examination / diagnosis device. In particular, the present invention relates to a bodily fluid immediate test / diagnosis device used in the same day test of anti-HIV antibodies and HIV (antigens and genes) in serum.

  For the diagnosis of HIV infection, a screening test using a simple rapid antibody test kit with an immunochromatographic method that can be obtained in 15 minutes has been developed. The same day test at some health centers and private clinics and at home Is possible.

  FIG. 9 is a schematic view of a conventional HIV immediate test kit. A conventional HIV test kit includes a stick 14, a lancet (blood sampling needle) 15, a dropper 16, a test plate 17, and a test liquid 18 shown in FIG.

  As shown in FIG. 9 (b), the tip 14a (not shown) of the stick 14 is inserted into the lancet 15, and the needle 15a is pushed into the connecting portion 15c and fixed so as to prevent movement in the central axis direction. . Thereafter, as shown in FIG. 9C, the stick 14 is removed from the lancet 15. Subsequently, as shown in FIG. 9D, the lancet 15 is applied to the fingertip, the button 15b is pressed, and the fingertip is punctured with the needle 15a.

  A small amount of blood coming out of the fingertip is collected with the dropper 16 and appropriately lowered into the concave portion 17 a marked “S” of the test plate 17 as shown in FIG. Subsequently, as shown in FIG. 9 (f), a predetermined amount of the inspection liquid 18 is dropped into the concave portion 17 a marked “S” of the same inspection plate 17.

  When the specific component in the blood reacts with the test solution 18, the mixed solution penetrates into the test plate 17, and the determination result 19 is displayed on the test window 17 b of the test plate 17. In the case of negative (non-infection) determination, as shown in FIG. 9 (g), one line on the “c” mark side of the examination window 17b, and in the case of positive (infection) determination, as shown in FIG. 9 (h). In addition, two (or three) lines are displayed on the “c” mark side of the inspection window 17b.

  However, with a conventional HIV test kit, it is difficult to accurately collect a small amount of blood obtained by puncturing a fingertip with a dropper. In addition, the blood cannot touch the inside of the syringe cylinder or the air mixed in the syringe cylinder to perform a hygienic inspection. Furthermore, if a substantial blood sample is insufficient, an accurate test cannot be performed. Even if the amount of the test solution is insufficient, accurate determination cannot be displayed.

  Therefore, an object of the present invention is to provide a body fluid immediate test / diagnosis device that can accurately collect a small amount of blood and easily perform an HIV test using a fixed amount of test solution.

  The object is to provide a transparent blood collection tool main body according to claim 1, an external diagnostic agent-containing test paper disposed inside the blood collection body, and a liquid-absorbing liquid attached to the tip of the blood collection device. This can be achieved by having a blood collection tool.

  The above object is also achieved by a developing liquid container according to claim 2, which has a protrusion for pushing the liquid absorption of the blood collection tool into the blood collection body, and stores the development liquid to be brought into contact with the liquid absorption. .

  Further, the above object can be achieved by a body fluid immediate examination / diagnosis device comprising the blood collecting device according to claim 1 and the developing fluid container according to claim 2 according to claim 3.

  Furthermore, the object is stored in the developing solution container by absorbing the body fluid or the like by inserting the tip of the blood collecting device main body of the blood collecting device according to claim 4 into the developing solution container. It is also achieved by the bodily fluid immediate examination / diagnosis device according to claim 3, wherein the developing fluid is brought into contact with and the sucked liquid is pushed into the main body of the blood collection tool by the protrusion of the developing solution container.

  According to the bodily fluid immediate examination / diagnosis device according to the present invention, a trace amount of blood can be accurately collected by the design that holds the sucked liquid at the tip of the blood collecting tool.

  Furthermore, according to the bodily fluid immediate test / diagnosis device according to the present invention, the HIV test can be easily performed using a fixed amount of test liquid by a design in which the liquid suction is pushed into the main body of the blood collection tool by the protrusion of the developing liquid container. It can be performed.

  Furthermore, according to the body fluid immediate test / diagnosis device according to the present invention, the test result can be visually confirmed by the design of holding the external diagnostic agent-containing test paper in the inner tube of the transparent blood collection tool.

  FIG. 1 is a schematic diagram showing a partially broken structure of the body fluid immediate examination / diagnosis device. The body fluid immediate examination / diagnosis device includes a blood collection tool 1 and a developing solution container 8 (hereinafter referred to as “container”) that stores the developing solution 7.

  The blood collection tool 1 includes a cylindrical outer tube 3 having an opening on the bottom surface and an external diagnostic agent-containing test paper 4 containing an external diagnostic agent that reacts with a specific component in a subject (body fluid, plasma, serum, etc.). A filter-like liquid absorption liquid 5 for collecting a subject (body fluid, plasma, serum, etc.) is incorporated in the bottom opening 6 of the outer cylinder 3.

  The outer cylinder 3 and the inner cylinder 2 are formed of a synthetic resin material such as plastic. In a preferred embodiment of the present invention, the outer cylinder 3 has an outer diameter of 25 mm, a height of about 50 mm, and the inner cylinder 2 has an outer diameter of 18 mm × height of about 30 mm. The outer cylinder 3 is formed with hemispherical locking portions 9a and 9b that are recessed inward on the left and right sides of the outer shape, and the container 8 is a hemispherical locking that protrudes outward on the inner left and right wall surfaces. The portions 10a and 10b are formed. When the engaging portions are engaged with each other, the outer tube 3 and the container 8 are prevented from being detached when the liquid absorption 5 is pushed into the blood collection device main body by the protrusion 11.

  The container 8 is provided with a cylindrical protrusion 11 at the center of the inner bottom surface, and when the blood collection tool 1 is inserted into the container 8, the protrusion 11 absorbs into a sealed space defined by the inner cylinder 2 and the outer cylinder 3. The liquid 5 is pushed in and the subject is developed inside the blood collection tool.

  In a preferred embodiment of the present invention, the above external diagnostic agent includes “Dynascreen HIV-1 / 2” anti-HIV-1 and anti-HIV-2 antibody detection reagents (hereinafter referred to as “HIV-1”) manufactured by Abbott, USA. / 2 detection sheet "). When 50 μl (microliter) of an analyte (plasma, serum, etc.) is dropped onto the HIV-1 / 2 detection sheet and left for a predetermined time, the reagent and blood components react. It is a reagent for simple and rapid antibody detection that displays the determination result with a red line.

  FIG. 2 is a schematic diagram showing a partially broken front view of the blood collection device 1 according to the embodiment of the present invention. The skin is punctured with a dedicated capillary (not shown), and the liquid-absorbing liquid 5 incorporated in the tip opening 6 of the blood collection tool 1 is brought into contact with a very small amount of blood that has come out from the fingertip or the like, and quantitatively collected. The blood collection tool according to the present invention can accurately collect a small amount of blood by the design that holds the liquid absorption 5 at the tip.

  FIGS. 3-6 is the schematic which partially fractures and shows the front shape of the bodily fluid immediate test | inspection / diagnostic device in embodiment of this invention.

  As shown in FIG. 3, the blood collection tool 1 is inserted in the long axis direction into the container 8 in which the developing solution 7 is stored. The inner bottom cylindrical projection 11 of the container 8 is in contact with the liquid absorption 5 sucking blood, and pushes the liquid absorption 5 into the sealed space defined by the inner cylinder 2 and the outer cylinder 3.

  Next, as shown in FIG. 4, the sucked liquid 5 is pushed into the outer cylinder 3 so as to be in close contact with the bottom surface of the inner cylinder 2.

  Subsequently, as shown in FIG. 5, the liquid absorbing liquid 5 slides on the inner peripheral wall of the outer cylinder 3 via the contractility and the pressure of the protrusion 11, and then the developing liquid 7 in the container 8 is transferred to the liquid absorbing liquid 5. And is pushed out into a sealed space defined by the inner cylinder 2 and the outer cylinder 3. According to the bodily fluid immediate inspection / diagnosis device according to the present invention, the HIV absorption test can be easily performed using a fixed amount of test liquid by a design in which the liquid absorption is pushed into the body of the blood collection tool by the protrusion of the developing liquid container. It can be carried out.

  Subsequently, as shown in FIG. 6, after the blood sucking liquid 5 and the developing liquid 7 are provided in the sealed space defined by the inner cylinder 2 and the outer cylinder 3, the blood collection tool 1 is held in the hand. Stir in the left-right direction as indicated by the arrows. The blood and the developing solution 7 contained in the liquid absorbing liquid 5 are mixed in the sealed space by stirring.

  FIG. 7 is a schematic diagram showing a partially broken front view of the mixed solution 12 and the external diagnostic agent-containing test paper 4 in contact with each other. In a sealed space defined by the inner tube 2 and the outer tube 3 of the blood collection tool, a specific component of blood in the mixed solution 12 reacts with the external diagnostic agent and penetrates into the external diagnostic agent-containing test paper 4. After standing for a predetermined time, the determination result is displayed as a line on the external diagnostic agent-containing test paper 4.

FIG. 8 is a schematic diagram showing the front shape in a state in which the determination result is displayed on the external diagnostic agent-containing test paper, partially broken. In the case of positive (infection) judgment, a line is displayed on the test paper. If no line is displayed, it means a negative (non-infected) determination.
In addition, the bodily fluid immediate test / diagnosis device according to the present invention can visually check the test result from the appearance of the blood collecting tool by the design of holding the external diagnostic agent-containing test paper in the transparent inner tube of the blood collecting tool.

For the diagnosis of HIV infection, a screening test using a simple rapid antibody test kit that can obtain results in 15 minutes using an immunochromatographic method has been developed, and it can be tested on the same day at general health centers and private clinics.
However, with the increase in the number of examinees, the maintenance of personnel and facilities is still insufficient. According to the bodily fluid immediate test / diagnosis device according to the present invention, the convenience and accuracy of the test are enhanced, the increase of the spontaneous test is promoted, and the possibility of contributing to the early detection of an infected person is high.

In the Example of this invention, it is the schematic which shows the structure of a bodily fluid immediate test | inspection / diagnostic device partly fractured | ruptured. It is the schematic which partially fractures and shows the front shape of the blood collection tool in embodiment of this invention. 1 is a schematic view showing a partially broken front shape of a body fluid immediate examination / diagnosis device according to an embodiment of the present invention. 1 is a schematic view showing a partially broken front shape of a body fluid immediate examination / diagnosis device according to an embodiment of the present invention. 1 is a schematic view showing a partially broken front shape of a body fluid immediate examination / diagnosis device according to an embodiment of the present invention. 1 is a schematic view showing a partially broken front shape of a body fluid immediate examination / diagnosis device according to an embodiment of the present invention. It is the schematic which partially fractures | ruptures and shows the front shape of the state which the mixed solution and the external diagnostic agent containing test paper contacted. It is the schematic which partially fractures and shows the front shape of the state which displayed the determination result on the external diagnostic agent containing test paper. It is the schematic of the conventional HIV immediate test kit. (A) is the schematic which shows a stick and a lancet. (B) is the schematic which shows the state which inserts a stick in a lancet and pushes and fixes a needle | hook to a connection part. (C) is the schematic which shows the state which pulls out a stick from a lancet. (D) is the schematic which shows the state which applies a lancet to a fingertip and pushes a button and punctures a fingertip. (E) is a schematic diagram showing a state in which a small amount of blood collected with a dropper is properly placed in a recess of a test plate. (F) is a figure which shows the state which dripping predetermined amount of test | inspection liquid to the recessed part of a test | inspection plate. (G) is the schematic which shows the state which displayed negative (non-infectious) determination with the inspection window with one line. (H) is the schematic which shows the state which displayed the positive (infection) determination by the two lines on the test | inspection window.

Explanation of symbols

1 ... Blood collection tool 2 ... Inner tube 3 ... Outer tube 4 ... Test paper containing external diagnostic agent 5 ... Absorbing liquid 6 ... Tip 7 ... Developing solution 8 ... Container (Developing solution)
9a ... Locking part 9b ... Locking part 10a ... Locking part 10b ... Locking part 11 ... Projection 12 ... Mixing solution 13 ... Determination result 14 .... Stick 14a ... Tip 15 ... Lancet 15a ... Needle 15b ... Button 15c ... Connection 16 ... Dropper 17 ... Inspection plate 17a ...・ Concavity 17b ... Inspection window 18 ... Inspection liquid 19 ... Determination result

Claims (4)

    A blood collecting tool comprising: a transparent blood collecting tool main body; an external diagnostic agent-containing test paper disposed inside the blood collecting tool main body; and a liquid-absorbing liquid attached to the tip of the blood collecting tool.   A developing solution container that has a protrusion for pushing the liquid absorption of the blood collection tool into the blood collection device main body, and stores the development liquid to be brought into contact with the liquid absorption.   A bodily fluid immediate examination / diagnosis device comprising the blood collecting device according to claim 1 and the developing fluid container according to claim 2.   By inserting the tip of the blood collection device main body of the blood collection device into the developing solution container, the developing solution stored in the developing solution container is brought into contact with the liquid absorbing the body fluid or the like, and the protrusion of the developing solution container 4. The bodily fluid immediate examination / diagnosis device according to claim 3, wherein the sucked liquid is pushed into the blood collection device main body.

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