JPH03244439A - Clinical inspection device - Google Patents

Abstract

PURPOSE:To obtain instantly the inspection result with high reliability by forming a clinical inspection apparatus concerned from a suction/exhaust tool for specimen solution having an inlet/outlet and a penetrative inspection tube in which a cylindrical solid reagent layer is fixed to the inner wall being capable of coupling with the mentioned inlet/outlet. CONSTITUTION:A clinical inspection apparatus concerned is equipped with a suction/ exhaust tool 1 for specimen solution having an inlet/outlet 1a and a tube for inspection with hole penetrativeness capable of coupling with the mentioned inlet/outlet 1a as desired, wherein the suction/exhaust tool 1 assumes the form of an injector for medical use and is composed of a cylinder 1b having inlet/outlet 1a and a piston 1c interiorly fitted therein with possibility of sliding. The inspection tube 2 is made of glass or plastics, to whose inner wall 2a a cylindrical solid reagent layer 2c in which a specimen solution accommodating hole 2b is provided penetratively is affixed, that is accomplished by fixing the reagent using a water soluble solidifying substance, for example, glue-like substance such as gelatine, semi-dried agar, polybinylalcohol. The tip mouth 2e of the tube 2 is intruded into the specimen solution, and the piston 1c of the suction/ exhaust tool 1 is pulled, and now the specimen solution can be introduced into the specimen solution accommodating hole 2b of the tube 2.

Description

Detailed Description of the Invention (Field of Industrial Application) The present invention is directed to the detection of specific substances (blood The present invention relates to a clinical test device suitable for use in quantifying glucose, urea nitrogen, uric acid, clematinin, etc.

(Conventional/Previous technology) As is known, clinical tests that are essential for disease diagnosis involve collecting blood collected by doctors and others at a clinical testing center established during the reform, and then testing each patient there. Usually, this is done according to the request.

For this reason, not only are the number of requests to the above testing centers increasing, but also the number of emergency tests that require results in a shorter time is also increasing. It is only natural from a patient's point of view that they are concerned about the danger, and it should be natural for them to request an emergency test.

Therefore, it is desirable for the test to be performed at the doctor's consultation and the results to be immediately issued.If this is to be achieved, testing equipment and devices must be miniaturized, and the test results must be made smaller. The following conditions must be met: operation is not complicated and inspection can be carried out regardless of location.

By the way, most current clinical tests involve causing a chemical reaction to a specific substance that is present in a sample liquid, such as in the human body. The target substance is quantified by causing a color reaction in a colorless and transparent liquid, and by electrically extracting changes in the concentration of the substance due to the progress of the chemical reaction.

- Among the testing methods listed in F, the former is widely used; in this method, a sample solution, which is a specimen, is subjected to a color reaction with a substrate that reacts only with the target substance therein; At this time, the density is measured using a spectrophotometer, etc.
At this time, the target substance is quantified by utilizing the fact that the absorbance changes depending on the shade of color.

That is, if we now specifically describe the measurement of blood sugar levels, the target substance in this case is glucose;
The sample solution to be tested is serum obtained from blood collected from the subject by means such as centrifugation. Due to the enzymatic action of 3.4), D-
Glucono-δ-lactone and hydrogen peroxide (H2O2) are generated, and the generated hydrogen peroxide is combined with O(ortho)-dianisidine and peroxidase (E,
C.1.

Due to the action of 11.1.1), O-dianisidine is oxidized and develops color.

The degree of color development is measured as absorbance at a wavelength of 460 mm, and glucose is quantified using a calibration curve created using a known amount of glucose.

This reaction is shown below.

Glucose oxidase Glucose◆02 D-Glucono-δ-1actone + H2O
2Peroxidase Hz02+AHz 2HzO
+A (^H2: o-dianisidine) When the above glucose quantification is performed in a solution, glucose oxidase, O-dianisidine,
Peroxidase is added in advance, and glucose is added last; if the glucose is added, the above reaction will not proceed at all.

In the reaction shown above using glucose as an example, a solution reaction method based on a homogeneous reaction in a dilute aqueous solution and transmission photometry is called wet chemistry.
Here, transmission photometry is a method in which light of a certain wavelength is applied to a solution showing a color reaction, and the degree of absorption of light removed is measured. It is a simple optical measurement technology, and the operation of the device itself is not very complicated, but as the name wet chemistry suggests, it is complicated because it requires handling solutions.

Therefore, in addition to the above method, an analysis member is prepared in which the reagent necessary for the detection reaction with the target substance is incorporated into a filter paper or plastic film, and a sample solution such as serum is attached to it. It is also known to quantify the amount of dye produced by reflection photometry, and this method is called dry chemistry in contrast to the above-mentioned wet chemistry.

According to the above dry chemistry, although the troublesomeness of handling solutions is eliminated, reflected light must be measured.
The measuring instrument must be equipped with an integrating sphere, but since the integrating sphere is not a perfect sphere, it is not possible to measure the amount of all reflected light, which may cause problems with the accuracy of the test results.

Furthermore, even if the above-mentioned method is adopted, in the case of testing using serum, the serum components must be separated first, and for this purpose, centrifugation is generally used. However, equipment for this purpose is required, and its operation is troublesome and takes a considerable amount of time.Therefore, there are some devices that cannot respond to urgent requests or are susceptible to changes after blood collection. Considering this, the conventional methods are not satisfactory in terms of the separation operation prior to inspection.

(Problem to be Solved by the Invention) In view of the problems of the above-mentioned prior art, the present application is based on claim (1).
In this case, by inhaling the sample solution with a suction/draining device such as a syringe, pump, or dropper, the solution can be immediately stored in the translucent test tube, and the sample solution can be immediately stored in the translucent test tube. The cylindrical solid reagent layer formed in advance is dissolved in the sample solution, and the color reaction that occurs at this time can be used to quantify the target substance by using the translucent test tube itself. The purpose of this is to allow doctors and others who draw blood to quickly and accurately obtain test results on the spot.

In claim (2), the translucent test tube according to claim (1) is formed of a rectangular tube, and when a color reaction is detected by exposing it to light with a -degree wavelength, The light beam and the light-receiving surface of the translucent test tube that receives the light beam are made to be likely to be perpendicular to each other, thereby preventing measurement errors as much as possible.

According to claim (3), the suction/drainage tool according to claim (1) is equipped with a syringe needle, so that a sample solution collected from a human body or the like can be directly and quickly transferred to the translucent test tube, and the We are trying to improve the reliability of test results by making it possible to generate a color reaction almost simultaneously with collection.

In claim (4), by providing not only the suction/exhaust tool and the translucent inspection tube but also the suction/exhaust pipe with a switching valve, the switching valve of the suction/exhaust pipe with the switching valve can be operated. , the sample solution stored in the suction/drainage tool can be supplied to the translucent test tube by the ejection operation of the suction/drainage tool, thereby further improving the operability and speed of the test.

In claim (5), the suction and evacuation tool and the translucent test tube are provided as described above, but the latter, the translucent test tube, includes not only the above-mentioned cylindrical solid reagent layer, By providing a filter layer adjacent to this, blood to be used as a sample solution is collected from the human body, and the blood is filtered through the filter layer immediately before being sent to the cylindrical solid reagent layer. This allows only blood samples from which other components have been separated to be used as a sample solution, eliminating the need for troublesome separation operations before the original test, and providing highly reliable blood samples even if there are substances that change easily after blood collection. The purpose is to obtain test results.

In claim (6), the filter layer in claim (5) is not formed as a single layer, but the components to be removed can be removed in order from those having the largest particle size. By stacking the required number of filters with different pore diameters, clogging of the filter layers can be avoided and blood components can be separated sufficiently even during long-term use.

(Means for solving the problem) The present application attempts to achieve the above object, and claims (
1) consists of a sample solution suction/discharge device with an inlet/outlet, and a translucent test tube that can be freely connected to the inlet/outlet, and the reagent is immobilized on the inner wall of the test tube with a water-soluble immobilizing substance. , attempts to provide a clinical test device characterized in that a cylindrical solid reagent layer is fixedly installed through a sample solution storage hole,
) is made of a square tube.

Claim (3) comprises a sample solution suction/discharge device having an inlet/outlet, and a syringe needle and a translucent testing tube, respectively, which can be freely connected to the inlet/outlet, and the inner wall of the translucent testing tube includes: The present invention aims to provide a clinical test device characterized in that a cylindrical solid reagent layer is fixed with a reagent immobilized by a water-soluble immobilization substance and penetrated through a sample solution accommodation hole, and furthermore, claim (4) ), a sample solution suction/drainage device with an inlet/outlet, a suction/drainage pipe with a switching valve that is connected to the inlet/outlet and can freely connect a syringe needle to the tip, and a suction/drainage pipe with a switching valve that protrudes from the switching valve. It consists of a translucent test tube that can be freely connected to the provided switching path, and a reagent is immobilized on the inner wall of the translucent test tube with a water-soluble immobilizing substance, and the sample solution containing hole is passed through the tube. The content is that a cylindrical solid reagent layer is fixedly provided.

Furthermore, the clinical test device of claim (5) comprises a sample solution suction/drainage tool having an inlet/outlet, and a translucent test tube that can be freely connected to the inlet/outlet; A cylindrical solid reagent layer is fixed on the inner wall of the cylindrical solid reagent layer in which the reagent is immobilized with a water-soluble immobilizing substance and penetrated through the sample solution accommodation hole, and the cylindrical solid reagent layer is placed adjacent to the cylindrical solid reagent layer. The feature is that the filter layer for removing desired components from the sample solution is provided, and in claim (8), the filter layer for removing desired components from the sample solution in claim (5) is , the content is that it is formed by stacking filters of different pore sizes, which remove particles of different pore size in order of size from among the desired components.

(Function) When using the clinical test device of claim (1), a translucent test tube is connected to the entrance and exit port of the suction/drainage tool, and the sample solution is introduced into the test tube by the suction operation of the suction/drainage tool. Then, the sample solution dissolves the glue-like substance in the cylindrical solid sample layer, and the reagent and target substance in the sample solution react with each other.

By setting the tube for translucency test in which a color reaction has occurred in this way into a spectrophotometer, etc., it is possible to measure the color density due to the color development, and also to test the translucency of the suction and evacuation tool. If the test tube is not removed from the test tube, the sample solution will not inadvertently leak out from the test tube even if the diameter of the test tube is large.

In claim (2), the translucency test tube is formed of a rectangular tube and therefore has a flat light-receiving surface. Since the irradiated light is not scattered on the light-receiving surface, measurement errors are less likely to occur and desirable results can be obtained.

In claim (3), by connecting a syringe needle to the entrance/exit of the suction/exhaust tool, a sample solution directly collected from a human body can be immediately transferred to a translucent test tube.

When using a clinical test device according to claim 0, when attempting to inhale a sample solution from a human body or other source into the suction/exhaust pipe, the switching valve of the suction/exhaust pipe with a switching valve should be kept in the open state of the main flow path, and the inhalation should be completed. For example, by switching the switching valve to the open state of the switching path, the suction/draining tool may be discharged, and the sample solution thus flows through the switching path into the cylindrical solid reagent layer of the translucent test tube. The sample solution is introduced into the sample solution accommodation hole in the sample solution storage hole, and the test can be performed by the same operation as in claim (1).

In the clinical test device according to claim (5), by connecting the inlet/outlet of the suction/drainage tool to the connection port of the translucent test tube and performing a predetermined suction/drainage operation, the sample solution can be subjected to the above-mentioned translucent test. However, at this time, the sample solution must first pass through the filter layer, so after the components to be removed are filtered out, the remaining components of the sample solution pass through the cylindrical solid sample layer. Here, a color reaction occurs between the reagent and the target substance, and separation and testing of blood components and the like are performed through a series of operations.

In claim (6), since the filter layer of claim (5) is formed by stacking filters with different pore sizes, components with larger particle sizes are removed in sequence, and therefore, the components to be removed are removed at once. Compared to a method that removes all removed components, the filter layer is not clogged.

(Embodiments) The present invention will be described in detail with reference to illustrated embodiments.
), as shown in Figure 1(d), there is a sample solution suction/drainage tool with an inlet/outlet 1a! and a permeability testing tube 2 that can be freely connected to the entrance/exit 1a.

Here, the illustrated suction/discharge tool 1 is syringe-like, and is composed of a cylinder 1b having an inlet/outlet 1a, and a piston 1c slidably fitted into the cylinder 1b. There is no limitation, and for example, a pump dropper can also be used.

Next, the translucent test tube 2 is preferably made of glass or plastic, and in this case, as shown in FIG.
Although it is preferable to use a rectangular tube as shown in (Claim (2)), it is also possible to use a circular tube as shown in FIG.

In the present invention, the inner wall 2a of the translucent test tube 2 is
On the other hand, a cylindrical solid reagent layer 2c is attached which penetrates the sample solution storage hole 2b. It is immobilized by an immobilizing substance, and in the illustrated embodiment, the sample solution accommodation hole 2b, which is a cavity, is formed at its axis, and the sample solution can be introduced into the accommodation hole 2b as described below. It has become.

According to claim (1), a translucent inspection tube 2 is connected to the entrance/exit 1a of the suction/exhaust tool 1 as shown in FIG. 1(d). It is preferable to form a fitting opening 2d for connection using a backing (not shown) or the like at one end of the translucent inspection tube 2 so that the entrance/exit 1a can be fitted therein.

Incidentally, the above-mentioned cylindrical solid reagent layer 2C can be formed as follows.

That is, if the target specific substance is glucose, gelatin is made into a liquid by heating it to 70°C, and the reagent Glucoseoxidas is added to it.
E, peroxidase, and 0-dianisidine are mixed, and the mixed solution is placed in a translucent tube,
With a rod inserted through the center, it is poured into the same tube as above, and after solidifying by lowering the temperature to about 30° C., the rod is pulled out and passed through the sample solution accommodation hole 2b.

Therefore, in the state shown in FIG. 1(d), if the tip end 2e of the translucent test tube 2 is immersed into the sample solution and the piston IC of the suction/drainage tool 1 is pulled in the direction of arrow A, the sample solution can be removed. It can be introduced into the sample solution accommodation hole 2b of the translucent test tube 2.

When the sample solution comes into contact with the cylindrical solid reagent layer 2c in this way, the reagent layer 2C solidified with gelatin or the like is dissolved and mixed with the sample solution, and the reagent becomes the target in the sample solution. Since a color reaction occurs with the substance in the translucent test tube 2, the target substance can be quantified by setting this in a spectrophotometer or the like.

At this time, if you do not disconnect the suction/drainage tool and the translucent test tube 2, even if the diameter of the tube 2 is large, the sample solution, etc. will not leak out unintentionally. However, of course, if this translucent test tube 2 can be formed to have a small diameter, there will be no leakage of the sample solution even if the above two are disconnected.
It is best to keep it below about 1.

Here, if the translucent test tube 2 is formed of a rectangular tube as in claim (2), light of a predetermined wavelength can be transmitted to the translucent test tube 2 in a spectrophotometer or the like. When irradiated with a circular tube as shown in FIG. Since the light is perpendicularly incident on the light-receiving surface 2f and enters the sample solution that exhibits a color reaction, highly accurate measurement results can be obtained.

Next, in FIG. 1(a) (Claim (3)), not only the suction/discharge tool l and the translucent inspection tube 2 but also a syringe needle that can be freely connected to the entrance/exit port 1a of the suction/discharge tool l are provided. Therefore, in this case, after collecting a sample solution from a human body by using it as a so-called syringe, the injection needle 3 is removed and a translucent test tube 2 is inserted into the entrance/exit 1a of the suction/drainage tool 1.
By connecting the pistons 1c and pushing the piston 1c in this state, the collected sample solution in the cylinder 1b can be supplied into the translucent test tube 2.

Furthermore, regarding the clinical test device according to claim 0, this will be explained with reference to FIG. However, it also has a suction/exhaust pipe 4 with a switching valve connected integrally or separately to the inlet/outlet 1a, and the suction/exhaust pipe 4 has a suction/exhaust pipe 4 that protrudes from the open state of the main channel 4a. A switching valve 4C that can be freely switched to the switching path 4b is provided, and a syringe needle 3 can be freely connected to the tip port 4d of the suction/discharge pipe 4 with the switching valve. A translucent inspection tube 2 can be freely connected to the path 4b.

Therefore, in the state shown in FIG. 2, if suction operation is performed using the suction/discharge tool 1, the sample solution will be transferred from the human body or other parts through the injection needle 3, the suction/discharge pipe 4 with a switching valve, the switching valve 4C, and the inlet/outlet port 1a to the cylinder 1b. Next, when the switching valve 4C is switched and the suction/drainage tool 1 is discharged, the sample solution is transferred to the light-transmitting pipe connected to this via the inlet/outlet 1a-switching path 4b. It enters into the sex test tube 2, and a clinical test can be quickly performed as described above.

The translucent test tube 2 shown in FIG. 3 has the following differences from the tube shown in FIG. 1(b), as follows:
It is used as a component of a clinical testing device according to claim (5).

This clinical test device also has an aspirating and discharging tool 1 and a translucent test tube 2 as essential components, but the latter component is located on its inner wall 2a as in the previous one, and is used to hold reagents in water-soluble form. Immobilized with an immobilizing substance, the sample solution accommodation hole 2b
Not only is the cylindrical solid reagent layer 2C fixed therethrough, but also a filter layer 5 is installed next to the cylindrical solid reagent layer 2C, and the filter layer 5 removes desired components from the sample solution. It fulfills the role of

The filter layer 5 can be made of cellulose acetate, polypropylene, etc. In the embodiment shown in FIG.
a, 5b, 5c, and 5d are fitted in a stacked state, and an annular packing 6 is fitted inside the right end side of the cylindrical solid reagent layer 2C, and an inlet/outlet 1a of the suction/discharge tool l is inserted into this. They are configured to be removably connected.

The different pore size filters 5a, 5b, 5c, and 5d are arranged so that filters with smaller pore sizes are arranged in order, so that, for example, white blood cells (particle size 10 to 20 IL layer) are first removed from the blood components. , then red blood cells (particle size 7-1
0IL■) and platelets (particle size 1 to 5 pm) are removed through different pore size filters, and finally the clotting factors are removed from the blood clot by passing through a different pore size filter 5d with a pore size smaller than the minimum particle size of platelets. By doing this, you will be able to obtain a sample solution as serum with the
Suddenly, the sample solution in which the blood components have been sufficiently separated without clogging caused by passing through the following filter is transferred to the cylindrical solid reagent layer 2C.
The sample solution will flow into the sample solution accommodation hole 2b.

Figure 4 shows the entrance and exit port 1 of the suction/discharge tool l for the case shown in Figure 3.
The difference is that the connectable annular packing 6 is placed adjacent to the filter layer 5 instead of the cylindrical solid reagent layer 2c. The collected blood, etc. is introduced into the cylindrical solid reagent layer 2c from the annular gasket 6 side through the filter layer 5, so that only plasma is contained in the cylindrical solid reagent layer 2c necessary for the detection reaction. Reacts with reagents.

(Effect of the invention) Since the present invention is configured as described above,
When using the clinical test device according to claim (1), the sample solution can be supplied to the cylindrical solid reagent layer in the translucent test tube by simple operation of the suction/discharge tool, and the color development in the test tube can be performed. By directly setting the reaction on a spectrophotometer, test results can be obtained immediately, making use of the advantages of both wet chemistry and dry chemistry.
Easy and highly reliable test results can be obtained.

In claim (2), the translucency test tube is formed of a rectangular tube and has a flat light-receiving surface, so that the problem of measurement errors due to diffused reflection can be solved.

In claim (3), since a syringe needle is also added as a component, a sample solution collected from a human body etc. can be reacted with an instant reagent simply and quickly, and a test with higher reliability can be performed in a short time. It can be completed in time.

According to claim (4), by installing a suction/drainage pipe with a switching valve, operations from collecting a sample solution to supplying the same solution into the translucent test tube can be performed simply by operating the switching valve. , can be performed without operations such as removing and connecting members, and a simpler and faster inspection can be performed with high reliability.

In the case of claim (5), the light-transmitting test tube not only has a cylindrical solid reagent layer but also a filter layer, so that blood, etc. as a sample solution is treated in a whole blood state. Pretreatment for testing, which involves removing and separating blood components, can be carried out in a short time by simply collecting the blood. After blood collection, highly reliable test results can be obtained even if there are substances that are susceptible to change.

In claim (6), the filter layer in claim (5) is not composed of a single layer, but is composed of filters with different pore sizes stacked in order of particle size, so that clogging occurs due to the removed components. It is possible to eliminate deficiencies such as the inability to fulfill the role immediately.

[Brief explanation of drawings]

1(a), (b), (c), and (d) are a front view of the clinical test device according to the present invention in which the suction/discharge tool and the syringe needle are directly connected, a perspective view of the translucent test tube, and a perspective view of the test tube. An end view showing other embodiments of the tube and a front view showing the connected state of the suction/exhaust tool and the translucent test tube (Claims (1), (2), and (3)
) ), Fig. 2 is a front view showing the connected state of each member of the clinical testing device according to claim (4), and Fig. 3 (a) and (b) are transparent views of the clinical testing device according to claim (5). FIG. 4 is a perspective view and a longitudinal front view showing a sex test tube, respectively, and FIG. 4 is a longitudinal front view showing a different example of the translucent test tube. 1... Suction/exhaust tool 1a... Entrance/exit 2... Translucent inspection tube 2a... Inner wall 2b... Sample solution accommodation hole 2c ...... Cylindrical solid reagent layer 3 ... Injection needle 4 ... Suction and discharge pipe with switching valve 4b ... Switching path 4c ... Switching Valve 4d... Tip port 5... Filter layer

Claims (6)

[Claims] (1) Consists of a sample solution suction/drainage tool with an inlet/outlet, and a translucent test tube that can be freely connected to the inlet/outlet.Reagents are immobilized on the inner wall of the test tube with a water-soluble immobilizing substance. 1. A clinical test device, characterized in that a cylindrical solid reagent layer is fixedly installed through a sample solution storage hole. (2) The clinical test device according to claim (1), wherein the translucent test tube is formed of a square tube. (3) Consists of a sample solution suction/discharge device with an inlet/outlet, a syringe needle and a translucent test tube that can be connected to the inlet/outlet, respectively. 1. A clinical test device, characterized in that a cylindrical solid reagent layer is fixed with a sex-immobilizing substance and penetrated through a sample solution storage hole. (4) A sample solution suction/drainage device with an inlet/outlet, a suction/drainage pipe with a switching valve connected to the inlet/outlet and with a syringe needle freely connectable to the tip port, and a suction/drainage pipe with a switching valve that protrudes from the switching valve of the suction/drainage pipe with the switching valve. It consists of a translucent test tube that can be freely connected to the switching path, and the inner wall of the translucent test tube
1. A clinical test device comprising a fixed cylindrical solid reagent layer in which a reagent is immobilized with a water-soluble immobilizing substance and penetrated through a sample solution storage hole. (5) Consists of a sample solution suction/drainage tool with an inlet/outlet, and a translucent test tube that can be freely connected to the inlet/outlet. A cylindrical solid reagent layer is immobilized with a chemical substance and penetrated through the sample solution accommodation hole, and a filter layer is provided next to the cylindrical solid reagent layer to remove desired components from the sample solution. A clinical testing device characterized by: (6) The filter layer for removing the desired component from the sample solution is formed by stacking different pore size filters that sequentially remove particles having larger particle sizes than the desired component. Clinical testing equipment.