JPS6026972B2 - analysis tools - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a novel analytical tool suitable for general chemical analysis, particularly biochemical analysis in clinical medicine.

In recent years, due to improved awareness of health management and the need for accurate diagnosis and quick treatment, the necessity of specimen testing in clinical testing has increased significantly.
Autoanalyzer) has been developed and is becoming widely used.

However, although this fully automatic method is very useful in terms of labor savings and rapid processing of large quantities of specimens, on the other hand, the capacity of the equipment is excessive for the number of specimens required. As the pupil size has become larger, it is no longer possible to adequately respond to the demands of examination rooms in small and medium-sized hospitals and large hospitals to process four or more tests for a large number of items in a short period of time. In addition, these large automated chemical analyzers have complicated mechanisms, and require time to warm up the equipment and prepare reagents in advance. In many cases, they are unable to undergo testing. In order to compensate for these shortcomings, simple analytical instruments called so-called mono-test simple colorimeter have recently become available for doctors' bedside tests. The procedure is based on a manual method, and not only is it relatively labor-intensive, but it also has the drawback that reliable results cannot be obtained in terms of accuracy unless the operator is skilled and has a certain level of analytical background. It can only serve as a semi-quantitative measurement for emergency analysis, and is not satisfactory for bedside testing.

In addition, the reagents are sealed in disposable plastic bags.
This can be used as a disposable cuvette if necessary, as described in Special Publication No. 46-25596 and Hakama-kosho 49-14.
It is known from the publication No. 8157.

However, since such a bag serves both as a reaction vessel and a measuring cuvette, the entire bag is made flexible in order to destroy the reagent compartment and allow the sample and reagent to mix. The bag is vibrated by placing a diaphragm between them and applying vibrations that change the distance between the diaphragms.
In addition, in order to use the bag as a cuvette and to optically measure the reactants after the reaction is complete, a special plastic material that is highly transparent not only in the visible but also in the ultraviolet region is used. what you need to do,
There are various problems such as the necessity of strict optical and morphological quality control during bag manufacturing and various auxiliary devices to accurately maintain the distance between the opposing transparent walls of the reaction container during measurement. However, the equipment and bags are inevitably expensive. Moreover, since the bag itself is necessarily flexible, it is difficult for the bag to maintain a perfectly flat surface, and it is easily warped. Problems such as getting stuck in the equipment and getting jammed often occur. The purpose of the present invention is to solve the drawbacks of such existing devices and systems, to form a simple and inexpensive reagent addition means and a chemical analysis system using the same, and to improve the technical knowledge of chemical analysis, especially clinical testing. The object of the present invention is to provide a means for obtaining analysis accuracy comparable to that of a professional engineer or an automatic chemical analyzer while being simple and easy to operate by a person without knowledge.

As a result of research and consideration on various methods and means for such purposes, the present inventors have developed a reagent pack that has the functions of dividing and storing analytical reagents and adding reagents as a means of adding reagents used for analysis. After creating a new analytical tool consisting of a mechanically coupled glass or transparent resin container that can be measured with an ordinary colorimeter or spectrophotometer, and conducting various studies and tests on it, the present invention was completed. Ta.

That is, the present invention provides a pack formed from a flexible or easily deformable film or sheet on at least one side and an adhesive film, sheet or plastic plate on the other side, A reagent pack having one or more reagent enclosures, a passage for guiding reagents in the enclosure to the reaction vessel, a closing part that closes due to external pressure to the enclosure, and a three-chamber reaction vessel suspension section, and the reaction vessel suspension section. The present invention relates to an analysis tool comprising a reaction vessel connected to a reaction vessel capable of being measured by optical means.

In the present invention, the material for the film or sheet forming the reagent pack must be moldable to form an empty chest for forming a reagent enclosure, a passage for reagent outflow, etc. by a vacuum forming method, a molding method, etc. A film or sheet having flexibility or flexibility to the extent that it can be relatively easily deformed by applying mechanical pressure to the reagent enclosing part from the outside, and an empty arm for forming a nuclear reagent enclosing part. The reagent enclosing part of the present invention can be formed by using such a film or sheet on one or both surfaces forming the part.

However, for the other surfaces, a film, sheet, or plastic plate other than the film or sheet on the upper surface may be used. In this case, such films, sheets or plastic plates are preferably relatively hard. In addition, as long as the surface that comes into contact with the reagent is a water-resistant and chemical-resistant film, plastic sheet, or plastic plate, the outside may be laminated with metal, paper, or cloth. In addition to the above-mentioned formability, the flexible or easily deformable film or sheet forming at least one surface of the present invention can be heat-sealed with the film, sheet, or plastic plate forming the other surface. It is preferable that the surface that comes into contact with the reagent has excellent chemical resistance in order to preserve the reagent in a sealed container for a long period of time.

Examples of the material for the film or sheet used in the present invention include polyethylene, polypropylene, polypynyl chloride, polyester, polyamide, etc. When using a polyester or polyamide film, an unstretched film is easy to form. It is preferable in this respect.
When using a composite film or sheet made by combining these materials, the surface that will come into contact with the reagent should be made of polyethylene or polyethylene, which has excellent chemical resistance. Preferably, pyrene is used. Particularly preferred materials for forming the pack of the present invention include a composite film of polyethylene and polyvinyl chloride, a composite film of a polyethylene film and an unstretched film of polyester (for example, polyethylene terephthalate), and a composite film of a polyethylene film and a polyester film (stretched film). Examples include composite films with In particular, in the present invention, it is preferable that the hollow part forming the reagent sealing part take a blister shape as shown in 4, 4' and 5 in FIG. 1 from the viewpoint of completely releasing the reagent in the sealing part. In this case, the thickness of the polyethylene layer of the composite film is 10 to 100r, preferably <
The thickness of the polyvinyl chloride layer or polyester layer is 50 mm, 300 mm, preferably 1
It is preferable that there is no 00, and it is 250 Buddha.

In addition, when forming a blister-shaped reagent pack, it is preferable to use a composite film of polyethylene and polyester for the film or sheet that forms the other surface that does not have a cavity that forms the reagent enclosing part. ,
It is particularly preferred that the thickness of the polyethylene layer is from 20 to 100 mm, preferably from 30 to 70 mm, and the thickness of the polyester layer is from 10 mm to 50 mm, preferably from 10 to 30 mm. In the reagent pack of the present invention, the reagent enclosure (for example, 4 and 5 in FIG. 1, FIG. 2, FIG. 3, and FIG. 10) is used during the period from the manufacture of the reagent pack until it is used in actual analysis. It serves as a container to preserve or store reagents without altering or denaturing them, so it is preferable to use water-resistant and chemical-resistant materials for the inner surface of the pack, that is, the surface that comes into contact with the reagents. Examples of materials suitable for this purpose include polyethylene and polypropylene. The shape of the reagent enclosing part is not particularly limited, and may be, for example, a shape as shown in FIGS. 1 and 10, a bag shape as shown in FIG. 14, or a hemispherical shape. Although it may be cup-shaped, it is preferable that the reagent pack has a shape that does not have sharp edges or edges, especially in the lower part, so that the reagent solution does not become droplets and remain in the same area. The purpose of this reagent pack is to store reagents quantitatively and separately, and to add almost all the reagents in each enclosure to the reaction container independently and without fail during analysis.
Although there are two or more reagents in each pack, one of the reagents may be pre-sealed in the reagent-sealing portion of the pack, and the other reagent may be pre-sealed in the reaction container attached to the reagent pack.

In this case, the number of reagent enclosures in the discussion drug pack may be one. In the reagent pack of the present invention, reagents necessary for a series of analysis operations are quantitatively sealed in the reagent enclosure in advance, but the reagents in the present invention do not necessarily include color formers, enzyme preparations, and reaction substrates. It is not limited to the above, and may also refer to a buffer solution, a solvent for dissolving a sample, a diluent such as water, etc., if necessary. Further, a sample injection section (for example, 4' in FIG. 1) may be provided in connection with one of the reagent enclosures (for example, 4 in FIG. 1). This is to help quantitative addition of the sample from outside.
The sample injection part (4' in Figure 1) is the reagent enclosure part (4' in Figure 1).
) is formed in such a way that the upper end of the cavity is elongated and has a shallow recess compared to the reagent sealing part, and as shown in Figure 15, it is cut once when adding the sample for analysis. (15th
The opening in the figure) can be closed, and then, after adding the sample, the closed part can be closed again by heat sealing (FIG. 15C). Alternatively, instead of heat-sealing the barrier, the lower part of the barrier 4' is mechanically sealed as shown by A and Gate in FIG. 4
) can be crushed by external pressure, thereby breaking the blockage 9 in its lower part, and introducing the sample and reagent from 4 into the reaction vessel 11 via the passages 6' and 6. In addition, the section 12 in FIGS. 1 and 10 has the primary purpose of easily cutting off a part of 4' by tearing it off by hand and closing the sample injection part 4'. The presence or absence of 12 can also be used as an indicator to indicate whether or not a sample has been added to the reagent pack of the present invention. For example, in an automatic analyzer equipped with the pack of the present invention, the presence or absence of the section can be detected using an optical detection device. The reagent pack for reagent blank measurement to which no sample is added can be detected, the blank value can be measured and recorded in a memory circuit, and can be used to calculate data from the sample analysis results. Typical reagent packs and analysis tools of the present invention include the first
As shown in the figure, a blister-shaped one is preferable because it allows the reagent to flow out most completely, but as shown in the cross-sectional view of Figure 14, the reagent pack is made by joining two sheets of flexible film to form the reagent enclosing part. You can also make it while forming it.

Further, if necessary, a gas such as air or an inert gas can be sealed in the reagent enclosure together with the reagent in a small amount or up to about the same volume as the reagent. By enclosing gas together with reagents in this way, during analysis operations,
The reagent enclosure can be externally compressed to allow the reagent to flow almost completely through the occlusion and into the reagent passageway. In the present invention, the passage for guiding the reagent in the reagent enclosure to the reaction column means the passage 6', the concentration passage 6, and the outlet 8 shown in FIGS. 1 and 10. For example, the passage shown in FIG. 4 or 5, respectively, through which the reagent is vigorously released by breaking through the closing part 9. In each part of this passage, the reagent is released more forcefully than the reagent containing part (for example, 4 or 5 in FIG. 1). The flow of well-released reagents is relaxed, preventing loss of reagents and samples in the reaction vessel 11 due to scattering or adhesion to the outer wall, and serves to prevent an increase in analysis errors.

This passage does not necessarily have the shape shown in FIGS.
′ and various other variations are possible. Next, the closing part in the reagent pack of the present invention is located in the middle of the passage (for example, 6' in FIG. 1) that fits into the reagent enclosing part, and each reagent in the reagent pack is enclosed in the reagent enclosing part, and is used for analysis. Until the reagent is released into the passage by applying external pressure to the reagent enclosure of the reagent pack and compressing it, the reagent will not leak under any handling conditions during transportation or storage, and will remain in the reagent enclosure during analysis. It has the function of opening the closed part only by applying external pressure and releasing the reagent in the sealed part into the passage, and the closed part has a strength smaller than the heat seal or adhesive strength of the pack in the reagent sealed part. Moreover, it must be able to tear open with appropriate breaking strength and allow the reagent in the enclosure to be easily removed.
It is desirable that the occluding strength of the occluding portion is between 0.3 and 45k9, preferably between 2 and 25k9.

As a means for imparting the above-mentioned appropriate occlusion strength to the occluding portion, m is applied to the inner surfaces of the two films or sheets (or plastic plates) that are in contact with the reagent, the front and back surfaces forming the pack of the present invention. , A method of sandwiching a film made of a material different from the above-mentioned pack forming material and heat-sealing the pack while laminated, and applying an appropriate adhesive to the '21 closed part, or further heat-sealing as necessary. [3] There is a method of changing heat sealing conditions such as sealing temperature, sealing pressure, and sealing time.

In the pack of the present invention, method '1'' of the above-mentioned means is adopted, that is, the pack is made of a material different from the material forming the surface of the reagent pack, and has a sealing strength to the extent that it can be broken by external pressure on the reagent enclosing part. It is desirable to have a blockage formed by a film, and in this case, the blockage has a thickness of 0.3
It is preferable to have a occluding strength of 2 to 25 kg, and more preferably a occluding strength of 2 to 25 kg.

The film made of a material different from the surface-forming material of the reagent pack is preferably polypropylene when the surface of the reagent pack and the inner surface of the rhomboid-forming film that contacts the reagent are made of polyethylene. Desired closing strength can be imparted by inserting this into the passageway portion of the pack and heat sealing the pack while sandwiching it. In this case, the closing strength is suitably controlled by the heat sealing temperature, sealing time, sealing compression force, and the thickness and thickness of the polypropylene film. For example, Fig. 18 shows a biaxially oriented polyester film with a thickness of 15 cm and a biaxially oriented polyester film with a thickness of 40 mm as the material for forming both sides of the pack.
Use a composite film with a polyethylene film of r thickness, the polyethylene side is the inner surface of the pack, and 2
When a polypropylene Nito stretched film with a thickness of 0 mm is sandwiched and heat sealed together with a pack, the closing strength of the occluded part was measured by the air pressure (k9/water) of the reagent sealing part when the occluded part was broken. It is displayed on the koji and the heating/cooling scale of the impulse sealer is displayed on the horizontal axis.Curve a is the case where the film itself of the pack body is heat-sealed at the closed part without using polypropylene film. Curve b uses a polypropylene film with a length of 8 ribs in the direction parallel to the passage and 5 ribs inside, and curve c uses a polypropylene film with a length of 8 ribs and 8 sides in the middle in the direction parallel to the passage. This shows the relationship between the sealing conditions and the closing strength when used. This allows you to select the sealing conditions so that the closing strength is considerably lower than that of the pack body when a polypropylene film is used to form the closure. . In the present invention, when the closing part is formed with a film made of a material different from the surface-forming material of the reagent pack, the film made of a different material sandwiched in the closing part is placed on the surface of the film of the pack body or on the inner side of the film on the surface. After point adhesion or temporary sealing, a reagent is dispensed into the empty chest of the surface film, and then the entire pack is sealed together with the film on both sides of the surface and hair, thereby forming an occluded part at the same time. In the reagent pack of the present invention, a hanging part 10 is formed by forming films or seals 2 and 3 like fins on both sides of the passage near the lower end of the passage leading the reagent to the reaction container. The lower end fin constitutes a hooking part 10' formed in the middle, and a first
As shown in FIG. 1 or FIG. 10, a reaction vessel with a tapered capital can be suspended. By doing so, the reagent pack of the present invention can be mechanically connected to the reaction container to form the analysis tool of the present invention. The side wall of the reaction container that can be measured by optical means used in the analysis tool of the present invention may be curved or flat, and a cylindrical container is usually used, but a square cylinder, an octagonal cylinder, etc. It may also be in the shape of a square tube such as a tube.

The container can also be used to separate and store a portion of the reagents if necessary, but usually it is used as a reaction container for mixing reaction reagents and samples, straining, heating, etc. After the reaction is completed, the container is m) Can be used to measure reaction results. If this reaction result is to be measured by optical means such as absorbance in the visible or ultraviolet region, a container made of glass or a highly transparent polymer (such as a polymer with good chemical resistance, such as polypropylene, polyethylene, or methylbentene polymer) should be used. can be used. In addition, a rope stirrer (11' in FIG. 1) such as a magnetic stirrer may be placed in the reaction vessel to facilitate mixing of reagents, etc. Further, the reagent pack of the present invention can be provided with a label as shown in FIG. 1 or 7 in FIG. This sign is 7 in Figures 1 and 10.
It may be an optically distinguishable label, such as a label, or a label made by magnetic or other means. Next, an example of the method for manufacturing the reagent pack of the present invention will be described.

First, when making a reagent pack into a blister shape, the cavity on the surface of the pack that encloses the reagent is formed by vacuum forming, molding, or a combination of the two using a flexible or easily deformable film or sheet. After molding and dispensing reagents into the empty arms of the film or sheet on the surface of the pack, the front and back sides are joined and heat set to complete the reagent pack. First, the films or sheets on both sides of the front and diamond sides are joined together, and after the back is completed, a reagent is injected into the cavity with a syringe, and if necessary, the needle hole is sealed with adhesive. The method can also produce reagent packs. Next, in order to explain the reagent pack and analysis tool of the present invention in more detail, Figures 1 to 10 are shown, but these are only preferred examples of the present invention, and the present invention applies only to such packs. It is not limited to this, and various modifications may be made. The bag 1 illustrated in FIG. 1 is made by joining two relatively thin film sheets 2 and 3. First, the front side sheet 2 is vacuum formed to form a cavity with a protrusion on the front side. , a reagent is sealed in the empty arm, and the back side sheet 3 is bonded to the surface excluding the cavity. In the example shown in FIG. 1, an empty chest 4 constitutes a reagent enclosure, and the enclosure 4 is fitted into a sample injection section 4'. The other cavities 5, 5, 5 are reagent enclosures, respectively, and the lower portions of these enclosures 4 and 5 each form a circuit 6' and are suitable for the central passage 6. A blockage 9 is formed in a part of this passage 6'.
The closed portion 9 opens the passage 6' when the reagent sealing portion 4 or 5 is compressed by external pressure, and the reagent is released. 6 is a concentration passage for the discharged sample and reagent, and the bottom part thereof is formed low in the center to form a funnel for guiding the sample and reagent to the reaction vessel;
The lotus is suitable for the outlet 8.

These passages 6', concentrated passages 6, and outlet 8 collectively form a passage referred to in the present invention, and each of these is composed of a top sheet 2 and a back sheet 3. Then, on both sides of the outlet 8, the sheets 2 and 3 are formed like fins to form a hanging part 10, and the lower end fin part of the hanging part 10 constitutes a stopper part 10' formed in the middle to react. The container 11 is suspended. The koji-locking part 10' is formed from the sheets 2 and 3 and is bendable, and by pushing it into the neck of the reaction vessel 11, the pack and the reaction vessel can be mechanically connected in one operation. 1
Reference numeral 1' indicates a rope made of a magnetic material placed in a reaction vessel, and this is rotated or vibrated as necessary by a magnetic device from outside the vessel.

Reference numeral 7 denotes a mark formed on a part of the pack, which indicates the type of analysis item and other contents by the position and number of through holes.

The pack 1 constructed in this way is preferably mounted on a carrier 14 to ensure correct positioning and transfer. By using the reagent pack and analysis tool of the present invention, the reagent can be added by manually compressing the reagent enclosure, and the result can be used in conjunction with a current simple clinical testing machine or colorimeter using the reaction container as it is. However, this significantly simplifies the manual work of collecting and adding reagents, and also requires special and expensive pack materials and analysis since the reaction container is not integrated with the pack, unlike conventional analysis packs. The analysis tool, which is a combination of this pack and reaction container, does not require a hawk and can easily obtain analytical results comparable to those obtained manually by a professional engineer. By combining it with a mounter that automatically compresses and destroys the parts, it can be applied to an analysis system using a cheap and simple fully automatic analyzer or semi-automatic analyzer.

EXAMPLES Hereinafter, the usage of the analysis tool of the present invention will be explained using a few examples.

Example 1 Preparation of reagent pack for glucose analysis and analysis operation (preparation of analytical reagent) Reagent 1 Diethylaniline enzyme solution; NaHP04/12, 2012.9 evening, K ratio P04 (anhydrous) 8.7 evening, sun 3P0312 .37 Evening, ED
TA・2Na・2LOO. 372 days ago, an aqueous solution containing 0.5% of diethylaniline was prepared.

Reagent 2 Peroxidase/4-aminoantipyrine solution: Peroxidase 0.2 hours, NaHP 04/12L
023. Total evening, K5904 (anhydrous) 4.54 evening, sun 3P
On the evening of 0312.37, a solution containing 0.3 hours of 4-aminoantipyrine was prepared.

Reagent 3 Glucose oxidase lyophilized powder; Glucose oxidase 0.5 Evening, Sun 3B030. Group 6 Yu, N
a2 & 07.1 Indo-Japan 200-048 evening, EDTA/2N
a・2LOO. Make a solution of 50 ml containing 0186 yen,
This is a glass cuvette for storage and color comparison (capacity 6M)
0.5 samples were taken, 13 pi 0, 0. A freeze-dried product was prepared by treating it under pressure of Hg overboard for a day and night.

The above prepared reagents were stored in a refrigerator at 2 to 8°C immediately after preparation.

(Creation of reagent pack for analysis) The surface part of the reagent pack shown in Fig. 1 (having four reagent enclosing parts) was covered with a two-layer composite film (polyethylene film/polyvinyl chloride stretched film, thickness 50 mm/cm). 20
0)) was vacuum formed.

When this material is viewed from the concave side, the serum addition section is located on the right side. Fill one bird each with reagent 1 into the first, second, and serum addition section (right side) recesses from the left. Next, 1 part of Reagent 2 is filled into the third recess from the left. A polyethylene film/polyester unstretched film (thickness 50 threads/15
) is heat set in a specific mold with the polyethylene side in contact with the reagent side. The polyethylene/polyester (polyethylene terephthalate) composite film is coated with a reagent spill area (
A polypropylene film with a thickness of about 20 r is dot-adhered to the position where the occlusion part is to be formed, and the occlusion part also appears at the same time as the front and back surfaces are heat set. If the reagent is to be stored for a long time or if the reagent is unstable, set the device so that the reagent is filled and sealed in an inert gas atmosphere as necessary. (Analysis operation) A reagent pack for glucose analysis and a cuvette containing a freeze-dried reagent were taken out from the reagent pack management room (temperature-controlled refrigerator at 2 to 8° C.), and a cuvette with a seal at the bottom of the pack was set to serve as an analysis tool.

The serum addition part was cut, and after adding 20' of serum, it was resealed by heat setting. The reagent pack was preheated to 370℃ for 5 minutes using a warm air incubator or a vertical plate heater. When looking at the convex part of the reagent pack from the front (the serum addition part is on the left end), from the right side of the reagent enclosing part,
Compress the 2nd and 3rd bags and the serum addition part bags one by one with your fingers.
The reagent blockage was broken, releasing the reagent through the passageway and into the cuvette. Next, the cuvette was stirred for 1 minute to dissolve the freeze-dried reagent in the cuvette, and then left in the 370 for 15 minutes, and the sample was measured using light with a wavelength of 5 millimicrons.
A reagent blank was measured using the same procedure without adding the sample serum, and the glucose concentration was calculated from these measurements. The above is
Although analysis is performed by manually adding reagents to the reagent pack of the present invention, it is also possible to transport the reagent pack, add reagents, mix, drain, and measure using a fully automatic processing device.

Example 2 Analysis of urea nitrogen in serum (preparation of analytical reagents) Reagent I EDTN buffer (pH 7.0) Reagent 2 Sodium salicylate solution (85 ml/100' of water) Reagent 3 Sodium nitroprusside solution (130 ml of water)
o/100 of [) water reagent 4 dichloroisocyanuric acid solution (2.5 tano 0.7 N Na○ka solution) reagent 5 urease tablet (3 units tabletted with 4 o of common salt) ) (Preparation of reagent pack for analysis) Looking at the surface of the reagent pack prepared in the same manner as in Example 1 from the concave side, place reagent 1 in the serum addition part (rightmost concave part) and reagent 2.
Fill the first recess from the left, reagent 3 into the second recess from the left, and reagent 4 into the fourth recess from the left, and then fill the back surface material film (with which a polypropylene film to create a reagent closure area is dot-glued). The tube was heat-sheeted with polyethylene film/polyester film, and the reagent was sealed.

Furthermore, one tablet of urease (reagent 5) was placed in a glass cuvette for reagent enclosure and colorimetry. The obtained analytical reagent pack and oxygen-containing cuvette were stored in a cold room at 2 to 8°C. (Analysis operation) Reagent pack 1 and cuvette 11 (containing enzyme) from the refrigerator
, cut off the serum addition part of the reagent pack, and add serum 2.
After adding the top layer of 0, it was resealed using a heat seal.

A cuvette 11 with the cap opened at the lower end 101 of the pack was attached as an analysis tool, and preheated at 3700 for 5 minutes using a hot air incubator or a vertical plate heater. Next, from the front (convex part) of the reagent pack, first compress the reagent sealing part (first from the left) of the serum addition part to release the reagent, and then move the cuvette for about 1 minute to dissolve the urease tablet. It was left at 370 for 4 minutes. Next, the remaining three reagent enclosures were sequentially compressed to release the reagents into the cuvette, and the cuvette was lit for 1 minute.
After being left for 5 minutes, measurement was performed using light with a wavelength of 5 millimicrons. Similar reagent pack processing operations can also be performed to automatically and quickly analyze multiple items and multiple samples using a fully automatic analyzer with a built-in reagent pack pack processing mechanism.

Example 3 Preparation and analysis of reagent pack for cholesterol analysis (preparation of analytical reagents) Reagent I KH2P0412.03 evening, N also HP0444
．． 03 evening, Gua BQ 12.37 evening, EDTA, a, 2nd day 200.372 evening, Triton X-1000.5', oleyl alcohol (ethoxylated) 0.35 evening,
An aqueous solution containing 1.29 mg of sodium cholate.

Reagent 2 Peroxidase 24,000 units, KH2P
An aqueous solution (pH 65) of 0424.99 pm, N and HP 0430.71 pm, and boric acid 12.37 pm.

Reagent 3 4-aminoantipyrine 0.072M, dimethylaniline 0.09M, 85% phosphoric acid 0.0306M
1 quart aqueous solution containing.

Reagent 4 Make a 500' aqueous solution containing 500 units of lipoproten lipase, 80 units of cholesterol oxidase, 19 units of cholesterol esterase, and 0.5 units of albumin, and add this to a glass cuvette (capacity: 6 0.5 qo each)
A freeze-dried reagent was prepared by treating the mixture under a reduced pressure of 0.2 Hg overnight.

The prepared reagents were stored in a cool place at 2-8°C.

(Creation of reagent pack for analysis) In the same manner as in Example 1, looking at the surface of the reagent pack created from the concave side, reagent 1 is placed in the first reagent bag from the left, reagent 2 is placed in the second reagent bag from the left, and reagent 3 is placed in the first reagent bag from the left. The first bag from the right (serum addition section) was filled with one volume of each bag.

Next, a back composite film (polyethylene film/polyester film, thickness 40/15) is heat-sealed together. A polypropylene film (thickness: 15) is point-adhered to the polyethylene side of the surface film, and the reagent closure part is formed at the same time as the surface and diamond surfaces are heat-sealed. (Analysis operation) A cuvette containing a freeze-dried reagent was attached to the bottom end of the reagent pack to serve as an analysis tool.

- Cut the serum addition part, add 20 ml of serum sample, and reseal. The reagent pack was set in a hot air incubator or a vertical plate heater, and preheated to 37° C. for 5 minutes. Viewing the reagent pack from the front (convex side), the first and second bags from the right were compressed to allow the reagents to flow into the cuvette, and the cuvette was lit for about 1 minute to dissolve the lyophilized reagent. Furthermore, leave it at 370 degrees for 4 minutes, compress the reagent sealing part on the right end to release the reagent, use a rope pestle for 1 minute, leave it at 370 degrees for another 4 minutes, and then measure the spots with light with a wavelength of 5 millimicrons to determine the concentration. did. The above is a manual method for using reagent packs, but it is possible to process a large number of specimens extremely efficiently by combining a simple destroyer and incubator to destroy the reagent sealing part of the reagent pack. Serve.

[Brief explanation of drawings]

FIG. 1 is a sketch showing an example of the reagent pack and analysis tool of the present invention, and FIGS. 2 to 9 are cutting lines 0 in FIG. 1.
-ro, m-m, W-N, V-V, W-'s, skin-to-skin, W-
10 is a cross-sectional view taken along the film surface 2 of the reagent pack 1,
11 and 12 are plan views showing other embodiments of the reagent pack of the present invention, and FIGS. 13 and 14 are plan views showing other embodiments of the reagent pack of the present invention.
FIG. 15 is a side view of the pack shown in FIG. 1, and FIG. 16 is a side view showing the entrance and heat-sealed state of the sample injection section 4' of the reagent pack shown in the sketch of FIG. FIG. 17 shows the entrance state A and the mechanically sealed state of the sample injection section 4'. FIG. 18 is a diagram showing the relationship between the closing strength of the closing portion, the size of the film, and the heat sealing conditions. 1
: Pack, 2: Top sheet, 3: Back sheet, 4': Sample injection port, 4, 5: Reagent enclosure, 6: Concentration passage, 7: Label, 8: Outlet, 9: Blocking part, 10: Hanging Lower part, 11; reaction container, 11'; rope trunk, 12: section, 13: pressure sealing lever, 14: carrier. Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 11 Figure 12 Figure 10 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18

Claims (1)

[Claims] 1 A pack formed of a flexible or easily deformable film or sheet on at least one side and an adhesive film, sheet or plastic plate on the other side, and having at least one reagent enclosing part. a reagent pack having a passage for guiding the reagent in the sealed part to the reaction vessel, a closing part that opens when external pressure is applied to the sealed part, and a reaction vessel hanging part; and an optical means connected to the reaction vessel hanging part. An analysis tool consisting of a reaction container that can be measured by