JPH05504404A - Disease diagnosis kit - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Disease diagnosis kit Explanation regarding related earthworks This application is filed on June 9, 1989, Ser. No. 363, which is pending. , 854, and this Ser. No. 363,854 is filed in 1986. In a continuation application of Ser. No. 902,313 of the earlier application filed on August 28, Also, the earlier application Ser, which is currently abandoned.

No. 547,767, a continuation in part of this Ser.

No. 547,767 was filed on September 30, 1986, as U.S. Patent No. 4,614.7. Published as 22.

Further, the present application is filed under Ser. No. 913,940 in November 1988. Related to a patent published as U.S. Patent No. 4,788.155 on the 29th Ru.

Background of the invention The present invention provides a kit for diagnosing whether or not a disease exists in a subject's body; In particular, it relates to a kit for carrying out the tests described in the prior patents.

In related prior patents and pending applications (the disclosures of which are incorporated as notes) prior to exposure to a substance with a known relationship to the disease being tested. and later compare the number and size distribution of the subject's blood cells. describes a novel method for diagnosing disease in a subject by comparing

For ease of explanation, my inventive text aimed at diagnosing the presence or absence of a disease Mention inspection. However, the term should be interpreted in a broad sense, and the test is for the known cause of the disease. It is used to identify the cause. For example, it turns out that you have a migraine. If you are a patient, you can say that you have already received a diagnosis. However, my test Tests may be used to determine the cause of migraines, such as food sensitivity reactions. cormorant.

Thus, the dietary intake of the patient contrasts with migraines caused by other causes. Used to diagnose migraines caused by allergic reactions to objects or drugs Will.

My early patents contain many specific examples of tests, so I will discuss them here. There is no need to describe the steps in detail. The patented test is designed to detect the presence of the disease in the test subject. It will suffice to summarize that it is a method of objectively and reliably determining nothingness.

In outline only, the method includes the following steps.

(a) Collect a sample of the subject's blood.

(b) Divide the sandals into separate volumes, each containing ensure that the number of blood cells in the cell has a roughly equal distribution .

(c) at least one test of the blood for a substance with a prescribed association with the disease; volume).

(d) Number and number of blood cells in a control volume of the subject's blood. and/or size distribution.

(e) Reacting the blood in the test volume with the substance.

(f) the number and/or size of blood cells in the test volume after the reaction has had a chance to occur; Measure the distribution.

(g) Compare the measurement results of the control amount and test amount to determine whether the subject is suffering from the disease. Determine.

The above is only a summary of the patented tests, and we will refer again to the disclosure of related patents. Annotations are added.

However, to date, no effective and convenient equipment has existed to perform the test.

In past tests, in order to contain the selected reagent (test substance), Several containers had to be collected (excluding, of course, the containers used for control amounts) , reagents are purchased from different vendors, and different types of reagents are sold separately. Had to get it from the source.

For example, food extracts can be purchased from some sources but are used to test for certain cancers. The monoclonal antibodies produced would have to be collected from other sources.

Furthermore, although it was known that control samples were needed, how many samples could be used? It was unclear how many samples should be prepared, as it was unclear whether It was clear.

Therefore, it brings together the tools needed to perform the above-mentioned tests in a variety of ways. This became necessary.

Purpose of invention and IT cost The object of the present invention is to provide a test for disease diagnosis that overcomes the drawbacks of the prior art. The goal is to provide kits that can

Still another object of the present invention is to provide at least one test for diagnosis of diseases. An object of the present invention is to provide a kit comprising a container and at least one control container.

Still another object of the present invention is to provide multiple pairs of tests for a wide range of different diseases. The purpose of the present invention is to provide a disease diagnostic kit containing a diagnostic sample.

Briefly, a disease test container comprising at least one test container having a reagent disposed therein. Provide disease diagnostic kits. Each test container contains a different reagent or The six kits containing the mixture further include at least one control container. The number of control containers is related to the number of tests performed. That is, 1 per control. 0 tests are performed and a minimum of 5 tests are performed. Lyses blood cells that are not used for testing It is even better if you have a solvent to dilute the blood being measured and a blood thinner to dilute the blood being measured. desirable. The kit also includes at least one Two empty containers and a box to hold the various kit components for ease of transport. including carriers.

In accordance with the above and other objects of the present invention, whether a disease is present in the subject; A kit used for diagnosing A reagent that has a predetermined relationship with the disease, which is stored in a test container, and a second control container, etc. In order to measure the degree of reaction between the reagent and the test subject's blood, Separate volumes of blood are sequentially placed in the first and second containers. We provide a kit that can be stored in

Furthermore, according to a feature of the present invention, for diagnosing whether or not a disease exists in a subject; A kit used for testing, the kit comprising a first plurality of first test containers and a second plurality of test containers. reagents, at least one of the reagents contained in each of the first containers of the first plurality; each of the plurality of reagents has a predetermined relationship with at least one disease. and a second control container, the degree of reaction between the reagent and the test subject's blood, respectively. A separate amount of the subject's blood is sequentially transferred to a plurality of first and second containers in order to measure the amount of blood. We provide a kit that can be stored in each of the following.

Furthermore, according to a feature of the present invention, for diagnosing whether or not a disease exists in a subject, A kit used for testing, the kit comprising: a first plurality of first test containers; reagents, at least one of which is in each of the first containers of the first plurality. each of the plurality of reagents has a predetermined relationship with at least one disease. and at least five control containers and instruments used in the third disease diagnosis. A cleaning container to clean the blood and a blood thinner to dilute the patient's blood during diagnosis. , consisting of a solvent for dissolving blood cells in the subject's blood, and containing 10 cells in the first container. and at least one control container, which configuration allows the reagent to be mixed with the subject's blood. Separate volumes of the subject's blood or sequential replicates were collected to determine the degree of reaction between each of the To provide a kit stored in each of a number of first containers and a number of second containers.

The above and other objects, features and advantages of the invention will be apparent from the same elements as in the accompanying drawings. will become clear from the following description with relevant numbers.

Brief description of the drawing FIG. 1 is a perspective view showing various elements of the kit of the present invention.

2 is an enlarged perspective view of one container of the kit of FIG. 1; FIG.

FIG. 3 is a perspective view of a second embodiment of the kit of the present invention.

Detailed description of preferred embodiments Hereinafter, a kit 10 for disease diagnosis according to an embodiment of the present invention will be explained with reference to FIG. Ru. In its most basic configuration, the kit 10 includes a plurality of test containers. 12 and a plurality of separate control containers 14.

The test container 12 and the control container 14 are different except for their respective contents. Rohanai. The containers are each sealed and made of e.g. polystyrene. It is made of durable and unbreakable material. In FIG. 2, an illustrative container 16 is shown. show.

Container 16 includes a roughly cylindrical body 18 and M2O.

When the container 16 is closed, it is protected from external contamination. child This keeps the inside of the container 16 clean. Furthermore, the container 16 contains contents 2 It is desirable that a label 22 be attached so that the container 4 can be identified. Even if the type of contents 24 in 16 is unknown, which one is the test container (not shown)? Is the substance being tested an edible extract from corn, or , it can be seen whether it is a control container or not.

Returning to FIG. 1, kit 10 preferably includes a carrier 26, which A 26 has a plurality of recesses 28 for holding the test container 12 and the control container 14. is provided.

Carrier 26 is of a material suitable for holding test container 12 and control container 14. Those skilled in the art will be able to fully imagine the manufacturing method.

The only difference between the test container 12 and the control container 14 is what is put inside them! II The only difference is J (24 in FIG. 2).

Appropriate reagents are stored as contents 24 in each test container 12 (Fig. 24), the nature of the contents 24 is that of a given test container 12. Depends on the type of disease being diagnosed. As mentioned in the related patents above, inspection can be carried out in different ways depending on the type of disease being diagnosed; for example, , potential irritant-reactive substances (e.g., food items to which the subject is expected to be sensitive). Allergens or chemicals) or antibodies specific to the disease (for example, if the disease is cancerous). If so, we will add a monoclonal antibody specific drug that is effective against that cancer, like this. For further details regarding the nature of the reaction determined by such tests, see U.S. Pat.

4.778,155. Shown in column 19, line 27-column 10, line 5.

Then, the reagent and the reaction it causes are associated in advance, and the test is carried out. to confirm that the reagents actually caused the expected reaction. The relationship between the reagent and its reaction will be determined.

The method of putting what kind of predetermined substance into the test container 12 depends on the reagent. depends on the nature of For example, if the reagent is an edible extract or mold, the substance When investigating allergic reactions to foods, a very small amount of extract (several millimeters) is necessary. regram) is required for effective testing. Take all these substances Since it is difficult to handle the reagents in a carrier, the reagents are transported in a transport medium (carrier). It is desirable to do so. This transport medium ensures that the extract is kept in a stable state, i.e. in the environment. is a complex which makes it unaffected by moisture and/or air, in particular non-reactive with moisture and/or air. This is desirable.

A stable reagent is a suspension-mediated solution such as a mixture of equal parts glycerin and water. It is made by making a solution containing liquid and test extract. The preferred solution is The weight ratio of the research extract to the suspension medium may be 1:9.

The solution is mixed and approximately 10 microliters of the solution is divided into the carrier. child In this embodiment, the carrier is preferably a nylon disk.

This disk is then immediately frozen. At this time, the liquid part of the solution that has become an ice body Minutes are produced by sublimation in a high vacuum and at a low temperature of approximately -50 degrees Celsius. will be removed.

It was noted here that this manufacturing method is specific to the case of food extracts. For other types of reagents, the general procedure is the same, but for suspension vehicles. The exact proportions of reagents and reagents are a matter of concern. From a person skilled in the art, it would take a little experimentation. All you have to do is

Also, I would like to clarify that reagents do not have to be pure substances, e.g. It is desired to investigate the reaction caused by the combination of drugs in the human body, and two reagents are required. (or more) drugs can be combined.

It will also be understood that this is a typical method of preparing the test container 12. If the container is configured to allow this type of manufacturing, plastic pallets may be It is also possible to carry the reagents in a suitable neutral medium, such as a container, or in the bottom of the container itself. It is Noh. Those skilled in the art will appreciate the manufacturing of test containers 12 and control containers 14. The law is a matter of design choice. The format of the kit and the test and control containers are also important. The details of the configuration of the vessels 12 and 14 are not limited to this embodiment, and various modifications are possible. capacity Equipment must be suitable for its intended use.

It is also within the skill of those skilled in the art to be able to use it for its intended purpose. This is a matter of design choice.

An important factor in the manufacture of kit 10 is the selection of each test container 12 and control container. The contents of the vessel 14 are the same, with the reagent contained in the test container. paraphrase If the reagent is directed onto the carrier medium in such a way as to keep the subject's blood neutral, This carrier medium should be transferred to the control container 14. Transport medium and subject Reactions may also occur with the blood of other people. Moreover, the amount of substances in various types of containers By making the quantities equal, possible problems during measurements can be avoided.

For the relevant number of test and control vessels 12.14, at least 5 each Two control samples should be used. In fact, each measurement is performed consecutively. are not performed in parallel, i.e. each measurement is performed with a slight time difference. be exposed. When making many measurements, sometimes more than 100, the first It may take more than an hour from the first measurement to the final measurement. First the control sample If analyzed, even in non-responsive situations and when the patient has a low percentage of blood cells. As it worsens over time, features appear more pronounced than when last measured.

Additionally, comparisons are made based on correlation to the standard deviation from the expected result. should be more accurate by using the average value of several control samples. results.

Erroneous judgments can be avoided by using several control samples . For example, if the control samples were prepared at regular intervals and the test samples More accurate judgments can be made when compared with a similar control sample. moreover , since the measurement results are based on comparisons, judgments are made against several control samples. By averaging the cross-sections, more accurate judgments can be made and the accuracy of the measurement results will be improved.

After the test, at least one pair is recorded in the sequential preferred measurement observation record. For the measurement of light, 10 measurements each are made on a minimum of 5 control samples. It turns out that it should. This is useful when overtime, more accurate, or Differences where faster and more advanced facilities are available, resulting in worse The number of elements can be reduced.

As described above, as a preferred embodiment of the present invention, the test container held in the carrier and the Although we have described a kit consisting only of containers for A pond element may be added as a constituent element.

FIG. 3 shows an attached kit 30 which is one element of the kit of the present invention. Indicates an addition that becomes part of.

The attachment kit 30 should be attached to the kit 10 and should be manufactured as such. Here, they are shown separately for ease of illustration.

The attached kit 30 is used to clean test instruments used for conducting tests. an empty container 32, a solvent 34, and a blood diluent 36, which are arranged in a recess 40. It is held in a carrier 38 having a.

Empty container 32 is used to clean test instruments used to perform tests. . As can be easily seen, tests involved in medical diagnosis must be performed carefully; Therefore, the testing equipment used must always be controlled, and the empty container 32 must be , is used to store detergent for soaking and cleaning test instruments, and after cleaning, Detergent is removed.

As mentioned above, some applications require blood cells to be lysed for measurement. In these applications, solvent 34 is effective. Active solvent (e.g. For example, saponin (manufactured by Sigma Chemical Co., Ltd.) is 1% in the bacterial growth inhibitory solution? fjm Preferably, the amount is sufficient for testing. The actual measurement is , may be carried out according to the methods described in the above-referenced US patents.

Furthermore, the type of cell lysing agent is determined by the type of blood cells to be lysed. Because different The measurements are based on the type of cells that each cell, such as red blood cells, white blood cells, and platelets, originated from. This is because it will be done accordingly.

Since blood diluent is used in most applications, the attached kit 3 0 preferably contains a hemodiluent 36, which is non-reactive with human blood. Preferably, it is a substance with a pH equal to the acidity of human blood (7,4).

A suitable solution is 0.9% sodium chloride and sodium carbonate at approximately pH 7.4. 11w adjusted to ! It is a liquid.

The total volume of hemodiluent 36 is determined by the number of tests (and control tests) to be performed; Therefore, it depends on how you test using kit 10 and attached kit 30. Ru.

The assembly of the parts described above provides all the components necessary to perform the inspection. Only then can I carry out my patented test efficiently and accurately. Become.

Although preferred embodiments of the present invention have been described with reference to the accompanying drawings, the present invention Without being limited to such precise embodiments, as defined in the appended claims, Various modifications and variations can be made by those skilled in the art without departing from the scope and spirit of the invention. It is possible.

abstract A carrier with a plurality of recesses 28 for holding at least one test container 12. Kit 1o is used to diagnose diseases including Ria 26, and the test container is Reagents are placed in container 12! be done. Each test container 12 has a different Contains reagents or complexes of those substances. Additionally, this kit includes at least one control container 14, and the number of control containers is preferably is related to the number of tests performed. That is, one control for every 10 tests. A minimum of 5 control vessels are included. Preferably, this kit further includes: The kit also includes a diluent blood solvent to dissolve the amount of blood to be measured. , at least one used for cleaning the instruments used to perform the test. May include empty containers.

Submission of translation of written amendment (Article 184-7, Paragraph 1 of the Patent Act) June 20, 1992

Claims (20)

[Claims] 1. A kit used for diagnosing whether a disease exists in a subject, , a first test container, and a sample having a predetermined relationship with the disease stored in the first container. a drug, and a second control container, which controls the reaction between the reagent and the subject's blood. Different amounts of the subject's blood are sequentially placed in the first and second containers to measure the stored inside. 2. The kit of claim 1, wherein the reagent is carried in a first volume of a first carrier medium. It will be done. 3. The kit of claim 2, wherein the second container contains a second quantity of a second carrier medium. including. 4. The kit of claim 3, wherein the first and second carrier media are the same. 5. The kit of claim 3, wherein the first and second quantities are the same. 6. The kit of claim 1, further comprising blood for dissolving the blood of the subject. Equipped with solvent. 7. The kit according to claim 1, further comprising: a kit for diluting blood cells in the blood of the subject; Contains a diluent. 8. It is a kit of claim 1, and it is also a kit that cleans instruments used for disease diagnosis. A third cleaning container is provided for cleaning. 9. The kit of claim 1, further for transporting the first and second containers. Equipped with means for 10. A kit used to diagnose whether a disease exists in a subject. the first plurality of first test containers, the second plurality of reagents, at least one of the reagents; one is disposed in each of the first plurality of said first containers, each of said reagents having at least one and a third plurality of second control containers having a predetermined association with one disease. , to measure the degree of reaction between said reagent and the subject's blood. The blood of the examiner is sequentially stored in the first and second containers. 11. The kit of claim 10, wherein at least one of the reagents is a first carrier medium. A first volume of the body is introduced. 12. The kit of claim 11, wherein each of the second containers contains a second carrier medium. and a second quantity. 13. The kit of claim 12, wherein the first and second carrier media are the same. . 14. The kit of claim 12, wherein the first and second quantities are the same. 15. The kit according to claim 10, further comprising: for dissolving the blood of the subject. blood solvent. 16. The kit of Claim 10 further dilutes blood cells in the blood of the subject. A diluent is provided for this purpose. 17. Claim 10 kit, which also cleans instruments used for disease diagnosis A third cleaning container is provided for cleaning. 18. A kit according to claim 10, further transporting the first and second containers. Provide means for 19. A kit according to claim 10, comprising at least There is also one control container and contains a minimum of 5 control containers. 20. A kit used to diagnose whether a disease exists in a subject. the first plurality of test containers, the second plurality of reagents, at least one of the reagents is disposed in each of the first plurality of test containers, each of the reagents having at least one with a defined association with the disease, at least five control containers, used for disease diagnosis. A cleaning container for cleaning used equipment, a container for lysing the patient's blood during diagnosis. The kit consists of a blood solvent, a diluent for diluting blood cells in the subject's blood, and the kit includes: There is at least one control container for every 10 test containers, with a minimum of five a control container for determining the degree of reaction between said reagent and the subject's blood; Then, separate amounts of the subject's blood are sequentially added to each of the plurality of test containers and control containers. will be stored in.