WO1991009138A1 - Kit for use in diagnosing maladies - Google Patents
Kit for use in diagnosing maladies Download PDFInfo
- Publication number
- WO1991009138A1 WO1991009138A1 PCT/US1990/007560 US9007560W WO9109138A1 WO 1991009138 A1 WO1991009138 A1 WO 1991009138A1 US 9007560 W US9007560 W US 9007560W WO 9109138 A1 WO9109138 A1 WO 9109138A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- kit
- test
- receptacles
- blood
- subject
- Prior art date
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
Definitions
- the present invention relates to a kit for use in diagnosing the presence or absence of maladies in a subject, and, more particularly, to a kit for use in performing the test described in my prior patents.
- the test may be used to ascertain the cause of a known malady. For example, a patient who is known to suffer from migraine headaches, may be said to have had a diagnosis already performed. However, my test may be used to ascertain the cause of the migraine, such as a food sensitivity. In this sense, then, the test may be used to diagnose a migraine as being a migraine caused by an allergic reaction to a food or a chemical ingested by the patient, as opposed to being a migraine resulting from some other cause.
- this methodology includes the steps of: (a) drawing a sample of the subject's blood; (b) separating the sample into a plurality of separate volumes, each having approximately equal distributions of blood cells therein;
- test substance would be purchased separately, from a different vendor, and different types of test substances would have to be collected from different sources.
- food extracts could be purchased from certain sources, while monoclonal antibodies, used for testing for certain types of cancers, would have to be collected from a different source.
- kits which contains at least one test receptacle and at least one control receptacle for use in performing a diagnosis for a malady. It is a still further object of the invention to provide a kit for use in diagnosing maladies which includes a number of control samples for performing a broader range of tests for different maladies.
- kits for use in diagnosing maladies that includes at least one test receptacle, having a test substance disposed therein. Each test receptacle has a different test substance, or combination of test substances, therein.
- the kit further includes at least one control receptacle.
- the number of control receptacles preferably relates to the number of tests to be performed, namely one control for every ten tests to be done, with a minimum of five.
- the kit further includes a lysing agent for lysing blood cells which are not used as part of the test to be performed, and a blood diluent for diluting the volume of blood to be measured.
- the kit may also include at least one empty receptacle for use in cleaning the equipment used to perform the test, and a carrier to hold the various components of the kit together for ease of transportation.
- kits for use in diagnosing the presence or absence of a malady in a subject comprising: a first, test, receptacle; a test substance disposed within the first receptacle, the test substance having a predetermined relationship with the malady; and a second, control, receptacle; whereby separate volumes of the subject's blood may be placed into the first and second receptacles, for measuring the degree of reaction between the test substance and the blood of the subject.
- kits for use in diagnosing the presence or absence of maladies in a subject comprising: a first plurality of first, test, receptacles; a second plurality of test substances, at least one of the test substances being disposed in each of the first plurality of the first receptacles, each of the plurality of test substances having a predetermined relationship with at least one malady; and a second, control, receptacle; whereby separate volumes of the subject's blood may be placed into each of the plurality of the first receptacles and the second receptacle, for measuring the degree of reaction between each of the test substances and the blood of the subject.
- kits for use in diagnosing the presence or absence of maladies in a subject comprising: a first plurality of first, test, receptacles; a second plurality of test substances, at least one of the test substances being disposed in each of the first plurality of the first receptacles, each of the plurality of test substances having a predetermined relationship with at least one malady; and at least five control receptacles; a third, cleaning, receptacle, for cleaning equipment used in performing the diagnoses; a blood diluent for diluting the blood of the subject during the diagnoses; and a lysing agent, for lysing blood cells in the blood of the subject; wherein the kit includes at least one control receptacle for each ten of the first receptacles; whereby separate volumes of the subject's blood may be placed into each of the plurality of the first receptacles and the control
- Fig. 1 is a perspective showing the various elements of the inventive kit.
- Fig. 2 is an exploded perspective showing a single receptacle of the kit of Fig. 1.
- Fig. 3 is a perspective of a secondary embodiment of the inventive kit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
- Fig. 1 there is shown, generally at 10, a kit for use in diagnosing maladies in a subject, in accordance with the invention.
- kit 10 includes a plurality of test receptacles 12, and a second plurality of control receptacles 14. Test receptacles 12 and control receptacles
- each sealed receptacle 14 differs not at all, except in their respective contents. They are each sealed receptacles made of any sturdy and durable material, such as polystyrene. An exemplary receptacle is shown in Fig. 2, generally at 16.
- Receptacle 16 includes a generally cylindrical body 18, and a lid 20. When receptacle 16 is closed, it will be secure against outside contaminants. This will preserve the integrity of receptacle 16.
- Receptacle 16 also preferably includes a label 22, for identifying contents 24 thereof, i.e. whether it is a test receptacle (such as pictured, where the test substance is a food extract for corn), or a control receptacle, in which case contents 24 will be neutral.
- kit 10 further preferably includes a carrier 26, having a plurality of apertures 28 for retaining test receptacles 12 and control receptacles 14.
- Carrier 26 may be made of any suitable material for holding test receptacles 12 and control receptacles 14, and its mode of manufacture will be appreciated by those of ordinary skill in the art.
- test receptacle 12 The difference between test receptacle 12 and control receptacles 14 is solely in their respective contents (24 in Fig. 2).
- a suitable test substance Into each test receptacle 12, a suitable test substance will be placed as its contents (see 24 in Fig. 2).
- contents 24 will depend on the type of malady to be diagnosed with that particular test receptacle.
- a test may be made for a particular malady in different ways, for example, by adding a suspected reaction-provoking substance (e.g. a suspected food allergen, or a suspected chemical to which the subject is perhaps sensitive) or an antibody specific to that malady (e.g. a monoclonal antibody specific to a cancer for which the subject is tested).
- a suspected reaction-provoking substance e.g. a suspected food allergen, or a suspected chemical to which the subject is perhaps sensitive
- an antibody specific to that malady e.g. a monoclonal antibody specific to a cancer for which the subject is tested.
- the predetermined relationship may be that a ttest substance may cause a reaction, and the test may be performed, then, to determine if the test substance in fact has caused the suspected reaction.
- test substance is to be a food extract, or a mold, to test for an allergic reaction to the food, very little extract (on the order of a few milligrams) is needed to perform the test effectively. This amount of material is difficult to handle, and so it is preferred that the test substance be carried on a carrier medium. This preference is compounded, in that the extract should be in a stable state, i.e. non-reactive with the environment, particularly with respect to moisture and or air.
- a stable test substance may be fabricated by preparing a solution containing the extract and a suspension medium, such as a mixture of equal parts glycerine and water.
- the preferred solution would have one part extract to nine parts suspension medium by weight.
- the carrier which in this embodiment is preferably a nylon disk.
- test substance need not be a pure substance.
- the test substance may be desired to test for reactions caused by a combination of medications in a patient, and so the test substance could be a combination of the two (or more) medicines.
- test receptacles 12 this is but one method of preparing test receptacles 12. It would be possible to carry test substances on any suitable, neutral, medium, such as a plastic pellet, or even on the floor of the receptacle itself, if the receptacle is so formed as to permit such manufacture.
- suitable, neutral, medium such as a plastic pellet
- control receptacles 14 will be strictly a matter of design choice, within the purview of such an ordinarily skilled person.
- the precise details of the shape and construction of test and control receptacles 12 and 14, respectively, will depend on the intended application. The receptacles must conform to the intended use.
- kit 10 An important factor in the manufacture of kit 10 is that the contents of each test receptacle 12 and control receptacle 14 should be identical, but for the inclusion of the test substance in the test receptacle. In other words, even though the test substance is carried on a carrier medium which is believed to be neutral with respect to the subject's blood, that carrier medium should also be placed in control receptacles 14 as well, in case there is any reaction between that medium and the subject's blood. Additionally, it assists in avoiding any potential problem in measurement, by ensuring that the volume of material in each type of receptacle is identical.
- control samples 12 and 14 it is preferred that at least five control samples be used. In practice, different tests are performed sequentially, not in parallel. This means that each measurement is performed at a slightly different time. Where a number of tests are to be performed, possibly over one hundred in some instances, the difference in time between the first measurement and the final measurement could be as much as an hour or more. If the control specimen is analyzed first, it may have different characteristics than if it were measured last, since, even in a non-reactive situation, a small percentage of blood cells of some patients, in certain instances may deteriorate over time.
- comparisons be made on the basis of correlation to a standard deviation from the expected results, and the use of an average of several control samplings renders a more accurate result.
- control samples are prepared at different intervals, and the test samples are compared with the control sample nearest in time, then more accurate readings are possible. Furthermore, since the test results are comparative, an average of several control readings may provide a better average of test results, leading to more accurate readings.
- Figure 3 illustrates a supplemental kit, shown generally at 30, which illustrates the additional items which may be a part of the inventive kit.
- kit 30 may be affixed to kit 10, and it may be so manufactured. Here, for simplicity of illustration, it is shown separately.
- Supplemental kit 30 includes a set of blank receptacles 32, for use in cleaning equipment used to perform the diagnoses, a lysing agent 34 and a blood diluent 36 all carried in a carrier 38, having apertures 40.
- Blank receptacles 32 may be used for cleaning the equipment used for performing the diagnosis. As will be readily appreciated, the performance of any test involving medical diagnoses must be done carefully, and so the equipment used must be regularly maintained. Blank receptacles 32 may be used for carrying detergents to place them in the equipment for cleaning, and then carrying the detergents away after cleaning.
- lysing agent 34 would be useful. It is preferred that the active lysing agent (for example, Saponin, from Sigma Chemical Co.) be present in a one-per cent solution in bacteriostatic water, in an amount sufficient to perform the tests to be made. Precise measurements may be made in accordance with the protocols set forth in my U.S. patents referenced above. It will also be noted that the type of lysing agent will depend on the type of blood cell to be lysed, since different measurements may be taken of different types of cells, i.e. red blood cells, white blood cells or platelets.
- supplemental kit 30 include blood diluent 36, which is preferably a substance which is non-reactive with human blood, and is pH balanced to the acid level of human blood (7.4). Suitable solutions would be a mixture of buffered normal saline, 0.9% sodium chloride buffered to (appx.) pH 7.4 with sodium bicarbonate. The total volume of blood diluent 36 provided would depend on the number of tests (and controls) to be performed, and so will depend on the particular application contemplated for any kit 10 and supplemental kit 30.
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- Food Science & Technology (AREA)
- Biochemistry (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
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- Investigating Or Analysing Biological Materials (AREA)
- Water Treatment By Sorption (AREA)
- Lock And Its Accessories (AREA)
- Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP91502890A JPH05504404A (en) | 1989-12-20 | 1990-12-20 | Disease diagnosis kit |
BR909007927A BR9007927A (en) | 1989-12-20 | 1990-12-20 | SET FOR USE IN DISEASE DIAGNOSIS |
FI922862A FI922862A0 (en) | 1989-12-20 | 1992-06-18 | MEDEL FOER ANVAENDNING VID DIAGNOSTISERING AV SJUKDOMAR. |
NO922413A NO922413D0 (en) | 1989-12-20 | 1992-06-19 | EQUIPMENT FOR USE IN DIAGNOSIS OF DISEASES |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US45386989A | 1989-12-20 | 1989-12-20 | |
US453,869 | 1989-12-20 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1991009138A1 true WO1991009138A1 (en) | 1991-06-27 |
Family
ID=23802401
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1990/007560 WO1991009138A1 (en) | 1989-12-20 | 1990-12-20 | Kit for use in diagnosing maladies |
Country Status (10)
Country | Link |
---|---|
EP (1) | EP0506852A4 (en) |
JP (1) | JPH05504404A (en) |
AU (1) | AU7174391A (en) |
BR (1) | BR9007927A (en) |
CA (1) | CA2071909A1 (en) |
FI (1) | FI922862A0 (en) |
IE (1) | IE904616A1 (en) |
NO (1) | NO922413D0 (en) |
WO (1) | WO1991009138A1 (en) |
ZA (1) | ZA9010284B (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0549599A1 (en) * | 1990-07-17 | 1993-07-07 | Mark J. Pasula | Blood testing apparatus |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4614722A (en) * | 1983-11-01 | 1986-09-30 | Pasula Mark J | Method and apparatus for measuring the degree of reaction between antigens and leukocyte cellular antibodies |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4174202A (en) * | 1977-11-28 | 1979-11-13 | The Dow Chemical Company | Kit and method for testing liquids for hydrogen sulfide content |
US4303610A (en) * | 1980-05-19 | 1981-12-01 | Pennzoil Company | Test kit for field analysis of plant tissue magnesium and calcium |
-
1990
- 1990-12-20 AU AU71743/91A patent/AU7174391A/en not_active Abandoned
- 1990-12-20 CA CA002071909A patent/CA2071909A1/en not_active Abandoned
- 1990-12-20 ZA ZA9010284A patent/ZA9010284B/en unknown
- 1990-12-20 IE IE461690A patent/IE904616A1/en not_active Application Discontinuation
- 1990-12-20 BR BR909007927A patent/BR9007927A/en unknown
- 1990-12-20 WO PCT/US1990/007560 patent/WO1991009138A1/en not_active Application Discontinuation
- 1990-12-20 JP JP91502890A patent/JPH05504404A/en active Pending
- 1990-12-20 EP EP19910902518 patent/EP0506852A4/en not_active Withdrawn
-
1992
- 1992-06-18 FI FI922862A patent/FI922862A0/en not_active Application Discontinuation
- 1992-06-19 NO NO922413A patent/NO922413D0/en unknown
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4614722A (en) * | 1983-11-01 | 1986-09-30 | Pasula Mark J | Method and apparatus for measuring the degree of reaction between antigens and leukocyte cellular antibodies |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0549599A1 (en) * | 1990-07-17 | 1993-07-07 | Mark J. Pasula | Blood testing apparatus |
EP0549599A4 (en) * | 1990-07-17 | 1994-02-02 | Mark J. Pasula |
Also Published As
Publication number | Publication date |
---|---|
NO922413L (en) | 1992-06-19 |
NO922413D0 (en) | 1992-06-19 |
FI922862A (en) | 1992-06-18 |
ZA9010284B (en) | 1991-10-30 |
BR9007927A (en) | 1992-11-10 |
AU7174391A (en) | 1991-07-18 |
FI922862A0 (en) | 1992-06-18 |
CA2071909A1 (en) | 1991-06-21 |
IE904616A1 (en) | 1991-07-17 |
JPH05504404A (en) | 1993-07-08 |
EP0506852A4 (en) | 1993-03-03 |
EP0506852A1 (en) | 1992-10-07 |
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