JPH047955B2 - - Google Patents

Description

[Detailed Description of the Invention] (Industrial Application Field) The present invention relates to a test strip for simple fractional analysis of body fluids.
The present invention relates to test strips for simple fractional analysis used in screening tests to determine whether more detailed tests are necessary in body fluid tests that provide the most basic guidelines for diagnosing various diseases.

(Prior art and its problems) Conventionally, body fluids such as blood are analyzed, and various biochemical substances contained in the blood are quantified to determine whether they are in the normal range or abnormal range. , or in the transition range, and to help diagnose various diseases, collect blood, separate suspended matter such as blood cells by centrifugation, separate serum, and use this serum as a sample. Treatment methods include manual methods or biochemical analyzers.

This prior art method requires a relatively large amount of blood, which not only puts a burden on the person being tested, but also requires a series of steps including blood collection, serum separation, and test processing, making it difficult to use in clinical practice. It is not possible to obtain test results immediately, so testing is usually entrusted to specialized institutions.

Therefore, there is a need for a test result that can be obtained immediately in a clinical setting, even if it is for provisional screening. It has reached this point. The analytical element disclosed in this publication is a conventional analytical element of this kind in which filter paper is impregnated with a reagent, and due to the nature of filter paper, so-called "unevenness" tends to occur, which has a negative effect on analytical accuracy. In order to suppress the occurrence of unevenness, the reagent layer and the fibrous porous carrier layer are made separate, and a hydrophilic colloid substance is added to the reagent layer. In this analytical element, the fibrous porous carrier layer is preferably a synthetic paper, a filter paper, etc.
8), there is a problem in that some of the sample liquid (e.g. serum) is wasted due to its water absorption properties, and in the invention disclosed in this publication, the analysis is performed using spectrophotometry. The main focus of this method is to perform the test using a digital analyzer, so even though it is expected to improve the accuracy of analysis, the problem remains that the test results cannot be immediately obtained in a clinical setting.

(Objective of the Invention) Therefore, the object of the present invention is to make it possible for the body fluid to be tested to be almost completely used for the purpose of testing, to be able to be visually determined, and to be able to perform two or more tests in one test. We provide test strips for simple fractional analysis of body fluids that can be carried out in one test, thereby making it possible to carry out the test in a clinical setting and to immediately know the test results, and to provide necessary test samples. The goal is to reduce the amount of

(Means and actions for solving the problem and achieving the object) According to the present invention, the problem in the prior art is that the synthetic resin plate has many micropores with a diameter of 0.1 to 0.6 μm. a microfilter that separates suspended matter; a diffusion permeable membrane that disperses and flows down the liquid that has passed through the microfilter; A test piece containing a reagent whose color tone changes depending on consisting of individual specimens of
This is accomplished by a test strip for simple fractional analysis of body fluids, and the above objects are also achieved.

That is, in the test strip for simple differential analysis according to the present invention, the microfilter serves to separate suspended matter in body fluids, such as blood cells when the sample body fluid is blood, and to allow only serum to pass through. Since it is a synthetic resin plate, it does not absorb the body fluid under test, so the body fluid under test is not wasted, and it is inexpensive because it has many openings with a predetermined diameter according to the body fluid under test. can be produced. Examples of synthetic resin materials for manufacturing this microfilter include polycarbonate, polyamide, and polyester resin. The diffusion permeable membrane disperses and flows down the liquid that has passed through the microfilter, thereby making it possible for the liquid to evenly spread over the entire reagent-containing test piece. According to the test piece for simple fractional analysis according to the present invention, since the test piece is composed of at least two types of individual test pieces separated from each other, a different reagent is applied to each of these individual test pieces. Among the various biochemical substances contained in body fluids, 2
Tests covering one or more items can be performed in a single test. The test strip for simple fractional analysis according to the present invention is used, for example, to quantify biochemical substances in body fluids using the following color reaction, but it is not suitable for each of the above-mentioned specific individual tests. There is colored printing near the piece for distinguishing the analysis results, so one drop of body fluid, such as blood, is placed on the microfilter, and after a while, for example, several seconds to several + seconds, the microfilter and the diffuse permeable membrane are connected. If you peel off the test piece, expose the test piece, and visually compare the color tone on the test piece with the color tone displayed on the print, you can immediately determine whether it is normal or requires more detailed inspection. can be judged.

Therefore, by using the test strip for simple fractional analysis according to the present invention, screening tests can be carried out using extremely small amounts of body fluid as test samples in clinical settings, and without requiring any equipment. be.

(a) Quantification of 3-hydroxybutyrate (ketone body) 3-hydroxybutyrate dehydronase (3-hydroxybutyrate dehydronase)
3-Hydroxybutyric acid (3-OHBA) in the sample is converted to acetoacetic acid using acetoacetate (HBOH), and nitrotetrazolium Blue (NTB) is reduced to produce formazan, and 3-hydroxybutyric acid is quantified from the degree of coloration.

3-OHBA+NAD3-HBDH ――――――――→ Acetoacetic acid + NADH + H ⁺ NADH + NTBDI ――――→ NAD ⁺ + Formazan (b) Determination of glucose (sugar) (GOD-POD method) Determination of glucose in the sample by glucose oxidase At the same time, it is converted to gluconic acid, and chromogen indicators (ortholidine, benzidine,
orthodianisidine, etc.) into oxidized pigments,
Glucose is determined based on the degree of coloration.

Glucose + O ₂ glucose oxidase――――――――――――→ H ₂ O ₂ + gluconic acid H ₂ O ₂ + chromogen peroxidase――――――――――→ Oxidized pigment + H ₂ O (c) Determination of blood urea nitrogen (BUN) 1,3-dihydroxyisoindoline (DHI) produced by the reaction between BUN and o-phthalaldehyde is converted to 3-hydroxy-1,2,3,4-tetrahydro Chromogen is produced by reacting with benzo(h)quinidine (HTBQ), and an auxochrome is attached to it by a conventional method to develop color, and BUN is determined from the degree of coloration.

BUN + o-phthalaldehyde → DHI DHI + HTBQ → chromogen Chromogen + color development aid → pigment formation (Example) As shown in FIG. 1, the test strip 10 for simple fractional analysis of body fluids according to the present invention A microfilter 12 that filters out suspended matter, and a test piece 14 that contains a reagent that develops color by reacting with a specific biochemical substance in body fluids and whose color tone changes depending on the amount of the specific biochemical substance. , the above microfilter 1
2 and the test piece 14
6, and a strip-shaped support 2 that serves as a carrier and provides the examiner with a part to grasp when performing an inspection operation.
0.

The test strip 10 according to the illustrated embodiment uses blood as the sample body fluid, and has a microfilter 1.
The diameter of the specimen 2 is large enough to receive one drop of whole blood, and the test piece 14 is divided into six compartments, each of which is independent and accommodated in each compartment. Separate and known reagents are adsorbed on the test piece, so that by dropping one drop of blood onto the microfilter 12, six of the various biochemical substances contained in the blood can be removed. It is designed to be able to examine different types of substances at the same time. In this case, since floating substances such as blood cells cannot pass through the microfilter 12, only the liquid component, that is, serum, reaches the diffusion permeable membrane 16 and is dispersed by the diffusion permeable membrane 16 toward the test piece 14. As it flows down, it will evenly spread over the individual test pieces housed in each compartment, and therefore no detection errors will occur.

The above microfilter 12, diffuse permeable membrane 16 and test piece 14 are attached to frames 12a, 16a and 14a, respectively, and these frames are coated with an adhesive substance, and these frames can be peeled off. It is possible to overlap them. A protective sheet 18 is removably attached to the microfilter 12, thus preventing the test piece 10 from being contaminated during storage before use.

The above frame 1 to which the test piece 14 is attached
4a is the support 2 as shown in FIG.
The part surrounding the test piece 14 can have the same dimensions as 0, and the part surrounding the test piece 14 is a discrimination table 14b for each inspection item.
It consists of The discrimination table 14b is printed in two or more color tones for each inspection item,
For example, parts or areas having individual tones may be printed with letters such as "normal", "needs careful examination", "close examination", etc. as shown in the diagram, or "A", "B", "C", etc. It is constructed by printing symbols such as . Here, the "color" and "tone" to be printed
Of course, this refers to the "color" that the test piece exhibits when the reagent applied to the test piece 14 in advance reacts with a specific biochemical substance in the sample (in this case, serum). It refers to the "color tone" that depends on the concentration of a specific substance, and "normal" means that the concentration of the specific substance tested is within the concentration range recognized in healthy people.
In b, this area is generally printed in pale tones or is uncolored, and is not subject to "close inspection."
means that the concentration of the specific substance in question is high and therefore requires retesting using a different, more accurate test method; this area is printed in a dark tone, while " ``Detailed inspection required'' means that the concentration of a specific substance is within a concentration range in which it is difficult to determine whether re-examination using another highly accurate test method is required.
Therefore, prior to detailed re-examination using another method, it may be necessary to re-examine at a later date using the test strip according to the present invention in order to confirm whether or not the problem is temporary. are generally printed in medium tones.

The protective sheet 18, the microfilter 12 with the frame 12a, the diffuse permeable membrane 16 with the frame 16a, and the test piece 14 with the frame 14a are laminated together to form a unit, and this unit is assembled into a plurality of units on one support 20. If you attach a number of items, you can conduct tests on a large number of items continuously, and in this case, the test results for each subject can be summarized on one sheet. This will prevent the possibility of erroneously entering data.

(Effect of the invention) According to the test piece for simple separation analysis according to the present invention,
Only one drop of body fluid, such as blood, is required as a test sample, and the dropped blood is separated into floating components such as blood cells and serum by a microfilter, and only the serum is passed through the microfilter and the diffusion permeable membrane. The specific components in the serum react with the reagents contained in the specific test piece and develop a color, and the specific biochemical substances are quantified by visual observation. Since it does not have water absorption properties, (a) there is no need to pre-process the body fluid being tested, (b) the liquid content in the body fluid being tested reaches the test piece without being wasted. (c) The time required for the test is extremely short, (d) No equipment is required, and (e) The test results can be determined in a clinical setting. (f) Since it is composed of two types of individual test pieces, it has the advantage that two or more items can be tested simultaneously in one test.

[Brief explanation of drawings]

FIG. 1 is an exploded perspective view showing one embodiment of the test strip for simple fractional analysis of body fluids according to the present invention, and FIG. 2 is a partially cutaway enlarged plan view of the test strip, its frame and support, It is a drawing showing that a discrimination table is printed on a frame portion. 10... Test piece for simple analysis, 12... Micro filter, 12a... Frame, 14... Test piece, 14
a... Frame body, 14b... Discrimination table, 16... Diffusion permeable membrane, 16a... Frame body, 18... Protective sheet, 2
0...Support.

Claims (1)

[Claims] 1 A microfilter, which is a synthetic resin plate with many micropores with a diameter of 0.1 to 0.6μm, that separates suspended matter in body fluid as a sample; and a diffusion permeation membrane that disperses and flows down the liquid that has passed through the microfilter. ; a test piece containing a reagent that develops color by reacting with a specific biochemical substance in body fluids and whose color tone changes depending on the amount of the specific biochemical substance; and a strip-shaped support. A test strip for simple fractional analysis of body fluids, which are arranged in an overlapping manner, and the test strip is composed of at least two types of individual test strips separated from each other.