JP2614044B2 - Hemoglobin detector - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Technical Background) Diagnosis and treatment of diseases that cause gastrointestinal ulcers such as ulcers, carcinomas, tuberculosis, dysentery, typhoid, etc. It is extremely important to test for occult blood reactions (Izumi Kanai, Masamitsu Kanai, clinical laboratory requirements). In particular, occult blood tests are considered clinically possible in 50-77% of gastrointestinal ulcers and 87% of carcinomas with positive occult blood reactions (see above). This is a very important test. Also, hematuria
Inflammation of the urinary tract (acute nephritis, renal tuberculosis, nephritis, cystitis, urethritis, prostatitis, etc.), stones, tumors (carcinoma, papilloma, adrenal tumor, etc.) and hemorrhagic predisposition (hematosis, purpura) Disease, hemophilia, etc.), Filaria, etc. or idiopathic renal bleeding. Hemoglobinuria, in the case of paroxysmal hemoglobinuria, various other poisonings, infectious diseases, streptococcal sepsis, malaria (black water fever),
It is seen in the case of burns, blood transfusions, etc. Early micturition hematuria is specific to urethral disease, and terminal micturition is specific to bladder neck disease. Observing the occult blood reaction of urine is important not only for hemoglobinuria but also for hematuria. 5-8% of hematuria patients
Is said to be asymptomatic (26% is negative for urine protein), so a simple occult blood test is important for early detection of these latent diseases. Therefore, there is a demand for the development of an occult blood reaction test method and reagents that are effective and easy to use in group examinations and home use.

(Prior art) The principle of the occult blood detection method currently generally used is that the peroxidase-like catalysis of hemoglobin (Hb) contained in erythrocytes decomposes peroxide and oxidizes the coloring reagent with oxygen generated at this time. Based on color. Currently, several occult blood anti-fecal test kits are commercially available.

Test slides currently on the market are satisfactory for use in medical offices or hospitals, but for home use it has considerable disadvantages.
An application stick must be used to collect each sample of fecal material from the toilet bowl and apply the sample on a test slide. Therefore, there is a problem that a person using the test slide throws away the application stick and the test slide itself after coloring. Neither the application stick nor the test slide can be discarded in the toilet. Even when test slides are sent to a medical office or medical laboratory for analysis, the problem of discarding dirty application sticks remains with the user. Also, in the sample sampling, when the occult blood level of the subject is low, the occult blood in the stool is not uniform, and the application from only one stool sample increases the possibility of false negative. is there.

The technique of JP-A-59-204766 proposes a solution to this. That is, the technique disclosed in the publication can perform sampling by bringing a specific test slide into contact with the anus, and does not necessarily require an application stick. The test slide incorporates an indicator-impregnated laminated sheet such as guaiac, o-tolidine enclosed in a paperboard envelope. The entire panel of the envelope,
The first side of the indicator-impregnated paper has an opening for applying a stool material sample, and the components of the stool sample appear on the opposite indicator sheet side upon application of the sample, so that the The hydrogen peroxide solution is dropped on the indicator impregnated paper. The blue color on the indicator-impregnated paper indicates the presence of occult blood in the faecal sample on the opposite side. However, in this method of collecting feces using test slides,
The accuracy of the test cannot be assured because the sample can be collected from only one place of the feces. For an accurate test,
Separate sampling of feces from several different locations requires separate sampling and testing. For this purpose, this test slide is a large-scale test slide made of a laminate of tissue papers, is too expensive, and lacks economy.

(Object of the present invention) An object of the present invention is to improve the above-mentioned drawbacks of the prior art and to provide a test device that can perform an occult blood test simply, accurately, and inexpensively at home as well as at a hospital. It is in.

(Structure of the Present Invention) The present invention is configured such that a test sheet in which a hemoglobin detection indicator-containing part and a control part are continuously provided on a wipe stick via a water impervious part is joined to the hemoglobin detection indicator-containing part side. A hemoglobin detector is characterized in that:

The test sheet needs to contain at least an indicator for detecting hemoglobin.

Although the size and shape of the detector are not particularly limited, those having a size and shape that can be easily operated by hand are preferable, and the wipe stick and the inspection sheet are preferably made to have substantially the same length. Has a width of about 5 to 30 mm, a length of about 50 to 200 mm, a thickness of about 3 to 20 mm, and has a rectangular, circular, or elliptical rod or band shape in cross section, and the inspection sheet has a corresponding size. is there.

(Test Sheet of the Present Invention) The test sheet of the present invention may be any as long as it contains a hemoglobin detection indicator on paper, for example. Particularly preferred test sheets include a connection portion with a wipe stick, a detection indicator containing section, It is composed of a water impermeable part, a control part containing a detection indicator, and an operation part in some cases.

The connection part may have feces attached to it along with the wipe stick, but what is necessary is just to absorb the water of feces and the like and permeate the detection indicator containing part.
In addition, the connection portion may be eliminated and the detection indicator-containing portion may be directly provided.

In the hemoglobin detection indicator-containing portion, it is sufficient that the indicator is present to such an extent that a color that can be detected with the naked eye is sufficiently generated when Hb in the moisture permeating from the connection portion reacts with the indicator present therein.

Examples of the indicator for detecting hemoglobin contained in the test sheet of the present invention, that is, the reagent capable of developing color by peroxidase activity include, for example, guaiac butter and its individual components (α-, β-guaiaconic acid, guaiaretinic acid, guaiacic acid) and its components. Mixtures, aniline and its derivatives, o-
Trizine, o-, p-toluidine, benzidine, tetramethylbenzidine, di-anisidine, o-, m-cresol, α-, β-naphthol, catechol, guaiacol, pyrogallol, and a mixture of two or more of these And the like. When dissolving the color former or impregnating the color former, an antioxidant of 0.001 mg / 1 to 100 g / 1 may coexist to prevent the color from being formed due to the auto-oxidation of the reagent. Examples of antioxidants include phenyl-β-naphthylamine and phenyl-α-naphthylamine and other aromatic amines, hydroquinone, aldehyde amine condensate, vitamin E, dibutyloxytoluene (BHA), butylhydroxyanisole (BHT), guaiac Fats, nordihydroguaretic acid, isoamyl gallate, propyl gallate, N-phenylnaphthylamine, β-tocopherol, cesamol, vitamin C, quercetin, ethyl protocatechuate, phenols, β-naphthol, tetramethyldiaminodiphenylmethane and the like, and A mixture of two or more of these is mentioned.

A preferred method of impregnation of, for example, paper or the like with an indicator is to soak it in an indicator solution such as paper and then evaporate the solvent to leave a substantially uniformly dispersed indicator deposit on the paper. A preferred solution for impregnation of paper with the indicator is to use the indicator with a volatile organic solvent such as methanol, ethanol,
Dissolve in isopropanol or acetone and add about 0.5
It can be prepared by producing a solution of the indicator of about 5% by weight. A particularly preferred impregnation solution is a solution of about 1% by weight of indicator in ethanol.

The water impervious portion is only for the purpose of preventing moisture such as feces from invading the control portion, and when a test sheet uses, for example, one sheet of paper, a water spraying agent, a waterproofing agent, etc. May be impregnated, or only this portion may be made of a material that does not permeate water, such as a synthetic resin. In any case, this part should be kept small enough that disposal in the toilet does not have any adverse effects.

The control part is configured the same as the part containing the indicator for detecting hemoglobin. The reason is that an oxidizing agent such as a hydrogen peroxide solution is dropped in the same manner on the hemoglobin detection indicator-containing portion and the control portion for the color reaction, and the color difference between the control portion and the hemoglobin detection indicator-containing portion is sufficiently increased. This is to enable comparison. If the indicator is too long after the impregnation, even if an antioxidant is mixed, the indicator may be partially deteriorated, so that the comparison of the color with the control part will help an accurate inspection.

Since the operation part is a part only for holding by hand, the control part can be extended as it is, but it may be the same depending on the indicator and the manufacturing cost, or it may be formed with a layer that does not contain the indicator. Is also good.

(Wipe Stick of the Present Invention) The wipe stick, which is a holder for an inspection sheet, is made of, for example, a number of paper sheets having an absorbent, polynomial, soft and low wet strength of a kind used as toilet paper, or a certain length or more. Could be a stick made from toilet paper. The paper sheet and the toilet paper have sufficient strength in contact with the biological sample by overlapping each other. In wipes formed from toilet paper plies having low wet strength, the plies are bonded around their edges. Further, it may be formed by low-moisture compression.
At the time of low-humidity compression, water or a soluble or water-decomposable adhesive may be used. At the time of forming the wipe stick, the inspection sheet can be sandwiched and molded together.

(Solution for Color Reaction) As the oxidizing agent solution for performing the color reaction, an aqueous solution of hydrogen peroxide or a mixed solution of water and ethanol is used. The method of applying to the inspection sheet includes a method such as spraying or drip.

(Operation Method) In the operation method of the test tool of the present invention, the test sheet and the wipe stick are brought into contact with a generated sample, for example, a fecal sample as shown in FIG. 3, and a substance sample thereof is collected. Then, the test sheet is turned over to the back side of the wipe stick (FIG. 4), and the color reaction solution is applied to the indicator-containing part and the control part (FIG. 5).
Figure). If the reagent is properly active and the test slide
Unless contaminated with compounds that give a false indication of Hb, the color former-impregnated paper turns blue at the positive monitor portion and the control remains colorless.

(Effect of the present invention) (i) Since it can be thrown away in a toilet, there is no problem of throwing away a dirty diagnostic reagent and attached dirty substances.

(Ii) The operation is simple.

(Iii) The result can be immediately and accurately determined without using any special equipment.

(Iv) Sampling can be easily performed at various points in the feces.

(V) It shows clear color development up to a concentration of 1 to 10 μg / ml with respect to the human Hb solution, and human Hb can be detected.

(Vi) Regarding the effect of iron ions on color development, pH2
In contrast to the fact that a commercially available occult blood diagnostic reagent develops color with 1 mM ferric ion, the effect is significantly suppressed.

(Vii) It is inexpensive.

(Viii) When an antioxidant is used, color development due to autoxidation can be considerably suppressed.

(Ix) When a control section is provided, the judgment is extremely easy, and the judgment can be made highly reliable.

Example o-Tolidine was used as an indicator and hydroquinone was used as an antioxidant. A solution obtained by dissolving 40 mg of o-tolidine and 5 mg of hydroquinone in 10 ml of ethanol is impregnated with a filter paper or sheet which has low wet strength and loses its strength in a few minutes in water and decomposes, and is dried at room temperature. 9m width
m, length 10 cm). At this time, the indicator-impregnated paper is divided into two parts, a sample collection part and a control part, and the filter paper or sheet used for the connection part, the inspection part, the operation part, and the like uses a disposable thing for a toilet. On the other hand, 60-80 cm disposable paper such as toilet paper is folded into a width of about 1-1.5 cm, and an inspection sheet is inserted into the center of one end. It was fixed with glue and formed into a stick shape. FIGS. 1 and 2 show the configuration of this inspection tool. At this time, the inspection sheet is held by the wipe stick as shown in FIG. 1 and has the inspection indicator containing portion and the control portion which are clearly separated. In the examination, as shown in FIG. 3, an examination tool is inserted into a biological sample (in the case of a solid, several places are inserted) or immersed. At this time, the sample should never touch the control part. After bringing the sample into contact with the sample collection section,
As shown in FIG. 4, the operation section of the inspection sheet is picked up and turned over to the back side of the wipe. Therefore, the back side of the surface to which the sample is attached or impregnated is exposed. 3 containing 0.05% acetic acid
% Hydrogen peroxide solution is added dropwise. Also, it is dropped similarly on the control part. Thirty seconds after the dropping, the color of the non-colored part of the control part and the color of the part containing the indicator for inspection are compared. If Hb is present in a biological sample at a certain concentration or more, the color is blue.

The test sheet of the present invention can confirm clear color development at a concentration of 10 μg / ml or more with respect to a human Hb solution. Also,
In the absence of Hb, no color formation was observed even when the color reaction solution was dropped, and no false color development was observed.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of the inspection tool of the present invention, FIG. 2 is a developed view of the detection tool of the present invention, and FIGS. 3 to 5 show a procedure for using the inspection tool of the present invention. DESCRIPTION OF SYMBOLS 1 ... Inspection sheet 2 ... Wipe stick 3 ... Connection part 4 ... Indicator containing part for hemoglobin detection in an inspection sheet 5 ... Water impervious part 6, 6 ... Control part 7 ... Operation part, 8 ... Inspection device of the present invention 9: Feces for inspection, etc. 10: Sample attached matter, 11: Solution for color reaction

Claims (1)

(57) [Claims] 1. A test sheet comprising an indicator containing part for wipes hemoglobin detection and a control part continuously provided through a water impervious part on the side of the indicator containing part for hemoglobin detection. One surface is the sample contact part,
A hemoglobin detector, wherein the other surface is a color observation unit.