JPH11326339A - Testing instrument for use in diagnosis automatic analyzing apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a testing instrument which can prevent a cross contamination among measurement items or specimens and measure with a higher sensitivity. SOLUTION: Test pieces 4 each holding a measurement reagent are accommodated in a plurality of recesses 3 formed continuously via a distance. An opening of the recesses 3 is covered with a mesh 2, etc., or covered so that it can be opened at a measurement time. Accordingly, a humor specimen (except urea) in the recess 3 can be isolated from a humor specimen in the other recesses, whereby a cross contamination is prevented. The recess 3 is preferably formed to be recessed in a plate-like or sheet-like body.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test device provided with a test piece for a diagnostic automatic analyzer used for clinical tests at hospitals, sanitary laboratories, and the like.

[0002]

2. Description of the Related Art Heretofore, the following are known as test devices provided with a test piece for an automatic analyzer for diagnosis. 1. A test device having a plastic stick as a support, and a plurality of test pieces on which a reagent for each test item is carried are fixed or held at intervals. 2. In the reagent layer in which the carrier is impregnated with a reagent such as filter paper,
A test device in which a spreading / supporting layer capable of spreading a sample is laminated, and this is rolled many times in a roll shape.

[0003] 1. Test device (Japanese Patent Application Laid-Open No. 57-1681)
No. 59), in principle, one sample is used for one sample and measurement is performed by the dip-and-read method. However, since multiple items are usually reacted on the same support and measured, the However, there is a problem that the measurement is inaccurate due to mutual influence. In addition, if the sample amount is too large, this effect is likely to occur. Therefore, it is not preferable to impregnate the sample more than a certain amount, and it was not possible to increase the sample amount to increase the sensitivity.

[0004] Further, the above-mentioned 1. In the test device of the form described above, each test device had to be repeatedly loaded into the measurement device and measured, so when processing a large number of limited items as in a mass screening, the operation became extremely complicated. In addition, the measurement time is long.

[0005] In addition, in the conventional stick-type test paper, when a body fluid sample is removed on the test paper, an excessive sample (excess sample) adheres excessively to the space between the test papers or the surface of the test paper, causing color unevenness. Since a color flow may occur, a suction device for suctioning an excess sample between test papers or on the test paper surface to increase measurement accuracy is attached. Therefore, there has been a problem that the cost of the diagnostic automatic analyzer increases.

[0006] 2. Test tool (Japanese Patent Laid-Open No. 4-27306)
3)). Although improvements have been made to handle large numbers of specimens, such as mass screenings, the need to increase the time between dropping specimens to prevent one specimen from intersecting with the next, Since the reagent layer impregnated with the reagents is wasted, the running cost is increased. In addition, even if the amount of the sample is increased, only the planar spread is increased, so that it is impossible to increase the sensitivity by increasing the amount of the sample.

[0007] Further, the above-mentioned 2. In the test device of the form described above, the measurement items were limited to a single item, so when measuring multiple items, the test paper roll had to be replaced, but this replacement work was very time consuming. It was an operation that required

[0008]

Therefore, the conventional test device for an automatic analyzer for diagnosis used in mass examinations and hospitals has a problem in that cross-contamination (cross-contamination) occurs between measurement items or specimens, The running cost is high due to the large waste of test paper, the cost is high due to the necessity of an aspirating device for the excess sample, and it is difficult to increase the sample amount for the purpose of high sensitivity. It is not yet satisfactory.

The present invention according to claim 1 of the present invention is intended to prevent cross-contamination after sample impregnation or color unevenness caused by cross-contamination, that is, cross-contamination between measurement items or between samples (cross-contamination). It is an object of the present invention to provide a test device capable of preventing the occurrence of an excessive sample, preventing measurement, with a higher sensitivity, and omitting an aspirating device for a surplus sample.

The invention according to claim 4 provides, in addition to the above object, a test device that can easily measure a large number of items of a large number of samples as in a mass screening. Aim.

[0011]

According to the present invention, there is provided a semiconductor device comprising:
According to the configuration of the invention described in (1), an absorbent carrier (a test piece) carrying a reagent for measuring a component in a body fluid is accommodated in a plurality of spaced recesses, respectively, and the opening of the recess is filled with a body fluid sample. Can be passed and the internal absorbent carrier can be identifiably covered or can be detached during measurement to isolate the body fluid sample in the recess from the body fluid sample in other recesses. It is characterized by having such a configuration. It should be noted that urine is excluded from the “body fluid” of the present invention. Therefore, the concept of “body fluid” and “specimen” of the present invention does not include urine.

The invention described in claim 4 is the first invention.
Is characterized in that a large number of rows of a plurality of recesses each accommodating test pieces for each measurement item are arranged in parallel and formed in a sheet or roll shape.

In short, the test device for an automatic analyzer for diagnosis according to the present invention accommodates a plurality of test pieces separately in a recess so as not to cause cross-contamination between test items or specimens. The gist of the invention is that the opening of the concave portion is covered so that a body fluid sample can pass therethrough and the internal absorbent carrier can be identified or peeled off.

Conventionally, a plurality of test pieces are separately separated and accommodated in a recess so that cross-contamination does not occur between items or between samples when reacting with a sample. Nothing is known about a test device that covers the opening of the recess so that the body fluid sample can pass through and the internal absorbent carrier can be identified or peeled off. Not known at all.

[0015]

BEST MODE FOR CARRYING OUT THE INVENTION The concave portion of the present invention may be formed in a plate-like or sheet-like body by forming a concave portion (a concave portion) or by continuously forming a concave portion via a partition wall.

The purpose of the present invention is to cover the opening of the recess so that the body fluid sample can pass therethrough and the absorbent carrier in the inside can be identified so that the inner test piece is removed when the test device is manufactured and transported until use. The test piece impregnated with the reagent
In general, it is easily degraded by slight humidity, so in addition to the effective use of the desiccant attached separately, the specimen is directly supplied directly from the material covering the opening and the change in the internal test piece is detected. Is to be able to do it.

Further, in addition to the above objects, a surfactant can be effectively and uniformly supplied to the internal test piece by impregnating a surfactant into a mesh or the like covering the opening. By impregnating and holding the like, it can also be used for the purpose of pretreatment of the sample, such as decomposing ascorbic acid in the sample.

The opening of the concave portion is not particularly limited as long as the body fluid sample can pass therethrough and the internal absorbent carrier can be covered so that it can be identified. It is preferable to cover with a sheet material (a porous material sheet material). The mesh size or pore size can be selected according to the purpose.

In the present invention, the opening of the recess may be covered so that it can be peeled off at the time of measurement. In this case, the material of the sheet-like material covering the opening is not particularly limited. However, it is preferable to cover with a mesh or a porous sheet material because the sample can be directly supplied as it is.

The specimen impregnated by spotting, dripping or immersion on the test piece in the concave chamber reacts with the reagent in the test piece,
Generate reactants. This reactant is detected by a visible, ultraviolet or near-infrared partial photometer, turbidimeter, fluorometer, emission photometer, CCD sensor, microscope, ion meter, refractometer, etc., and the components in urine are detected. Is detected. Therefore, it is necessary to select a mesh or a porous sheet and those colors that do not adversely affect the measurement.

However, depending on the purpose, it is also possible to adopt a method in which a specimen is supplied and the reactant is detected after the mesh or the porous sheet is peeled off and removed. In this case, the material of the sheet-like material covering the opening is not particularly limited.

In the test device of the present invention, the recesses accommodating the test pieces are formed in one or more rows at intervals. The test pieces in the plurality of recesses may be test pieces of the same test item or test pieces of different test items.

However, it is particularly preferable to form the concave portions in a large number of rows and make them into a roll shape or a sheet shape, since it is possible to secure the reliability of the operation of the automatic analyzer for diagnosis and to perform the processing at a high speed. .

[0024]

Next, the present invention will be further described with reference to examples. FIG. 1 to FIG. 4 show a first embodiment of the present invention, in which a short cylindrical concave portion 3 protruding downward is formed in an elongated rectangular plastic flat plate or film 1.
Are formed at intervals and a single item test piece 4 is formed in the recess 3.
(A) is tightly filled, the upper surface thereof is covered with a mesh or a porous sheet material 2, and the test piece 4 is sealed.

FIGS. 5 to 8 show a second embodiment of the present invention, in which the test piece 4 is a multi-item measurement test piece (a to g).
That the concave portion 3 and the test piece 4 are formed in the shape of a short rectangular tube;
Except that the test piece 4 and the test piece 4 are in close contact with each other.
It is formed similarly to the embodiment.

The first embodiment is in the form of a test strip for single item measurement, and the second embodiment is in the form of a test strip for multi-item measurement. In any of the embodiments, there is a problem in the conventional various test devices, for example, cross contamination between body fluid specimens occurs due to the fact that the test strips are not configured to be sufficiently isolated. This eliminates or improves the problems that the sensitivity cannot be increased and that the running cost is increased due to waste of the reagent layer.

FIGS. 9 to 12 show a third embodiment of the present invention, in which a number of recesses 3 are formed in a plastic plate 1 and a test piece (a) for each item to be inspected is measured. ~
An example is shown in which the concave portions 3 each filled with g) are arranged in a line, and a large number of these are formed into a roll (or sheet), and the upper surface is covered with a mesh or a porous sheet 2.

With the configuration as in the third embodiment, in addition to the effects of the first and second embodiments, there is no need to repeatedly load each test tool into the measuring device for measurement.
It can process many samples at extremely high speed,
Even when measuring multiple items, there is no need to change the rolls, so the work can be performed in a short time, and the effect of extremely efficient processing of a large number of samples, such as mass screening, is obtained. Can be

In the above embodiment, sheet feed holes 5 are formed at regular intervals on both sides in the length direction. The use of the feed holes 5 enables intermittent transfer, attachment of body fluid samples line by line, and detection of reactants. Note that, instead of the feed hole, a concave portion or a convex portion may be provided, and these may be provided only on one side in the length direction.

In each embodiment, the test piece may be a single item or a plurality of items.
Is not particularly limited. However, if a plurality of items are formed, a plurality of items can be quickly tested from one body fluid sample.

In the case of a plurality of items, a bar code for identifying the measurement item is provided around the concave portion 3 or a display or mark for identifying the measurement item is provided so that the measurement item can be easily identified. And so on.

In the above Examples 2 and 3, the mesh or porous sheet 2 is in contact with the absorbent carrier 4, but in Example 1, it is not. In general, it is better to make contact because the test piece can be held securely and the test piece can be easily identified.However, if a large amount of sample is used to improve Good to do.

In the above embodiment, the test pieces 4 are accommodated in all the concave portions. However, the test pieces 4 are not accommodated in some of the concave portions, and the openings are not covered with the mesh or the like. It may be formed so as to be good. By storing the sample in the recess formed in this way and measuring the transmitted light or the reflected light, sample information such as coloring and turbidity of the sample can be obtained.

The cross-sectional shape of the concave portion 3 of the present invention can be various shapes such as a circle, an ellipse, and a polygon, and an appropriate shape may be selected according to the purpose. The depth of the recess 3 is generally 0.1 to 30 mm, preferably 0.2 to 1 mm.
5 mm, more preferably 0.3 to 2 mm.

By selecting the depth and size of the concave portion 3, it is possible to use an amount of sample that cannot be obtained with a conventional test device, so that sufficient measurement sensitivity according to the purpose can be obtained. .

The test piece 4 to be filled in the concave portion 3 may be any one that carries a reagent that reacts with the component to be detected in the body fluid. What has conventionally been used for this purpose is:
Either can be used. Further, when it is necessary to use a plurality of reagents for measurement of components in a body fluid, in order to prevent a reaction between the two, a plurality of reagents are carried on separate test pieces 4, which are put together in the same recess 3. It may be filled. Alternatively, the concave portion 3 may be formed as a multilayer prism and / or a multilayer cylinder and / or a concentric multilayer sphere in which another reagent is supported on multiple layers.
May be filled.

The material for forming the concave portion 3 is not particularly limited. For example, polyvinyl chloride, polyvinylidene chloride,
Examples include synthetic resin and paper such as polycarbonate, polyethylene, polypropylene, polyester, polystyrene, fluororesin, polyethylene oxide, and biodegradable polymer, paper, synthetic resin laminated paper, and aluminum laminated paper.

The material of the mesh or porous sheet material 2 may be any material that does not adversely affect the measurement.
For example, synthetic fibers, natural fibers, semi-synthetic fibers, recycled fibers, glass fibers, metal fibers, inorganic fibers, and the like can be used.

Examples of the synthetic fibers include polyethylene, polypropylene, polyester, polystyrene, polyvinyl chloride, polyvinylidene chloride, polycarbonate, nylon, tetron, vinylon, acryl, polycarbonate, and hydrophilically treated hydrophobic polymers. As semi-synthetic fiber, acetate, as regenerated fiber,
Viscose rayon and cuprammonium rayon, natural fibers include hemp, cotton, silk, wool, Japanese paper filter and filter paper, inorganic fibers include glass fibers, and metal fibers include alloy fibers.

The method of joining the upper surface of the concave portion 3 to the mesh or the porous sheet material 2 is not particularly limited, and examples thereof include a cellophane tape, a polypropylene adhesive tape, a polyester adhesive tape, a vinyl adhesive tape, a cloth adhesive tape, and a kraft adhesive tape. , Paper adhesive tape, hot melt adhesive, thermocompression bonding, press bonding, high frequency bonding, ultrasonic bonding, stitching, tacking, stapling, magnetic stopping, cellulose adhesive, acrylic emulsion adhesive, vinyl acetate emulsion adhesive A method using an adhesive, a cyanoacrylate-based adhesive, an air-blocking anaerobic adhesive, or the like.

The production of the test device for an automatic analyzer for diagnosis according to the present invention is performed, for example, by using a long plastic plate or film 1 having a large number of rows of recesses 3 as shown in FIG.
Is unwound from a roll 9 and an absorptive carrier (circular punched test piece) 4 is filled into a concave portion 3 from a test piece feeder 8, and the mesh or perforated sheet material 2 unwound from above is refilled.
Is pressed on a plastic plate or film 1 with a pressure roll 6 and wound up on a roll 10 as a roll-shaped body fluid test device 7 to be able to manufacture continuously.

The opening at the bottom of the test piece feeder (hopper) 8 is adjusted by applying vibration so that the circular punched test pieces 4 come out one by one. At the top, vibration is applied while the test piece feeder 8 is moved to fill the sheets one by one.

According to the present invention, since the body fluid sample supplied to the test piece 4 in the recess 3 is isolated from the body fluid sample in the other recess 3, cross contamination between body fluid samples is prevented. At the same time, the desired sample amount can be obtained, so that the measurement sensitivity can be improved. Further, unlike the conventional roll-shaped body fluid test device, the test layer is not wasted in order to prevent cross contamination, so that the running cost can be reduced.

Since a certain amount of sample can be supplied to the recess 3 of the present invention, the test device of the present invention can be used not only for qualitative purposes but also for quantitative or semi-quantitative purposes. Further, since the opening of the concave portion 3 is covered with the mesh 2 or the like, the test piece is prevented from jumping out, and furthermore, the body fluid sample can be supplied from above the material 2 as it is. The reactants can be detected as they are.

Further, in the present invention, since the sample enters the concave portion 3 and the sample adheres to the mesh surface on the surface in a substantially constant amount, it is possible to omit the device for sucking the excess body fluid.
The mechanical device can be simplified, and the equipment cost can be reduced.

Further, if the test device of the present invention is formed into a roll or a sheet, the form is the same as that of a conventional roll-shaped body fluid test paper or sheet-shaped body fluid test paper. As a result, it is possible to ensure the reliability of the sample and to perform high-speed processing, and it is possible to measure a large number of samples in a short time as in a mass examination.

The specimens of the test device of the present invention include specimens other than urine, such as serum, plasma, blood, saliva, lymph, fecal suspension and cerebrospinal fluid, preferably serum, plasma, blood , Saliva.

According to the present invention, the components in the sample, such as urobilinogen, occult blood, bilirubin, ketone bodies, ascorbic acid, glucose, protein, pH, specific gravity,
Single or multiple components such as leukocytes, nitrites, triglycerides, amylase, and phospholipids can be measured simultaneously.

[0049]

As described above, the first aspect of the present invention completely prevents cross-contamination during measurement and eliminates cross-contamination between measurement items or cross-contamination between samples. By increasing the amount of the sample, the measurement sensitivity can be improved, and the test layer is not wasted, so that the running cost can be reduced and the device for aspirating excess body fluid is omitted. Therefore, the present invention has many remarkable effects that are not seen at all in the conventional test device for an automatic analyzer for diagnosis, such as reduction in equipment cost.

Further, by changing the size and shape of the test piece and the concave portion, it is possible to effectively use an amount of the sample that could not be achieved by the conventional method, and it is possible to improve a desired measurement sensitivity. it can.

Further, the invention according to claim 4 is the same as the invention according to claim 1.
In addition to the effects of the invention described in (1), since it is not necessary to repeatedly load each test device into the measurement device and perform measurement, a large number of sample processing can be performed extremely quickly and easily. Even in the case of measurement, it is not necessary to change the rolls, so that the work can be performed in a short time and the processing capacity is improved, so that it is extremely effective in processing a large number of samples such as a mass examination.

[0052]

[Brief description of the drawings]

FIG. 1 is a perspective view showing a first embodiment of a test tool for an automatic analyzer for diagnosis of the present invention.

FIG. 2 is a plan view of FIG.

FIG. 3 is a cross-sectional view taken along line AA of FIG.

FIG. 4 is a sectional view taken along line BB of FIG. 2;

FIG. 5 is a perspective view showing a second embodiment of the test tool for a diagnostic automatic analyzer according to the present invention.

FIG. 6 is a plan view of FIG. 5;

FIG. 7 is a sectional view taken along line CC of FIG. 6;

FIG. 8 is a sectional view taken along line DD of FIG. 6;

FIG. 9 is a perspective view showing a third embodiment of the test device for an automatic analyzer for diagnosis of the present invention.

FIG. 10 is a plan view of FIG. 9;

11 is a sectional view taken along line EE in FIG.

FIG. 12 is a sectional view taken along line FF in FIG. 10;

FIG. 13 shows a test tool (third test) for an automatic analyzer for diagnosis of the present invention.
It is a perspective view which shows the manufacturing method of Example).

[Explanation of symbols]

Reference Signs List 1 plastic plate or film 2 mesh or porous material 3 recess 4 test piece (absorbent carrier impregnated with reagent) 5 feed hole 6 pressure roll 7 roll-shaped diagnostic test tool 8 test piece feeder (hopper)

Claims (14)

[Claims] An absorbent carrier carrying a reagent for measuring a component in a body fluid (but excluding urine) is accommodated in a plurality of spaced recesses, and the opening of the recess is filled with a body fluid sample. (However, a urine sample is excluded) is covered so as to be able to pass through and to identify the absorbent carrier inside, or to be able to be peeled off at the time of measurement, so that the body fluid sample in the recess and the other fluid in the other recess are covered. A test device for an automatic analyzer for diagnosis, characterized in that it is configured to be able to isolate a body fluid sample. 2. The test device according to claim 1, wherein the recess is formed as a recess in a plate or sheet. 3. The test device according to claim 1, wherein the opening of the recess is covered with a mesh or a porous sheet. 4. The method according to claim 1, wherein a plurality of rows of the plurality of recesses for separately accommodating the absorptive carriers for each measurement item are arranged in a row and formed in a sheet shape or a roll shape. Or the test device according to item 1. 5. The method according to claim 1, wherein the recess is formed in a vertical direction and / or a horizontal direction.
2. The semiconductor device according to claim 1, wherein said first metal member is formed at an interval of 0.5 mm to 30 mm.
Or the test device according to 4. 6. The test device according to claim 1, wherein a cross-sectional shape of the recess is a circle, an ellipse, or a polygon. 7. The depth of the recess is 0.1 mm to 30 mm.
The test device according to claim 1, wherein: 8. The test device according to claim 3, wherein the material of the mesh or the porous sheet is a synthetic fiber, a natural fiber, a semi-synthetic fiber, a recycled fiber, a glass fiber, a metal fiber, or an inorganic fiber. 9. A transfer hole, a concave portion or a convex portion is formed on at least one side of the length direction of the test device.
Or the test device according to 4. 10. The test device according to claim 1, wherein the absorptive carriers contained in the concave portion include a plurality of absorptive carriers carrying different reagents and an absorptive carrier for detecting one component. 11. The test tool according to claim 4, wherein a bar code for measuring item identification or a display or mark for identifying the measuring item is provided around the concave portion. 12. A method for measuring a component in a body fluid, comprising using the test device according to any one of claims 1 to 11. 13. The means used for measurement includes a spectrophotometer, a turbidimeter, a fluorometer, a refractometer, a CCD sensor,
The measuring method according to claim 12, which is a microscope or an ion meter. 14. A body fluid sample used for measurement may be serum,
13. The measuring method according to claim 12, wherein the measuring method is plasma, blood or saliva.