This disclosure relates to a medical consumable for in vitro diagnosis in particular to an excrement detecting disc for qualitatively or quantitatively detecting a specific component of excrement such as urine and feces, and a manufacturing method of an excrement detecting disc.
Human excretions, especially urine and feces, contain a large amount of physiological and pathological information. Therefore, urine and stool examinations have become clinical routine check item.
With the progress of the dry chemical test strips and cooperating scanning test equipment related to the routine detection items of urine, the routine examinations of urine are basically automated. The conventional automated detection of feces has also made significant progress in recent years.
The detection reagent “all-in-one” of the detection item of the urine or feces is collected on the test strip to improve the detection efficiency. But there are still deficiencies including:
(1) The number of detection items increases, the length of test strips increases, and the corresponding detection equipment increases in volume so that an increase of the amount of excrement samples is required;
(2) Interference between reagents for the detection items, affecting the accuracy of the results;
(3) Items with significantly different detection principles cannot coexist in the same test strip, for example, the needs to heating, cooling, and add specific reagents, etc.;
(4) The test strip moves back and forth, left and right, and moves more than the circumference, which consumes more energy and has lower efficiency;
(5) Multiple tests share a blank control, and the error is large, making it difficult to achieve quantitative detection;
In view of the above, the test strip is designed into a disc having a spoke-like shape, which completely separates the interference between the reagents, multiplies the space for installation of the detection items, and the personalized detection items and the general detection items can be mashed up and coexist to assist the automation of the manual operation. The results are more accurate and the work is more efficient.
The object of this disclosure is to provide an excrement detecting disc for detecting specific components of excrement such as urine and feces, and a manufacturing method thereof For avoiding mutual interference between reagents of different detection items, the personalized detection items and the general detection items are mashed and coexist in the same detecting disc to improve work efficiency.
To achieve the above object, the solution according to this disclosure is:
An excrement detecting disc includes a substrate and reagent blocks. The substrate includes fan-shaped blades with spoke-like arrangement and a handle, and a ring coupled with the blade by the handle. Each of the blades has a front side and a back side, and an identification code is set on the front side of each of the blades. The corresponding reagent block is pasted at the position of the corresponding identification code. The identification codes are set on the blades for a detecting device to identify types of excrement and detection items, and to choose appropriate wavelength. The center of the ring is formed with a slot. The slot is coupled with a corresponding component of the detecting device. The corresponding component of the detecting device is fixed to a motor shaft for completion of transferring and transporting a test strip, rotating, and completion scanning. The slot is matched with an mechanical arm for clamping. It is convenient for clamping suction or negative-pressure suction of the mechanical arm to the ring, and beneficial to automation. The reagent blocks include a chemical reagent block, an enzymatic reagent block, an immunological reagent block, a biochip reagent block, and a background control reagent block.
The chemical reagent block includes bilirubin, cholesterol, ketone body, specific gravity, pH value, nitrite, protein, starch, fat, and/or inorganic salt. The enzymatic reagent block includes glucose, hemoglobin, and/or white blood cells. The immunological reagent block includes hemoglobin, transferrin, pathogenic microorganism, and/or hormone. The biochip reagent block includes a microbial gene chip and/or a cancer cell gene chip.
Each of the blades has a width of 3 mm to 6 mm and a length of 10 mm to 20 mm. The blades are spaced apart from each other by not less than 2.5 mm. There is no direct contact between the blades to avoid interference from reagents of different detection items. The handle has a width of 2.5 mm and a length of 2.5 mm. The ring is disc-shaped with a diameter of 10 mm to 15 mm and can be rotated, thereby reducing the volume of the detecting device for transmission and scanning, and shortening the detection time. Each of the blades is further divided into a plurality of troughs for containing a liquid. The troughs are composed of grooves and frames on the blades. The troughs are installed with the reagent blocks or a blank therein. The blank is used for identifying, classifying, and counting of excrement samples.
The fan-shaped blades with spoke-like arrangement may be further formed into formed as three-dimensional structures having multi-layered fan-shaped blades. The layers of the blades are spaced apart from each other by 5 mm. The multi-layered blades are arranged alternately and correspondingly increasing the number of the blades and the number of the reagent blocks.
An outer edge of the ring is further provided with a socket. The socket is adapted to receive the handle. The handle is insertable and replaceable, modular-designed. The detection items are randomly combined according to needs thereby saving resources.
Each of the reagent blocks includes an item detection reagent block and a background control reagent block. Each detection item is installed with negative control, to eliminate the colors of the excrements itself, the backgrounds of reagents, the influences of dyeing of the different reagent blocks, and to improve the reliability of the detection results. In addition, a standard control of the detected component is set if necessary to achieve accurate quantitative detection. The item detection reagent blocks and the background control reagent blocks are spaced apart by 2.5 mm and arranged in series or in parallel on the blades. The background control reagent block can be a quality control reagent block. The background control reagent block is shared. Two or more item detection reagent blocks can be provided in the same blade to save spaces and to accommodate more detection items.
The item detection reagent block includes urine detection, stool detection, saliva detection, prostatic fluid detection, semen detection, milk detection, and human body drainage detection.
The reagent blocks are mounted on the blades with spoke-like arrangement and arranged in the order of pH values of the reagents. The pH values are arranged in a circular order as from 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 7.0, 6.0, 5.0 to 4.0. It is completely avoided that the mutual contacts and pollutions between the reagents and the changes of pH conditions which brings about unrealistic coloring by reactions. The width of the blades can be increased or decreased.
A method for manufacturing an excrement detecting disc includes the steps of: preparing a substrate, preparing a large-sized adsorption reagent carrier, cutting the large-sized adsorption reagent carrier into a reagent block, and bonding and packaging the reagent block to the substrate. Preparing the substrate includes three-dimensionally designing the substrate, designing a mold, PVC injection molding, and spraying an identification code. Preparing the large-sized adsorption reagent carrier includes preparing a detection reagent and a large carrier adsorption reagent. Bonding the reagent blocks to the substrate is making the reagent blocks pasted on a front side of a blade of the substrate.
By the above technical means, a detecting disc made by the method for manufacturing the excrement detecting disc of the present disclosure can accommodate more detection items since the reagent blocks are attached to the fan-shaped blades with spoke-like arrangement. At the same time, the spaces between the blades are used to avoid mutual interference between reagents of different detection items. The personalized detection items and general detection items are mashed up and coexist in the same detecting disc to improve work efficiency. Each of the detection items is set with a negative control to improve the reliability of the detection results.
For a detailed description of the technical contents, structural features, objects and advantages of the present disclosure, the embodiments will be described in detail below with reference to the accompanying drawings.
As shown in
The substrate includes fan-shaped blades 1 with spoke-like arrangement and a handle 2, and a ring 3. The blade 1 and the ring 3 are coupled by the handle 2. Each of the blades 1 has a front side and a back side
An identification code is set on the front side of each of the blades 1. The corresponding reagent block 11 is pasted at the position of the corresponding identification code. The identification codes are set on the blades 1 for a detecting device to identify types of excrements and detection items and to choose appropriate wavelength. The center of the ring 3 is formed with a slot 4. The slot 4 is coupled with a corresponding component of the detecting device 7. The corresponding component of the detecting device 7 is fixed to a motor shaft for completion of transferring and transporting the testing disc, rotating, and completion of scanning.
The slot 4 is matched with a mechanical arm 5 for clamping. The mechanical arm 5 is configured to suck the ring 3 or clamp the slot 4. The mechanical arm 5 can perform suction by negative pressure. Clamping the detecting disc is carried out in the first working position, soaking the detecting disc into an excrement sample container 6 is carried out in the second working position, and taking the detecting disc out of the excrement sample container 6 and sending into the detecting device 7 is carried out in the third working position, which are all performed through automate operations.
The reagent blocks include a chemical reagent block, an enzymatic reagent block, an immunological reagent block, a biochip reagent block, an item detection reagent block 11 and a background control reagent block 12. The chemical reagent block includes bilirubin, cholesterol, ketone body, specific gravity, pH value, nitrite, protein, starch, fat, and/or inorganic salt. The enzymatic reagent block includes glucose, hemoglobin, and/or white blood cells. The immunological reagent block includes hemoglobin, transferrin, pathogenic microorganism, and/or hormone. The biochip reagent block includes a microbial gene chip and/or a cancer cell gene chip.
Each of the blades 1 has a width of 3 mm to 6 mm and a length of 10 mm to 20 mm. The blades 1 are spaced apart from each other by not less than 2.5 mm. There is no direct contact between the blades 1 to avoid interference from reagents of different detection items.
The handle 2 has a width of 2.5 mm and a length of 2.5 mm. The ring 3 is disc-shaped with a diameter of 10 mm-15 mm.
The substrate has a diameter of 50 mm and can be rotated to reduce the volume of detecting device 7 for transmission and scanning and to shorten the detection time, that is, the detecting disc according to the disclosure accommodates as many detection items. Compared with the conventional long test strip, the detecting disc of the present disclosure is designed in the shape of a disc. To a certain extent, the length of the scanning of the detecting device can be reduced. Compared with the forward and backward motions for scanning of the conventional long test strip, the disc-shaped structure designed according to the present disclosure carries out scanning by rotation. To a certain extent, the detection time can be shortened.
The outer edge of the ring 3 is further provided with a socket 8. The socket 8 is adapted to receive the handle 2. The handle 2 has a length of 5 mm, and an insertable socket section 22 of the handle 2 has a length of 2.5 mm. The handle 2 is pluggable, detachable, and replaceable with the socket 8, achieving modular design. The detection items are randomly combined according to needs thereby saving resources.
The fan-shaped blades 1 with spoke-like arrangement may be further formed as three-dimensional structures having multi-layered fan-shaped blades. Each of the layers of the blades 1 is linked by a rotor 10. The rotor 10 is pluggable with the slot 4. The layers of the blades 1 are spaced apart from each other by 5 mm. The multi-layered blades 1 are arranged alternately and correspondingly increasing the number of the blades 1 and the number of the reagent blocks 11. The alternate arrangement will allow the reagent blocks provided in the blades 1 to be detected by the detecting device 7.
In this embodiment, each of the reagent blocks includes an item detection reagent block 11 and a background control reagent block 12. Each detection item is installed with negative control, to eliminate the colors of the excrements itself, the backgrounds of reagents, the influences of dyeing of the different reagent blocks, and to improve the reliability of the detection results. In addition, a standard control of the detected component is set if necessary to achieve accurate quantitative detection. The item detection reagent block 11 and the background control reagent block 12 are spaced apart by 2.5 mm and arranged in series or in parallel. The background control reagent block 12 can be shared. A third item detection reagent block 13 can be provided in the same blade 1 to save spaces and to accommodate more detection items.
The detection items include urine detection, stool detection, saliva detection, prostatic fluid detection, milk detection, and human drainage detection. The urine detection includes urine specific gravity, pH, vitamin C, nitrite, protein, albumin, leukocytes, occult blood, creatinine, urobilinogen, bilirubin, glucose, ketone bodies, hormones, inorganic salts, and other metabolites; the stool test includes feces: pH, white blood cells, occult blood (hemoglobin, transferrin), cancer cells ingredients, fecal urobilin, stercobilinogen, glucose, protein, starch, fat, pathogenic microorganisms, and intestinal flora.
The reagent blocks are mounted on the blades with spoke-like arrangement and arranged in the order of pH values of the reagents. The pH values are arranged in a circular order as from 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 7.0, 6.0, 5.0 to 4.0. It is completely avoided that the mutual contacts and pollutions between the reagents and the changes of pH conditions which brings about unrealistic coloring by reactions.
The width of the blades can be increased or decreased. The blade 1 can also be divided into a trough 14 for the detection item and a background control trough 15 to contain a liquid; the trough 14 is composed of a groove and a frame on the blade 1. A reagent block is arranged at the bottom of the trough 14 to detect the components of the excrement sample by enzymatic, chemical or immunological methods, or by a biochip method. The trough 14 can also be a blank, to carry samples, used for identifying, classifying, and counting of excrement samples.
As shown in
The above is only the embodiment of the present disclosure is not intended to limit the technical scope of the present disclosure. Therefore, any minor alterations, equivalent changes and modifications made to the above embodiments in accordance with the technical spirit of the present invention still belong to the present invention, within the scope of the technical solution.
Number | Date | Country | Kind |
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201711087603.X | Oct 2017 | CN | national |