CN113670910A - Total bilirubin test card and manufacturing method thereof - Google Patents
Total bilirubin test card and manufacturing method thereof Download PDFInfo
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- CN113670910A CN113670910A CN202110977274.6A CN202110977274A CN113670910A CN 113670910 A CN113670910 A CN 113670910A CN 202110977274 A CN202110977274 A CN 202110977274A CN 113670910 A CN113670910 A CN 113670910A
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- total bilirubin
- test card
- blood
- film
- upper cover
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/775—Indicator and selective membrane
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/7756—Sensor type
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/7769—Measurement method of reaction-produced change in sensor
- G01N2021/7773—Reflection
Abstract
The invention provides a total bilirubin test card and a manufacturing method thereof, the test card comprises an upper cover, a gauze, a blood suction pad, a blood filtering membrane, a chromogenic membrane, a PET negative and a lower cover, and the total bilirubin test card is formed by sequentially assembling the upper cover, the gauze, the blood suction pad, the blood filtering membrane, the chromogenic membrane, the PET negative and the lower cover from top to bottom. The method is convenient for quickly, conveniently and accurately measuring the total bilirubin concentration in the serum of the human body.
Description
Technical Field
The invention belongs to the technical field of detection equipment, and particularly relates to a total bilirubin test card and a manufacturing method thereof.
Background
Bilirubin is one of the bile pigments, which is the major pigment in human bile and is orange yellow. The bilirubin in the serum is mostly derived from hemoglobin produced after aged red blood cells are destroyed, the bilirubin is called direct bilirubin after being subjected to glucuronidation in the liver, the bilirubin is called direct bilirubin without being subjected to glucuronidation in the liver, the bilirubin is called indirect bilirubin without being subjected to glucuronidation in the liver, and the sum of the bilirubin and the indirect bilirubin is the bilirubin.
Jaundice is the clinical manifestation of hyperbilirubinemia, i.e. when serum total bilirubin is greatly increased, the skin, sclera, urine and serum of a human body are yellow, so that the jaundice is called. Jaundice can be generally classified into the following categories: (1) hemolytic jaundice: when hemolytic anemia is caused, a large number of red blood cells are destroyed to form a large number of non-combined bilirubin, and the absorption, combination and excretion capacities of stem cells are exceeded, so that bilirubin is retained in blood to cause jaundice; (2) hepatocellular jaundice: due to liver cell damage, the ability to take, bind and excrete bilirubin is reduced, and various liver diseases are common; (3) cholestatic jaundice, the reverse flow of bilirubin in the bile into the blood. Bilirubin is an important basis for clinically judging jaundice and also an important index of liver function.
Currently, the measurement of bilirubin in serum requires the use of large biochemical analyzers and specialized technicians, which undoubtedly increases the time and cost of the measurement.
Disclosure of Invention
The invention aims to solve the defects in the prior art and provides a total bilirubin test card and a manufacturing method thereof, the total bilirubin test card is convenient for quickly, conveniently and accurately measuring the total bilirubin concentration in human serum, the limitation of the current total bilirubin test paper on the sample requirement is perfectly solved, the test card is not only limited to serum, the technology can be applied to whole blood, and the test operation of a user is greatly facilitated and the cost is reduced.
The invention adopts the following technical scheme:
the invention relates to a total bilirubin test card, which comprises an upper cover, a gauze, a blood sucking pad, a blood filtering film, a color developing film, a PET negative film and a lower cover. The upper cover, the gauze, the blood sucking pad, the blood filtering film, the color developing film, the PET bottom sheet and the lower cover are assembled in sequence from top to bottom to form the test card.
The upper cover is rectangular, and the middle part of the upper cover is provided with a sample dripping hole. The upper cover is buckled with the lower cover. The lower cover is provided with a hand-held part and a buckling part, and the middle part of the buckling part is provided with a test area.
Preferably, the inner side of the upper cover is provided with a buckling column for buckling, and the middle part of the upper cover is provided with a laminated sheet with a grid hole.
Preferably, the fastening part has a fastening hole matched with the fastening column and a fastening groove matched with the upper cover, and the two sides of the test area are provided with protrusions.
Preferably, the hand-held portion has a hand-held aperture.
The PET film is rectangular, the length is 19mm, the width is 4.7mm, the thickness is 0.17mm, a round hole with the diameter of 3.8mm is formed in the middle of the PET film, round holes with the diameter of 2.5mm are formed in two sides of the round hole in the middle, and the center distance between the round hole in the middle and the round holes in the two sides is 7.5 mm.
The blood filtering membrane is rectangular, the length is 10mm, the width is 4.7mm, and the thickness is 0.12 mm.
The membrane was shown to be rectangular, 6mm in length, 4.7mm in width and 0.12mm in thickness.
The blood sucking pad is rectangular, and has a length of 10mm, a width of 4.7mm, and a thickness of 0.12 mm.
The gauze is rectangular, the material is polyester, the length is 11mm, the width is 4.7mm, the thickness is 0.2mm, and the aperture is 348 female/inch.
A method for manufacturing a total bilirubin test card comprises the following steps:
And 2, preparing a reaction liquid medicine, spotting the prepared reaction liquid medicine on a color developing film in a spotting way, and then baking in a baking channel at the baking temperature of 37 ℃ for 25 min. Each test card contains the following chemicals: 0.12mg of sulfanilic acid, 0.05mg of sodium nitrite and 0.08mg of diprophylline.
And 3, after baking, integrally sticking a layer of blood filtering film on the display film and the PET bottom sheet, sticking a blood sucking pad and a gauze, fixing the stuck multilayer film by using an ultrasonic welding machine, then detaching and cutting the whole test strip into small strips by using a small strip detaching and cutting machine, then mounting the detached small strips into an upper cover and a lower cover, and finishing the bilirubin test card.
The invention has the beneficial effects that:
the method is suitable for whole blood to test, does not limit the test sample to serum, avoids the defects of large blood drawing amount, centrifugal step and operation dependence on professionals, and eliminates the interference caused by red blood cells when the whole blood is suitable for testing.
The invention mainly utilizes the blood filtering membrane to remove red blood cells in the whole blood, thereby avoiding the interference on the detection result.
Drawings
FIG. 1 is a schematic view of the structure of an upper cover;
FIG. 2 is a schematic view of a gauze structure;
FIG. 3 is a schematic view of a blood sucking pad;
FIG. 4 is a schematic view of a structure of a blood filtration membrane;
FIG. 5 is a schematic view of a structure of a color developing film;
FIG. 6 is a schematic view of a PET backsheet construction;
FIG. 7 is a schematic view of the structure of the lower cover;
FIG. 8 is a schematic front view of the present invention;
FIG. 9 is a schematic view of the overall backside structure of the present invention;
FIG. 10 is a standard curve diagram of the biochemical concentration of total bilirubin and the signal value (the vertical axis of the curve represents the total bilirubin concentration, and the horizontal axis represents the signal value, and it can be seen from the standard curve that the linear correlation is good and can reach 0.9949);
FIG. 11 is a schematic view of a cut PET backsheet;
FIG. 12 is a schematic view of a cut blood filtration membrane;
FIG. 13 is a schematic view of a cut color-developing film;
FIG. 14 is a schematic view of a cut blood sucking pad;
fig. 15 is a schematic view of a cut screen structure.
In the figure: 1-upper cover, 2-gauze, 3-blood sucking pad, 4-blood filtering membrane, 5-color developing membrane, 6-PET negative film and 7-lower cover;
100-sample dropping holes, 101-buckling columns, 102-laminated sheets and 103-grid holes;
701-hand held portion, 702-fastening portion, 703-testing region, 704-fastening hole, 705-protrusion, 706-fastening groove, 707-hand held hole.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention are described below clearly and completely, and it is obvious that the described embodiments are some, not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
T-Bil: total bilirubin
CODE: the linear relationship between response signal and concentration for a batch of test cards (e.g., y. kx + b, this equation is known as CODE), also known as the standard curve.
As shown in fig. 1-15, the total bilirubin test card of the present invention comprises an upper cover 1, a gauze 2, a blood absorption pad 3, a blood filter 4, a color development film 5, a PET base sheet 6, and a lower cover 7.
The test card is formed by sequentially assembling an upper cover 1, a gauze 2, a blood sucking pad 3, a blood filtering film 4, a color developing film 5, a PET bottom sheet 6 and a lower cover 7 from top to bottom.
The upper cover 1 is rectangular, and the middle part of the upper cover 1 is provided with a dripping sample hole 100. The upper cover is buckled with the lower cover 7. The lower cover 7 has a handle 701 and a fastening portion 702, and the middle portion of the fastening portion 702 has a testing area 703.
Preferably, the upper cover 1 has a fastening post 101 for fastening on the inner side and a laminated sheet 102 having a grid hole 103 in the middle.
Preferably, the fastening portion 702 has a fastening hole 704 for engaging with the fastening post 101, and a fastening groove 706 for engaging with the top cover 1, and the two sides of the testing area 703 have protrusions 705.
Preferably, the handle 701 has a handle aperture 707.
The PET bottom plate 6 is rectangular, the length is 19mm, the width is 4.7mm, the thickness is 0.17mm, a round hole with the diameter of 3.8mm is formed in the middle of the PET bottom plate 6, round holes with the diameter of 2.5mm are formed in two sides of the round hole in the middle, and the center distance between the round hole in the middle and the round holes in the two sides is 7.5 mm.
The blood filtering membrane 4 is rectangular, the length is 10mm, the width is 4.7mm, and the thickness is 0.12 mm.
The membrane 5 is shown as rectangular, 6mm in length, 4.7mm in width and 0.12mm in thickness.
The blood absorption pad 3 is rectangular, and has a length of 10mm, a width of 4.7mm and a thickness of 0.12 mm.
The gauze 2 is rectangular, is made of polyester, has the length of 11mm, the width of 4.7mm, the thickness of 0.2mm and the aperture of 348 meshes/inch.
The test method of the invention comprises the following steps:
blood drips from dripping into the hole 100, diffuse to on the blood filter membrane 4 through gauze 2 and blood sucking pad 3, red blood cell can be filtered to the blood filter membrane 4, the remaining serum after filtering red blood cell enters into on the color development membrane 5, total bilirubin in the serum can take place the color development with the liquid medicine on the color development membrane 5, monitor the color intensity on the color development membrane 5 through the instrument, this color intensity is directly proportional with total bilirubin in the serum, promptly total bilirubin concentration is higher, the colour after the reaction is darker, can obtain the concentration of total bilirubin in the serum through the depth of this color intensity promptly.
The reaction principle of the invention is as follows:
blood is dripped from a dripping sample port, the blood is fully diffused through gauze and a blood sucking pad and enters a blood filtering membrane, red blood cells are filtered by the blood filtering membrane, serum enters a display membrane, total bilirubin in the serum reacts with sulfanilic acid and sodium nitrite under the action of diprophylline to generate red azo bilirubin, the azo bilirubin has a maximum absorption peak at the position with the wavelength of 550nm, the intensity of the reaction showing red is detected according to a reflection spectrophotometry, and the color intensity is in a certain proportion to the total bilirubin concentration in the serum, so the concentration of the total bilirubin in the serum can be calculated according to the color intensity.
The manufacturing method of the total bilirubin test card comprises the following steps:
And 2, preparing a reaction liquid medicine, spotting the prepared reaction liquid medicine on the color developing film 5 in a spotting way, and then baking in a baking channel at the baking temperature of 37 ℃ for 25 min. Each test card contains the following chemicals: 0.12mg of sulfanilic acid, 0.05mg of sodium nitrite and 0.08mg of diprophylline.
And 3, after baking, integrally sticking a layer of blood filtering film 4 on the display film 5 and the PET bottom sheet 6, sticking a blood sucking pad 3 and a gauze, fixing the stuck multilayer film by using an ultrasonic welding machine, detaching and cutting the whole test strip into small strips by using a small strip detaching and cutting machine, and then mounting the detached small strips into the upper cover 1 and the lower cover 7, thus completing the bilirubin test card.
Examples
Taking 5 parts of fresh sample whole blood with gradient total bilirubin concentration, dividing each concentration into 3 parts, carrying out total bilirubin test by biochemical analysis on the first part, determining a total bilirubin standard curve on the second part, carrying out test by using a total bilirubin test card on the third part, comparing the obtained result with the biochemical analysis, and obtaining test data and a standard curve as follows:
the test data is a standard curve confirmation from which can be derived: the repeatability of the tested signal value is good, and the detected signal is a reflected light intensity signal, so that the higher the total bilirubin concentration is, the darker the reaction color development color is, the more the absorbed light intensity is, the less the reflected light is, and the smaller the signal value is; the lower the total bilirubin concentration is, the larger the signal value is; from the experimental data, a standard curve of total bilirubin biochemical concentration versus signal value was fitted linearly, as shown in FIG. 10.
The third sample was tested using the total bilirubin test card and the results are shown in the following table:
the test result shows that the total bilirubin test card has good repeatability, the CV is within 5 percent, and the deviation from the biochemical value tested by a large-scale biochemical instrument is small, which indicates that the total bilirubin test card has high accuracy, the sample can be suitable for both serum and whole blood, the interference caused by red blood cells is completely eliminated, the limitation of the current total bilirubin test paper on the test sample is completely solved, and the complexity and the cost of the test are greatly reduced.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (10)
1. A total bilirubin test card is characterized by comprising an upper cover, a gauze, a blood sucking pad, a blood filtering film, a color developing film, a PET negative film and a lower cover;
the total bilirubin test card is formed by sequentially assembling an upper cover, a gauze, a blood sucking pad, a blood filtering film, a color developing film, a PET bottom sheet and a lower cover from top to bottom;
the upper cover is rectangular, a sample dripping hole is formed in the middle of the upper cover, the upper cover is connected with the lower cover in a buckled mode, the lower cover is provided with a handheld portion and a buckling portion, and a testing area is formed in the middle of the buckling portion.
2. The total bilirubin test card of claim 1, wherein the top cover has snap posts on the inside and a laminate sheet with a grid hole in the middle.
3. The total bilirubin test card of claim 1, wherein the latching portion has a latching hole for engaging with the latching post and a latching groove for engaging with the top cover, and the test area has protrusions on both sides; the hand-held portion has a hand-held aperture.
4. The total bilirubin test card according to claim 1, wherein the PET substrate is rectangular, has a length of 19mm, a width of 4.7mm and a thickness of 0.17mm, and has a central circular hole with a diameter of 3.8mm in the middle thereof, and has two circular holes with a diameter of 2.5mm on both sides thereof, and the center distance between the central circular hole and the two circular holes is 7.5 mm.
5. The total bilirubin test card of claim 1, where the membrane is rectangular, 10mm long, 4.7mm wide and 0.12mm thick.
6. The total bilirubin test card of claim 1, in which the display membrane is rectangular in shape and has a length of 6mm, a width of 4.7mm and a thickness of 0.12 mm.
7. The total bilirubin test card of claim 1, wherein the blood pad is rectangular, 10mm long, 4.7mm wide and 0.12mm thick.
8. The total bilirubin test card of claim 1, wherein the mesh is rectangular and is made of polyester, and has a length of 11mm, a width of 4.7mm, a thickness of 0.2mm, and a pore size of 348 mesh/inch.
9. A method for manufacturing a total bilirubin test card is characterized by comprising the following steps:
step 1, cutting the color developing film, the blood filtering film, the blood sucking pad and the gauze into strips according to a certain size, and firstly pasting the cut color developing film on the punched PET substrate;
step 2, preparing a reaction liquid medicine, spotting the prepared reaction liquid medicine on a color developing film in a spotting way, and baking in a baking channel at the baking temperature of 37 ℃ for 25 min;
and 3, after baking, integrally sticking a layer of blood filtering film on the display film and the PET negative film, sticking a blood sucking pad and a gauze, fixing the stuck multilayer film by using an ultrasonic welding machine, detaching and cutting the whole test strip into small strips by using a small strip detaching and cutting machine, and then mounting the detached small strips into the upper cover and the lower cover.
10. The method for manufacturing total bilirubin test cards according to claim 1 wherein each test card contains the following chemical solutions: 0.12mg of sulfanilic acid, 0.05mg of sodium nitrite and 0.08mg of diprophylline.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110977274.6A CN113670910A (en) | 2021-08-24 | 2021-08-24 | Total bilirubin test card and manufacturing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110977274.6A CN113670910A (en) | 2021-08-24 | 2021-08-24 | Total bilirubin test card and manufacturing method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN113670910A true CN113670910A (en) | 2021-11-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202110977274.6A Pending CN113670910A (en) | 2021-08-24 | 2021-08-24 | Total bilirubin test card and manufacturing method thereof |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4119401A (en) * | 1977-06-07 | 1978-10-10 | Technicon Instruments Corporation | Total bilirubin assay |
| JPH09113515A (en) * | 1995-10-20 | 1997-05-02 | Kdk Corp | Total bilirubin measuring test paper |
| US20020086435A1 (en) * | 2000-12-28 | 2002-07-04 | Fernandez Decastro Aurora L. | Test strip for simultaneous detection of a plurality of analytes |
| CN1950700A (en) * | 2004-04-30 | 2007-04-18 | 爱科来株式会社 | Sample analyzing tool |
| CN109580927A (en) * | 2019-01-04 | 2019-04-05 | 杭州联晟生物科技有限公司 | A kind of test card of liver function and preparation method thereof |
-
2021
- 2021-08-24 CN CN202110977274.6A patent/CN113670910A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4119401A (en) * | 1977-06-07 | 1978-10-10 | Technicon Instruments Corporation | Total bilirubin assay |
| JPH09113515A (en) * | 1995-10-20 | 1997-05-02 | Kdk Corp | Total bilirubin measuring test paper |
| US20020086435A1 (en) * | 2000-12-28 | 2002-07-04 | Fernandez Decastro Aurora L. | Test strip for simultaneous detection of a plurality of analytes |
| CN1950700A (en) * | 2004-04-30 | 2007-04-18 | 爱科来株式会社 | Sample analyzing tool |
| CN109580927A (en) * | 2019-01-04 | 2019-04-05 | 杭州联晟生物科技有限公司 | A kind of test card of liver function and preparation method thereof |
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