TWI550272B - The Method and Structure of Biological Test Specimen - Google Patents

Description

Method for manufacturing biological test strip and structure thereof

The present invention relates to a test piece for biological detection use, and more particularly to a method for manufacturing the biological test piece and a structure thereof.

With the advancement of medical technology, many kinds of testing instruments are provided to assist in judging the cause and monitoring the physiological state, in order to achieve the purpose of preventing diseases, early diagnosis and early treatment. For example, in the case of diabetes with a high prevalence rate in the country, if diabetes is not diagnosed early and treated properly, diabetic patients are prone to retinopathy, neurological and vascular lesions and kidney disease. Therefore, how to track patients for a long time and regularly Blood sugar, blood pressure, and control of the disease, in order to prevent the occurrence of other complications, is an important issue in the current control and treatment of chronic diseases.

In order to assist in the control of chronic diseases, in the field of existing medical devices, there are many simple biological testing instruments, such as blood glucose, cholesterol and other biological testing instruments. When these biological detecting instruments are used, they use biological test strips to provide people to treat. The detected sample is placed thereon, and is sent to the biodetection device for bioassay test analysis. Since the bioassay test piece is a medical device, the quality of its products is related to the correctness of the test results, so the relevant industry pays great attention to its product quality and quality.

At present, the biological detection test piece manufacturing method is mainly characterized in that the conductive adhesive is printed on the bare material of the plastic material, and the conductive adhesive is formed on the bare material of the plastic material through the drying step, and secondly, according to the biological detection test piece detection. In the project, a biological detection material such as an enzyme is placed at a predetermined position on the electrode, and after the biological detection material is dried, the upper cover of the plastic material is attached to the bare piece having the electrode, and the electrode is covered therein, wherein the upper cover is covered Forming two windows, such as a reaction zone and an electrical connection zone, so that a section of the electrode having a biodetection material layer such as an enzyme is exposed at the window of the reaction zone, and the contact pads of the electrode are exposed at the window of the electrical connection zone, and then, the continuation After the cutting and forming step, it is made into a biological test piece to be formed.

However, the method for manufacturing the conventional biological test strip can achieve the method for detecting the test piece of the mass product. However, in the method for manufacturing the test strip, the paste is formed by the screen printing method using a paste-like conductive paste. On the film, the electrode is formed by the drying step, and the conductive paste is prone to defects during the printing process, resulting in unstable quality such as insufficient shape integrity of the electrode.

Furthermore, in the manufacturing method of the conventional biological test strip, in order to meet the purpose of mass production, the bare chip and the upper cover of the bioassay test piece are in the form of a flat plate, and can only be used in the number of electrode shapes. Simple changes, so the current biological test strips do not have the foolproof and coding function. Therefore, in order to ensure the correctness of the combination of the bioassay test piece and the biological test instrument, in order to correct the correctness of the test result, the biometric test piece is paired with a specific coding module, that is, when used, the sample to be detected is used ( If the blood is dropped on the biological detection material, the biological test piece and the corresponding coding module are inserted into the biological detection device, and after the determination is correctly matched, the biological detection device performs the detection, and the result after the detection is displayed. On the screen of the biometric device.

However, the biological detection test piece itself does not have the function of preventing fool and coding, but must be paired with the coding module, which is not only inconvenient to operate, but also the biodetection device must be inserted into the biodetection test piece and the coding module. And there are problems with complicated structure.

The main purpose of this creation is to provide a method and structure for the production of bioassay test strips, and to create a solution to the problem of unstable yield of existing bioassay test strip products.

For the purpose of achieving the foregoing disclosure, the method for manufacturing a bioassay test piece provided by the present invention comprises: providing a plate having conductivity; stamping the plate into a terminal group including a plurality of terminals; and forming a forming means by means of burying Forming a plastic test piece housing integrally on the outer side of the terminal group to form the bio-detection test piece, and forming a reaction window and an electrical connection window on the formed test piece housing, in the terminal group The terminal has a biomaterial contact pad exposed at the reaction window and an electrical contact pad exposed at the electrical connection window.

In order to achieve the foregoing disclosure, the biodetection test piece additionally provided by the present invention comprises: a terminal group comprising a plurality of conductive metal material stamped and formed terminals, wherein the plurality of terminals are adjacent and spaced apart, and the terminal includes a biomaterial contact pad and an electrical contact pad; and a test piece housing integrally molded on the outer side of the terminal set, wherein the test piece housing is formed with a reaction window and an electrical connection window, and the terminal is in contact with the biological material The pad is exposed at the reaction window and the electrical contact pads of the terminals are exposed at the electrical connection window.

By the method for manufacturing the biological test strip and the structure creation thereof, the main purpose is to use a terminal set formed by press forming, and a test piece housing integrally formed on the outer side of the terminal group by means of a buried incident means, so as to ensure each The integrity of the shape of the terminal and the correctness of the electrical connection, and the use of the injection molded test piece housing directly cover the terminal group, and can accurately control the biological test piece has a stable high product yield and quality.

The second purpose of the present invention is that the test piece housing of the injection molding is integrally formed on the outer side of the stamped and formed terminal block, so that the outer shape of the test piece housing can be greatly changed, and the side surface of the test piece housing can be further integrally formed. The alignment unit, thereby allowing the biometric test strip to have both a foolproof and a coding function, so that it does not need to be used together with a conventional coding module, and the biometric test strip is specified by its test strip housing The alignment portion formed by the position allows the bioassay test piece to be inserted into the biodetection device in only one direction, thereby ensuring 100% correctness of the test item. On the other hand, since the bio-detection test piece can have a foolproof and coding function by the shape of the test piece housing, it does not need to be paired with the conventional coding module, so that the bio-detection device can be reduced by the coding module. It is used to simplify the overall structure, reduce costs, and make the bioassay operation easier and easier without any operational errors.

The present invention comprises a method for manufacturing a biological test strip and a structure thereof. According to the technical proposal proposed in the foregoing invention, as shown in FIG. 1 and FIG. 3, the manufacturing method of the bioassay test piece proposed by the present invention is embodied. The method comprises the steps of: providing a conductive plate 10A. In the present process, the plate 10A may be made of copper, steel, iron plate or other plate having good conductivity, wherein the bioassay test is performed according to the method. It is preferable to select a suitable material for the predetermined biological detection item, as shown in FIG. 2, and further confirm the conditions such as the thickness and the area size of the plate 10A; and press the plate 10A into a plurality of terminals 11A, The terminal group 10 of 11B, the number of the terminals 11A, 11B and the shape thereof are set according to the biological detection item, and the plurality of terminals 11A, 11B in the terminal group 10 may be the same shape or different shapes; Forming means integrally forming a plastic test piece housing 20 on the outer side of the terminal block 10 to form the bio-detection test piece. In the present procedure, the terminal set 10 is placed in the mold set. In the mold cavity of the mold installed in the molding machine, the molten plastic material is injected into the cavity after the mold is closed, and after being cooled and solidified, the mold is taken out and integrally formed on the outer side of the terminal group 10. The test piece housing 20 is formed to form the bio-detection test piece, and a reaction window 21 and an electrical connection window 22 are formed on the formed test piece housing 20, and the terminals 11A, 11B in the terminal block 10 have The biomaterial contact pads 12 exposed at the reaction window 21, and the electrical contact pads 13 exposed at the electrical connection window 22, may further form protrusions thereon.

As shown in FIG. 3 and FIG. 4, a test piece housing 20 of a plastic material is integrally formed on the outer side of the terminal group 10 by the burying and immersing molding means to prepare the bioassay test piece. The at least one side surface of the housing 20 is integrally formed with an alignment portion 23 corresponding to the shape of the test strip slot of the predetermined biomaterial detecting device, that is, the alignment portion 23 can be formed to protrude In the preferred embodiment, the aligning portion 23 may be an elongated ridge or groove, in the convex portion of the surface of the sheet housing 20, or a recess or the like recessed on the surface of the test piece housing 20. However, it is not limited to this. The test piece case 20 having the aligning portion 23 can be changed in shape according to the purpose of preventing the test and coding of the biometric test piece.

As shown in FIG. 2, in the method for producing a bioassay test piece, the sheet material 10A is press-formed into a terminal group 10 including a plurality of terminals 11A and 11B, and then formed into a bioassay test piece by burying and forming. Previously, it may further include applying a surface treatment program to the terminals 11A, 11B of the terminal group 10 for improving the activity and biosensing performance of the biodetection test piece, the surface treatment program including a surface cleaning step and An anti-oxidation layer forming step for removing deposits on the surface of the terminal after stamping, the step of forming the anti-oxidation layer may be formed by electroplating, coating or spraying to form an electrically conductive surface The metal film serves as an anti-oxidation layer and maintains the original conductive characteristics of the terminals 11A and 11B. The material of the metal film is determined according to the material of the selected plate. In the preferred embodiment, the material of the metal film can be selected. Gold, silver, nickel, zinc, etc., to improve the conductivity, oxidation resistance, corrosion resistance and other properties of the terminal.

As shown in FIG. 2, the surface treatment program may further include a surface inspection process for confirming the size and dimensions of the surface, and measuring the size of the metal film formed on the outer surfaces of the terminals 11A and 11B to determine whether or not Meet the standards to ensure quality.

As shown in FIG. 2, in the method for manufacturing a bioassay test piece, a test piece housing 20 of a plastic material is integrally formed on the outer side of the terminal group 10 by means of a buried incident molding means to prepare the bioassay test piece program. Thereafter, a forming process of the bio-detecting material layer 30 may be further included, in which the bio-detecting material is filled in the biomaterial contact pad 12 of the terminal set 10 at the reaction window 21 of the test strip housing 20, and Forming a bio-detection material layer 30, the bio-detection material is determined according to an item detected by the bio-detection test piece, for example, when the bio-detection test piece is used for blood glucose concentration detection, the bio-detection material layer 30 can be selected. A biological test material containing glucose oxidase (GOD), but the biological test material is not limited thereto.

In the method for producing a bioassay test piece, a test piece housing 20 of a plastic material is integrally formed on the outer side of the terminal group 10 by means of a buried incident molding method to prepare the bioassay test piece program, or biodetection. After the forming process of the material layer 30, a procedure for inspection of the finished product is further included to confirm whether the product of the raw test strip 1 conforms to the relevant regulations of the medical device.

As shown in FIG. 4 and FIG. 5, the structure of the biological test strip proposed by the present invention comprises a terminal set 10 and a test strip housing 20, or the biometric test strip further includes A biodetective material layer 30.

As shown in FIG. 4 and FIG. 5, the terminal group 10 includes terminals 11A and 11B formed by press molding of a plurality of conductive metal materials, and the number and shape of the terminals 11A and 11B are set according to biological detection items. The plurality of terminals 11A and 11B are arranged adjacent to each other, and the terminals 11A and 11B include a biomaterial contact pad 12 and an electrical contact pad 13. The surface of the terminals 11A and 11B may further form a metal film to provide resistance. The function of oxidation. As shown in FIG. 7 and FIG. 9, the convex contact portions 131 of the convex or granular shape may be further formed on the electrical contact pads 13 of the terminals 11A and 11B.

As shown in FIG. 4 and FIG. 5, the test piece housing 20 is integrally molded on the outer side of the terminal block 10, and a reaction window 21 and an electrical connection window 22 are formed on the test piece housing 20, and the reaction is performed. The window 21 and the electrical connection window 22 may be located on the same side or different sides of the test strip housing 20, and the biomaterial contact pads 12 in the terminals 11A, 11B in the terminal set 10 are exposed at the reaction window 21, The contact pads 13 are exposed at the electrical connection window 22. As shown in FIG. 8 and FIG. 10, when the electrical contact pads 13 of the terminals 11A, 11B have convex or curved convex portions 131, the convex portions 131 may be lower than the top edge of the electrical connection window 22, or The convex portion 131 is equal to the top edge of the electrical connection window 22, or the convex portion 131 may also protrude from the top edge of the electrical connection window 22.

As shown in FIG. 4 and FIG. 6 , the test strip housing 20 may further form at least one pair of position portions 23 and 24 on at least one side surface thereof, so that the test strip housing 20 has both a function of preventing fool and coding. The aligning portions 23 and 24 may be convex portions or grooves, and have a foolproof function corresponding to the shape of the test piece slot of the biological material detector, as shown in FIG. 4, in the preferred embodiment. The test piece housing 20 has a reaction window 21 and an electrical connection window 22 formed on the upper side thereof, and two parallel elongated rib-shaped alignment portions 23 are formed on the lower side; as shown in FIG. In a preferred embodiment, the test strip housing 20 forms a reaction window 21 and an electrical connection window 22 on the upper side thereof, and two parallel elongated strip-shaped alignment portions on the upper and lower sides of the test strip housing 20, respectively. 23, 24, and the elongate convex strip-shaped alignment portions 23, 24 of the upper and lower sides are arranged in a staggered arrangement.

As shown in FIGS. 4 and 5, the bio-detection material layer 30 is formed on the reaction window 21 of the test piece housing 20 and attached to the biomaterial contact pads 12 of the terminals 11A, 11B. According to the decision of the test item scheduled by the biological test strip, for example, enzymes.

As shown in FIG. 6, when the bioassay test piece is used, the sample to be detected (such as blood) is dropped on the biomaterial contact pad 12 of the terminals 11A, 11B at the biological test strip reaction window 21. On the bio-detection material layer 30 on the bio-material contact pad 12, as shown in FIG. 11, the bio-detection test piece is inserted in the test piece slot 2A of the bio-detection device 2, wherein The alignment portions 23 and 24 of the test piece housing 20 of the bioassay test piece are provided with a foolproof and coding function, so that the biometric test piece can be correctly inserted into the biodetection device 2, and the terminals 11A and 11B are The electrical contact pads 13 are electrically connected to corresponding circuitry in the biodetection device 2. As shown in FIGS. 7 and 9, the terminals 11A, 11B can also ensure that the electrical contact pads 13 of the terminals 11A, 11B are in proper contact with the corresponding circuits in the biodetection device by the projections 131 on the electrical contact pads 13. The biodetection device 2 is electrically connected, and the detection of the sample is performed, and the result of the detection is displayed on the screen of the biodetection device 2.

10‧‧‧Terminal group
10A‧‧‧ plates
11A, 11B‧‧‧ terminals
12‧‧‧Biomaterial contact pads
13‧‧‧Electric contact pads
131‧‧‧ convex
20‧‧‧ test piece housing
21‧‧‧Reaction window
22‧‧‧Electrical connection window
23, 24 ‧ ‧ aligning department
30‧‧‧Biodetection material layer
2‧‧‧Biological testing equipment
2A‧‧‧ test strip slot

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a flow chart showing a preferred embodiment of a method for producing a biological test strip of the present invention. Fig. 2 is a flow chart showing another preferred embodiment of the method of manufacturing the biometric test strip of the present invention. Fig. 3 is a perspective view showing a preferred embodiment of the method for manufacturing the bioassay test piece shown in Fig. 1. 4 is a perspective view showing a preferred embodiment of the method for producing a bioassay test piece shown in FIG. 2 to increase a layer of a shaped biodetection material. Fig. 5 is a perspective view showing a preferred embodiment of the present invention. Figure 6 is a plan view showing a preferred embodiment of the bioassay test piece shown in Figure 5. Figure 7 is a perspective view of a preferred embodiment of another terminal set selected for use in the present invention. Figure 8 is a perspective view of a preferred embodiment of a bioassay test strip having the terminal set of Figure 7. Figure 9 is a perspective view of a preferred embodiment of another terminal set selected for use in the present invention. Figure 10 is a perspective view of a preferred embodiment of a bioassay test strip having the terminal set of Figure 9. Figure 11 is a perspective view showing another preferred embodiment of the present biological test strip and the biodetection device.

Claims (11)

A method for manufacturing a bio-detection test piece, comprising: providing a plate material having conductivity; forming the plate material into a terminal group including a plurality of terminals; and integrally forming a plastic material on the outer side of the terminal group by means of a buried incident molding means The test piece housing is formed into the bio-detection test piece, and the outer surface of the test piece housing is integrally formed with at least one pair of portions, and a reaction window is formed on the formed test piece housing In conjunction with an electrical connection window, the terminals in the terminal set have biomaterial contact pads exposed at the reaction window and electrical contact pads exposed at the electrical connection window. The method for producing a bioassay test piece according to claim 1, wherein after the plate material is formed by press-forming a terminal group including a plurality of terminals, before the process of burying and forming the biodetection test piece is performed, And comprising applying a surface treatment program to the terminal of the terminal group, the surface treatment program comprising a surface cleaning step and an oxidation resistant layer forming step, the surface cleaning step is to remove the adhesion of the terminal surface after the stamping, and the oxidation resistance The layer forming step forms a metal film as an oxidation resistant layer on the outer surface of the terminal. The method for producing a bioassay test strip according to claim 2, wherein the surface treatment program further comprises a step of confirming the size and size of the anti-oxidation layer after molding, and measuring the outer surface of the terminal The size of the metal film is judged to meet the standard. The method for producing a bioassay test piece according to any one of claims 1 to 3, wherein the test piece case of a plastic material is integrally formed on the outer side of the terminal group by means of a buried incident molding means to produce the above-mentioned After the bioassay test strip program, a further step of forming a bio-detection material layer is formed by forming a bio-detection material layer on the biomaterial contact pad of the terminal at the reaction window of the test piece housing. A bio-detection test piece comprising: a terminal set comprising a plurality of conductive metal material stamped and formed terminals, the plurality of terminals being adjacent and spaced apart; and a test piece housing integrally molded on the terminal group On the outer side, a reaction window and an electrical connection window are formed on the test piece housing, and an alignment portion is formed on at least one surface of the test piece housing; and the terminal in the terminal group is exposed at the reaction window. The biomaterial contact pad, the portion of the terminal exposed at the electrical connection window is an electrical contact pad. The biological test strip according to claim 5, wherein the surface of one side of the test piece housing forms two parallel alignment portions. The biological test strip according to claim 5, wherein the opposite side surfaces of the test piece housing respectively form two parallel alignment portions, and the two alignment portions of the two side surfaces are arranged in a staggered manner. The bioassay test strip of any one of claims 5 to 7, wherein the test strip housing forms a biodetection material layer on the biomaterial contact pad at its reaction window. The biodetection test strip according to any one of claims 5 to 7, wherein a convex portion is formed on the electrical contact pad of the terminal. The biological test strip according to claim 9, wherein the convex portion on the electrical contact pad of the terminal is convex. The biological test strip according to claim 9, wherein the convex portion on the electrical contact pad of the terminal is curved.