TW200413727A - Immunoassay method for determining glycosylated protein and test liquid thereof - Google Patents

Abstract

This invention discloses an immunoassay method for determining glycosylated protein, such as advance glycosylation end products (AGEs) and a test liquid thereof, which comprises a test solution for determining a glycosylated protein containing an indication carrier suspension liquid and antigen or antibody immobilized on the surface of the indication carrier. A test strip is used, containing a bottom plate and assembly parts disposed on the bottom plate, in which the assembly parts comprise a specimen water-absorption pad, a porous fiber membrane, an indication carrier fiber block and at least one immobilization material. After the test liquid is injected into the test strip, an immune reaction of the glycosylated protein antigen and the glycosylated protein antibody is determined by the coagulation phenomenon or accompanying absorbance change or color change. Therefore, it can be determined if the existence of AGEs before the diabetes is taking effect, which then allows medical staff to prevent the occurrence of diabetic complication or further inhibit progression of the complication at the earliest time.

Description

200413727

[Technical field to which the invention belongs] The present invention relates to an immunoassay method for measuring the autoantigen or antibody of a glycated egg and an assay solution thereof, which are injected into a test strip through the assay solution, and the agglutination phenomenon or accompanying absorbance change or Color change to determine the immune response to the glycated protein antigen or anti-glycated antibody. [Prior art] As far as saccharification is possible, it can be used effectively. It has been tested by a kind of proteinuria patients. It is most unfortunate to use saccharified eggs. [Invented tube today knows that drugs that are destroyed by highly glycosylated cells have early specific whether there are complications. Diabetes-specific leukemia is the content of this day.] Our protein for the condition of glucose and blood sugar (such as' especially for the effective control of sugar prediction. The control methods and reagents are in place, so that the doctor can produce, or the final saccharification and the most sensitive person or antibody, for example, there is no measurable pathogenic mechanism of urinary disease has been changed, protein (such as • final glycosylated protein), diabetic patients The blood glucose content of this urine patient is diagnosed to detect the specific method used by the sugar nurse to know the earliest protein that can block the complications. This is to use immunological analysis such as: the final glycated protein is glycated protein Immune power is fully grasped,: Albumin) will be caused by this' Although it is also currently, but still unable to survive. The final sugar stage of urinary disease is therefore developed to prevent sugar from continuing. This method and assay solution are used to determine the antigen or antibody. Analytical Technology

200413727 V. Description of the invention (2) " ~ ----------, to determine the immune response of the glycated protein antigen or anti-furfurated protein antibody, thus completing the present invention. In another part, the present invention proposes an immunoassay using an anti-glycated protein antibody (proteinized protein antigen) to measure the glycosylated protein antigen (antibody), and / or includes the use of immunoassay technology via agglutination or concomitant The absorbance changes or the color changes 彳 b to determine the protein antigen in the test sample. For example, the final glycated protein antigen or antibody is saccharified in another part. The present invention proposes the use of an anti-glycated protein. Protein antigen) to determine the immunity of glycated protein antigen (antibody). Do not test the sera, for example, by anti-glycated antibody antibodies, and immune complexes with glycated protein: antigen (such as the final glycated protein antigen). The formation of the spin set phenomenon to determine the presence or absence of glycated protein antigen. Z In the & section, the present invention proposes another method for measuring the glycated protein antigen (antibody) using anti-glycosylated protein and protein antigen (antigen). : The absorbance change caused by the formation of immune complexes against antibodies to glycosylated proteins and disc protein antigens (such as final glycosylated protein antigens) to determine the presence or absence of glycosylated protein antigens. In the case of stings, the present invention proposes a method for using Anti-glycosylated antibody (glycosylated protein antigen) to determine the glycated protein antigen (antibody) immunoassay test strip 'It is passed on a bottom plate, for example: anti-glycosylated antibody / and glycated protein antigen (such as The final immune complex formation of the glycated protein antigen) and the color change caused by the control line are used to determine the presence or absence of the glycated protein antigen.

200413727 V. Description of the invention (3) The characteristics, objects and advantages of the present invention can be understood from the following description with reference to the drawings. In the drawings. [Embodiments] The present invention uses several immunoassay techniques to determine the glycated protein antigen in a test sample, such as the presence or absence of the final glycated protein antigen. The antibodies used can be obtained by immunizing rabbits or goats directly with purified antigens (such as final glycated protein antigens) (eg, multiple strains of antibodies), or by using mouse immunization to make fusion tumor cells. Obtained (for example: monoclonal antibodies). For the traditional familiar immunoassay technology, you can refer to, for example, Fuji kawa H ·, Igarashi, H ·, published in 1 988, which uses high-density latex particles to make rapid latex agglutination reagents for detection. Enterotoxin A ~ E (Appl. Envir. Microbiol. '54/10, 2345-2348, 1998) ° Delanghe, JR., Chapele, JP, Vander Schueren, SC., 1 990 Determination by turbidimetry

Myoglobin (Clin · Chem ·, 36/9, 1 675-1 678, 1 990). WO 88/08534 (1988) describes a so-called immunoassay device that uses an immunochromatography membrane as a medium to measure HCG and LH. US Patent No. 5,238,652 (1,993) discloses the use of immunochromatographic techniques to determine non-protein antigens. However, none of the foregoing prior arts mentions the immunoassay technique and assay solution for determining the glycated protein antigen or antibody described in the present invention. In one part of the present invention, an immunoassay assay solution for measuring glycated protein antigen (antibody) using an anti-glycated protein antibody (glycated protein antigen) is proposed, which uses immunoagglutination technology to measure glycated protein. anti-

200413727 V. Description of the invention (4) Progenitors or antibodies, for example, the final glycated protein antigen or antibody; including: a kind of carrier suspension; and a fixed protein antigen or antibody on the carrier surface, After determining whether the glycosylated protein antigen or antibody is present or not, whether or not an agglutination phenomenon has occurred after the measurement solution of the suspension is in contact with the test substance Γ is tested. … Μ ί In the conventional embodiment, ′ is to display one or more anti-glycosylated antibody antibodies in the solid-liquid display carrier, and then use a blocking protein to fill the carrier. When a sample containing a certain amount of glycated protein antigen, such as a body sugar antigen, and an unsupported suspension in which one or more anti-f antibodies have been immobilized are mixed on a reaction plate, an antibody or multiple antibodies will be formed Antibodies—final glycated protein antigens—anti-display carriers— " immune complexes. This reaction 2 = a kind of agglutination reaction that is visible to the naked eye. It is yang. When the final glycosylated protein antigen does not exist in the female test sample, ^ # .. after the carrier suspension of one or more antibodies is displayed, it produces i. The agglutination reaction is a negative reaction. According to the present invention, the carriers *, /, are fine particles with color, and the size of the beans is between 0 and half and 60 microns. In the present invention, the antibodies of water-releasing particles, lipid particles, gold sol particles, carbon particles, and dyes in the O.Oli are one or more of the above-mentioned anti-sugar white; several bodies: said: t fixed a structural formula Glycated protein antigen or multiple: Structured: Glycated protein antibody; non-agglutination reaction is for 疋 = anti-being is positive reaction. ^, Subtraction reaction, 9303130.ptd Page 8 200413727 V. Description of the invention (5) In another part of the present invention, an anti-glycated protein antibody (glycated protein antigen) was used to determine the glycated egg antigen ( Anti-glycated protein antibody) immunoassay measurement solution, which uses immunoturbidimetric or turbidity technology to determine the glycated protein antigen or antibody 5 For example, the final glycated protein antigen or antibody; including-re-display carrier suspension ; It shows that the surface of the carrier is immobilized with the above-mentioned glycated protein antigen or antibody; and a measuring device for the absorbance of the contact species; after passing the measuring solution and the object to be measured 5 to determine whether the display carrier has an absorbance change 5 to determine The presence or absence of the glycated protein antigen or antibody is suspended in one embodiment. A variety of antibodies are fixed on the display carrier float, and a blank protein is used to fill the blank space of the carrier. Prepare a negative standard serum 5 and a weak positive standard serum> and _ an unknown test sample 5 Then take 250 microliters of each of the fixed antibody display carrier suspensions into the prepared colorimetric test tubes A1 A2 and A3; add 20 microliters of negative standard serum 5 A2 colorimetric tubes to the A1 colorimetric tube 20 microliters of weakly positive standard serum was added to the test tube> 20 microliters of unknown sample was added to the A3 colorimetric test tube. The two colorimetric speech tubes should be turbidity or turbidity optical chromatography analyzer immediately after adding the sample. At 340nm 丨 (nm) colorimetric (return to zero with air in advance), * record 0D value (absorbance value) 5 and then colorimetrically again in the second 40 seconds after adding the sample, 'record OD value (absorbance value) 0 Subtract the 0D value of the first color comparison 0D than eleven times the value of the color, i.e. the difference of the reaction OD value of 0 if not known at this time t iHL JI ·· · Ι · 0D Following the reaction the sample is greater than the difference between the value of the clearance weak positive serum standard reaction Shu difference DD

200413727 V. Explanation of the invention (6) The value ′ is a positive reaction. If the inverse difference of the σ standard serum of unknown sample is the standard solution whose value is less than the weak positive one's example # ·· 〇 unit / millisecond; position mouth: known concentration / ml, 4 units / ml, 2 liters, 2 units, based on the concentration of 2 = bit / ml drawn from the standard solution. According to the present invention, the particles of the sample to be tested can be latex particles or lipid particles? Or enzymes; the micro =, dye particles, enzymes, coffee particles, etc., size: Erla 0. = Meters, the colorimetric range can be between 260 nm to 84 nm. The antibody referred to in the present invention is the above-mentioned one. MI, Xi: Carrying fixed-a glycated protein antigen of a glycated protein structure with a structural formula, can be used to determine the result to be determined. For example, according to the above-mentioned determination method, oral, The positive or negative glycated protein antigen or antibody reacts with the test sample ^ Γΐίί: negative standard solution, and reacts with the suspension of the display carrier (with the antibody or antigen immobilized on it) at the same time, and the result can be determined. (In another part of glycogenization Λ, a kind of use is proposed: the glycated protein resists Ϊ Λ Λ original) to determine the glycated protein antigen (anti-glycated egg == epidemic analysis test strip, which uses immunity Chromatographic analysis technology or anti # .m 1 protein antigen or antibody, for example: final glycated protein antigen: two-. 1 immunochromatographic test strip 1 shown in Figure 1 3 is porous; = most = linked to one The bottom plate 丨 7.11 is the sample absorbent II. The test strip 10 is at the end and overlaps with the porous fibrous membrane 13. 12 is the display page 10 9303130.ptd 200413727 V. Description of the invention (7) Ding Er 2蓝色 It is impregnated with a blue display carrier, and the carrier is immobilized with the -Γ »^, 3 antigen. The carrier fiber block 1 2 ^ (stands on the fiber membrane 13 of the sample absorbent pad 1 1 and is connected with the sample absorbent pad 11 and porous fiber in; overlapping connection. 14 is the reading section (can be a line or a point), the surface h = -dibody or antigen, the reading section 14 is located on the porous fiber membrane 13 table A, ϋί A slave Inside, the leading end of the reading section 14 faces the display carrier fiber block 12, ΐ: ί; = Γ control section 15 (can be a line or a point), which is also located at # h © * In a section of the surface of the membrane 13; the antibody 1 is fixed on the control section 15 and then faces an absorption pad 16. The above-mentioned porous fibrous membrane 13 θ π rot fiber membrane, nitrocellulose membrane, polyester fiber membrane , Fiber material shell membrane, or chemical synthetic membrane, etc .. Straight from the j j is the built-in immune test strip 10-waterproof device box 20.., ,, 21 is the sample hole. 2 2 is the reaction Area hole. ^ The figure shows a three-dimensional " waterproof device box 20 with a test strip 10 inside, " The sample water absorption pad 11 is located below and connected to the sample hole 21. The area of the sample hole 21 It should be smaller than the water absorption of the sample. The ㈣ and 段 sections 15 are located in the hole 22 of the reaction zone, but they are not in contact with them, and can be directly observed. 16 The absorbing 塾 is located at the end of the device box 20 μ. Antibodies or antigens are immobilized on the blue display carrier on 2 ': So although the blue display carrier on the fiber block 12 is shown to meet the sample to be tested, this blue display carrier will be self-contained on the test strip 10: The stack 13 "flows in the direction of the stacker 16; the bottom plate 17 is connected to the device box two, and the bottom plate Π is connected above Porous fibrous membrane 13, = The fibrous membrane 13 is provided with a reading segment 14 and a control segment 15 and is blocked by the egg 9303130.ptd Page 11 200413727 Filling the rest of the pore 2 can be moved immediately with the body or antigen If the protein, protein, protein, and antibody are anti-glycemic, they will completely bind and account for the glycated protein. The blue body or the antigen appears as a piece of meat. It should be fixed if the test substance is fixed. The test sample contains 'antigen-knotting protein' that will immediately or more be resistant to anti-glycation, and will be filled with the antigen. Judging the carrier following (for example: the positive reaction that is visible to the eye does not appear in the blue line or multiple anti-glycosylated protein strips. The naked eye can illuminate the segment 1 5 The line is five. Description of the invention (8) White is completely covered when the sample is tested Fixed anti-absorption pad 1 6 The final glycated egg species is anti-saccharified full anti-glycosylated binding site protein antigen) fixed on the blue line of a colored display carrier Anti-binding, and no blue line should be negative or negative test; otherwise, it indicates that the protein antigen on the carrier is fixed on section 14)) The display carrier will read the test solution fiber block 12 on the section 1 4 Drive the glycosylated egg with blue to show the glycosylated protein binding site; the body or multiple anti-protein antigens (this cannot be moved with the judged glycosylated egg reading segment 14 and should continue to move, and the mouse is immune to the blue line; The control strip is used to bind the glycated protein antigen in the sample to be tested (see the blue line '疋 is a negative reaction; blue in the body sample shows blue antigen, and the solid antibody on the carrier reacts in blue Eggs that are significantly glycated, for example, the most read segment 1 4 is invisible on the white antigen junction line and will be compared to the control globulin G. Therefore, the interpretation of segment 1 5 is not self-identified. Pad 16, the carrier to be displayed is, for example, one of the following, and occupies the final glycosylation of the carrier's white antibody, blue into the visible segment 15 antibody) Segment 14 positive and negative test blue display and interpretation The final saccharification blue. So is used to

9303130.ptd Page 12 200413727 V. Description of the invention (9) Absorption of all streams Of course, the protein antigen performs sandwiches The present invention is between 60 micrometers of fine particles, fluorescent particles of 0.1 micrometers to 20 micrometers, dye particles and so on. When the particles are made, the carrier can be directly displayed as a result, which is called a water-based plastic. The material of the carrier is a carrier fiber block. In the first embodiment of the present invention, the above method is used to change to a solid measurement method. The light-emitting substance, micron-size material particles, the present invention interprets a kind of yeast indirect display or prevention, which is a kind of liquid that will continue to form a capillary reaction. In two cases, as long as one or more anti-glycosylated antibodies are fixed to the glycated protein fixed in the reading section 14, the porous fibrous membrane can be used as a display or enzyme; The display results used in the present invention, lipid microparticles, and gold are referred to as a prime molecule, and need to pass through a display carrier. This hair paper. The water-insoluble fiber of this hair, but the higher the water absorption, is non-limiting, and its pore size is between 0. Seeds with large grains can be carbon black microspheres as a color-bearing display carrier; It is better to make the bottom plate used by Ming as the one used by Ming. The present dimension. The example uses a carrier, which is a fine particle of one color called a fine sol particle, which is 1 micron to absorb water, and the color is small at 0. Yes: milk, poly fine particles can be used to read the seeds with anti-pad and suction display Clarify that the culture of antibodies against glycated protein will be obtained by immunizing the purified antigen (such as the final glycated protein antigen) directly with rabbits or tadpoles (eg, multiple antibodies), or by immunizing mice to form fusion tumor cells. Obtained (for example: monoclonal antibodies).

9303130.ptd p. 13 200413727

Example 2 was saccharified. The milliliter obtained in 8 micrometers was used for 1 hour. Set 8 small twice. Shock treatment quasi-zero units of weak yang milliliters and 16 units each followed by the floating solution, the protein antibody showed the final concentration of polyphenylene oxide. When adding again. Add 2% to make three uniform preparations per milliliter. One strong standard per milliliter is taken as 10. Each original immunoagglutination test particle is diluted to 3% of ethylene particles or other antibodies with glycosylated protein. Take 10¾ liters of phosphorus each. Put 1g of bovine albumin on the glass and centrifuge 30 bovine albumin solution to a uniform suspension at 1 200 rpm to make a negative standard serum which is the most '1 unit / ml. Serum, whose final glycation is 1% sex standard serum , And an unknown serum sample of 0 microliters of the original sample of the test sample, and then spread it out, wait for 3-5 minutes, the concentration of the color of the micro-acid buffer glass tube mixed glass tube within 20 minutes after the amount of 20 The milliliter of the carrier showed the final glycated egg and the final glycated product of 2.5 protein antigen. Put into individual, add 50 micron to the naked eye to show that the carrier can be granulated. Dilute the solid into 2 parts and mix until the supernatant is removed. Float again. The content of the white antigen unit / milligram is 5 protein antigens. Select 0. Example 1 mg / stand 8 ′ and let it ‘repeat’. The volume of each liter and one unit / content is detected on the original. Rising display carrier suspension Interpretation results. result·

200413727

4 ^ Display carrier agglutination suspension ^ a negative standard blood level 0 military position / ml P-p negative standard blood level 1 unit / ¾ liter Θ-P negative standard blood level 2.5 units / ml θ -p weakly positive blood sample 5 units / ml θ Ten θ strong positive standard blood 淸 16 units / ml θ Unknown test sample < Example 3 Immune turbidimetric or turbidity test of glycated protein antigen Take out 0.2 g of carrier particles and put them in Bucket wheel τ & ^ β Where 1 liter of distilled water is placed to make a #translation solution. The display carrier can use 0.3 μm white polysilicon 17… can be stepped on the Gan / L to make white water-based vinyl particles of wood (also Ding = use, other colored particles at different wavelengths). Add 30 antibody to the final glycated protein, mix it well and let it stand for 8 hours. If there is an agglutination reaction, it is final. For those without agglutination, set the lowest positive response value to 5 for the final sugar. When a positive response is indicated, the concentration to be measured is 35 units / ml. Glycated protein antigen test was positive. Glycated protein antigen test was negative. Unit / ml, then the test sample is unknown The final glycated protein antigen contained in the sample

9303130.ptd Page 15 200413727 V. Description of the invention (12) Add 4 grams of bovine white eggs at 12000 rpm and centrifuge for 30 minutes and 1% albumin solution to the total suspension. Make six standard positions per milliliter, 1 unit, 8 Units / ml and each within 250 microtubes, each within 20 microtubes, and then take 20 microliters each to add the turbidity colorimetry to 20 microliters of individual colorimetric test tubes, use 'and in 2 4 Subtract the first OD value at 0 seconds and clear the concentration of each standard reaction sample drawn from the positive reaction value to the OD value of each reaction. Unknown test sample concentration results: White mixing clock, remove * 1 liter of carrier suspension serum / ml 16 Before the single liter's significant rise, it is unknown that the analyzer to be analyzed will first set the standard gray turbidity ratio to '35', which will be determined as a line. The standard test sample uses 3 clear and color separation to set an inverse unit standard to calculate 9 orders and let stand for 18 hours. Use serum and repeat three times. Join. Then it is made into homogeneous η glycated protein antigen by sonication. It contains early position / ml, 4 ml and an unknown body suspension. It is added to inaccurate serum, added to individual products, and added to another than 40 nm. After measuring the sample, the analyzer should measure its OD value. The OD value (absorbance value) should be 0 D difference. / Ml, plot each standard curve. It can be determined according to the unknown sample position / ml, and each of the samples is 0 units / ml. Same colorimetric test inside the colorimetric test tube. Oxygen * returns to zero. When ’should be (absorbance) immediately. The second quasi-sera obtained was based on the standard blood quantitative concentration. Sexual response.

9303130.ptd Page 16

200413727 V. Description of Invention (13)

According to this embodiment, the response of only 5 units of positive standard serum per sample to be tested and the OD value of 3 positive OD values are positive reactions. Prepare a negative standard serum 0 unit / mL to perform a qualitative determination. If the unknown standard serum is 5 units / ml, otherwise it is negative. 0 seconds 〇D 240 seconds 〇d 値 θ reaction OD 値 Λ unit + standard blood A # 0.86 ^ 0.85 ^ 0.01 ^ ~ 〇7 standard serum 0.92 # 0.87 ^ 0.05 ^ _—— V "quasi blood c # 0.98 ^ 0.82 ^ 〇16 ^ 2 ^ Standard blood sample D # 1.02 # 0.8343 〇19 ^ Standard blood sample E # 0.94 ^ 0.69 ^ 0.25 ^ 8 ^ ^ Quasi blood sample F— '0.99 ^ 0.69 ^ 0.3 ^ 16 ^ Unknown test sample 1.07 ^ 0.81 ^ 0.26p 9 ^ Example 4: Immune test strips are used to test the glycosylated protein antigen, and 3% of the blue display carrier is used. The microparticles are shown as i. The carrier can be colored particles of 0. 3 microns. The protein antibody is buffered with acid. Dilute the solution to 2 * ,, °, put the final anti-sugar 4 ml) in a glass tube and mix: into a mash. The concentration of liter ...

The bovine albumin was mixed in a glass tube for one hour. Join U again

σ < and left to stand for 8 hours. (2) Centrifuge at 12,000 rpm for 30 minutes, and then drop the solution. Then, use., T n 0 / & ) Enter 2 /. Bovine albumin, 10% carbohydrate solution to a total of 2 shock-absorbing treatment to make a uniform suspension of the ocean liquid 'to make a display carrier, will be 0.4 cm wide, 15 cm county Xiru 2 knife length of the display carrier fiber block finished 1

△ yjyj gas ίο / 厶 / V. Description of the invention (14) Immerse in a display carrier containing 10% sucrose and suspend it at room temperature. After it is dried, it is taken out again and placed in a drying box, and then placed in a dense lyophilizer with a desiccant. Dry for 2 hours and save ιϊί :: ;; Or it can also be placed on a porous fiber membrane: 'f Suspension is placed on a sample absorbent pad. Take the other side, but it is not conducive to mass production. Take a share of the spray coating line and IgG) spray, and then nitric acid solution. Infiltrated, washed and juxtaposed. The bottom of the bottom plate was stored in lyophilized for 15 cm, and the final saccharification was fixed. Fix several pieces of fiber membrane for at least 2 hours. Put the dryer in the inner chamber of the drying box 2 cm and dry it at 2 4 ° C. The nitrocellulose membrane of 4.5 cm in the 1.8-g protein (Anti-AGEs Ab) solution, which will then contain anti-rabbit IgG (Anti-rabbit 4 cm. This spray line is also called the control line. Run = Dissolve the phosphate buffer solution containing 5% bovine albumin, then take out the nitrocellulose membrane and dry it in the clear water solution, and then stick it on the plastic bottom plate, and then let it be completely aligned to cover the bottom plate. Sealing bag for desiccant㈣ΐ: The sample absorbent pad is 15 cm long, $ 2 cm. The sample absorbent pad ^ 7 pads are not limited in material, but the higher the absorbency, the better, and the size of the sample absorbent is variable. ^ Will The display carrier fiber block is placed on the front end of the porous fiber membrane and the mouth of the bottom plate, and the display carrier fiber block and the nitrocellulose fiber membrane are overlapped and connected to each other. It shows that the body and the dimension block are connected to each other. Finally, the absorbent pad is adhered to the end of the porous fiber membrane finished product, above the end of the bottom plate. At least part of the surface of the absorbent pad 200413727 V. Description of the invention (15) cm test strip Product and fiber membrane Stack the connection. Then cut it into a finished product with a width of 0 yuan. Place the completed type check strip σα into a waterproof device box. The sample hole position of this device box should be above the sample absorbent pad and contact each other. Sample ^ area ^ = On the sample absorbent pad. The reading section and control line of the test strip should be located in the hole in the reaction zone of the box and visible to the naked eye. The acid is in front of the section i. The sample absorbs water. It is in overlapping contact with the absorbent pad of hanging Zhaojie Ershe L sample. After reading the section, it is eight; inside; 'after the line is the absorbent pad. After adding the sample to be tested, about 5 knives', σ with the naked eye in the reaction zone Interpret the results directly in the well. It shows that 150 microliters of negative liquid serum samples are inserted, the blue moves, and enters the most principle and is transferred to the reaction line (interpretation section and control line): This negative sample is not Containing the final glycated body cannot be interpreted as the anti-final glycated protein anti-Fr π π h 尤, and the anti-final glycated protein anti-fixed by the fixed person does not form a naked eye. Combining, while the resistance is fixed online τ inexpensive, water strip. The i-color display carrier will be combined with the control blue line to form a visible line for the anti-fG antibody to make it continue to form: thin reverse ;: the absorbent pad will absorb all the flowing liquid to the sample Kongjia A η ～ Carrier is not reached, the positive serum sample is raised, the blue shows the antibody, and the serum = Erzhi =, the anti-final glycosylated protein fixed on it shows that the carrier moves to the final glycosylated protein Antigen binding. When the antibody to the chromatin protein binds to the final sugar, the anti-final sugar is bound and fixed to the final glycated protein antigen to form a piece of meat.

9303130.ptd Page 19 200413727 V. Description of the invention (16) The blue color visible to the eye will be combined with of course, the direct contact with the '' ~ paragraph is as before. Using the spray method on the competition law section, the competition law can be implemented. In summary, it can be seen that diabetes continued in the earliest period. line. For the remaining control lines, take the test strips for the reaction time; in addition, it is also feasible to experiment with fixed substances in addition to making. After the final saccharification of the hair to prevent diabetes, the blue display carrier will pass the reading segment = a positive response to Meijizawa. After completing 2, you can complete the experimental results as described above by combining the front part of the sample pad with the sample to be tested. The sandwich method can be used to complete the above tests. According to the knowledge and implementation of Example 4, as long as the interpretation ‘for example’ the final glycated protein antigen, it is clear that the specific measurement solution and method are used to test whether the peptone is present, which can allow the medical staff to perform or block the complications of the patient.

9303130.ptd Page 20 200413727 Brief description of the diagram. The first diagram is the three-dimensional structure diagram of the immunochromatographic test strip of the present invention. The second diagram is the three-dimensional appearance of a waterproof device box. The waterproof device box is used to hold the first The immunochromatographic test strip shown in the figure; and FIG. 3 is a schematic overall sectional view of the waterproof device box shown in FIG. 2 containing the test strip of the present invention. < Description of element symbols > 10 Test strips 11 Absorbent pad 12 Display carrier fiber block

13 Porous fiber membrane 14 Reading section 15 Control section. 16 Absorbent pad 17 Bottom plate 18 Test strip 10 front end 19 Test strip 10 rear end 20 Waterproof device box 21 Sample hole

22 pore of reaction zone

9303130.ptd Page

Claims (1)

ZUU413727 Six application patent scopes' · An assay solution used for determination of protein, which includes: a suspension of a specific carrier; and, glycosylated anti-glycosylated protein antibody fixed on the surface of the display carrier And other affinity substances; then protein antigens or anti-antibiotic charges can be determined by contacting the test sample with the reagent, whether there is a phenomenon of coagulation I to determine the test sample. No. The presence of glycated protein antigens or antibodies in σσσ 2 · According to the scope of the patent application, the colored particles have a size ranging from 0. 〇1. The micronized protein antigen or antibody is based on the scope of the patent application. The structure is based on the scope of the patent application. Anti-glycated protein antigen is determined according to the scope of the patent application. Anti-glycated protein is determined according to the scope of the patent application. The measurement solution for the first item is determined. The measurement solution for the first item is between 0 and 60 microns. The measurement solution of item 1, glycated protein antibody. The measurement solution of item 1, glycated protein antigen. The measurement solution of item 1, glycated protein antibody. The measuring solution of item 1, or the anti-glycosylated protein, the anti-glycosylated protein of item 1, wherein the display carrier is the display carrier of which the display carrier can be used to determine the affinity of the affinity substance in the sugar. Sexual substances are tested by competition law. It uses sandwich method to antibody. An assay solution for measuring a glycated protein includes: a display carrier suspension; and a glycated protein antigen or anti-capsule immobilized on the surface of the display carrier. 200413727 6. The scope of the patent application: Affinity substances such as glycosylated antibodies; After a certain sample to be tested is brought into contact with the measurement, an absorbance measuring device can be used to determine whether the display carrier has an absorbance change to determine the saccharification. The presence or absence of a protein antigen or antibody. 1 (λ The measurement liquid according to item 9 in the scope of the patent application, wherein the display carrier is a particle or an enzyme. 11. The measurement liquid according to item 10 in the scope of the patent application, wherein the particles are a latex particle, a lipid particle , Dye microparticles, polyethylene glycol microparticles, NADH microparticles, NAD microparticles, polymeric microparticles, or carbon microparticles. 1 2. The measuring solution according to item 9 of the scope of patent application, wherein the absorbance of the display carrier is between 260 nm ( nm) -840 nm. 1 3. The measuring solution according to item 9 of the scope of the patent application, wherein the size of the display carrier is between 0.001 and 20 microns. 1 4. According to the scope of the patent application The determination solution of item 9, wherein the affinity substances are glycated protein antigens of various structural formulas. 1 5. The measurement solution according to item 9 of the patent application scope, wherein the affinity substances are a variety of anti-glycated antibody antibodies. 1 6. The measuring solution according to item 9 of the scope of the patent application, which is used to determine the glycated protein antigen or anti-glycosylated antibody. 1 7. According to the measuring solution of the scope of patent application 16, the measurement method is based on competition. Enter 1 8. The measurement liquid according to item 16 of the scope of patent application, the measurement is performed by the Sanmeiji method. 9303130.ptd Page 23