Quality control liquid and application thereof

Abstract

The invention provides a quality control solution and application thereof, the quality control solution comprises a buffer solution, a polymer, EDTA (Ethylene Diamine Tetraacetic Acid) or a salt thereof, a preservative, a blood simulation dye and an analyte, and the polymer is selected from PEG (Polyethylene Glycol) 2000-6000, propylene glycol, glycerol or a combination thereof. The quality control liquid provided by the invention can be used for quality control of at least one analyte; the kit does not need refrigeration, freezing or freeze-drying, can be placed at room temperature, is convenient to use, and can be used in the fields of immunodetection, biochemical detection and electrochemical detection.

Description

[0001] This application is a divisional application of a patent application filed on September 18, 2021, with application number 2021110986110 and invention name “A quality control fluid and its application”. Technical Field

[0002] The present invention mainly relates to a quality control liquid, in particular to a quality control liquid suitable for immunoassay, biochemical assay and electrochemical assay. Background Art

[0003] Exploring the early prevention and treatment of chronic kidney disease (CKD) and delaying its progression has become a hot topic of common concern in public health and clinical medicine. In recent years, the focus of the nephrology community has shifted from chronic renal failure and replacement therapy to the early stages of CKD. Clinical surveys show that early intervention treatment for patients with chronic kidney disease can significantly reduce the mortality rate of patients, effectively delay the progression of the disease, reduce or even avoid the occurrence of end-stage renal disease, and also help reduce patients' medical expenses. Therefore, there is market demand and space for multifunctional analyzers that can detect three indicators of renal function (serum creatinine, blood urea and blood uric acid). As a kidney disease detection instrument, it can effectively detect the severity of the patient's kidney disease by detecting the levels of creatinine, urea and uric acid in the patient's blood, and make corresponding judgments, which can be used as a basis for selecting further treatment plans.

[0004] When using a test strip to electrochemically detect at least one of creatinine, urea, and uric acid in biological fluids such as blood and urine, it is necessary to use creatinine, urea, and / or uric acid with a known concentration for quality control. During the test, insert the test strip into the test strip jack of the electrochemical tester, add the quality control solution to the sample port of the test strip, and then observe whether the reading of the electrochemical tester is within the normal quality control range. If it is within the normal quality control range, it means that the electrochemical tester and the test strip are normal. If it exceeds the normal quality control range, the electrochemical tester or the test strip should be replaced.

[0005] However, in the prior art, most of the quality control solutions used for electrochemical biological detection are single-item quality control solutions, and there are few quality control solutions for two or more items. In addition, they have the disadvantages of poor stability, easy to affect other items, and easy to cause inaccurate test results. Most of the quality control solutions on the market currently need to be refrigerated, frozen or freeze-dried, which is inconvenient to use. Summary of the invention

[0006] In view of the deficiencies of the prior art, the present invention provides a quality control solution, comprising a buffer, a polymer, EDTA or its salt, a preservative, a blood simulation dye and an analyte, which is suitable for the fields of immunoassay, biochemical assay and electrochemical assay.

[0007] The present invention also provides a composite quality control solution, including a buffer, a polymer, EDTA or its salt, a preservative, a blood simulation dye, and at least two of the three analytes of urea, sodium urate, and creatinine. The present invention also provides a quality control solution for renal function detection, including a buffer, a polymer, EDTA or its salt, a preservative, a blood simulation dye, and at least one of the three analytes of urea, sodium urate, and creatinine. The present invention also provides a quality control solution for detecting creatinine, including a buffer, a polymer, EDTA or its salt, a preservative, a blood simulation dye, creatinine, and creatine.

[0008] Furthermore, the buffer solution is 0.01 mol / L to 2 mol / L, pH 6.5 to 7.5; the polymer is 10% to 40% (w / w), EDTA or its salt is 0.1% to 1% (w / w), the preservative is 0.1% to 2% (w / w), and the blood simulation dye is 0.1% to 2% (w / w).

[0009] Further, the analyte is selected from urea, sodium urate, creatinine or a combination thereof. Further, when the analyte includes creatinine, the creatinine is 0.0001% to 3% (w / w); when the analyte includes sodium urate, the sodium urate is 0.0001% to 3% (w / w); when the analyte includes urea, the urea is 0.0001% to 3% (w / w). Further, when the analyte includes creatinine, the quality control solution also includes creatine. Further, the concentration of creatine is 0.0001% to 3% (w / w).

[0010] Furthermore, the polymer is selected from PEG2000-6000, propylene glycol, glycerol or a combination thereof.

[0011] Further, the blood simulation dye is selected from sulforhodamine B, Congo red, Mito Red, acid red, fluorescent red, allura red, cresol red, amaranth, chlorophenol red and sulforhodamine 101. Further, the preservative can be selected from sodium azide, thimerosal, sodium benzoate, Proclin-150, Proclin-200, Proclin-300 or Proclin-5000.

[0012] Furthermore, the quality control solution also includes calcium chloride or sodium chloride, or a combination of calcium chloride and sodium chloride. Further, when the quality control solution includes calcium chloride, the concentration of calcium chloride is 0.02% to 0.5% (w / w); when the quality control solution includes sodium chloride, the concentration of sodium chloride is 0 to 0.1% (w / w).

[0013] Further, the buffer is a Good's buffer. Preferably, the Good's buffer is selected from HEPES (4-hydroxyethylpiperazineethanesulfonic acid), MES (2-morpholineethanesulfonic acid), BES (N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonic acid) and TAPSO (3-trihydroxymethylmethylamine-2-hydroxypropanesulfonic acid). Most preferably, the Good's buffer is selected from TAPSO. Most preferably, the Good's buffer is selected from TAPSO. Further, the concentration of the Good's buffer is 0.05mol / L to 0.5mol / L, and the pH is 6.5 to 7.2.

[0014] The invention also provides application of the quality control solution in detecting urea, creatinine and urea.

[0015] The beneficial effects of the present invention are as follows: (1) The present invention does not simply add several analytes (creatinine, urea and uric acid) to the two-item quality control solution or the three-item quality control solution: first, uric acid is unstable in aqueous solution, sodium urate is relatively more stable, and sodium urate is selected to replace uric acid; second, creatinine is unstable in aqueous solution, and adding a certain amount of creatine can prevent the creatinine content from changing significantly; third, in addition to selecting a suitable Good's buffer, it is also necessary to find a suitable pH value so that the multiple components in the two-item quality control solution or the three-item quality control solution are stable. The two-item quality control solution or the three-item quality control solution of the present invention can be used to electrochemically detect creatinine, urea and uric acid, and can simultaneously perform quality control on at least two of the three analytes without the need to prepare a separate quality control solution for each analyte; (3) the quality control solution of the present invention does not need to be refrigerated, frozen or freeze-dried, and can be placed at room temperature, making it more convenient to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 An exploded view of a first biosensor of a first electrochemical test strip.

[0017] Figure 2 for Figure 1 Schematic diagram of the first biosensor when assembled together.

[0018] Figure 3 An exploded view of the second biosensor of the first electrochemical test strip.

[0019] Figure 4 for Figure 3 Schematic diagram of the second biosensor when assembled together.

[0020] Figure 5 An exploded view of a second electrochemical test strip.

[0021] Figure 6 for Figure 5 Schematic diagram of the electrochemical test strips in FIG. 1 when assembled together.

[0022] Figure 7 It is a side view of an electrochemical test strip, wherein the first biosensor and the second biosensor do not share the same insulating substrate. DETAILED DESCRIPTION

[0023] The following examples further illustrate the present invention. These examples are not intended to limit the scope of the present invention, but to provide a further understanding of the present invention.

[0024] The quality control solution of the present invention comprises Good's buffer, polymer, EDTA or its salt, preservative, blood simulation dye, analyte, wherein the polymer is selected from PEG2000-6000, propylene glycol, glycerol or a combination thereof. The analyte is selected from urea, sodium urate, creatinine or a combination thereof, which means that the analyte can be any one of urea, sodium urate and creatinine, or a combination of any two of urea, sodium urate and creatinine, or a combination of urea, sodium urate and creatinine. The blood simulation dye can make the quality control solution of the present invention red, which is used to simulate the color of blood and is convenient for observing the injection situation.

[0025] In the present invention, PEG2000-6000 refers to polyethylene glycol with a molecular weight of 2000-6000. Preferably, the quality control solution of the present invention also contains calcium chloride, which acts as a conductor and stabilizer. EDTA or its salt acts as a stabilizer in the quality control solution of the present invention. EDTA or its salt is preferably selected from EDTA, disodium EDTA or dipotassium EDTA. Preferably, the quality control solution of the present invention can also be added with an appropriate amount of sodium chloride, which can enhance the ionic strength, increase the test current value of uric acid and creatinine, and improve the electrical signal gradient.

[0026] The two-item quality control solution or the three-item quality control solution of the present invention is not prepared by simply combining several analytes together. In view of the instability and poor solubility of uric acid in conventional methods, the quality control solution of the present invention uses sodium urate instead of uric acid when used for quality control of uric acid; in addition, sodium urate has poor stability and a significant decrease in concentration when the pH value of the quality control solution is highly alkaline. Therefore, in addition to selecting a suitable buffer and polymer, a suitable pH value must be found so that the various components in the quality control solution, including sodium urate, remain relatively stable during storage and maintain a certain electrical signal when tested using an electrochemical test strip. When the quality control solution of the present invention contains creatinine, creatinine is unstable in an aqueous solution. Preferably, adding a certain amount of creatine can prevent a significant change in the content of creatinine.

[0027] The quality control solution of the present invention is usually used in combination with test strips in the fields of immunology, biochemistry and electrochemistry. Here, a test strip in the field of electrochemistry (hereinafter referred to as an electrochemical test strip) is used as an example for detailed description. Figures 1 to 7 As shown, the electrochemical test strip 200 includes a first biosensor 100 and a second biosensor 101, and the first biosensor 100 and the second biosensor 101 do not share the same insulating substrate. The first biosensor 100 has a first electrical connection terminal 7 and the second biosensor 101 has a second electrical connection terminal 13. The first electrical connection terminal 7 and the second electrical connection terminal 13 are located at the same end of the electrochemical test strip 200 and can be connected to the electrical connector of the detection instrument. The sample loading port of the electrochemical test strip 200 includes a first sample loading port 601 located on the side of the first biosensor 100 and a second sample loading port 602 located on the side of the second biosensor 101.

[0028] The first biosensor 100 is provided with a first insulating substrate 1, a first electrode system arranged on the first insulating substrate 1, a first reaction region forming layer 3, a first channel forming layer 4 and a first upper cover layer 5 in sequence. The first insulating substrate 1, the first reaction region forming layer 3, the first channel forming layer 4 and the first upper cover layer 5 are all made of insulating materials. The first electrode system includes a urea reference electrode 21, a urea working electrode 22, a creatinine working electrode 23, a creatinine counter electrode 24, a first contact 79, a second contact 77, a third contact 76 and a fourth contact 80 capable of conducting electricity at the first electrical connection end 7, and a first conductive trace 74 connecting the urea reference electrode 21 with the first contact 79, a second conductive trace 82 connecting the urea working electrode 22 with the second contact 77, a third conductive trace 72 connecting the creatinine working electrode 23 with the third contact 76 and a fourth conductive trace 73 connecting the creatinine counter electrode 24 with the fourth contact 80. The urea reference electrode 21 , the urea working electrode 22 , the creatinine working electrode 23 , and the creatinine counter electrode 24 are located on both sides of the first sample loading port 601 .

[0029] like Figure 1 , Figure 2 , Figure 5 and Figure 6 As shown, the first electrode system also includes a first sample filling electrode 25 and a second sample filling electrode 26. The urea reference electrode 21, the urea working electrode 22, the creatinine working electrode 23 and the creatinine counter electrode 24 are located between the first sample filling electrode 25 and the second sample filling electrode 26, and the first sample filling electrode 25 and the second sample filling electrode 26 are connected to the seventh contact 78 and the eighth contact 75 provided at the first electrical connection terminal 7 through the seventh conductive trace 81 and the eighth conductive trace 71, respectively. The first sample filling electrode 25 and the second sample filling electrode 26 are made of conductive material and can be formed on the first insulating substrate by screen printing.

[0030] The first reaction region forming layer 3 is covered on the first electrode system. The first reaction region forming layer 3 has three separated reaction regions: a first reaction region 42, a second reaction region 41 and a third reaction region 43, and the shapes of these reaction regions can be selected from geometric shapes such as rectangles, ellipses, circles, and cut-corner rectangles. The second reaction region 41 contains a urea first reaction reagent, the first reaction region 42 contains a urea second reaction reagent, and the third reaction region 43 contains a creatinine reaction reagent. The third reaction region 43 at least partially exposes the creatinine working electrode 23 and the creatinine counter electrode 24, the second reaction region 41 at least partially exposes the urea reference electrode 21, and the first reaction region 42 at least partially exposes the urea working electrode 22.

[0031] The first reaction region forming layer 3 also has a first exposure hole 44 and a second exposure hole 45. The first exposure hole 44 at least partially exposes the first sample filling electrode 25, and the second exposure hole 45 at least partially exposes the second sample filling electrode 26. The first exposure hole 44 is connected to the first air hole 51 provided on the first biosensor 100 in the air path, thereby facilitating the sample to flow to the creatinine working electrode 23 and the creatinine counter electrode 24. The second exposure hole 45 is connected to the second air hole 52 provided on the first biosensor 100 in the air path, thereby facilitating the sample to flow to the urea reference electrode 21 and the urea working electrode 22. When the sample is added, by detecting an electrical signal such as current, voltage or impedance between the first sample filling electrode 25 and the second sample filling electrode 26, it can be determined whether the sample flowing to the urea reference electrode 21 and the urea working electrode 22 and the sample flowing to the creatinine working electrode 23 and the creatinine counter electrode 24 are sufficient.

[0032] The first channel forming layer 4 is disposed on the first reaction region forming layer 3, and the first channel forming layer 4 has a first channel forming area 55. A notch 62 is disposed on one side of the first channel forming layer 4, and the notch 62 is connected to the first channel forming area 55. The first channel forming area 55 is located in the middle area of ​​the first channel forming layer 4, and the notch 62 is located in the middle part of one side of the first channel forming layer 4. The notch 62 divides the first channel forming area 55 into two parts. When a sample is added from the first sample adding port 601, the sample enters the first biosensor 100. When the sample enters the first channel forming layer 4 through the notch 62, the sample is split, and a part of the sample flows into the first part of the first channel forming area 55, and another part of the sample flows into the second part of the first channel forming area 55. The first part of the sample flowing into the first channel forming area 55 finally flows to the creatinine working electrode 23, the creatinine counter electrode 24 and the second sample filling electrode 26 through the third reaction area 43, and the second part of the sample flowing into the first channel forming area 55 finally flows to the urea reference electrode 21, the urea working electrode 22 and the first sample filling electrode 25 through the second reaction area 41 and the first reaction area 42. The width of the first part of the first channel forming area 55 is greater than the width of the second part of the first channel forming area 55. The first upper cover layer 5 is disposed on the first channel forming layer 4. The first upper cover layer 5 forms a first sample channel together with the first channel forming area 55, the second reaction area 41, the first reaction area 42 and the third reaction area 43.

[0033] The first upper cover layer 5 is provided with a first air hole 51 and a second air hole 52 for exhausting the air in the first sample channel when adding a sample. The first air hole 51 and the second air hole 52 are connected with the first channel forming area 55 in the air path.

[0034] The second biosensor 101 is provided with a second insulating substrate 8, a second electrode system arranged on the second insulating substrate 8, a second reaction region forming layer 10, a second channel forming layer 11 and a second upper cover layer 12 in sequence. The second insulating substrate 8, the second reaction region forming layer 10, the second channel forming layer 11 and the second upper cover layer 12 are all made of insulating materials.

[0035] The second electrode system includes a uric acid counter electrode 29, a uric acid working electrode 30, a fifth contact 86 and a sixth contact 84 capable of conducting electricity located at the second electrical connection end 13, and a fifth conductive trace 91 connecting the uric acid counter electrode 29 with the fifth contact 86 and a sixth conductive trace 89 connecting the uric acid working electrode 30 with the sixth contact 84.

[0036] The second electrode system is further provided with a third sample filling electrode 27. The third sample filling electrode 27 is connected to the ninth contact 85 through a ninth conductive trace 90. After the sample is added, it can be determined whether the sample flowing to the uric acid counter electrode 29 and the uric acid working electrode 30 is sufficient by detecting the electrical signal between the third sample filling electrode 27 and the uric acid counter electrode 29 or the uric acid working electrode 30.

[0037] The second electrode system of the second biosensor is also provided with a pair of dedicated HCT electrodes 28 for correcting the test difference caused by the different HCT of the blood samples; in the pair of HCT electrodes 28, one of the HCT electrodes is connected to the tenth contact 83 through the tenth conductive trace 88, and the other HCT electrode is connected to the eleventh contact 87 through the eleventh conductive trace 92. The pair of HCT electrodes 28, the uric acid counter electrode 29 and the uric acid working electrode 30 are located on both sides of the second sample loading port 602.

[0038] The second reaction region forming layer 10 is covered on the second electrode system. The second reaction region forming layer 10 has a fourth reaction region 46, and the shape of the fourth reaction region 46 can be selected from geometric shapes such as rectangle, ellipse, circle, and cut corner rectangle. The fourth reaction region 46 contains a uric acid reaction reagent. The fourth reaction region 46 is partially exposed on the uric acid counter electrode 29 and the uric acid working electrode 30. The second reaction region forming layer 10 has a third exposure hole 47, a fourth exposure hole 48, a fifth exposure hole 49 and a sixth exposure hole 50. The third exposure hole 47 at least partially exposes the third sample filling electrode 27. The third exposure hole 47 is connected to the third air hole 53 arranged on the second biosensor 101 on the air path.

[0039] The fourth exposure hole 48 and the fifth exposure hole 49 each at least partially expose one of the pair of HCT electrodes 28. Among the three exposure holes, the fourth exposure hole 48, the fifth exposure hole 49 and the sixth exposure hole 50, the distance between the sixth exposure hole 50 and the second electrical connection terminal 13 is the largest, followed by the fifth exposure hole 49, and the distance between the fourth exposure hole 48 and the back electrical connection terminal 13 is the smallest. The sixth exposure hole 50 is located near the third exposure hole 49, exposing a partial insulating area of ​​the second insulating substrate 8. The purpose of providing the sixth exposure hole 50 is to communicate with the fourth air hole 54 provided on the second biosensor 101 in the air path, thereby facilitating the sample to fully cover the pair of HCT electrodes 28.

[0040] The second channel forming layer 11 is disposed on the second reaction region forming layer 10, and the second channel forming layer 11 has a second channel forming region 56. A notch 66 is disposed on one side of the second channel forming layer 11, and the notch 66 is connected to one end or the middle portion of the second channel forming region 56. When a sample is added from the second sample addition port 602, the sample enters the second biosensor 101, then enters the second channel forming region 56 through the notch 66, and finally flows to the uric acid counter electrode 29 and the uric acid working electrode 30.

[0041] The notch 66 provided on one side of the second channel forming layer 11 is connected to the middle part of the second channel forming area 56, which divides the second channel forming area 56 into two parts. Therefore, when the sample is added from the second sample addition port 602 and enters the second channel forming layer 11 through the notch 66, the sample is split, with one part flowing into the first part of the second channel forming area 56 and the other part flowing into the second part of the second channel forming area 56. The sample flowing into the first part of the second channel forming area 56 eventually flows to a pair of HCT electrodes 28 through the fourth exposure hole 48 and the fifth exposure hole 49, and the sample flowing into the second part of the second channel forming area 56 eventually flows to the uric acid counter electrode 29 and the uric acid working electrode 30 through the fourth reaction area 46.

[0042] The second upper cover layer 12 is arranged on the second channel forming layer 11. The second upper cover layer 12 forms a second sample channel together with the second channel forming area 56 and the fourth reaction area 46. The second upper cover layer 12 contains a third pore 53 and a fourth pore 54. The second sample channel is used to provide samples to the uric acid counter electrode 29 and the uric acid working electrode 30, dissolve the reaction reagent in the fourth reaction area 46, and react to generate an electrical signal. The third pore 53 is located above the second sample channel, and is connected to the second sample channel on the gas path, and is used to exhaust the air in the second sample channel when adding samples. The fourth pore 54 is located above the first part of the second channel forming area 56, and is connected to the first part of the second channel forming area 56 and the sixth exposure hole 50 on the gas path, and is used to exhaust the air in the second sample channel when adding samples. The third pore 53 is located above the second part of the second channel forming area 56, and is connected to the second part of the second channel forming area 56 on the gas path, and is used to exhaust the air in the second sample channel when adding samples.

[0043] The first upper cover layer 5, the first channel forming layer 4, the first reaction region forming layer 3 and the first insulating substrate 1 are provided with a notch 61, a notch 62, a notch 63 and a notch 64 on the same side. The notch 61, the notch 62, the notch 63 and the notch 64 are aligned in position. The "alignment" mentioned in this article means that when two notches are aligned, if the sizes (i.e., size and / or shape) of the two notches are consistent, one of the notches completely overlaps with the projection area of ​​the other notch, and if the sizes of the two notches are inconsistent, one of the notches is located inside the projection area of ​​the other notch. On the first biosensor 100, the notch 61, the notch 62, the notch 63 and the notch 64 together form the first sample addition port 601. The second upper cover layer 12, the second channel forming layer 11, the second reaction region forming layer 10 and the second insulating substrate 8 are provided with notches 65, 66, 67 and 68 on the same side. The notch 65, the notch 66, the notch 67 and the notch 68 are aligned in position. On the second biosensor 101, the notch 65, the notch 66, the notch 67 and the notch 68 together form a second sample loading port 602. When the first biosensor 100 and the second biosensor 101 are assembled together, the first sample loading port 601 and the second sample loading port 602 are located on the same side of the electrochemical test strip 200 and aligned in position, thereby forming the sample loading port 6 of the electrochemical test strip 200 together.

[0044] When the first biosensor 100 and the second biosensor 101 are assembled together, a part of the sample added to the sample injection port 6 flows into the first biosensor 100 through the first sample injection port 601, and enters the first channel forming area 55 through the notch 61 and the notch 62. The notch 62 divides the first channel forming area 55 into two parts. Therefore, the sample entering the first channel forming area 55 is split at this time, and a part of the sample flows into the first part of the first channel forming area 55, and the other part of the sample flows into the second part of the first channel forming area 55. The first part of the sample flowing into the first channel forming area 55 passes through the third reaction area 43 and finally flows to the creatinine working electrode 23 and the creatinine counter electrode 24, and the second part of the sample flowing into the first channel forming area 55 passes through the second reaction area 41 and the first reaction area 42 and finally flows to the urea reference electrode 21 and the urea working electrode 22. Another part of the sample added to the sample adding port 6 flows into the second biosensor 101 through the second sample adding port 602, and enters the second channel forming area 56 through the notch 65 and the notch 66. At this time, the sample entering the second channel forming area 56 is split, with one part flowing into the first part of the second channel forming area 56 and the other part flowing into the second part of the second channel forming area 56. The sample flowing into the first part of the second channel forming area 56 finally flows to a pair of HCT electrodes 28 through the fourth exposure hole 48 and the fifth exposure hole 49 for detecting the HCT value of the sample, and the sample flowing into the second part of the second channel forming area 56 finally flows to the uric acid counter electrode 29 and the uric acid working electrode 30 through the fourth reaction area 46 for detecting uric acid.

[0045] The second reaction area 41 contains a first reaction reagent of urea, the first reaction area 42 contains a second reaction reagent of urea, the third reaction area 43 contains a creatinine reaction reagent, and the fourth reaction area 46 contains a uric acid reaction reagent. These four reaction reagents can be added to the corresponding reaction areas by methods such as liquid dot or screen printing. The present invention combines the two methods of liquid dot and solution screen printing to add these four reaction reagents to the corresponding four reaction areas.

[0046] In the electrochemical test strip 200, the urea reference electrode 21 and the urea working electrode 22 detect urea in the sample by potentiometric measurement, the creatinine working electrode 23 and the creatinine counter electrode 24 detect creatinine in the sample by amperometric measurement, and the uric acid counter electrode 29 and the uric acid working electrode 30 detect uric acid in the sample by amperometric measurement. In order to detect urea, the urea first reaction reagent contains a buffer such as PBS; a polymer binder such as methylcellulose; a surfactant such as Triton X-100; and urease. The urea second reaction reagent contains a buffer such as PBS; a polymer binder such as methylcellulose; a surfactant such as Triton X-100; an electron transfer agent such as a ruthenium compound (e.g., hexaammonium ruthenium trichloride). In order to detect creatinine, the creatinine reaction reagent contains a buffer such as PBS; a polymer binder such as methylcellulose; a stabilizer such as sucrose; a surfactant such as Triton X-100; creatinase, creatinase, sarcosine oxidase; and an electron transfer agent such as a ruthenium compound, potassium ferrocyanide, or potassium ferrocyanide. In order to detect uric acid, the uric acid reaction reagent contains a buffer, such as PBS; a polymer binder, such as methylcellulose; a stabilizer, such as trehalose; a surfactant, such as Triton X-100; and an electron transfer agent, such as a ruthenium compound, potassium ferrocyanide or potassium ferrocyanide. The urea first reaction reagent and the urea second reaction reagent for detecting urea and the creatinine reaction reagent for detecting creatinine can be added to the second reaction area 41, the first reaction area 42 and the third reaction area 43 respectively by means of solution dot liquid, and the uric acid reaction reagent for detecting uric acid is added to the fourth reaction area 46 by screen printing.

[0047] Example 1 Preparation of quality control solution

[0048] The three quality control solutions of the present invention include: Good's buffer solution 0.01mol / L-2mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), sodium urate 0.0001%-3% (w / w), urea 0.0001%-3% (w / w), creatinine 0.0001%-3% (w / w) and creatine 0.0001%-3% (w / w).

[0049] The three quality control solutions 1 of the present invention include: TAPSO 0.01 mol / L (pH 7.0), PEG3350 40% (w / w), calcium chloride 0.02% (w / w), EDTA 1% (w / w), sodium benzoate 0.1% (w / w), allura red 0.1% (w / w), sodium urate 3% (w / w), urea 0.0001% (w / w), creatinine 3% (w / w) and creatine 0.0001% (w / w).

[0050] The three quality control solutions 2 of the present invention include: TAPSO 2mol / L (pH 6.5), PEG2000 10% (w / w), calcium chloride 0.5% (w / w), dipotassium EDTA 0.1% (w / w), sodium benzoate 2% (w / w), allura red 2% (w / w), sodium urate 0.0001% (w / w), urea 3% (w / w), creatinine 0.0001% (w / w) and creatine 3% (w / w).

[0051] The three quality control solutions 3 of the present invention include: TAPSO 1 mol / L (pH 7.5), PEG6000 5% (w / w), calcium chloride 0.3% (w / w), disodium EDTA 0.1% (w / w), sodium benzoate 1.0% (w / w), allura red 0.22% (w / w), sodium urate 0.0052% (w / w), urea 0.2118% (w / w), creatinine 0.0066% (w / w) and creatine 0.0031% (w / w).

[0052] The three quality control solutions 4 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0052% (w / w), urea 0.1026% (w / w), creatinine 0.0028% (w / w), and creatine 0.0020% (w / w).

[0053] The three quality control solutions 5 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0095% (w / w), urea 0.1408% (w / w), creatinine 0.0044% (w / w), and creatine 0.0031% (w / w).

[0054] The three quality control solutions 6 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0161% (w / w), urea 0.2118% (w / w), creatinine 0.0066% (w / w), and creatine 0.0046% (w / w).

[0055] The three quality control solutions 7 of the present invention include: HEPES 0.05 mol / L (pH 6.8), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0096% (w / w), urea 0.1340% (w / w), creatinine 0.0038% (w / w), and creatine 0.0027% (w / w).

[0056] The three quality control solutions 8 of the present invention include: MES 0.05 mol / L (pH 6.8), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0096% (w / w), urea 0.1340% (w / w), creatinine 0.0038% (w / w), and creatine 0.0027% (w / w).

[0057] The three quality control solutions 9 of the present invention include: BES 0.05 mol / L (pH 6.8), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0096% (w / w), urea 0.1340% (w / w), creatinine 0.0038% (w / w), and creatine 0.0027% (w / w).

[0058] The three quality control solutions 10 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0096% (w / w), urea 0.1340% (w / w), creatinine 0.0038% (w / w), and creatine 0.0027% (w / w).

[0059] The three quality control solutions 11 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0059% (w / w), urea 0.1001% (w / w), creatinine 0.0027% (w / w), and creatine 0.0019% (w / w).

[0060] The three quality control solutions 12 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0104% (w / w), urea 0.1525% (w / w), creatinine 0.0047% (w / w), and creatine 0.0033% (w / w).

[0061] The three quality control solutions 13 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0160% (w / w), urea 0.2270% (w / w), creatinine 0.0068% (w / w), and creatine 0.0048% (w / w).

[0062] The three quality control solutions 14 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0087% (w / w), urea 0.1621% (w / w), creatinine 0.0037% (w / w), and creatine 0.0026% (w / w).

[0063] The three quality control solutions 15 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.0087% (w / w), urea 0.1621% (w / w), and creatinine 0.0037% (w / w).

[0064] The three quality control solutions 16 of the present invention (containing neither CaCl2 nor NaCl) include: TAPSO 0.2 mol / L (pH 7.0), propylene glycol 15% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.010% (w / w), urea 0.1561% (w / w), creatinine 0.0058% (w / w) and creatine 0.0041% (w / w).

[0065] The three quality control solutions 17 of the present invention (containing CaCl2 but not NaCl) are: TAPSO 0.2mol / L (pH 7.0), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.010% (w / w), urea 0.1561% (w / w), creatinine 0.0058% (w / w) and creatine 0.0041% (w / w).

[0066] The three quality control solutions 18 of the present invention (containing CaCl2 and also containing NaCl) are: TAPSO 0.2 mol / L (pH 7.0), propylene glycol 15% (w / w), calcium chloride 0.05% (w / w), sodium chloride 0.1% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.010% (w / w), urea 0.1561% (w / w), creatinine 0.0058% (w / w) and creatine 0.0041% (w / w).

[0067] The two quality control solutions a of the present invention include: Good's buffer solution 0.01 mol / L-2 mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), sodium urate 0.0001%-3% (w / w), creatinine 0.0001%-3% (w / w) and creatine 0.0001%-3% (w / w).

[0068] The two quality control solutions a1 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.009% (w / w), creatinine 0.0045% (w / w) and creatine 0.0037% (w / w).

[0069] The two quality control solutions b of the present invention include: Good's buffer solution 0.01mol / L-2mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), urea 0.0001%-3% (w / w), creatinine 0.0001%-3% (w / w) and creatine 0.0001%-3% (w / w).

[0070] The two quality control solutions b1 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), urea 0.1978% (w / w), creatinine 0.0045% (w / w) and creatine 0.0037% (w / w).

[0071] The two quality control solutions c of the present invention include: Good's buffer 0.01mol / L-2mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), sodium urate 0.0001%-3% (w / w) and urea 0.0001%-3% (w / w).

[0072] The two quality control solutions c1 of the present invention include: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), sodium urate 0.009% (w / w) and urea 0.1978% (w / w).

[0073] The single-item quality control solution a of the present invention comprises: Good's buffer solution 0.01 mol / L-2 mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), creatinine 0.0001%-3% (w / w) and creatine 0.0001%-3% (w / w).

[0074] The single-item quality control solution a1 of the present invention comprises: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w), creatinine 0.0045% (w / w) and creatine 0.0037% (w / w).

[0075] The single-item quality control solution b of the present invention comprises: Good's buffer solution 0.01 mol / L-2 mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w) and urea 0.0001%-3% (w / w).

[0076] The single quality control solution b1 of the present invention comprises: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w) and urea 0.1978% (w / w).

[0077] The single-item quality control solution C of the present invention comprises: Good's buffer solution 0.01 mol / L-2 mol / L, pH 6.5-7.5; polymer 10%-40% (w / w), calcium chloride 0.02%-0.5% (w / w), EDTA or its salt 0.1%-1% (w / w), preservative 0.1%-2% (w / w), blood simulation dye 0.1%-2% (w / w), sodium urate 0.0001%-3% (w / w), urea 0.0001%-3% (w / w), creatinine 0.0001%-3% (w / w) and creatine 0.0001%-3% (w / w).

[0078] The single quality control solution c1 of the present invention comprises: TAPSO 0.05 mol / L (pH 7.0), PEG3350 7.5% (w / w), propylene glycol 7.5% (w / w), calcium chloride 0.05% (w / w), disodium EDTA 0.3% (w / w), sodium benzoate 0.15% (w / w), allura red 0.22% (w / w) and sodium urate 0.009% (w / w).

[0079] In the quality control solution of the present invention, Good's buffer can be selected from HEPES, MES, BES and TAPSO, preferably TAPSO; the blood simulation dye can be selected from sulforhodamine B, Congo red, Mito Red, acid red, fluorescent red, allura red, cresol red, amaranth, chlorophenol red, sulforhodamine 101, preferably allura red; the polymer can be selected from PEG2000-6000, propylene glycol, glycerol or a combination thereof; the preservative can be selected from sodium azide, thimerosal, sodium benzoate, Proclin-150, Proclin-200, Proclin-300 and Proclin-5000.

[0080] Preferably, the single-item quality control solution, the two-item quality control solution and the three-item quality control solution of the present invention can also be added with an appropriate amount of sodium chloride, and the concentration thereof is 0-0.1% (w / w).

[0081] When preparing the quality control solution of the present invention (single-item quality control solution, two-item quality control solution and three-item quality control solution), first mix Good's buffer (pH 6.5-7.5) and polymer, then add EDTA or its salt, preservative and blood simulation dye to mix, and finally add at least one of sodium urate, urea and creatinine to mix thoroughly. When the quality control solution of the present invention contains calcium chloride or sodium chloride or contains calcium chloride and chloride at the same time, calcium chloride or sodium chloride should be mixed with Good's buffer and polymer. When the quality control solution of the present invention contains creatine, creatine and at least one of sodium urate, urea and creatinine are added simultaneously.

[0082] Example 2: Quality control solution detection

[0083] Before the test, the electrochemical test strip is inserted into an electrical connector of a detection instrument, and the first biosensor and the second biosensor of the electrochemical test strip are electrically connected to the electrical connector of the detection instrument. After a period of time, the quality control solution (single-item quality control solution, two-item quality control solution, or three-item quality control solution) configured in Example 1 is added through the sample addition port, and then the electrochemical signal corresponding to urea, creatinine and / or uric acid in the quality control solution is detected.

[0084] After adding the quality control solution, the urea in the quality control solution (if present) reacts with the urea first reaction reagent and the urea second reaction reagent, and the urea concentration is measured by the potentiometric method, the test time is 3s to 100s, and the detected potential signal (mV) is recorded; the creatinine in the quality control solution (if present) reacts with the creatinine reaction reagent and is measured by the amperometric method, the test time is 3s to 100s, and the detected current signal (μA) is recorded; the uric acid in the quality control solution (if present) reacts with the uric acid reaction reagent and is measured by the amperometric method, the test time is 2s to 100s, and the detected current signal (μA) is recorded.

[0085] Example 3: Evaluation of storage stability

[0086] The three quality control solutions 4, 5 and 6 in Example 1 were tested at room temperature (RT) using the detection method in Example 2, and then placed at 65°C for 2 weeks (65C2W), and then tested again using the detection method in Example 2, and 10 electrochemical test strips from the same batch were selected for testing. The test results are shown in Tables 1, 2 and 3, respectively.

[0087] Table 1. Potential signal detection results for urea

[0088]

[0089] Table 2. Current signal detection results for creatinine

[0090]

[0091] Table 3. Current signal detection results for uric acid

[0092]

[0093]

[0094] In Table 1, the potential signal for urea is detected at low (0.1026% (w / w)), medium (0.1408% (w / w)) and high (0.2118% (w / w)) urea concentrations. In Table 2, the current signal for creatinine is detected at low (0.0028% (w / w)), medium (0.0044% (w / w)) and high (0.0066% (w / w)) creatinine concentrations. In Table 3, the current signal for uric acid is detected at low (0.0052% (w / w)), medium (0.0095% (w / w)) and high (0.0161% (w / w)) sodium urate concentrations.

[0095] The three quality control solutions placed at 65°C for 2 weeks are equivalent to being stored at 30°C for 1 year. The data in Tables 1, 2 and 3 show that the three quality control solutions 4, 5 and 6 placed at 65°C for 2 weeks have no particularly significant differences in the detected potential signals for urea, the current signals for creatinine and the current signals for uric acid compared with the same three quality control solutions at room temperature. This indicates that the three quality control solutions of the present invention remain stable at 30°C for 1 year.

[0096] Example 4: Evaluation of different buffers

[0097] The three quality control solutions 7, 8, 9 and 10 in Example 1 were tested at room temperature (RT) using the detection method in Example 2, and then placed at 65°C for 2 weeks (65C2W), and then tested using the detection method in Example 2. The difference between these four three-item quality control solutions is that different Good's buffers are used: HEPES (pH 6.8), MES (pH 6.8), BES (pH 6.8) and TAPSO (pH 7.0). During the test, 10 electrochemical test strips from the same batch were selected for testing. The test results are shown in Tables 4, 5 and 6, respectively.

[0098] Table 4. Potential signal detection results for urea

[0099]

[0100]

[0101] Table 5. Current signal detection results for creatinine

[0102]

[0103] Table 6. Current signal detection results for uric acid

[0104]

[0105]

[0106] It can be seen from Tables 4, 5 and 6 that under these four different Good's buffers, the deviations of the electrochemical signals for urea, creatinine and uric acid under both RT and 65C2W conditions are within 10%, and the deviations are small. Overall, compared with TAPSO (pH7.0) buffer, the electrochemical signals for urea, creatinine and uric acid maintain a small deviation under both RT and 65C2W conditions, which is better than the other three Good's buffers. In addition, further experiments conducted by changing the concentration and pH of these four different Good's buffers showed that these four different Good's buffers can keep the electrochemical signals for urea, creatinine and uric acid at a small deviation under both RT and 65C2W conditions when their concentrations are 0.05mol / L~0.5mol / L (pH 6.5~7.2).

[0107] Example 5: Detection Accuracy

[0108] The three quality control solutions 11, 12 and 13 in Example 1 were prepared at room temperature, and 3 batches of each three quality control solution were prepared. Then, the three quality control solutions 11, 12 and 13 of each batch were tested using the detection method in Example 2. Before the detection, 10 electrochemical test strips of the same batch were selected for testing. The test results are shown in Tables 7, 8 and 9, respectively.

[0109] Table 7. Potential signal detection results for urea

[0110]

[0111]

[0112] As shown in Table 7, after adding the three quality control solutions 11, 12 and 13 of different batches of the present invention, the CV of the current detection results between the 10 electrochemical test strips of the same batch were 1.57%, 2.21% and 2.27%, respectively, all less than 5%. This shows that the potential values ​​obtained by the three quality control solutions of different batches of the present invention when detecting different urea concentrations with the electrochemical test strips of the same batch have good precision.

[0113] Table 8. Current signal (μA) detection results for creatinine (0.0027%)

[0114]

[0115] As shown in Table 8, after adding the three quality control solutions 11, 12 and 13 of different batches of the present invention, the CV of the current detection results between the 10 electrochemical test strips of the same batch were 2.74%, 2.77% and 2.51%, respectively, all less than 5%. This shows that the current values ​​obtained by the three quality control solutions of different batches of the present invention when detecting different creatinine concentrations with the electrochemical test strips of the same batch have good precision.

[0116] Table 9. Current signal (μA) detection results for uric acid

[0117]

[0118] As shown in Table 9, after adding the three quality control solutions 11, 12 and 13 of different batches of the present invention, the CV of the current detection results between the 10 electrochemical test strips of the same batch were 2.48%, 1.76% and 2.19%, respectively, all less than 5%. This shows that the current values ​​obtained by the three quality control solutions of different batches of the present invention when detecting different uric acid concentrations with the electrochemical test strips of the same batch have good precision.

[0119] Example 6: Evaluating the Effect of Creatine

[0120] The three quality control solutions 14 and 15 in Example 1 were prepared at room temperature (RT). The difference between the three quality control solutions 14 and 15 is that the former adds creatine, while the latter does not. After conversion, the uric acid concentration in the three quality control solutions 14 and 15 is about 460 μmol / L; the creatinine concentration is about 330 μmol / L; and the urea concentration is about 27 mmol / L. The uric acid, urea and creatinine concentrations (μmol / L) in the three quality control solutions 14 and 15 were detected at room temperature using a Mindray BS-350E fully automatic biochemical analyzer, and the detection was repeated twice. After the three quality control solutions 14 and 15 were stored at 65°C for 2 weeks, the uric acid, urea and creatinine concentrations (μmol / L) in the three quality control solutions 14 and 15 were detected using this biochemical analyzer, and the detection was repeated twice. The detection results are shown in Table 10.

[0121] Table 10. Evaluation of the effects of creatine

[0122]

[0123]

[0124] As shown in Table 10, when creatinine and creatine are present at the same time, after storage at 65°C for 2 weeks, the biochemical test value of creatinine in the three-item quality control solution 14 did not change significantly; the biochemical test value of creatinine in the three-item quality control solution 15 decreased by 15%, and the creatinine content changed significantly. The presence of creatine can effectively keep the creatinine content in the three-item quality control solution 14 stable.

[0125] Example 7: Evaluation of the Effects of Sodium Chloride and Calcium Chloride

[0126] The three quality control solutions 16, 17 and 18 prepared at room temperature (RT) in Example 1 were tested using the test method in Example 2. At the same time, the three quality control solutions 16, 17 and 18 were placed at 65° C. for 2 weeks (65C2W) and then tested using the test method in Example 2. Before the test, 5 electrochemical test strips from the same batch were selected for testing. The test results are shown in Tables 11, 12 and 13, respectively.

[0127] Table 11

[0128]

[0129] Table 12

[0130]

[0131]

[0132] Table 13

[0133]

[0134] It can be seen from Tables 11, 12 and 13 that the deviations of the electrochemical signals for creatinine, urea and uric acid in the three quality control solutions 16, 17 and 18 under both RT and 65C2W are within 10%, and the deviations are small. This shows that the three quality control solutions 16, 17 and 18 of the present invention remain stable within 1 year at 30°C. In addition, in the three quality control solutions 18, in the presence of CaCl2 and NaCl, the deviations of the electrochemical signals for creatinine, urea and uric acid under both RT and 65C2W are less than 4%, while in the three quality control solutions 16, the deviation of the electrochemical signal for creatinine under both RT and 65C2W is 7.9%, which is less than 10%, but greater than 5%; in the three quality control solutions 17, the deviation of the electrochemical signal for creatinine under both RT and 65C2W is 6.9%, which is less than 10%, but greater than 5%. In addition, it can be seen from Tables 11, 12 and 13 that adding an appropriate amount of NaCl can enhance the ionic strength, increase the test current values ​​of uric acid and creatinine, and improve the electrical signal gradient.

[0135] Example 8: Evaluation of the Storage Stability of Other Quality Control Solutions of the Present Invention

[0136] The single-item quality control solutions a1, b1, c1 and the two-item quality control solutions a1, b1 and c1 in Example 1 were tested at room temperature using the test method in Example 2, and then placed at room temperature (RT) and 65°C for 2 weeks (65C2W), and then tested using the test method in Example 2, and 10 electrochemical test strips from the same batch were selected for testing. The test results are shown in Tables 14, 15, 16 and 17, respectively.

[0137] Table 14

[0138]

[0139] As shown in Table 14, the electrochemical signal for creatinine in the single quality control solution a1, the electrochemical signal for urea in the single quality control solution b1, and the electrochemical signal for uric acid in the single quality control solution c1 have a deviation of less than 10% under both RT and 65C2W conditions, which indicates that the single quality control solutions a1, b1, and c1 of the present invention remain stable at 30°C for 1 year.

[0140] Table 15

[0141]

[0142]

[0143] Table 16

[0144]

[0145] Table 17

[0146]

[0147] As shown in Tables 15, 16 and 17, the electrochemical signals for creatinine and uric acid in the two control solutions a1, the electrochemical signals for creatinine and urea in the two control solutions b1, and the electrochemical signals for uric acid and urea in the two control solutions c1 are all within 10% under both RT and 65C2W conditions, and the deviations are small. This shows that the two control solutions a1, b1 and c1 of the present invention remain stable at 30°C for 1 year.

Claims

1. A quality control solution, characterized in that: The quality control solution comprises a buffer, a polymer, EDTA or its salt, a preservative, a blood simulation dye and an analyte.

2. The quality control solution according to claim 1, characterized in that Buffer solution 0.01mol / L~2mol / L, pH 6.5~7.5; polymer 10%~40% (w / w), EDTA or its salt 0.1%~1% (w / w), preservative 0.1%~2% (w / w), blood simulation dye 0.1%~2% (w / w).

3. The quality control solution as claimed in claim 1, wherein the analyte is selected from urea, sodium urate, creatinine or a combination thereof.

4. The quality control solution according to claim 3, characterized in that: When the analyte includes creatinine, the creatinine is 0.0001% to 3% (w / w); when the analyte includes sodium urate, the sodium urate is 0.0001% to 3% (w / w); when the analyte includes urea, the urea is 0.0001% to 3% (w / w).

5. The quality control solution as claimed in claim 1, wherein the polymer is selected from PEG2000-6000, propylene glycol, glycerol or a combination thereof.

6. The quality control solution according to claim 1, characterized in that: The quality control solution also includes calcium chloride or sodium chloride, or a combination of calcium chloride and sodium chloride.

7. The quality control solution according to claim 6, characterized in that: When the quality control solution includes calcium chloride, the concentration of calcium chloride is 0.02% to 0.5% (w / w); when the quality control solution includes sodium chloride, the concentration of sodium chloride is 0 to 0.1% (w / w).

8. The quality control solution according to claim 3, characterized in that: When the analyte includes creatinine, the quality control solution also includes creatine. Preferably, the concentration of creatine is 0.0001% to 3% (w / w).

9. The quality control solution according to claim 1, characterized in that: The buffer is Good's buffer, which is selected from HEPES, MES, BES and TAPSO. Preferably, the concentration of the Good's buffer is 0.05 mol / L to 0.5 mol / L, and the pH is 6.5 to 7.

2.

10. Use of the quality control solution according to any one of claims 1 to 9 in detecting urea, creatinine and / or urea.

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