Control solution and use thereof

Abstract

The present invention provides a control solution and a test system comprising the control solution. The control solution comprises an aqueous solution of an analyte, and an organic compound. The control solution of the present invention meets the performance requirements of control solutions, and can reduce the probability of secondary sampling when test paper is being used again, thereby ensuring that an operator can correctly use disposable test paper and obtain accurate test results.

Description

Control fluid and its application Technical Field

[0001] The present invention relates to the field of detection, in particular to a control liquid used for verifying whether a test system is normal and an application thereof in verifying a blood test system. Background Art

[0002] With the development of testing technology, many tests can be directly performed by ordinary people who have not received professional training. These tests are often in the form of disposable test strips to measure specific components in body fluids. For example, electrochemical test strips are currently used by patients with related diseases to monitor blood sugar, uric acid, and blood ketone levels. During the test, the blood sample to be tested is added to the inlet of the test strip, and the blood sample immediately enters the inlet channel of the test strip. After the blood sample is filled, the tester collects the test signal and calculates the test result to complete the test. After the operator completes a test, the used test strip needs to be discarded. If the inlet channel of the test strip is dark red, it means that the test strip has been used before with a blood sample added and cannot be used again.

[0003] Test strips and instrument systems also come with control solutions of varying concentrations. These solutions contain a known concentration of the analyte, used to verify the proper functioning and effectiveness of the instrument and test strips, and to verify the accuracy of test results. For example, the control solution in a blood glucose test system contains a known concentration of glucose, the control solution in a uric acid test system contains a known concentration of sodium urate, and the control solution in a blood ketone test system contains a known concentration of sodium beta-hydroxybutyrate. Control solutions can be used to verify the test system if the operator suspects instrument malfunction, inaccurate test strips, or after cleaning the instrument. When the control solution is added to the test strips, the analyte in the control solution reacts with the reagent in the test strips, generating a current signal. The tester detects this current signal and converts it into a test result for display. If the test result displayed by the tester is within the control solution's specified range, the test system is functioning properly and the procedure is correct. Otherwise, the user is advised not to use the test system for testing until the cause is determined.

[0004] The test system generally prepares two or three control solutions of different concentrations. Some manufacturers add red dye to the control solution to make it appear red, while some manufacturers' control solution is colorless.

[0005] If a test strip with control solution added to it is not discarded after verification, the operator may unknowingly use the used test strip for sample testing without observing the color change of the test strip's injection channel. For another example, after the test strip with control solution added to it has been verified and naturally dried, the color of its injection channel becomes essentially the same as that of a new test strip. The control solution remaining in the injection channel is difficult to detect, requiring the operator to carefully observe the color of the injection channel to determine whether the test strip is new.

[0006] If a test strip that has been added with control liquid is mistakenly used by the user and reused, and blood or control liquid contacts the test strip's sampling port, two situations may occur: the first is that the blood or control liquid cannot re-enter the sampling channel. In this case, the tester will give a prompt message indicating that the sample has not been added, the sample amount is insufficient, or the sample is incorrectly added; the second is that the blood or control liquid still enters the sampling channel smoothly, and the sampling channel is filled with blood or control liquid. The tester begins to collect signals and gives test results. According to statistics, the probability of the second situation occurring is still relatively high. In this case, the tester cannot recognize this type of secondary sampling error and will not give an error message. The test data obtained from re-testing the used test strip is inaccurate, causing the operator to unknowingly obtain an incorrect test result, which may lead to misdiagnosis.

[0007] Therefore, attempts to improve the control liquid to avoid the test paper with added control liquid from being reused are a technical problem that urgently needs to be solved in the field of disposable electrochemical test paper. Summary of the Invention

[0008] In order to reduce the probability of secondary injection when the test strip is reused after verification by adding a control solution to the test strip, the present invention provides a control solution comprising a certain concentration of an analyte and an organic compound with a hydroxyl group.

[0009] Furthermore, the organic compound includes a hydroxyl functional group.

[0010] Furthermore, the organic compound includes alcohols or esters with hydroxyl groups.

[0011] Furthermore, the organic agent is selected from polyethylene glycol, tetrabutylol, poly(ethylene glycol) methacrylate, isopropyl alcohol, glycerol or propyl gallate.

[0012] Furthermore, the concentration of the organic compound is greater than 0.1%.

[0013] Furthermore, the concentration of the organic compound ranges from 1% to 30%.

[0014] Furthermore, the concentration of the organic compound is 3% to 15%.

[0015] Furthermore, the control solution also includes a buffer solution, which is selected from but not limited to a phosphate buffer solution and a citric acid buffer solution.

[0016] Furthermore, the control solution may further include a dye, wherein the dye is selected from but not limited to Allura Red AC dye, lemon yellow, quinoline yellow, and brilliant blue.

[0017] Furthermore, the control liquid can be used for verification of a test system, for example but not limited to verification of a blood glucose test system, a uric acid test system, or a blood ketone test system.

[0018] Among them, the analyte contained in the control solution for verifying the blood glucose test system is glucose, the analyte contained in the control solution for verifying the uric acid test system is sodium urate, and the analyte contained in the control solution for verifying the blood ketone test system is sodium β-hydroxybutyrate.

[0019] The test system comprises a tester, a test paper and the control liquid of the present invention.

[0020] The test paper is selected from but not limited to electrochemical test paper. Further, the sample injection channel of the test paper is hydrophilic, and the sample injection channel adopts the capillary action principle to inject sample.

[0021] The present invention also provides a test system with a control liquid, comprising a tester and the control liquid of the present invention.

[0022] Furthermore, the test system also includes test strips. For example, a blood glucose test system includes blood glucose test strips, a uric acid test system includes uric acid test strips, and a blood ketone test system includes blood ketone test strips.

[0023] Furthermore, the test paper is an electrochemical test paper, which at least includes a working electrode and a counter electrode.

[0024] The analyte contained in the control solution is selected from but not limited to glucose, uric acid or sodium β-hydroxybutyrate, and the test strips used in conjunction with the control solution are blood glucose, uric acid or blood ketone test strips.

[0025] Furthermore, the sampling channel of the test paper is hydrophilic, and the sampling channel adopts the capillary action principle to inject samples.

[0026] Secondary injection of the test strip refers to the situation where, when the test strip with the control solution added is used again, the sample or the control solution waiting to be tested can still enter the injection channel from the injection port of the used test strip and reach the test area.

[0027] The present invention has the beneficial effect of ensuring that the control solution still meets its performance requirements after adding an alcohol or ester reagent, while also reducing the probability of secondary injection when a test strip containing the control solution is reused. If an operator finds that the sample fails to enter the test strip's injection channel after adding it, or that the sample partially enters the injection channel but fails to reach the reaction zone, the operator may consider that the test strip currently in use is previously used and that a new test strip is necessary for testing. This ensures that the operator correctly uses disposable test strips and obtains accurate test results. DETAILED DESCRIPTION

[0028] The structure of the electrochemical test paper includes an insulating base plate, electrodes and electrode leads arranged on the insulating base plate, a middle partition layer with open grooves covering the electrodes, and a hydrophilic layer with vents covering the middle partition layer. The insulating base plate, the open grooves of the middle partition layer and the hydrophilic layer are superimposed to form an injection channel, and the front end of the injection channel is the injection port. The injection channel is treated with hydrophilicity so that the blood sample or control liquid can smoothly enter the injection channel and cover the reaction area of ​​the electrode. The reagent layer is added to the electrode in the reaction area. For example, the reagent layer of the blood glucose test paper contains an enzyme, a buffer system and a surfactant. The injection channel of the test paper adopts capillary action injection, and in some embodiments, the injection channel can be observed.

[0029] The method for determining the analyte in the sample includes: inserting the test strip into the tester, and after the blood sample or control liquid waiting to be tested contacts the test strip sampling port, it enters the sampling channel and reaches the reaction area under capillary action. The current generated during the test is measured by the current detector in the tester, and then converted into the corresponding concentration and displayed on the tester display.

[0030] The test paper cannot be used for sample detection again after the control liquid is added. The method for judging whether the test paper with the control liquid added will be subjected to secondary sampling includes the following steps: Step 1: Take a new unused test paper and insert the test paper into the tester. The control liquid contacts the test paper sampling port and enters the test paper sampling channel; Step 2: The tester test is completed, the test data is obtained, and the verification experiment is completed; Step 3: The test paper with the control liquid added is dried in a natural state. The test paper at this time is called a used test paper; Step 4: Insert the used test paper into the tester again to allow the control liquid or blood sample to wait for the test sample to be tested. The test paper contacts the injection port; Step 5: Observe the flow of the control liquid or blood sample in the injection channel. If the sample to be tested flows into the injection channel and reaches the reaction area, it means that secondary injection has occurred. If the sample to be tested does not enter the injection channel further after contacting the injection port, or if the sample to be tested flows into the injection channel but does not reach the reaction area, the used test paper has not undergone secondary injection. While observing whether secondary injection occurs, record whether the tester will give error messages such as no sample added, insufficient sample amount or sample addition error.

[0031] Example 1: Secondary injection test using blood glucose test strips

[0032] The control solution of the control group contained the following reagents: 65.0% (w / w) phosphate buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.3% (w / w) glucose and water.

[0033] Experimental group control solution: The present invention adds the reagents listed in Table 1 at a concentration of 3% (w / w) to the control solution of the control group. The other components and contents in the experimental group control solution are the same as those in the control solution of the control group.

[0034] In this embodiment, the reaction reagents of the blood glucose test strip used for testing include glucose dehydrogenase, phosphate buffer solution, Triton X-100 and hydroxyethyl cellulose, etc. The sample injection channel of the blood glucose test strip is hydrophilic.

[0035] Take a new, unused blood glucose test strip, insert the test strip into the tester, add the control solution of the control group and the control solution of the experimental group to the test strip's injection channel respectively. After completing the verification, dry the test strip with the control solution in a natural state, and then insert the dried used test strip into the tester again, so that the blood sample to be tested contacts the injection port of the test strip. Observe the flow of the blood sample in the injection channel. If the blood sample flows into the injection channel and reaches the reaction area, secondary injection has occurred. If the blood sample does not enter the injection channel further after contacting the injection port, or the blood sample flows into the injection channel but does not reach the reaction area, then the used test strip has not undergone secondary injection. Statistically calculate the proportion of secondary injection after using different control solutions. The results are shown in Table 1.

[0036] According to the secondary injection test results in Table 1, the experimental control solutions containing polyethylene glycol (PEG), DL-glyceraldehyde, tyloxapol, poly(ethylene glycol) methacrylate, isopropyl alcohol, propyl gallate, or glycerol all demonstrated significant effectiveness in preventing secondary injection, reducing the incidence of secondary injection to varying degrees. The secondary injection test results for the control solution in the control group showed a very high incidence of secondary injection, with the blood glucose meter failing to generate an error message after secondary injection.

[0037] The inventors discovered that when a test strip that has been treated with a control solution containing an alcohol or ester reagent is reused, the added sample is extremely difficult to enter the test strip's injection channel, effectively reducing the probability of secondary injection. The inventors analyzed that the alcohol or ester reagent in the control solution may have destroyed the hydrophilic reagent on the hydrophilic layer of the blood glucose test strip, changing the original hydrophilic state of the injection channel and weakening the capillary action of the injection channel, preventing the test sample from entering the injection channel.

[0038] The inclusion of reagents with -OH functional groups in the control solution can effectively reduce the incidence of secondary injections when the test strip is reused. Reagents with -OH functional groups include, but are not limited to, polyethylene glycol series, glyceraldehyde, tetrabutylphenol, poly(ethylene glycol) methacrylate, isopropyl alcohol, propyl gallate, glycerol, etc.

[0039] Table 1 Test results of adding different reagents

[0040] Example 2: Secondary injection test using blood glucose test strips

[0041] The control solution of the control group contained the following reagents: 65.0% (w / w) citric acid buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.3% (w / w) glucose and water.

[0042] Experimental group control solution: The present invention adds the reagents listed in Table 1 at a concentration of 3% (w / w) to the control solution of the control group. The other components and contents in the experimental group control solution are the same as those in the control solution of the control group.

[0043] In this embodiment, the reaction reagents of the blood glucose test strip used for testing include glucose dehydrogenase, phosphate buffer solution, Triton X-100 and hydroxyethyl cellulose.

[0044] Take a new, unused blood glucose test strip and insert it into the tester. Add the control solution from the control group and the control solution from the experimental group to the test strip's injection channel, respectively. After verifying the tester or test strip is functioning properly, air dry the test strip with the added control solution. Then reinsert the used test strip into the tester, allowing the control solution or blood sample to contact the test strip's injection port. Observe the flow of the control solution or blood sample within the injection channel. If the control solution or other test sample flows into the injection channel, secondary injection has occurred. If the control solution or other test sample does not enter the injection channel after contacting the injection port, secondary injection has not occurred with the used test strip. The proportion of secondary injections that occurred after using different control solutions is calculated. The results are shown in Table 2.

[0045] Table 2 Test results of adding different reagents

[0046] Example 3: Secondary injection test using uric acid test strips

[0047] The control solution of the control group contained the following reagents: 68.0% (w / w) phosphate buffer solution pH 6.3, 1.0% (w / w) Allura Red AC dye, 0.4% (w / w) sodium urate and water.

[0048] Experimental group control solution: The present invention adds the reagents listed in Table 1 at a concentration of 3% (w / w) to the control solution of the control group. The other components and contents in the experimental group control solution are the same as those in the control solution of the control group.

[0049] The reaction reagents of the uric acid test strip used in this embodiment include potassium ferricyanide, phosphate buffer solution, Triton X-100 and polyvinyl pyrrolidone.

[0050] Take a new, unused uric acid test strip and insert it into the tester. Add the control solution of the control group and the control solution of the experimental group to the test strip's injection channel, respectively. After verifying whether the tester or test strip is functioning properly, air dry the test strip with the added control solution. Then, reinsert the used test strip into the tester, allowing the control solution or blood sample to contact the injection port of the test strip. Observe the flow of the control solution or blood sample in the injection channel. If the control solution or other test sample flows into the injection channel, secondary injection has occurred. If the control solution or other test sample does not enter the injection channel after contacting the injection port, the used test strip has not experienced secondary injection. The proportion of secondary injection after using different control solutions is calculated. The results are shown in Table 3.

[0051] Table 3 Test results of adding different reagents

[0052] Example 4: Secondary injection test using blood ketone test strips

[0053] The control solution of the control group contained the following reagents: 72.0% (w / w) phosphate buffer solution pH 7.8, 1.0% (w / w) Allura Red AC dye, 0.5% (w / w) sodium β-hydroxybutyrate and water.

[0054] Experimental group control solution: The present invention adds the reagents listed in Table 1 at a concentration of 3% (w / w) to the control solution of the control group. The other components and contents in the experimental group control solution are the same as those in the control solution of the control group.

[0055] In this embodiment, the reaction reagents of the blood ketone test strip used for testing include β-hydroxybutyrate dehydrogenase, phosphate buffer solution, Triton X-100, and polyvinyl pyrrolidone.

[0056] A new, unused blood ketone test strip was inserted into the tester. The control solution from the control group and the control solution from the experimental group were added to the test strip's inlet channel, respectively. After verifying the tester or test strip was functioning properly, the test strip with the control solution added was allowed to air dry. The used test strip was then reinserted into the tester, allowing the control solution or blood sample to contact the test strip's inlet port. The flow of the control solution or blood sample within the inlet channel was observed. If the control solution or test sample flowed into the inlet channel, secondary injection had occurred. If the control solution or test sample did not enter the inlet channel after contacting the inlet port, secondary injection had not occurred with the used test strip. The proportion of secondary injections that occurred after using different control solutions was calculated. The results are shown in Table 4.

[0057] Table 4 Test results of adding different reagents

[0058] Example 5: Amount of reagents used in control solution and evaluation of control solution performance

[0059] The control solution contains the following reagents: 65.0% (w / w) phosphate buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.2% (w / w) glucose, glycerol and water, wherein the content of glycerol is shown in Table 5.

[0060] Using the same batch of blood glucose test strips, control solutions containing varying concentrations of glycerol were added to the test strips. The effectiveness of the control solutions in reducing the incidence of secondary injections when the test strips were reused was evaluated using a secondary injection test method. Each control solution containing varying concentrations of glycerol was tested 500 times, and secondary injections of the used test strips were observed and recorded. Table 5 shows the statistical data for the different amounts (concentrations) of glycerol in the control solution and the corresponding secondary injection rates of the test strips.

[0061] Table 5 Secondary injection test results of control solution containing different concentrations of glycerol

[0062] The results in Table 5 show that adding glycerol to the control solution can reduce the rate of secondary injections when a previously used test strip is reused. This allows users to promptly identify whether the test strip being used is new based on the sample injection status. Furthermore, the results in Table 5 show that as the glycerol concentration in the control solution increases, the rate of secondary injections decreases, and after reaching a certain concentration, the rate of secondary injections no longer changes significantly.

[0063] Using the same batch of blood glucose test strips, control solution was added to the test strips according to the sample testing method. The glucose content of the control solution was then measured using a blood glucose meter. Control solutions containing different glycerol concentrations were tested 10 times, yielding 10 test results. Table 6 shows the performance evaluation results for different glycerol concentrations in the control solution.

[0064] Table 6 Product performance evaluation results of control solutions with different glycerol concentrations

[0065] The results in Table 6 show that, compared with the control solution without glycerol added, the deviations of the test results of the control solution containing 0.1% to 30% glycerol meet the requirements of the control solution.

[0066] Example 6 Product Performance Evaluation of Control Fluid

[0067] The control solution formulation in this embodiment includes 65.0% (w / w) phosphate buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.2% (w / w) glucose, glycerol and water, wherein the glycerol (w / w) concentration is selected from 0%, 5%, 10% and 15%.

[0068] The performance of the control liquid with different concentrations of propylene glycol added was evaluated and confirmed. The performance evaluation of the control liquid was carried out according to accelerated stability test and temperature test.

[0069] (1) Accelerated stability test results (aging test)

[0070] Accelerated stability testing was used to evaluate the performance of the control solution. The 75°C (6-day) test indicated that the control solution was stored at 75°C for 6 days, while the 75°C (9-day) test indicated that the control solution was stored at 75°C for 9 days. A control group consisted of the control solution stored at room temperature. The removed control solution was allowed to stabilize at room temperature for at least 30 minutes before testing. The control solution was tested 10 times under each condition, yielding 10 test results. Aging tests were conducted on control solutions containing 0%, 5%, 10%, and 15% glycerol concentrations. The evaluation results are shown in Table 7.

[0071] Table 7 Accelerated stability test results of control solutions containing different amounts of glycerol

[0072] The results showed that after adding glycerol to the control solution, the accelerated stability of the control solution was normal. The deviation between the control solution and the control solution at different levels was within ±10%, meeting the stability requirements of the control solution product.

[0073] (2) Temperature performance analysis and evaluation

[0074] The control solution in this example includes 65.0% (w / w) phosphate buffer solution at pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.2% (w / w) glucose, 15% (w / w) glycerol and water.

[0075] Several blood glucose test strips from the same batch and 10 testers were used. The control solution, blood glucose test strips from the same batch, and the testers were placed in incubators at different temperatures. The incubators were set to 7.5°C, 21°C, and 42.5°C. At least 10 test values ​​were obtained under each condition. The experimental evaluation results are shown in Table 8.

[0076] Experimental evaluation results show that the control solution of the present invention exhibits good linearity and test accuracy within the test temperature range of 7.5°C to 42.5°C. For control solutions with the same blood glucose concentration, the deviations from the test results at different temperatures are consistent with those at 21°C, and the operating temperature range of 7.5°C to 42.5°C is achieved.

[0077] Table 8 Temperature performance evaluation results

[0078] The control fluid of the present invention meets the performance requirements of control fluid products. Using the control fluid of the present invention to measure the performance of a test system reduces the incidence of incorrect injections when test strips tested with the control fluid of the present invention are reused. If a test strip tested with the control fluid of the present invention is reused, the tester can promptly detect that the test strip in use has been used, thereby ensuring that the tester correctly uses the test strip for testing and obtains accurate test results.

[0079] Example 7: Secondary injection test using blood glucose test strips

[0080] The control solution of the control group contained the following reagents: 65.0% (w / w) citric acid buffer solution pH 5.4, 0.3% (w / w) glucose and water.

[0081] Experimental group control solution: The present invention adds the reagents listed in Table 1 at a concentration of 3% (w / w) to the control solution of the control group. The other components and contents in the experimental group control solution are the same as those in the control solution of the control group.

[0082] In this embodiment, the reaction reagents of the blood glucose test strip used for testing include glucose dehydrogenase, phosphate buffer solution, Triton X-100 and hydroxyethyl cellulose.

[0083] Take a new, unused blood glucose test strip and insert it into the tester. Add the control solution from the control group and the control solution from the experimental group to the test strip's injection channel, respectively. After verifying the tester or test strip is functioning properly, air dry the test strip with the added control solution. Then reinsert the used test strip into the tester, allowing the control solution or blood sample to contact the test strip's injection port. Observe the flow of the control solution or blood sample within the injection channel. If the control solution or test sample flows into the injection channel, secondary injection has occurred. If the control solution or test sample does not enter the injection channel after contacting the injection port, secondary injection has not occurred with the used test strip. The proportion of secondary injections after using different control solutions is calculated. The results are shown in Table 9.

[0084] Table 9 Test results of adding different reagents

[0085] Example 8: Amount of reagents used in control solution and evaluation of control solution performance

[0086] The control solution contains the following reagents: 65.0% (w / w) phosphate buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.2% (w / w) glucose, polyethylene glycol 200 and water, wherein the content of polyethylene glycol 200 is shown in Table 10.

[0087] Using the same batch of blood glucose test strips, control solutions containing varying concentrations of polyethylene glycol 200 were added to the test strips. The effectiveness of these control solutions in reducing the incidence of secondary injections during reuse of the test strips was evaluated using a secondary injection test method. Each control solution containing varying concentrations of polyethylene glycol 200 was tested 500 times, and secondary injections of the used test strips were observed and statistically analyzed. Table 10 shows the statistical data for the different amounts (concentrations) of polyethylene glycol 200 in the control solution and the corresponding secondary injection probabilities.

[0088] Table 10 Secondary injection test results of control solution containing different concentrations of polyethylene glycol 200

[0089] The results in Table 10 demonstrate that adding polyethylene glycol 200 to the control solution can reduce the incidence of secondary injections when a previously used test strip is reused. This allows users to promptly identify whether the test strip being used is new based on the sample injection status. Furthermore, the results in Table 10 demonstrate that as the concentration of polyethylene glycol 200 in the control solution increases, the incidence of secondary injections decreases, and after reaching a certain concentration, the incidence of secondary injections no longer changes significantly.

[0090] Using the same batch of blood glucose test strips, control solution was added to the test strips according to the sample testing method. The glucose content of the control solution was then measured using a blood glucose meter. Control solutions containing different concentrations of polyethylene glycol 200 were tested 10 times, yielding 10 test results. Table 11 shows the performance evaluation results for the control solutions with varying polyethylene glycol 200 concentrations.

[0091] Table 11 Product performance evaluation results of control solutions with different concentrations of polyethylene glycol 200

[0092] The results in Table 11 show that, compared with the control solution without polyethylene glycol 200, the deviations of the test results of the control solution containing 0.1% to 30% polyethylene glycol 200 meet the requirements of the control solution.

[0093] Example 9: Amount of reagents used in control solution and evaluation of control solution performance

[0094] The control solution contained the following reagents: 65.0% (w / w) phosphate buffer solution pH 5.4, 1.0% (w / w) Allura Red AC dye, 0.2% (w / w) glucose, poly (ethylene glycol) methacrylate and water, wherein the content of poly (ethylene glycol) methacrylate is shown in Table 12.

[0095] Using the same batch of blood glucose test strips, control solutions containing varying concentrations of poly(ethylene glycol) methacrylate were added to the test strips. The effectiveness of these control solutions in reducing the incidence of secondary injections during reuse of the test strips was evaluated using a secondary injection test method. Each control solution containing varying concentrations of poly(ethylene glycol) methacrylate was tested 500 times, and secondary injections of the used test strips were observed and statistically analyzed. Table 12 shows the statistical data for the different amounts (concentrations) of poly(ethylene glycol) methacrylate used in the control solution and the corresponding secondary injection probabilities.

[0096] Table 12 Secondary injection test results of control solutions containing different concentrations of poly (ethylene glycol methacrylate)

[0097] The results in Table 12 demonstrate that the addition of poly(ethylene glycol) methacrylate to the control solution can reduce the incidence of secondary injections when a previously used test strip is reused. This allows users to promptly identify whether the test strip currently in use is new based on the sample injection status. Furthermore, the results in Table 12 demonstrate that as the concentration of poly(ethylene glycol) methacrylate in the control solution increases, the incidence of secondary injections decreases, and after reaching a certain concentration, the incidence of secondary injections no longer changes significantly.

[0098] Using the same batch of blood glucose test strips, control solution was added to the test strips according to the sample testing method. The glucose content of the control solution was then measured using a blood glucose meter. Control solutions containing different concentrations of poly(ethylene glycol) methacrylate were tested 10 times, yielding 10 test results. Table 13 shows the performance evaluation results for control solutions containing different concentrations of poly(ethylene glycol) methacrylate and their corresponding control solutions.

[0099] Table 13 Product performance evaluation results of control solutions with different concentrations of poly (ethylene glycol) methacrylate

[0100] The results in Table 13 show that, compared with the control solution without poly(ethylene glycol) methacrylate, the deviations of the test results of the control solution containing 0.1% to 30% poly(ethylene glycol) methacrylate meet the requirements of the control solution.

Claims

1. A control solution comprising an analyte, characterized in that: Also included are organic compounds with hydroxyl groups.

2. The control liquid according to claim 1, characterized in that The organic compound includes alcohols or esters having a hydroxyl group.

3. The control liquid according to claim 1, characterized in that The organic compound is selected from polyethylene glycol, tetrabutylol, poly(ethylene glycol) methacrylate, isopropyl alcohol, glycerol or propyl gallate.

4. The control liquid according to claim 1, characterized in that The concentration of the organic compound is greater than 0.1%.

5. The control liquid according to claim 4, characterized in that The concentration of the organic compound ranges from 1% to 30%.

6. The control liquid according to claim 5, characterized in that The concentration of the organic compound is 3% to 15%.

7. The control liquid according to claim 1, characterized in that Buffer is also included.

8. The control liquid according to claim 1, characterized in that The analyte of the control solution for a blood glucose testing system is glucose, or the analyte of the control solution for a uric acid testing system is sodium urate, or the analyte of the control solution for a blood ketone testing system is sodium beta hydroxybutyrate.

9. The control liquid according to claim 1, characterized in that The control liquid is used for verifying a test system, and the test system includes an electrochemical test paper.

10. The control liquid according to claim 9, characterized in that The sampling channel of the test paper is hydrophilic and adopts the capillary action principle to inject samples.

11. A test system comprising a tester and a control fluid, characterized in that: The control liquid is the control liquid according to any one of claims 1 to 10.

12. The test system according to claim 11, characterized in that: Also includes test strips.

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