技术领域Technical Field
本发明涉及金标适配体试纸条质量检测技术领域，尤其涉及一种用于胃癌的金标适配体试纸条的质量测试与分析方法。The present invention relates to the technical field of quality detection of gold-labeled aptamer test strips, and in particular to a quality testing and analysis method of a gold-labeled aptamer test strip for gastric cancer.
背景技术Background Art
适配体是一类短的单链DNA或RNA分子，它们能够通过折叠成特定的三维结构来与各种目标分子（如蛋白质、小分子、细胞等）特异性结合。在胃癌检测中，适配体被设计用来识别和结合胃癌相关的癌胚抗原，胶体金是一种纳米材料，通常用于生物检测中作为显色标记。金标适配体试纸条利用胶体金的特性，通过金颗粒的聚集产生颜色变化，从而实现目标物质的视觉检测，免疫层析技术涉及将样品沿着金标适配体试纸条移动，通过一系列的捕获、过滤和检测区域，最终通过颜色变化显示结果。Aptamers are a class of short single-stranded DNA or RNA molecules that can specifically bind to various target molecules (such as proteins, small molecules, cells, etc.) by folding into specific three-dimensional structures. In gastric cancer detection, aptamers are designed to recognize and bind to gastric cancer-related carcinoembryonic antigens. Colloidal gold is a nanomaterial that is commonly used as a colorimetric marker in biological detection. Gold-labeled aptamer test strips use the properties of colloidal gold to produce color changes through the aggregation of gold particles, thereby achieving visual detection of target substances. Immunochromatography technology involves moving the sample along the gold-labeled aptamer test strip, through a series of capture, filtration and detection areas, and finally displaying the results through color changes.
例如公开号为：CN118330224A专利申请公开的一种新型的核酸适配体金标适配体试纸条检测甲胎蛋白，包括：底板、样品垫、结合垫、硝酸纤维素膜和吸收垫。该新型的核酸适配体金标适配体试纸条检测甲胎蛋白，将目标物甲胎蛋白抗原加入核酸适配体金标适配体试纸条内部，当甲胎蛋白抗原通过层析作用经过结合垫上时，会与金标适配体结合形成AFP抗原-金标适配体偶联物，从而在经过检测区时，会被AFP适配体的捕获探针捕获，出现红色条带，而多余的金标适配体偶联物继续层析到核酸适配体金标适配体试纸条内的质控线区处，质控线处是与核酸适配体检测探针互补的一段DNA序列，因此在质控线出现红色条带，经试验，核酸适配体金标适配体试纸条用肉眼能够检测甲胎蛋白的最低浓度为10ng/mL。For example, the patent application with publication number CN118330224A discloses a novel nucleic acid aptamer gold-labeled aptamer test strip for detecting alpha-fetoprotein, comprising: a bottom plate, a sample pad, a binding pad, a nitrocellulose membrane and an absorption pad. The novel aptamer gold-labeled aptamer test strip detects alpha-fetoprotein, and the target alpha-fetoprotein antigen is added to the inside of the aptamer gold-labeled aptamer test strip. When the alpha-fetoprotein antigen passes through the binding pad through chromatography, it will combine with the gold-labeled aptamer to form an AFP antigen-gold-labeled aptamer conjugate, so that when passing through the detection area, it will be captured by the capture probe of the AFP aptamer, and a red strip will appear. The excess gold-labeled aptamer conjugate continues to chromatograph to the quality control line area in the aptamer gold-labeled aptamer test strip. The quality control line is a DNA sequence complementary to the aptamer detection probe, so a red strip appears on the quality control line. According to experiments, the minimum concentration of alpha-fetoprotein that can be detected by the naked eye of the aptamer gold-labeled aptamer test strip is 10 ng/mL.
例如公告号为：CN106053805B发明专利公告的一种用于检测沙门氏菌的增敏型核酸适配体金标适配体试纸条及其制备方法，包括：样品垫、金标垫、包被膜和吸水膜依次粘贴组合到PVC底板上，所述金标垫上涂覆有树枝状聚合物-金-适配体复合物增敏探针，包被膜上具有检测线和质控线，检测线上包被有抗沙门氏菌单克隆抗体，质控线上包被有链霉亲和素。该金标适配体试纸条的制备方法包括树枝状聚合物-金-适配体复合物增敏探针的制备、金标垫的制备、包被膜的制备以及金标适配体试纸条的组装等。For example, the invention patent announcement number is CN106053805B, which discloses a sensitized nucleic acid aptamer gold-labeled aptamer test strip for detecting Salmonella and its preparation method, including: a sample pad, a gold-labeled pad, a coating film and a water-absorbing film are sequentially pasted and assembled on a PVC bottom plate, the gold-labeled pad is coated with a dendritic polymer-gold-aptamer complex sensitization probe, the coating film has a detection line and a quality control line, the detection line is coated with an anti-Salmonella monoclonal antibody, and the quality control line is coated with streptavidin. The preparation method of the gold-labeled aptamer test strip includes the preparation of the dendritic polymer-gold-aptamer complex sensitization probe, the preparation of the gold-labeled pad, the preparation of the coating film, and the assembly of the gold-labeled aptamer test strip.
但本申请在实现本申请实施例中发明技术方案的过程中，发现上述技术至少存在如下技术问题：However, in the process of implementing the technical solution of the invention in the embodiments of the present application, the present application found that the above technology has at least the following technical problems:
现有技术中，金标适配体试纸条可能对温度、湿度、光照等环境因素敏感，影响其长期储存和运输的稳定性，存在用于胃癌的金标适配体试纸条环境适用性不足的问题。In the prior art, gold-labeled aptamer test strips may be sensitive to environmental factors such as temperature, humidity, and light, which may affect their stability in long-term storage and transportation. There is a problem of insufficient environmental applicability of gold-labeled aptamer test strips for gastric cancer.
发明内容Summary of the invention
本申请实施例通过提供一种用于胃癌的金标适配体试纸条的质量测试与分析方法，解决了现有技术中，用于胃癌的金标适配体试纸条环境适用性不足的问题，实现了提高用于胃癌的金标适配体试纸条环境适用性的效果。The embodiments of the present application solve the problem of insufficient environmental applicability of gold-labeled aptamer test strips for gastric cancer in the prior art by providing a quality testing and analysis method for gold-labeled aptamer test strips for gastric cancer, thereby achieving the effect of improving the environmental applicability of gold-labeled aptamer test strips for gastric cancer.
本申请实施例提供了一种用于胃癌的金标适配体试纸条的质量测试与分析方法，包括以下步骤：从生产的金标适配体试纸条进行随机抽取，使用三明治夹心法将适配体固定在层析膜上形成检测线，制备金标适配体并固定在结合垫上，组装样品垫、结合垫、层析膜和吸收垫，形成完整的金标适配体试纸条；进行初步的金标适配体试纸条功能测试，使用不同浓度的胃癌的癌胚抗体，测试金标适配体试纸条的最低检测限，并评估金标适配体试纸条的环境适用性和稳定性；分析金标适配体试纸条的环境适用性和稳定性，根据分析结果对金标适配体试纸条进行优化，在临床样本上进行金标适配体试纸条的验证测试，验证金标适配体试纸条的环境适用性和稳定性。The embodiment of the present application provides a quality testing and analysis method for a gold-labeled aptamer test strip for gastric cancer, comprising the following steps: randomly selecting from the produced gold-labeled aptamer test strips, fixing the aptamer on a chromatographic membrane using a sandwich method to form a detection line, preparing the gold-labeled aptamer and fixing it on a binding pad, assembling the sample pad, the binding pad, the chromatographic membrane and the absorption pad to form a complete gold-labeled aptamer test strip; performing a preliminary function test of the gold-labeled aptamer test strip, using different concentrations of oncofetal antibodies for gastric cancer to test the minimum detection limit of the gold-labeled aptamer test strip, and evaluating the environmental applicability and stability of the gold-labeled aptamer test strip; analyzing the environmental applicability and stability of the gold-labeled aptamer test strip, optimizing the gold-labeled aptamer test strip according to the analysis results, performing a verification test of the gold-labeled aptamer test strip on clinical samples, and verifying the environmental applicability and stability of the gold-labeled aptamer test strip.
进一步的，从生产的金标适配体试纸条进行随机抽取的具体抽取过程为：根据金标适配体试纸条的批次编号，以固定的抽样频率对金标适配体试纸条进行随机抽取，记录抽取样本的批次号、生产日期和抽样日期，抽取的样本按照相同的存储环境进行存储。Furthermore, the specific extraction process of randomly sampling from the produced gold-labeled aptamer test strips is as follows: according to the batch number of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips are randomly extracted at a fixed sampling frequency, the batch number, production date and sampling date of the extracted samples are recorded, and the extracted samples are stored in the same storage environment.
进一步的，使用三明治夹心法将适配体固定在层析膜上形成检测线的具体形成过程：将层析膜裁剪成适当的大小，并进行清洁和活化处理，将适配体溶液滴加到层析膜上，覆盖所需形成检测线的区域，让适配体溶液在层析膜上充分渗透并吸附，使用固定化试剂处理层析膜，使适配体与层析膜表面共价结合，清洗层析膜，去除未结合的适配体和固定化试剂，使用封闭剂处理固定有适配体的层析膜，对层析膜进行干燥，在适配体固定的区域滴加金标抗体溶液，形成检测线，再次干燥，确保金标抗体与适配体结合牢固。Furthermore, the specific formation process of fixing the aptamer on the chromatographic membrane using the sandwich method to form a detection line is as follows: the chromatographic membrane is cut into an appropriate size, and is cleaned and activated, the aptamer solution is dripped onto the chromatographic membrane to cover the area where the detection line is required to be formed, and the aptamer solution is allowed to fully penetrate and adsorb on the chromatographic membrane, the chromatographic membrane is treated with an immobilization reagent to covalently bind the aptamer to the surface of the chromatographic membrane, the chromatographic membrane is cleaned to remove unbound aptamers and immobilization reagents, the chromatographic membrane with the aptamer fixed is treated with a blocking agent, the chromatographic membrane is dried, and the gold-labeled antibody solution is dripped into the area where the aptamer is fixed to form a detection line, and the membrane is dried again to ensure that the gold-labeled antibody is firmly bound to the aptamer.
进一步的，测试金标适配体试纸条的最低检测限的具体测试过程为：收集一系列已知浓度的覆盖金标适配体试纸条预期检测范围的胃癌的癌胚抗体，包括低于预期的最低检测限的浓度，以作为无胃癌病症的空白对照，记录每个浓度下金标适配体试纸条的数据，使用线性回归方法分析金标适配体试纸条的最低检测限。Furthermore, the specific test process for testing the minimum detection limit of the gold-labeled aptamer test strip is as follows: collect a series of known concentrations of oncofetal antibodies for gastric cancer covering the expected detection range of the gold-labeled aptamer test strip, including concentrations below the expected minimum detection limit as blank controls with no gastric cancer symptoms, record the data of the gold-labeled aptamer test strip at each concentration, and use the linear regression method to analyze the minimum detection limit of the gold-labeled aptamer test strip.
进一步的，评估金标适配体试纸条的环境适用性和稳定性的具体评估过程为：在不同的储存环境下测试金标适配体试纸条的环境适用性，重复使用同一批次的金标适配体试纸条进行多次测试，评估其结果的稳定性。Furthermore, the specific evaluation process for evaluating the environmental applicability and stability of the gold-labeled aptamer test strips is as follows: testing the environmental applicability of the gold-labeled aptamer test strips under different storage environments, repeatedly using the same batch of gold-labeled aptamer test strips for multiple tests, and evaluating the stability of the results.
进一步的，分析金标适配体试纸条的环境适用性和稳定性的具体分析过程：分析金标适配体试纸条的环境适用性，得到金标适配体试纸条的环境适用评估系数，分析金标适配体试纸条的稳定性，得到金标适配体试纸条的稳定评估系数，对金标适配体试纸条的环境适用评估系数和金标适配体试纸条的稳定评估系数进行综合评估，得到金标适配体试纸条的综合评估系数。Furthermore, the specific analysis process of the environmental applicability and stability of the gold-labeled aptamer test strips is analyzed: the environmental applicability of the gold-labeled aptamer test strips is analyzed to obtain the environmental applicability assessment coefficient of the gold-labeled aptamer test strips, the stability of the gold-labeled aptamer test strips is analyzed to obtain the stability assessment coefficient of the gold-labeled aptamer test strips, and the environmental applicability assessment coefficient and the stability assessment coefficient of the gold-labeled aptamer test strips are comprehensively evaluated to obtain the comprehensive assessment coefficient of the gold-labeled aptamer test strips.
进一步的，根据分析结果对金标适配体试纸条进行优化的具体优化过程为：分析测试结果，确定金标适配体试纸条性能不足的因素，根据不同的因素确定不同的优化流程，包括重新评估适配体和金标抗体的质量，优化固定化试剂的选择，调整检测线和控制线的位置，优化样品垫、吸收垫和层析膜的材质或组合，调整适配体在层析膜上的固定化条件，改进金标抗体的标记过程，调整储存温度、湿度和光照条件。Furthermore, the specific optimization process of optimizing the gold-labeled aptamer test strip according to the analysis results is as follows: analyzing the test results, determining the factors causing the insufficient performance of the gold-labeled aptamer test strip, and determining different optimization processes according to different factors, including re-evaluating the quality of the aptamer and the gold-labeled antibody, optimizing the selection of the immobilization reagent, adjusting the position of the detection line and the control line, optimizing the material or combination of the sample pad, the absorption pad and the chromatographic membrane, adjusting the immobilization conditions of the aptamer on the chromatographic membrane, improving the labeling process of the gold-labeled antibody, and adjusting the storage temperature, humidity and light conditions.
进一步的，在临床样本上进行金标适配体试纸条的验证测试的具体测试过程为：收集已知胃癌患者和健康人的血清或血浆样本，对样本进行处理和储存，选择足够多的样本进行盲法选择，对样本进行测试，得到金标适配体试纸条的假阳性和假阴性概率，根据假阳性和假阴性的概率计算金标适配体试纸条的准确性，对部分样本进行重复测试，以验证结果的可靠性。Furthermore, the specific testing process of the validation test of the gold-labeled aptamer test strip on clinical samples is as follows: serum or plasma samples from known gastric cancer patients and healthy people are collected, the samples are processed and stored, a sufficient number of samples are selected for blind selection, the samples are tested, and the false positive and false negative probabilities of the gold-labeled aptamer test strip are obtained, the accuracy of the gold-labeled aptamer test strip is calculated according to the false positive and false negative probabilities, and some samples are tested repeatedly to verify the reliability of the results.
进一步的，使用线性回归方法分析金标适配体试纸条的最低检测限的具体分析过程为：对每个浓度的标准品进行金标适配体试纸条测试，记录每个浓度下的信号强度，信号强度是指通过视觉读取或使用读取仪将具体的浓度对应的结果输入到Python的数据，使用Python进行线性回归分析，建立信号强度与标准品浓度之间的线性关系，并在坐标系中自动形成标准曲线，通常横坐标为标准品浓度的对数值，纵坐标为信号强度。Furthermore, the specific analysis process of using the linear regression method to analyze the minimum detection limit of the gold-labeled aptamer test strip is as follows: the gold-labeled aptamer test strip is tested for each concentration of the standard, and the signal intensity at each concentration is recorded. The signal intensity refers to the data corresponding to the specific concentration input into Python by visual reading or using a reader. Python is used for linear regression analysis to establish a linear relationship between signal intensity and standard concentration, and a standard curve is automatically formed in the coordinate system. Usually, the horizontal axis is the logarithm of the standard concentration, and the vertical axis is the signal intensity.
进一步的，金标适配体试纸条的综合评估系数的具体约束公式为：Furthermore, the specific constraint formula of the comprehensive evaluation coefficient of the gold-labeled aptamer test strip is:
； ;
式中，表示金标适配体试纸条的综合评估系数，用于评估金标适配体试纸条的环境适用性和稳定性，表示金标适配体试纸条的环境适用性评估系数，表示金标适配体试纸条的稳定性评估系数。In the formula, It represents the comprehensive evaluation coefficient of the gold-labeled aptamer test strip, which is used to evaluate the environmental applicability and stability of the gold-labeled aptamer test strip. represents the environmental suitability assessment coefficient of the gold-labeled aptamer test strip, Represents the stability evaluation coefficient of the gold-labeled aptamer test strip.
本申请实施例中提供的一个或多个技术方案，至少具有如下技术效果或优点：One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:
1、通过分析金标适配体试纸条的环境适用性和稳定性，从而根据分析结果对金标适配体试纸条进行优化，进而实现了提高用于胃癌的金标适配体试纸条环境适用性的效果，有效解决了现有技术中，用于胃癌的金标适配体试纸条环境适用性不足的问题。1. By analyzing the environmental applicability and stability of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips are optimized according to the analysis results, thereby achieving the effect of improving the environmental applicability of the gold-labeled aptamer test strips for gastric cancer, and effectively solving the problem of insufficient environmental applicability of the gold-labeled aptamer test strips for gastric cancer in the prior art.
2、通过进行初步的金标适配体试纸条功能测试，使用不同浓度的胃癌的癌胚抗体，从而测试金标适配体试纸条的最低检测限，进而实现了提高金标适配体试纸的准确性。2. Through preliminary functional testing of the gold-labeled aptamer test strips, different concentrations of oncofetal antibodies for gastric cancer were used to test the minimum detection limit of the gold-labeled aptamer test strips, thereby improving the accuracy of the gold-labeled aptamer test strips.
3、通过分析金标适配体试纸条的环境适用性和稳定性，从而根据分析结果对金标适配体试纸条进行优化，进而实现了提高金标适配体试纸条的质量的效果。3. By analyzing the environmental applicability and stability of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips are optimized according to the analysis results, thereby achieving the effect of improving the quality of the gold-labeled aptamer test strips.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为本申请实施例提供的用于胃癌的金标适配体试纸条的质量测试与分析方法流程图；FIG1 is a flow chart of a quality test and analysis method of a gold-labeled aptamer test strip for gastric cancer provided in an embodiment of the present application;
图2为本申请实施例提供的一种用于胃癌的金标适配体试纸条的质量测试与分析方法中金标适配体试纸条的稳定性评估系数的图像。FIG2 is an image of the stability evaluation coefficient of a gold-labeled aptamer test strip in a quality testing and analysis method of a gold-labeled aptamer test strip for gastric cancer provided in an embodiment of the present application.
具体实施方式DETAILED DESCRIPTION
本申请实施例通过提供一种用于胃癌的金标适配体试纸条的质量测试与分析方法，解决了现有技术中，用于胃癌的金标适配体试纸条环境适用性不足的问题，通过分析金标适配体试纸条的环境适用性和稳定性，根据分析结果对金标适配体试纸条进行优化，实现了提高用于胃癌的金标适配体试纸条环境适用性的效果。The embodiments of the present application solve the problem of insufficient environmental applicability of gold-labeled aptamer test strips for gastric cancer in the prior art by providing a quality testing and analysis method for gold-labeled aptamer test strips for gastric cancer. By analyzing the environmental applicability and stability of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips are optimized according to the analysis results, thereby achieving the effect of improving the environmental applicability of the gold-labeled aptamer test strips for gastric cancer.
本申请实施例中的技术方案为解决上述，用于胃癌的金标适配体试纸条环境适用性不足的问题，总体思路如下：The technical solution in the embodiment of the present application is to solve the above-mentioned problem of insufficient environmental applicability of the gold-labeled aptamer test strip for gastric cancer. The overall idea is as follows:
通过分析金标适配体试纸条的环境适用性和稳定性，根据分析结果对金标适配体试纸条进行优化，实现了提高用于胃癌的金标适配体试纸条环境适用性的效果。By analyzing the environmental applicability and stability of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips were optimized according to the analysis results, thereby achieving the effect of improving the environmental applicability of the gold-labeled aptamer test strips for gastric cancer.
为了更好的理解上述技术方案，下面将结合说明书附图以及具体的实施方式对上述技术方案进行详细的说明。In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.
如图1所示，为本申请实施例提供的用于胃癌的金标适配体试纸条的质量测试与分析方法流程图，该方法包括以下步骤：从生产的金标适配体试纸条进行随机抽取，使用三明治夹心法将适配体固定在层析膜上形成检测线，制备金标适配体并固定在结合垫上，组装样品垫、结合垫、层析膜和吸收垫，形成完整的金标适配体试纸条；进行初步的金标适配体试纸条功能测试，使用不同浓度的胃癌的癌胚抗体，测试金标适配体试纸条的最低检测限，并评估金标适配体试纸条的环境适用性和稳定性；分析金标适配体试纸条的环境适用性和稳定性，根据分析结果对金标适配体试纸条进行优化，在临床样本上进行金标适配体试纸条的验证测试，验证金标适配体试纸条的环境适用性和稳定性。As shown in Figure 1, it is a flow chart of the quality testing and analysis method of the gold-labeled aptamer test strip for gastric cancer provided in an embodiment of the present application, and the method includes the following steps: randomly selecting from the produced gold-labeled aptamer test strips, using the sandwich method to fix the aptamer on the chromatographic membrane to form a detection line, preparing the gold-labeled aptamer and fixing it on the binding pad, assembling the sample pad, the binding pad, the chromatographic membrane and the absorption pad to form a complete gold-labeled aptamer test strip; conducting a preliminary function test of the gold-labeled aptamer test strip, using different concentrations of oncofetal antibodies for gastric cancer, testing the minimum detection limit of the gold-labeled aptamer test strip, and evaluating the environmental applicability and stability of the gold-labeled aptamer test strip; analyzing the environmental applicability and stability of the gold-labeled aptamer test strip, optimizing the gold-labeled aptamer test strip according to the analysis results, and performing a verification test of the gold-labeled aptamer test strip on clinical samples to verify the environmental applicability and stability of the gold-labeled aptamer test strip.
进一步的，从生产的金标适配体试纸条进行随机抽取的具体抽取过程为：根据金标适配体试纸条的批次编号，以固定的抽样频率对金标适配体试纸条进行随机抽取，记录抽取样本的批次号、生产日期和抽样日期，抽取的样本按照相同的存储环境进行存储。Furthermore, the specific extraction process of randomly sampling from the produced gold-labeled aptamer test strips is as follows: according to the batch number of the gold-labeled aptamer test strips, the gold-labeled aptamer test strips are randomly extracted at a fixed sampling frequency, the batch number, production date and sampling date of the extracted samples are recorded, and the extracted samples are stored in the same storage environment.
在本实施例中，根据金标适配体试纸条的批次编号，使用随机数生成器或随机抽样软件，为每个批次生成需要抽取的金标适配体试纸条序号，对于抽取的每个样本，记录其批次号（例如A1）、生产日期（例如2023-11-15）和抽样日期（例如2023-11-20），抽取的样本按照相同的存储条件进行存储，通过随机抽样，可以确保样本能够代表整个批次的产品质量，从而提高质量测试结果的可靠性和准确性。In this embodiment, according to the batch number of the gold-labeled aptamer test strips, a random number generator or random sampling software is used to generate the serial number of the gold-labeled aptamer test strips to be drawn for each batch. For each sample drawn, its batch number (for example, A1), production date (for example, 2023-11-15) and sampling date (for example, 2023-11-20) are recorded. The drawn samples are stored under the same storage conditions. Through random sampling, it can be ensured that the samples can represent the product quality of the entire batch, thereby improving the reliability and accuracy of the quality test results.
进一步的，使用三明治夹心法将适配体固定在层析膜上形成检测线的具体形成过程：将层析膜裁剪成适当的大小，并进行清洁和活化处理，将适配体溶液滴加到层析膜上，覆盖所需形成检测线的区域，让适配体溶液在层析膜上充分渗透并吸附，使用固定化试剂处理层析膜，使适配体与层析膜表面共价结合，清洗层析膜，去除未结合的适配体和固定化试剂，使用封闭剂处理固定有适配体的层析膜，对层析膜进行干燥，在适配体固定的区域滴加金标抗体溶液，形成检测线，再次干燥，确保金标抗体与适配体结合牢固。Furthermore, the specific formation process of fixing the aptamer on the chromatographic membrane using the sandwich method to form a detection line is as follows: the chromatographic membrane is cut into an appropriate size, and is cleaned and activated, the aptamer solution is dripped onto the chromatographic membrane to cover the area where the detection line is required to be formed, and the aptamer solution is allowed to fully penetrate and adsorb on the chromatographic membrane, the chromatographic membrane is treated with an immobilization reagent to covalently bind the aptamer to the surface of the chromatographic membrane, the chromatographic membrane is cleaned to remove unbound aptamers and immobilization reagents, the chromatographic membrane with the aptamer fixed is treated with a blocking agent, the chromatographic membrane is dried, and the gold-labeled antibody solution is dripped into the area where the aptamer is fixed to form a detection line, and the membrane is dried again to ensure that the gold-labeled antibody is firmly bound to the aptamer.
在本实施例中，将聚氯乙烯（PVC）或硝酸纤维素（NC）层析膜裁剪成5mm宽、10cm长的条状，使用无水乙醇或去离子水清洁层析膜表面，去除可能存在的杂质，将清洁后的层析膜浸泡在1%的戊二醛溶液中，进行活化处理，以引入能够与适配体共价结合的活性基团，活化处理后的层析膜需在去离子水中漂洗，去除未反应的戊二醛，将浓度为1mg/mL的适配体溶液滴加到层析膜的特定区域，确保覆盖整个检测线区域，让适配体溶液在层析膜上渗透并吸附30分钟，使用硼氢化钠溶液处理层析膜，使适配体与层析膜表面的活性基团共价结合，处理后，用磷酸盐缓冲液清洗层析膜3次，每次5分钟，以去除未结合的适配体和硼氢化钠，使用1%的牛血清白蛋白溶液作为封闭剂，处理固定有适配体的层析膜，封闭未反应的活性位点，封闭处理后的层析膜需在磷酸盐缓冲液中清洗，去除未结合的牛血清白蛋白溶液，将处理后的层析膜放置在37℃的烘箱中干燥2小时，在适配体固定的区域滴加金标抗体溶液（例如，浓度为1mg/mL），形成检测线，再次将层析膜放置在烘箱中干燥，以确保金标抗体与适配体结合牢固，适配体通过共价键固定在层析膜上，形成的检测线更加稳定，不易脱落。In this embodiment, a polyvinyl chloride (PVC) or nitrocellulose (NC) chromatographic membrane is cut into strips of 5 mm width and 10 cm length. The surface of the chromatographic membrane is cleaned with anhydrous ethanol or deionized water to remove possible impurities. The cleaned chromatographic membrane is immersed in a 1% glutaraldehyde solution for activation treatment to introduce active groups that can covalently bind to the aptamer. The activated chromatographic membrane needs to be rinsed in deionized water to remove unreacted glutaraldehyde. An aptamer solution with a concentration of 1 mg/mL is added dropwise to a specific area of the chromatographic membrane to ensure that the entire detection line area is covered. The aptamer solution is allowed to penetrate and adsorb on the chromatographic membrane for 30 minutes. The chromatographic membrane is treated with a sodium borohydride solution to allow the aptamer to covalently bind to the active groups on the surface of the chromatographic membrane. After treatment, the chromatographic membrane is washed with phosphate buffer for 3 times, 5 minutes each time, to remove unbound aptamers and sodium borohydride. A 1% bovine serum albumin solution is used as a blocking agent to treat the chromatographic membrane fixed with the aptamer to block the unreacted active sites. The chromatographic membrane after blocking treatment needs to be washed in phosphate buffer to remove the unbound bovine serum albumin solution. The treated chromatographic membrane is placed in an oven at 37°C for 2 hours to dry. A gold-labeled antibody solution (for example, a concentration of 1 mg/mL) is added dropwise to the area where the aptamer is fixed to form a detection line. The chromatographic membrane is placed in an oven to dry again to ensure that the gold-labeled antibody is firmly bound to the aptamer. The aptamer is fixed to the chromatographic membrane through a covalent bond, and the formed detection line is more stable and not easy to fall off.
进一步的，测试金标适配体试纸条的最低检测限的具体测试过程为：收集一系列已知浓度的覆盖金标适配体试纸条预期检测范围的胃癌的癌胚抗体，包括低于预期的最低检测限的浓度，以作为无胃癌病症的空白对照，记录每个浓度下金标适配体试纸条的数据，使用线性回归方法分析金标适配体试纸条的最低检测限。Furthermore, the specific test process for testing the minimum detection limit of the gold-labeled aptamer test strip is as follows: collect a series of known concentrations of oncofetal antibodies for gastric cancer covering the expected detection range of the gold-labeled aptamer test strip, including concentrations below the expected minimum detection limit as blank controls with no gastric cancer symptoms, record the data of the gold-labeled aptamer test strip at each concentration, and use the linear regression method to analyze the minimum detection limit of the gold-labeled aptamer test strip.
在本实施例中，收集一系列已知浓度的胃癌癌胚抗体样本，这些浓度应覆盖金标适配体试纸条的预期检测范围，并包括低于预期最低检测限的浓度，例如，准备以下浓度的样本：0ng/mL（空白对照），1ng/mL，5ng/mL，10ng/mL，50ng/mL，100ng/mL，500ng/mL，使用金标适配体试纸条对每个浓度的样本进行测试，对于每个浓度，至少重复测试3次，以减少实验误差，记录每个浓度下试纸条的检测结果，包括是否出现检测线，以及检测线的强度，结果可以记录为“阳性”（检测线出现）或“阴性”（检测线未出现），使用线性回归方法分析数据，建立浓度与检测结果之间的关系，分析每个浓度点的试纸条响应率（阳性结果的百分比），以确定最低检测限，根据线性回归分析，确定试纸条能够可靠区分阳性与阴性结果的最低浓度，通常，最低检测限定义为能够95%可靠地检测到的最低浓度，通过收集一系列浓度梯度样本，可以精确地确定试纸条的最低检测限。In this example, a series of gastric cancer carcinoembryonic antibody samples of known concentrations are collected. These concentrations should cover the expected detection range of the gold-labeled aptamer test strip and include concentrations below the expected minimum detection limit. For example, samples of the following concentrations are prepared: 0 ng/mL (blank control), 1 ng/mL, 5 ng/mL, 10 ng/mL, 50 ng/mL, 100 ng/mL, 500 ng/mL. Samples of each concentration are tested using the gold-labeled aptamer test strip. For each concentration, the test is repeated at least 3 times to reduce experimental errors. The test results of the test strip at each concentration are recorded, including The results can be recorded as "positive" (the test line appears) or "negative" (the test line does not appear). The linear regression method is used to analyze the data, and the relationship between concentration and test results is established. The test strip response rate (the percentage of positive results) at each concentration point is analyzed to determine the minimum detection limit. Based on the linear regression analysis, the minimum concentration at which the test strip can reliably distinguish between positive and negative results is determined. Usually, the minimum detection limit is defined as the lowest concentration that can be reliably detected with 95%. By collecting a series of concentration gradient samples, the minimum detection limit of the test strip can be accurately determined.
进一步的，评估金标适配体试纸条的环境适用性和稳定性的具体评估过程为：在不同的储存环境下测试金标适配体试纸条的环境适用性，重复使用同一批次的金标适配体试纸条进行多次测试，评估其结果的稳定性。Furthermore, the specific evaluation process for evaluating the environmental applicability and stability of the gold-labeled aptamer test strips is as follows: testing the environmental applicability of the gold-labeled aptamer test strips under different storage environments, repeatedly using the same batch of gold-labeled aptamer test strips for multiple tests, and evaluating the stability of the results.
在本实施例中，选择不同的储存环境，如室温（25℃）、高温（37℃）、低温（4℃）、高湿度（大于80%）和低湿度（小于30%），从同一批次中取出金标适配体试纸条，分成若干组，每组放置在不同的储存环境中，将试纸条在每种环境中储存一定时间，例如1周、1个月、3个月和6个月，在每个储存时间点，取出试纸条进行性能测试，包括检测限、特异性、灵敏度等，使用同一批次的金标适配体试纸条，在标准储存条件下（如室温、避光、干燥）进行多次测试，测试可以在不同的时间点进行，例如生产后立即测试，然后分别在1个月、3个月、6个月和12个月进行测试，记录每次测试的结果，包括检测限、假阳性率、假阴性率等，比较不同储存环境下以及不同时间点的测试结果，评估试纸条性能的变化，如果在不同环境下的测试结果以及在时间跨度上的测试结果变化不大，可以认为试纸条具有良好的环境适用性和稳定性，通过在不同环境下测试，可以确保试纸条在各种实际使用条件下都能保持良好的性能。In this embodiment, different storage environments are selected, such as room temperature (25°C), high temperature (37°C), low temperature (4°C), high humidity (greater than 80%) and low humidity (less than 30%). Gold-labeled aptamer test strips are taken out from the same batch and divided into several groups. Each group is placed in a different storage environment. The test strips are stored in each environment for a certain period of time, such as 1 week, 1 month, 3 months and 6 months. At each storage time point, the test strips are taken out for performance testing, including detection limit, specificity, sensitivity, etc. The gold-labeled aptamer test strips from the same batch are used under standard storage conditions (such as room temperature, dark, dry). Conduct multiple tests at different time points, such as testing immediately after production, and then testing at 1 month, 3 months, 6 months, and 12 months. Record the results of each test, including detection limit, false positive rate, false negative rate, etc. Compare the test results under different storage environments and at different time points, and evaluate the changes in the performance of the test strips. If the test results under different environments and over a certain time span do not change much, the test strips can be considered to have good environmental applicability and stability. By testing in different environments, it can be ensured that the test strips can maintain good performance under various actual use conditions.
进一步的，分析金标适配体试纸条的环境适用性和稳定性的具体分析过程：分析金标适配体试纸条的环境适用性，得到金标适配体试纸条的环境适用评估系数，分析金标适配体试纸条的稳定性，得到金标适配体试纸条的稳定评估系数，对金标适配体试纸条的环境适用评估系数和金标适配体试纸条的稳定评估系数进行综合评估，得到金标适配体试纸条的综合评估系数。Furthermore, the specific analysis process of the environmental applicability and stability of the gold-labeled aptamer test strips is analyzed: the environmental applicability of the gold-labeled aptamer test strips is analyzed to obtain the environmental applicability assessment coefficient of the gold-labeled aptamer test strips, the stability of the gold-labeled aptamer test strips is analyzed to obtain the stability assessment coefficient of the gold-labeled aptamer test strips, and the environmental applicability assessment coefficient and the stability assessment coefficient of the gold-labeled aptamer test strips are comprehensively evaluated to obtain the comprehensive assessment coefficient of the gold-labeled aptamer test strips.
在本实施例中，根据之前在不同储存环境下进行的测试结果，收集金标适配体试纸条的检测性能数据，计算出金标适配体试纸条的环境适用评估系数，收集金标适配体试纸条在不同时间点的测试结果，计算出金标适配体试纸条的稳定评估系数，将金标适配体试纸条的环境适用评估系数和金标适配体试纸条的稳定评估系数通过公式进行综合评估，得到金标适配体试纸条的综合评估系数，通过计算评估系数，可以将试纸条的环境适用性和稳定性量化，便于比较和分析。In this embodiment, based on the test results previously conducted under different storage environments, the detection performance data of the gold-labeled aptamer test strips are collected, and the environmental applicability assessment coefficient of the gold-labeled aptamer test strips is calculated. The test results of the gold-labeled aptamer test strips at different time points are collected, and the stability assessment coefficient of the gold-labeled aptamer test strips is calculated. The environmental applicability assessment coefficient of the gold-labeled aptamer test strips and the stability assessment coefficient of the gold-labeled aptamer test strips are comprehensively evaluated through a formula to obtain the comprehensive assessment coefficient of the gold-labeled aptamer test strips. By calculating the evaluation coefficients, the environmental applicability and stability of the test strips can be quantified, which is convenient for comparison and analysis.
进一步的，根据分析结果对金标适配体试纸条进行优化的具体优化过程为：分析测试结果，确定金标适配体试纸条性能不足的因素，根据不同的因素确定不同的优化流程，包括重新评估适配体和金标抗体的质量，优化固定化试剂的选择，调整检测线和控制线的位置，优化样品垫、吸收垫和层析膜的材质或组合，调整适配体在层析膜上的固定化条件，改进金标抗体的标记过程，调整储存温度、湿度和光照条件。Furthermore, the specific optimization process of optimizing the gold-labeled aptamer test strip according to the analysis results is as follows: analyzing the test results, determining the factors causing the insufficient performance of the gold-labeled aptamer test strip, and determining different optimization processes according to different factors, including re-evaluating the quality of the aptamer and the gold-labeled antibody, optimizing the selection of the immobilization reagent, adjusting the position of the detection line and the control line, optimizing the material or combination of the sample pad, the absorption pad and the chromatographic membrane, adjusting the immobilization conditions of the aptamer on the chromatographic membrane, improving the labeling process of the gold-labeled antibody, and adjusting the storage temperature, humidity and light conditions.
在本实施例中，通过之前的综合评估，发现金标适配体试纸条在特定环境条件下的性能下降，通过对比不同环境条件下的测试数据，确定是哪些因素导致了性能下降，例如，可能是适配体与层析膜的固定化不充分，或是金标抗体的标记效率低，包括重新评估适配体和金标抗体的纯度和活性，必要时更换供应商或改进生产过程，测试不同类型的固定化试剂，选择最佳的试剂以增强适配体与层析膜的固定，调整试纸条上检测线和控制线的位置，以提高检测线的灵敏度，评估和测试不同材质或组合，以改善样本流动性和信号捕获，调整适配体在层析膜上的固定化条件，如固定化时间、温度和试剂浓度，改进标记过程，例如优化标记试剂的比例或反应时间，根据环境适用性分析结果，调整储存温度、湿度和光照条件，以保持试纸条性能，根据确定的优化流程，对试纸条的生产过程进行改进，并再次进行测试以验证优化效果，通过针对性的优化，可以显著提升试纸条的性能，尤其是在之前表现不佳的方面。In this embodiment, through the previous comprehensive evaluation, it was found that the performance of the gold-labeled aptamer test strip decreased under specific environmental conditions. By comparing the test data under different environmental conditions, it was determined which factors caused the performance degradation. For example, it may be that the immobilization of the aptamer to the chromatographic membrane is insufficient, or the labeling efficiency of the gold-labeled antibody is low. This includes re-evaluating the purity and activity of the aptamer and the gold-labeled antibody, changing suppliers or improving the production process when necessary, testing different types of immobilization reagents, selecting the best reagent to enhance the fixation of the aptamer to the chromatographic membrane, and adjusting the positions of the test line and the control line on the test strip to improve the detection efficiency. line sensitivity, evaluate and test different materials or combinations to improve sample fluidity and signal capture, adjust the immobilization conditions of the aptamer on the chromatographic membrane, such as immobilization time, temperature and reagent concentration, improve the labeling process, such as optimizing the ratio of labeling reagents or reaction time, and adjust the storage temperature, humidity and light conditions according to the results of the environmental suitability analysis to maintain the performance of the test strips. According to the determined optimization process, improve the production process of the test strips and test them again to verify the optimization effect. Through targeted optimization, the performance of the test strips can be significantly improved, especially in areas that performed poorly before.
进一步的，在临床样本上进行金标适配体试纸条的验证测试的具体测试过程为：收集已知胃癌患者和健康人的血清或血浆样本，对样本进行处理和储存，选择足够多的样本进行盲法选择，对样本进行测试，得到金标适配体试纸条的假阳性和假阴性概率，根据假阳性和假阴性的概率计算金标适配体试纸条的准确性，对部分样本进行重复测试，以验证结果的可靠性。Furthermore, the specific testing process of the validation test of the gold-labeled aptamer test strip on clinical samples is as follows: serum or plasma samples from known gastric cancer patients and healthy people are collected, the samples are processed and stored, a sufficient number of samples are selected for blind selection, the samples are tested, and the false positive and false negative probabilities of the gold-labeled aptamer test strip are obtained, the accuracy of the gold-labeled aptamer test strip is calculated according to the false positive and false negative probabilities, and some samples are tested repeatedly to verify the reliability of the results.
在本实施例中，从医院收集已知胃癌患者和健康人的血清或血浆样本。确保样本标签准确，记录患者的诊断结果、样本收集日期和样本类型，对收集的样本进行标准化处理，如离心、过滤等，以去除可能的干扰物质，将处理后的样本储存在适当的条件下，例如-80°C冰箱，以保持样本的稳定性和活性，为了避免测试偏差，对样本进行盲法选择，选择足够多的样本，例如至少100个胃癌患者样本和100个健康人样本，以确保统计结果的可靠性，记录每个样本的测试结果，包括是否出现检测线，通过与样本的实际诊断结果对比，计算试纸条的假阳性（健康人样本测试结果为阳性）和假阴性（胃癌患者样本测试结果为阴性）概率，对部分样本进行重复测试，以验证测试结果的可靠性，在真实临床样本上进行测试，可以验证试纸条在实际应用中的性能。In this embodiment, serum or plasma samples from known gastric cancer patients and healthy people are collected from hospitals. Ensure that the sample labels are accurate, record the patient's diagnosis, sample collection date and sample type, perform standardized treatment on the collected samples, such as centrifugation, filtration, etc., to remove possible interfering substances, store the processed samples under appropriate conditions, such as -80°C refrigerator, to maintain the stability and activity of the samples, and select the samples blindly to avoid test bias. Select enough samples, such as at least 100 gastric cancer patient samples and 100 healthy person samples to ensure the reliability of the statistical results, record the test results of each sample, including whether the test line appears, and calculate the false positive (healthy person sample test result is positive) and false negative (gastric cancer patient sample test result is negative) probability of the test strip by comparing with the actual diagnosis result of the sample, repeat the test on some samples to verify the reliability of the test results, and test on real clinical samples to verify the performance of the test strip in actual applications.
进一步的，使用线性回归方法分析金标适配体试纸条的最低检测限的具体分析过程为：对每个浓度的标准品进行金标适配体试纸条测试，记录每个浓度下的信号强度，信号强度是指通过视觉读取或使用读取仪将具体的浓度对应的结果输入到Python的数据，使用Python进行线性回归分析，建立信号强度与标准品浓度之间的线性关系，并在坐标系中自动形成标准曲线，通常横坐标为标准品浓度的对数值，纵坐标为信号强度。Furthermore, the specific analysis process of using the linear regression method to analyze the minimum detection limit of the gold-labeled aptamer test strip is as follows: the gold-labeled aptamer test strip is tested for each concentration of the standard, and the signal intensity at each concentration is recorded. The signal intensity refers to the data corresponding to the specific concentration input into Python by visual reading or using a reader. Python is used for linear regression analysis to establish a linear relationship between signal intensity and standard concentration, and a standard curve is automatically formed in the coordinate system. Usually, the horizontal axis is the logarithm of the standard concentration, and the vertical axis is the signal intensity.
在本实施例中，准备一系列已知浓度的胃癌癌胚抗体标准品，浓度范围应覆盖预期检测限以下至高于检测限，对于每个浓度，记录试纸条的信号强度。信号强度可以通过视觉读取试纸条上的检测线颜色深浅，或者使用专门的读取仪器获取数值，将每个浓度下的信号强度数据输入到Python的数据结构中，例如使用pandas库创建一个数据框，使用Python中的统计或机器学习库进行线性回归分析，在坐标系中绘制标准曲线，通常横坐标为标准品浓度的对数值（log浓度），纵坐标为信号强度，使用matplotlib库或seaborn库在Python中自动生成标准曲线图，根据标准曲线，确定信号强度与背景信号强度有统计学差异的最小浓度，即为最低检测限，线性回归方法提供了一个客观的、数据驱动的分析手段来确定最低检测限。In this example, a series of known concentrations of gastric cancer carcinoembryonic antibody standards are prepared, and the concentration range should cover from below the expected detection limit to above the detection limit. For each concentration, the signal intensity of the test strip is recorded. The signal intensity can be obtained by visually reading the color depth of the detection line on the test strip, or by using a special reading instrument to obtain the value. The signal intensity data at each concentration is input into a Python data structure, such as using the pandas library to create a data frame, using the statistical or machine learning library in Python for linear regression analysis, and drawing a standard curve in the coordinate system, usually the horizontal axis is the logarithm of the standard concentration (log concentration), and the vertical axis is the signal intensity. The standard curve graph is automatically generated in Python using the matplotlib library or the seaborn library. According to the standard curve, the minimum concentration at which the signal intensity is statistically different from the background signal intensity is determined, which is the minimum detection limit. The linear regression method provides an objective, data-driven analytical method to determine the minimum detection limit.
进一步的，金标适配体试纸条的综合评估系数的具体约束公式为：Furthermore, the specific constraint formula of the comprehensive evaluation coefficient of the gold-labeled aptamer test strip is:
； ;
式中，表示金标适配体试纸条的综合评估系数，用于评估金标适配体试纸条的环境适用性和稳定性，表示金标适配体试纸条的环境适用性评估系数，表示金标适配体试纸条的稳定性评估系数。In the formula, It represents the comprehensive evaluation coefficient of the gold-labeled aptamer test strip, which is used to evaluate the environmental applicability and stability of the gold-labeled aptamer test strip. represents the environmental suitability assessment coefficient of the gold-labeled aptamer test strip, Represents the stability evaluation coefficient of the gold-labeled aptamer test strip.
在本实施例中，表示金标适配体试纸条的综合评估系数，用于评估金标适配体试纸条的环境适用性和稳定性对总体质量的影响，表示金标适配体试纸条的环境适用性评估系数，表示金标适配体试纸条的稳定性评估系数In this embodiment, It represents the comprehensive evaluation coefficient of the gold-labeled aptamer test strip, and is used to evaluate the impact of the environmental applicability and stability of the gold-labeled aptamer test strip on the overall quality. represents the environmental suitability assessment coefficient of the gold-labeled aptamer test strip, Indicates the stability evaluation coefficient of the gold-labeled aptamer test strip
本公式中金标适配体试纸条的综合评估系数与金标适配体试纸条的环境适用性评估系数成正相关，金标适配体试纸条的综合评估系数与金标适配体试纸条的稳定性评估系数成正相关，综合分析金标适配体试纸条的环境适用性评估系数越高，金标适配体试纸条的综合评估系数越高；金标适配体试纸条的稳定性评估系数越高，金标适配体试纸条的综合评估系数越高。In this formula, the comprehensive evaluation coefficient of the gold-labeled aptamer test strip is positively correlated with the environmental applicability evaluation coefficient of the gold-labeled aptamer test strip, and the comprehensive evaluation coefficient of the gold-labeled aptamer test strip is positively correlated with the stability evaluation coefficient of the gold-labeled aptamer test strip. Comprehensive analysis shows that the higher the environmental applicability evaluation coefficient of the gold-labeled aptamer test strip, the higher the comprehensive evaluation coefficient of the gold-labeled aptamer test strip; the higher the stability evaluation coefficient of the gold-labeled aptamer test strip, the higher the comprehensive evaluation coefficient of the gold-labeled aptamer test strip.
在本实施例中，金标适配体试纸条的环境适用性评估系数的具体约束公式为：In this embodiment, the specific constraint formula of the environmental applicability evaluation coefficient of the gold-labeled aptamer test strip is:
； ;
式中，表示金标适配体试纸条的环境适用性评估系数，用于评估金标适配体试纸条的环境适用性对金标适配体试纸条的质量的影响，设置若干空间监测点，p，表示空间监测点的总数，表示第个空间监测点下的金标适配体试纸条的存储环境温度与金标适配体试纸条的标准存储环境温度的差值，表示第个空间监测点下的金标适配体试纸条的存储环境湿度与金标适配体试纸条的标准存储环境湿度的差值，表示第个空间监测点下的金标适配体试纸条的存储环境PH值与金标适配体试纸条的标准存储环境PH值的差值，表示第个空间监测点下的金标适配体试纸条的交叉反应率。In the formula, It represents the environmental applicability evaluation coefficient of the gold-labeled aptamer test strip, which is used to evaluate the influence of the environmental applicability of the gold-labeled aptamer test strip on the quality of the gold-labeled aptamer test strip. Several spatial monitoring points are set. p, represents the total number of spatial monitoring points, Indicates The difference between the storage environment temperature of the gold-labeled aptamer test strips at each spatial monitoring point and the standard storage environment temperature of the gold-labeled aptamer test strips, Indicates The difference between the storage environment humidity of the gold-labeled aptamer test strips at each spatial monitoring point and the standard storage environment humidity of the gold-labeled aptamer test strips, Indicates The difference between the pH value of the storage environment of the gold-labeled aptamer test strip at each spatial monitoring point and the pH value of the standard storage environment of the gold-labeled aptamer test strip, Indicates The cross-reaction rate of the gold-labeled aptamer test strips at three spatial monitoring points.
在本公式中，所考虑的存储环境为金标适配体试纸条可以正常使用的环境，金标适配体试纸条的存储环境温度与金标适配体试纸条的标准存储环境温度的差值、金标适配体试纸条的存储环境湿度与金标适配体试纸条的标准存储环境湿度的差值、金标适配体试纸条的存储环境PH值与金标适配体试纸条的标准存储环境PH值的差值会影响金标适配体试纸条的交叉反应率、金标适配体试纸条的变异系数和金标适配体试纸条的检测限，从而影响到金标适配体试纸条的质量，高湿度可能导致试纸条上生物分子结构变化，增加非特异性结合；低湿度可能导致试剂层干燥，影响生物分子活性，从而增加金标适配体试纸条的交叉反应率，温湿度的波动可能导致试纸条上生物分子活性变化，影响检测结果的重复性，从而增加金标适配体试纸条的变异系数，不适宜的pH值可能导致生物分子结构变化，降低其与癌胚抗体的结合能力，从而提高检测限，在本公式中只考虑环境和金标适配体试纸条的交叉反应率之间的关系。当金标适配体试纸条的存储环境温度与金标适配体试纸条的标准存储环境温度的差值、金标适配体试纸条的存储环境湿度与金标适配体试纸条的标准存储环境湿度的差值、金标适配体试纸条的存储环境PH值与金标适配体试纸条的标准存储环境PH值的差值越大，金标适配体试纸条的交叉反应率越小，从而说明金标适配体试纸条的环境适用性越优秀，环境的变化对试纸条的影响越小。In this formula, the storage environment considered is the environment in which the gold-labeled aptamer test strip can be used normally. The difference between the storage environment temperature of the gold-labeled aptamer test strip and the standard storage environment temperature of the gold-labeled aptamer test strip, the difference between the storage environment humidity of the gold-labeled aptamer test strip and the standard storage environment humidity of the gold-labeled aptamer test strip, and the difference between the storage environment pH value of the gold-labeled aptamer test strip and the standard storage environment pH value of the gold-labeled aptamer test strip will affect the cross-reaction rate of the gold-labeled aptamer test strip, the coefficient of variation of the gold-labeled aptamer test strip and the detection limit of the gold-labeled aptamer test strip, thereby affecting the gold-labeled aptamer test strip. The quality of the paper strip. High humidity may cause changes in the structure of biomolecules on the test strip and increase nonspecific binding. Low humidity may cause the reagent layer to dry out and affect the activity of biomolecules, thereby increasing the cross-reaction rate of the gold-labeled aptamer test strip. Fluctuations in temperature and humidity may cause changes in the activity of biomolecules on the test strip and affect the repeatability of the test results, thereby increasing the coefficient of variation of the gold-labeled aptamer test strip. Inappropriate pH values may cause changes in the structure of biomolecules and reduce their binding ability with oncofetal antibodies, thereby increasing the detection limit. In this formula, only the relationship between the environment and the cross-reaction rate of the gold-labeled aptamer test strip is considered. The greater the difference between the storage environment temperature of the gold-labeled aptamer test strip and the standard storage environment temperature of the gold-labeled aptamer test strip, the difference between the storage environment humidity of the gold-labeled aptamer test strip and the standard storage environment humidity of the gold-labeled aptamer test strip, and the difference between the storage environment pH value of the gold-labeled aptamer test strip and the standard storage environment pH value of the gold-labeled aptamer test strip, the smaller the cross-reaction rate of the gold-labeled aptamer test strip, which means that the environmental applicability of the gold-labeled aptamer test strip is better, and the impact of environmental changes on the test strip is smaller.
本实施例算法结合金标适配体试纸条的环境适用性数据，综合分析得到金标适配体试纸条的环境适用性评估系数，本公式中在金标适配体试纸条的存储环境下，不同的存储环境的交叉反应率会对金标适配体试纸条的性能有影响，表明了金标适配体试纸条的存储环境的交叉反应率对金标适配体试纸条的环境适用性评估系数存在负向影响的效果，且金标适配体试纸条的存储环境的温度的变化也会同步影响金标适配体试纸条的交叉反应率的变化，综合分析可以精确地得到金标适配体试纸条的存储环境的交叉反应率越大，金标适配体试纸条的环境适用性评估系数越小，以下表格只取一组空间监测点的数据。The algorithm of this embodiment combines the environmental suitability data of the gold-labeled aptamer test strips, and comprehensively analyzes to obtain the environmental suitability evaluation coefficient of the gold-labeled aptamer test strips. In this formula, under the storage environment of the gold-labeled aptamer test strips, the cross-reaction rates of different storage environments will affect the performance of the gold-labeled aptamer test strips, indicating that the cross-reaction rate of the storage environment of the gold-labeled aptamer test strips has a negative effect on the environmental suitability evaluation coefficient of the gold-labeled aptamer test strips, and the change in the temperature of the storage environment of the gold-labeled aptamer test strips will also synchronously affect the change in the cross-reaction rate of the gold-labeled aptamer test strips. Comprehensive analysis can accurately obtain that the greater the cross-reaction rate of the storage environment of the gold-labeled aptamer test strips, the smaller the environmental suitability evaluation coefficient of the gold-labeled aptamer test strips. The following table only takes data from one set of spatial monitoring points.
在一个具体实施例中，金标适配体试纸条的环境适用性评估系数数据示例如下表。In a specific embodiment, the environmental suitability evaluation coefficient data of the gold-labeled aptamer test strip is exemplified in the following table.
表1金标适配体试纸条的环境适用性评估系数数据示例表Table 1 Example of environmental suitability evaluation coefficient data for gold-labeled aptamer test strips
通过表1数据可以看出在第个空间监测点的金标适配体试纸条的存储环境温度、第个空间监测点的金标适配体试纸条的存储环境湿度和第个空间监测点的金标适配体试纸条的存储环境PH值固定不变时，第个空间监测点的金标适配体试纸条的交叉反应率越大，金标适配体试纸条的环境适用性评估系数越低，第个空间监测点的金标适配体试纸条的交叉反应率和金标适配体试纸条的环境适用性评估系数成负相关。From the data in Table 1, it can be seen that The storage environment temperature of the gold-labeled aptamer test strips at each spatial monitoring point, Storage environment humidity of the gold-labeled aptamer test strips at each spatial monitoring point and the When the pH value of the storage environment of the gold-labeled aptamer test strip at each spatial monitoring point remains constant, The greater the cross-reaction rate of the gold-labeled aptamer test strips at each spatial monitoring point, the lower the environmental applicability assessment coefficient of the gold-labeled aptamer test strips. The cross-reaction rate of the gold-labeled aptamer test strips at each spatial monitoring point is negatively correlated with the environmental applicability assessment coefficient of the gold-labeled aptamer test strips.
金标适配体试纸条的存储环境温度是指金标适配体试纸条在存储过程中所处环境的温度，金标适配体试纸条的存储环境温度可以通过环境监控设备来测量，金标适配体试纸条的存储环境温度的取值范围为2-8℃，5℃为标准存储温度。The storage environment temperature of the gold-labeled aptamer test strips refers to the temperature of the environment in which the gold-labeled aptamer test strips are located during the storage process. The storage environment temperature of the gold-labeled aptamer test strips can be measured by environmental monitoring equipment. The storage environment temperature of the gold-labeled aptamer test strips ranges from 2-8°C, with 5°C being the standard storage temperature.
金标适配体试纸条的存储环境湿度是指金标适配体试纸条在存储过程中所处环境的相对湿度，金标适配体试纸条的存储环境湿度可以通过环境监控设备来测量，金标适配体试纸条的存储环境湿度的取值范围为15-50%，30%为标准存储湿度。The storage environment humidity of the gold-labeled aptamer test strips refers to the relative humidity of the environment in which the gold-labeled aptamer test strips are stored. The storage environment humidity of the gold-labeled aptamer test strips can be measured by environmental monitoring equipment. The storage environment humidity of the gold-labeled aptamer test strips ranges from 15% to 50%, with 30% being the standard storage humidity.
金标适配体试纸条的存储环境PH值是指金标适配体试纸条在存储过程中所处环境的酸碱度，金标适配体试纸条的存储环境PH值可以通过使用pH计来测量，金标适配体试纸条的存储环境PH值的取值范围为6-8，PH值在7时为标准存储PH值。The pH value of the storage environment of the gold-labeled aptamer test strips refers to the acidity and alkalinity of the environment in which the gold-labeled aptamer test strips are located during storage. The pH value of the storage environment of the gold-labeled aptamer test strips can be measured by using a pH meter. The pH value of the storage environment of the gold-labeled aptamer test strips ranges from 6 to 8, and a pH value of 7 is the standard storage pH value.
金标适配体试纸条的交叉反应率是指试纸条与结构类似但非目标分析物的其他物质发生反应的程度，金标适配体试纸条的交叉反应率可以通过测试试纸条与一系列已知结构类似但不同的物质的反应来确定，金标适配体试纸条的交叉反应率的取值范围为1-10%。The cross-reaction rate of the gold-labeled aptamer test strip refers to the degree to which the test strip reacts with other substances that are similar in structure but are not the target analytes. The cross-reaction rate of the gold-labeled aptamer test strip can be determined by testing the reaction of the test strip with a series of known substances with similar but different structures. The cross-reaction rate of the gold-labeled aptamer test strip ranges from 1-10%.
在本实施例中，金标适配体试纸条的稳定性评估系数的具体约束公式为：In this embodiment, the specific constraint formula of the stability evaluation coefficient of the gold-labeled aptamer test strip is:
； ;
式中，表示金标适配体试纸条的稳定性评估系数，用于评估移动载具对避障的影响，设置若干时间监测点，，表示时间监测点的总数，表示第个时间监测点下的金标适配体试纸条的交叉反应率，表示第个时间监测点下的金标适配体试纸条的变异系数，表示第个时间监测点下的金标适配体试纸条的检测限。In the formula, It represents the stability evaluation coefficient of the gold-labeled aptamer test strip, which is used to evaluate the impact of the mobile vehicle on obstacle avoidance. Several time monitoring points are set. , Represents the total number of time monitoring points, Indicates The cross-reaction rate of the gold-labeled aptamer test strips at each time monitoring point, Indicates The coefficient of variation of the gold-labeled aptamer test strip at each time monitoring point, Indicates Detection limit of the gold-labeled aptamer test strip at the three time monitoring points.
在本公式中，金标适配体试纸条的交叉反应率、金标适配体试纸条的变异系数和金标适配体试纸条的检测限均为在标准环境下进行测量得到的，若不是在标准环境下进行测量得到的，则本公式无法进行有效评估。In this formula, the cross-reaction rate of the gold-labeled aptamer test strip, the coefficient of variation of the gold-labeled aptamer test strip and the detection limit of the gold-labeled aptamer test strip are all measured under a standard environment. If they are not measured under a standard environment, this formula cannot be used for effective evaluation.
本实施例算法结合金标适配体试纸条的稳定性相关数据，综合分析得到金标适配体试纸条的稳定性评估系数，本公式中金标适配体试纸条的交叉反应率与金标适配体试纸条的变异系数存在关联，金标适配体试纸条的交叉反应率越大则金标适配体试纸条的变异系数越大，且金标适配体试纸条的变异系数对金标适配体试纸条的稳定性评估系数存在负面影响的效果，综合分析可以精确地得到金标适配体试纸条的变异系数越大，金标适配体试纸条的稳定性评估系数越小。The algorithm of this embodiment combines the stability-related data of the gold-labeled aptamer test strip, and comprehensively analyzes to obtain the stability evaluation coefficient of the gold-labeled aptamer test strip. In this formula, the cross-reaction rate of the gold-labeled aptamer test strip is correlated with the coefficient of variation of the gold-labeled aptamer test strip. The greater the cross-reaction rate of the gold-labeled aptamer test strip, the greater the coefficient of variation of the gold-labeled aptamer test strip, and the coefficient of variation of the gold-labeled aptamer test strip has a negative effect on the stability evaluation coefficient of the gold-labeled aptamer test strip. Comprehensive analysis can accurately determine that the greater the coefficient of variation of the gold-labeled aptamer test strip, the smaller the stability evaluation coefficient of the gold-labeled aptamer test strip.
金标适配体试纸条的交叉反应率是指试纸条与结构类似但非目标分析物的其他物质发生反应的程度，金标适配体试纸条的交叉反应率可以通过测试试纸条与一系列已知结构类似但不同的物质的反应来确定，金标适配体试纸条的交叉反应率的取值范围为1-10%。The cross-reaction rate of the gold-labeled aptamer test strip refers to the degree to which the test strip reacts with other substances that are similar in structure but are not the target analytes. The cross-reaction rate of the gold-labeled aptamer test strip can be determined by testing the reaction of the test strip with a series of known substances with similar but different structures. The cross-reaction rate of the gold-labeled aptamer test strip ranges from 1-10%.
金标适配体试纸条的变异系数是指衡量金标适配体试纸条测试结果一致性的统计量，它是标准差与平均值的比值，通常以百分比表示，金标适配体试纸条的变异系数可以通过重复测试同一批次的试纸条或同一样本多次，并计算每次测试结果的标准差和平均值来获得，金标适配体试纸条的变异系数的取值范围为1-10%。The coefficient of variation of the gold-labeled aptamer test strips refers to a statistic that measures the consistency of the test results of the gold-labeled aptamer test strips. It is the ratio of the standard deviation to the mean, usually expressed as a percentage. The coefficient of variation of the gold-labeled aptamer test strips can be obtained by repeatedly testing the same batch of test strips or the same sample multiple times and calculating the standard deviation and mean of each test result. The value range of the coefficient of variation of the gold-labeled aptamer test strips is 1-10%.
金标适配体试纸条的检测限是指金标适配体试纸条能够可靠地检测到目标分析物的最低浓度，金标适配体试纸条的检测限可以通过构建标准曲线，使用一系列已知浓度的目标分析物来确定金标适配体试纸条的检测限，金标适配体试纸条的检测限的取值范围为1ng/mL-100ng/mL。The detection limit of the gold-labeled aptamer test strip refers to the lowest concentration of the target analyte that the gold-labeled aptamer test strip can reliably detect. The detection limit of the gold-labeled aptamer test strip can be determined by constructing a standard curve and using a series of target analytes of known concentrations. The detection limit of the gold-labeled aptamer test strip ranges from 1ng/mL to 100ng/mL.
图2为本申请实施例提供的一种用于胃癌的金标适配体试纸条的质量测试与分析方法中金标适配体试纸条的稳定性评估系数的图像，其中，第个时间监测点下的金标适配体试纸条的交叉反应率为函数的横坐标自变量，函数a是在第个时间监测点下的金标适配体试纸条的变异系数为1%、第个时间监测点下的金标适配体试纸条的检测限为10ng/mL时金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率变化而变化的曲线，金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率的增大而减小，将第个时间监测点下的金标适配体试纸条的变异系数乘以第个时间监测点下的金标适配体试纸条的检测限并取倒数计算出固定值1为函数a横坐标自变量的系数，函数b是在第个时间监测点下的金标适配体试纸条的变异系数为2%、第个时间监测点下的金标适配体试纸条的检测限为10ng/mL时金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率变化而变化的曲线，金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率的增大而减小，将第个时间监测点下的金标适配体试纸条的变异系数乘以第个时间监测点下的金标适配体试纸条的检测限并取倒数计算出固定值2为函数b横坐标自变量的系数，函数c是在第个时间监测点下的金标适配体试纸条的变异系数为3%、第个时间监测点下的金标适配体试纸条的检测限为10ng/mL时金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率变化而变化的曲线，金标适配体试纸条的稳定性评估系数随第个时间监测点下的金标适配体试纸条的交叉反应率的增大而减小，将第个时间监测点下的金标适配体试纸条的变异系数乘以第个时间监测点下的金标适配体试纸条的检测限并取倒数计算出固定值3为函数c横坐标自变量的系数，a曲线、b曲线和c曲线代表了在第个时间监测点下的金标适配体试纸条的变异系数为1%、2%和3%时的函数图像，在第个时间监测点下的金标适配体试纸条的交叉反应率同取相同的值时，a曲线的金标适配体试纸条的稳定性评估系数最大，b曲线次之，c曲线最小，通过观察不同函数图像下金标适配体试纸条的稳定性评估系数的变化，解决了现有技术中对金标适配体试纸条稳定性监测不精准的问题。FIG2 is an image of the stability evaluation coefficient of a gold-labeled aptamer test strip in a quality testing and analysis method for a gold-labeled aptamer test strip for gastric cancer provided in an embodiment of the present application, wherein the Cross-reaction rate of gold-labeled aptamer test strips at each time monitoring point is the horizontal axis independent variable of the function, and function a is in the The coefficient of variation of the gold-labeled aptamer test strip at the monitoring time point was 1%, When the detection limit of the gold-labeled aptamer test strip at the monitoring time point is 10 ng/mL, the stability evaluation coefficient of the gold-labeled aptamer test strip increases with the The curve of the cross-reaction rate of the gold-labeled aptamer test strip at the time monitoring point is shown in Figure 2. The stability evaluation coefficient of the gold-labeled aptamer test strip changes with the time monitoring point. The cross-reaction rate of the gold-labeled aptamer test strip at the monitoring point in time decreased with the increase of The coefficient of variation of the gold-labeled aptamer test strip at each time point is multiplied by the The detection limit of the gold-labeled aptamer test strip at the time monitoring point is calculated by taking the inverse and taking the fixed value 1 as the coefficient of the horizontal axis independent variable of function a. Function b is at the The coefficient of variation of the gold-labeled aptamer test strips at the time monitoring point was 2%. When the detection limit of the gold-labeled aptamer test strip at the monitoring time point is 10 ng/mL, the stability evaluation coefficient of the gold-labeled aptamer test strip increases with the The curve of the cross-reaction rate of the gold-labeled aptamer test strip at the time monitoring point is shown in Figure 2. The stability evaluation coefficient of the gold-labeled aptamer test strip changes with the time monitoring point. The cross-reaction rate of the gold-labeled aptamer test strip at the monitoring point in time decreased with the increase of The coefficient of variation of the gold-labeled aptamer test strip at each time point is multiplied by the The detection limit of the gold-labeled aptamer test strip at the time monitoring point is calculated by taking the inverse to obtain a fixed value 2 as the coefficient of the abscissa independent variable of function b. Function c is at the The coefficient of variation of the gold-labeled aptamer test strips at the monitoring time points was 3%. When the detection limit of the gold-labeled aptamer test strip at the monitoring time point is 10 ng/mL, the stability evaluation coefficient of the gold-labeled aptamer test strip increases with the The curve of the cross-reaction rate of the gold-labeled aptamer test strip at the time monitoring point is shown in Figure 2. The stability evaluation coefficient of the gold-labeled aptamer test strip changes with the time monitoring point. The cross-reaction rate of the gold-labeled aptamer test strip at the monitoring point in time decreased with the increase of The coefficient of variation of the gold-labeled aptamer test strip at each time point is multiplied by the The detection limit of the gold-labeled aptamer test strip at the time monitoring point is calculated by taking the inverse and taking the fixed value 3 as the coefficient of the abscissa independent variable of function c. Curves a, b and c represent the detection limit of the gold-labeled aptamer test strip at the time monitoring point. The function graphs of the gold-labeled aptamer test strips at the monitoring time points when the coefficient of variation is 1%, 2%, and 3% are shown in the figure. When the cross-reaction rates of the gold-labeled aptamer test strips at the same time monitoring points take the same value, the stability evaluation coefficient of the gold-labeled aptamer test strips of curve a is the largest, followed by curve b, and curve c is the smallest. By observing the changes in the stability evaluation coefficients of the gold-labeled aptamer test strips under different function images, the problem of inaccurate stability monitoring of the gold-labeled aptamer test strips in the prior art is solved.
本领域内的技术人员应明白，本发明的实施例可提供为方法、系统、或计算机程序产品。因此，本发明可采用完全硬件实施例、完全软件实施例、或结合软件和硬件方面的实施例的形式。而且，本发明可采用在一个或多个其中包含有计算机可用程序代码的计算机可用存储介质（包括但不限于磁盘存储器、CD-ROM、光学存储器等）上实施的计算机程序产品的形式。It will be appreciated by those skilled in the art that embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Furthermore, the present invention may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.
本发明是参照根据本发明实施例的方法、设备（系统）、和计算机程序产品的流程图和／或方框图来描述的。应理解可由计算机程序指令实现流程图和／或方框图中的每一流程和／或方框、以及流程图和／或方框图中的流程和／或方框的结合。可提供这些计算机程序指令到通用计算机、专用计算机、嵌入式处理机或其他可编程数据处理设备的处理器以产生一个机器，使得通过计算机或其他可编程数据处理设备的处理器执行的指令产生用于实现在流程图一个流程或多个流程和／或方框图一个方框或多个方框中指定的功能的装置。The present invention is described with reference to the flowcharts and/or block diagrams of the methods, devices (systems), and computer program products according to the embodiments of the present invention. It should be understood that each process and/or box in the flowchart and/or block diagram, as well as the combination of the processes and/or boxes in the flowchart and/or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to generate a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate a device for implementing the functions specified in one or more processes in the flowchart and/or one or more boxes in the block diagram.
这些计算机程序指令也可存储在能引导计算机或其他可编程数据处理设备以特定方式工作的计算机可读存储器中，使得存储在该计算机可读存储器中的指令产生包括指令装置的制造品，该指令装置实现在流程图一个流程或多个流程和／或方框图一个方框或多个方框中指定的功能。These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing device to work in a specific manner, so that the instructions stored in the computer-readable memory produce a manufactured product including an instruction device that implements the functions specified in one or more processes in the flowchart and/or one or more boxes in the block diagram.
这些计算机程序指令也可装载到计算机或其他可编程数据处理设备上，使得在计算机或其他可编程设备上执行一系列操作步骤以产生计算机实现的处理，从而在计算机或其他可编程设备上执行的指令提供用于实现在流程图一个流程或多个流程和／或方框图一个方框或多个方框中指定的功能的步骤。These computer program instructions may also be loaded onto a computer or other programmable data processing device so that a series of operational steps are executed on the computer or other programmable device to produce a computer-implemented process, whereby the instructions executed on the computer or other programmable device provide steps for implementing the functions specified in one or more processes in the flowchart and/or one or more boxes in the block diagram.
尽管已描述了本发明的优选实施例，但本领域内的技术人员一旦得知了基本创造性概念，则可对这些实施例作出另外的变更和修改。所以，所附权利要求意欲解释为包括优选实施例以及落入本发明范围的所有变更和修改。Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.
显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.
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| CN202411296473.0ACN118858635B (en) | 2024-09-18 | 2024-09-18 | Quality testing and analyzing method of gold-labeled aptamer test strip for gastric cancer |
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| CN202411296473.0ACN118858635B (en) | 2024-09-18 | 2024-09-18 | Quality testing and analyzing method of gold-labeled aptamer test strip for gastric cancer |
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