Application of Quantitative Biology in Product Development

With the continuous advancement of life science and technology, IVD also presents development trends such as diversification, intelligence, and personalization, which put forward higher requirements for the performance, efficiency, and accuracy of IVD reagents and equipment. Quantitative biology is a new discipline emerging after the rapid development of life sciences in recent years, intersecting and merging with quantitative disciplines such as mathematics, physics, chemistry, information science, and engineering. It utilizes quantitative methods and tools that organically combine theory, computation, and experiment to ask and solve key biological questions. The goal of quantitative biology is to discover the basic quantitative laws and universal principles in the biological world, and to find the mathematical language of life and the physics of life through the quantitative interdisciplinary research on biological systems. Quantitative biology has a wide range of applications in various fields of life sciences, such as systems biology, synthetic biology, developmental biology, neurobiology, molecular biology, etc.

This article introduces the application of the following three aspects:

● Utilize the methods and tools of quantitative biology to design and construct IVD reagents and equipment with high sensitivity, high specificity, high stability and high throughput, such as IVD products based on nucleic acid amplification, immune chromatography, biochip and other technologies .

●Use the methods and tools of quantitative biology to establish and optimize the standardized process and quality control system of IVD testing, such as formulating the quality standards, testing methods and evaluation indicators of IVD reagents.

● Use quantitative biology methods and tools to analyze and interpret the results and data of IVD tests, such as establishing mathematical models, algorithms and data analysis platforms to provide quantitative analysis, prediction and diagnosis of IVD tests.

Application in the design and construction of IVD reagents and equipment

IVD reagents refer to chemical reagents or biological reagents used in in vitro diagnostic tests, such as nucleic acid probes, enzyme-labeled antibodies, stains, etc. IVD equipment refers to instruments or devices used for in vitro diagnostic testing, such as PCR instruments, immunochromatography instruments, chip readers, etc. IVD reagents and equipment are the core components of IVD testing, and their performance, efficiency and accuracy directly affect the quality and results of IVD testing. Therefore, designing and constructing IVD reagents and devices with high sensitivity, high specificity, high stability and high throughput is an important task in IVD development.

Quantitative biology is widely used in the design and construction of IVD reagents and equipment. Quantitative biology can provide accurate measurement and mathematical modeling of biological processes such as biomolecular interactions, signal transduction, and gene expression. The sensitivity, specificity, stability and reliability provide theoretical guidance and optimization schemes. Quantitative biology can use synthetic biology methods to design and construct biological components with specific functions (such as enzymes, antibodies, nucleic acid probes, etc.), and provide efficient biological recognition and signal amplification tools for IVD reagents and equipment. Quantitative biology can combine automation, high-throughput and digital technology platforms to realize rapid development and verification of IVD reagents and equipment, and improve the standardization and intelligence of IVD reagents and equipment. Quantitative biology can use machine learning and artificial intelligence methods to analyze and mine a large amount of data generated by IVD reagents and equipment, and provide more accurate and personalized diagnostic results and treatment recommendations for the clinical application of IVD reagents and equipment.

Application in IVD test standardization and quality control

Standardization of IVD testing refers to the establishment and implementation of a unified, scientific, and reliable IVD testing process and specifications to ensure the quality of IVD testing and the consistency and comparability of results. Quality control of IVD testing refers to monitoring and evaluating various links and factors of IVD testing to ensure the accuracy and precision of IVD testing. IVD test standardization and quality control is an important task in IVD development, which is of great significance to improve the reliability and validity of IVD test, reduce the error and risk of IVD test, and ensure the safety and effectiveness of IVD test.

Quantitative biology is widely used in IVD test standardization and quality control. Through quantitative analysis of different types of human specimens (such as blood, urine, saliva, etc.), determine the best specimen sampling method, storage conditions, pretreatment Methods, etc., to improve the quality and reliability of specimens. Through the quantitative analysis of different types of IVD reagents, the optimal reagent configuration, storage, use and other conditions are determined to ensure the activity and stability of the reagents. Through quantitative analysis of different types of IVD equipment (such as PCR instrument, immunochromatography instrument, chip reader, etc.), determine the best equipment calibration, maintenance, operation and other conditions to ensure the function and accuracy of the equipment. Through quantitative analysis of different types of IVD testing processes, determine the best testing methods, steps, parameters and other conditions to ensure the repeatability and reproducibility of testing. Through quantitative analysis of different types of IVD test results, determine the best conditions for result interpretation, recording, reporting, etc., to ensure the comprehensibility and transferability of results.

Taking an immunochromatographic test strip based on colloidal gold method as an example, the application of quantitative biology in the standardization and quality control of immunochromatographic test strips was introduced.

Colloidal gold method immunochromatography test strip is an immunochromatographic product based on colloidal gold method, which uses a paper strip coated with colloidal gold and antibodies or antigens to form color strips on a solid carrier to detect targets substance. Colloidal gold immunochromatographic test strips usually include the following parts:

● Sample absorption area: used to absorb the sample to be tested (such as blood, urine, etc.) and transfer it to the reaction area.

● Reaction area: used for specific binding reaction between antigen and antibody, and form color change. The reaction zone usually includes two parts: the detection line (T line) and the quality control line (C line). The T-line is the part coated with antibodies or antigens that specifically bind to the target substance. When the target substance exists, it will form a complex with the colloidal gold and the antibody or antigen on the T-line, and form a color band at the T-line. The C-line is the part coated with antibodies or antigens that specifically bind to the colloidal gold. When the sample flows through, it will form a complex with the colloidal gold and form a color band at the C-line. The C line is used to monitor whether the test is performed normally. If there is no color band on the C line, it means that the test is invalid.

● Absorption area: used to absorb excess samples and reagents to prevent reverse flow and interference.

● Backboard: Used to support the strips and hold the parts in place, usually made of plastic or fiberglass.

Quantitative biology is widely used in the standardization and quality control of colloidal gold immunochromatography test strips, and its methods and tools can achieve the following goals:

● Through quantitative analysis of different types of human specimens, determine the best conditions for specimen collection, preservation, transportation, and processing to ensure the integrity and representativeness of specimens. For example, by measuring the concentration, stability, variability and other indicators of the target substance in the sample, determine the best collection time, collection amount, storage temperature, storage time, processing method, etc.

● Through the quantitative analysis of different types of colloidal gold immunochromatography reagents, determine the best reagent type, configuration, storage, use and other conditions to ensure the activity and stability of the reagents. For example, by measuring the size, shape, distribution, density, hydrophilicity and hydrophobicity of colloidal gold and antibodies or antigens in the reagent, determine the best preparation method, ratio, concentration, pH value, buffer, etc.

● Through quantitative analysis of different types of colloidal gold immunochromatographic paper strips, determine the best paper strip structure, function, operation and other conditions to ensure the performance and accuracy of the paper strips. For example, by measuring the length, width, thickness, porosity, wettability and other indicators of the sample absorption area, reaction area and absorption area in the paper strip, determine the best material selection, cutting method, coating method, etc.

● Through quantitative analysis of different types of colloidal gold immunochromatography test process, determine the best test method, steps, parameters and other conditions to ensure the repeatability and reproducibility of the test. For example, by measuring the sample drop volume, reaction time, reaction temperature, color band intensity and other indicators during the test, determine the best operating specifications, time control, temperature control, etc.

● By quantitatively analyzing the test results of different types of colloidal gold immunochromatography, determine the best conditions for interpretation, recording, and reporting of results to ensure the comprehensibility and transferability of results. For example, by measuring the color band position, width, color depth and other indicators in the measurement results, determine the best interpretation method, recording method, report format, etc.

Application in the analysis and interpretation of IVD test results and data

IVD test results and data refer to qualitative or quantitative information produced by IVD tests, such as color bars, numerical values, images, etc. IVD test results and data are the final output of IVD tests, which are of great significance for evaluating the effectiveness and safety of IVD tests, providing diagnostic significance and treatment recommendations for IVD tests, and guiding clinical decision-making and public health policies. Therefore, analyzing and interpreting IVD test results and data is an important task in IVD development.

Quantitative biology has broad applications in the analysis and interpretation of IVD test results and data, utilizing its methods and tools to:

● Use mathematical models and algorithms to quantitatively analyze IVD test results and data, such as calculating sensitivity, specificity, accuracy, precision, linear range, detection limit, etc., to evaluate the performance and quality of IVD testing.

● Use machine learning and artificial intelligence to intelligently analyze IVD test results and data, such as using chatbots to identify patient symptoms and provide advice; use deep learning and machine vision to identify images of skin cancer, tumors, pathology, etc.; use facial recognition and deep learning to diagnose rare diseases and more.

● Use the data analysis platform to visually analyze the IVD test results and data, such as using charts, reports, etc. to display the results and indicators of the IVD test; use methods such as ABTest to compare the results of IVD tests under different algorithms or parameters; Methods such as data mining and knowledge discovery extract valuable information and knowledge from IVD test results and data.

In conclusion

Quantitative biology is an emerging interdisciplinary subject, which utilizes quantitative methods and tools and organically combines theory, calculation and experiment to propose and solve key biological problems. Quantitative biology is widely used in various fields of life sciences, especially in the development of in vitro diagnostics (IVD). Quantitative biology can be used for the design and construction of high sensitivity, high specificity, high stability and high throughput IVD Reagents and equipment, establish and optimize the standardized process and quality control system of IVD testing, analyze and interpret the results and data of IVD testing to provide strong support. With the continuous advancement of life science technology, the role of quantitative biology in IVD development will become more and more important, bringing more innovations and breakthroughs to the field of medical care. Of course, we also need to constantly break through our own limitations and difficulties.