2023 Vol. 67, No. 5

Research Progress
A Review on the Advancements in Molecular Point-of-Care Tests
FEI Yue, LI Jianxin, WANG Di, WANG Zhidong, WU Xiao, GAO Yunhua
2023, 67(5): 3-8. doi: 10.12338/j.issn.2096-9015.2022.0280
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The Molecular Point-of-Care Test (POCT) represents a rapidly evolving nucleic acid testing method primarily grounded on isothermal amplification and microfluidic technologies. This technique provides numerous advantages including rapid testing, compact hardware, and simplicity in operation, thereby paving the way for immediate "sample in, result out" diagnostics. It serves as a powerful tool for the containment and management of epidemics such as COVID-19. Currently available molecular POCT diagnostic tools can detect various pathogenic microorganisms like human papillomavirus, human immunodeficiency virus, hepatitis C virus, and Neisseria gonorrhoeae, all while providing fast results and convenient portability. Despite its advantages, this technology remains in the nascent stages of industrial development, necessitating enhancements in the accuracy and consistency of molecular POCT products. Improvement in the relevant quality control measures and standards is required, with the establishment of a standardized validation and assessment system. This paper presents a comprehensive review of the most recent advancements in molecular POCT technologies, devices, and applications, which are underpinned by isothermal amplification and microfluidic principles. It also offers a forecast on the prospective trajectory of this technology.
A Review on the Advancements in Quantitative Nuclear Magnetic Resonance Spectroscopy of Fluorine and Phosphorus
HUANG Ting, WU Huaxin
2023, 67(5): 9-15. doi: 10.12338/j.issn.2096-9015.2023.0095
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Quantitative Nuclear Magnetic Resonance (qNMR) stands as a selective, accurate, and prompt method for quantitative analysis, predominantly employed in purity assessments of organic compounds. Its potential as a primary method has generated burgeoning interest and applications in international metrological comparisons. The recent international metrological development strategy plans to extend its conventional scope from hydrogen spectroscopy (1H) to fluorine and phosphorus spectroscopy. The incorporation of qNMR in new domains such as metabolomics, environmental analysis, and physiological research has introduced more intricate molecules and systems, like natural products, biomolecules, proteins, and metabolites, thereby challenging the standard 1H-qNMR. This has led to an increased focus on qNMR methodologies based on other NMR-active nuclei such as fluorine (19F) and phosphorus (31P). These methodologies offer comparable sensitivity, enhanced resolution, and the ability to eliminate interference from residual solvents or water peaks relative to 1H-qNMR. This review presents the distinctive advantages, methodological enhancements, and the latest research developments in 19F-qNMR and 31P-qNMR. Particular emphasis is placed on the development of traceable reference materials, coaxial internal standard insertion methods, and parameter optimization. The application domains of 19F-qNMR encompass medicine, materials, and environmental sciences, whereas 31P-qNMR is centered around food, medicine, and biological sectors.ound food, medicine, and biological sectors.
Advancements in Drug Residue Analysis Techniques in Hair
WEI Qi, SU Fuhai
2023, 67(5): 16-22, 30. doi: 10.12338/j.issn.2096-9015.2023.0103
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Compared to other biological samples, hair offers an extended window for drug detection. The pre-treatment process in hair analysis is notably more complex than standard matrices, involving procedures such as sampling, cleaning, hydrolysis, and extraction purification. Techniques employed for drug residue analysis in hair encompass immunoassays, chromatographic methods, gas chromatography-tandem mass spectrometry (GC-MS/MS), and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Owing to their high sensitivity and selectivity, GC-MS/MS and LC-MS/MS serve as the prevalent methods for drug analysis in hair. Hair analysis can furnish information pertaining to a history of drug addiction or drug toxicity, making it a subject of keen interest in forensic science research. Presently, research related to hair matrix standard materials is rather sparse, predominantly concentrating on prohibited drugs. This article reviews the development over the past few decades in hair drug analysis techniques and related standard materials. By examining the relevant literature, this review presents an overview of the research progress in hair drug analysis techniques and associated reference materials, focusing on their characteristics, pre-treatment processes, analytical methods, applications, and the current state of related reference material research.
An Overview of Algorithm Traceability
WANG Tingting, CUI Weiqun
2023, 67(5): 23-30. doi: 10.12338/j.issn.2096-9015.2022.0270
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In the digital age, software algorithms imbued with artificial intelligence and other next-generation information technologies serve as crucial factors accelerating the digital transformation of the manufacturing sector. The concept of algorithm traceability has been proposed based on the distinct characteristics manifested by measuring instruments and standards during metrological value transfer and traceability in various stages of the industrial revolution, along with the impact of software algorithms within measuring instruments on the accuracy and reliability of metrological values. The objective of this concept is to quantitatively assess the output values of software algorithms during their execution from a metrological traceability perspective, thereby ensuring their precision and dependability. This paper offers a comprehensive exposition of algorithm traceability, including its definition, reference standards, methodologies, and traceability outcomes. Current research trends in algorithm traceability are discussed, laying a theoretical groundwork for further exploration into metrological applications of algorithm traceability.
A Study on Quality Assessment of Human Genome Data
YAN Weijun, ZHAO Zhengyi, XIONG Xingchuang
2023, 67(5): 31-38. doi: 10.12338/j.issn.2096-9015.2023.0089
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In the wake of the advancements in high-throughput sequencing technology, researchers are now equipped with the capacity to conduct in-depth analyses and processing of human genome sequencing data. The quality of these data inevitably serves as a pivotal factor impacting the credibility of analysis results. As such, precise quality assessment becomes a paramount process to circumvent needless loss and to ascertain the accuracy of outcomes. Both the academic and industrial communities place significant emphasis on data quality assessment, having introduced numerous methods for such assessment and developed a multitude of tools like FastQC and Qualimap software, along with various standard materials and standard reference data, which collectively underpin data quality assessment. However, there are scant systematic investigations of toolsets employed in each assessment stage and summarizations of toolset characteristics. Furthermore, the process of data quality assessment is laden with numerous issues and challenges. To aid human genome data assessment endeavors, this paper delves into potential solutions for these problems and puts forth several practically significant suggestions for reference.
A Review of Advances in Research and Practice of Metrology Digitalization
2023, 67(5): 39-44. doi: 10.12338/j.issn.2096-9015.2022.0278
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This review is built upon existing literature to explicate the concept of metrology digitalization, the global explorations in this field, and the current state of metrology digitalization research in China. It encapsulates the developmental practices of metrology digitalization in China, scrutinizes the challenges encountered, and suggests potential strategies for securing the future transformation of metrology digitalization in China. Such strategies encompass the continual refinement of the overarching design of metrology digitalization, the establishment of a comprehensive research, development, and application system for metrology digitalization, as well as the cultivation of versatile talent specializing in metrology digitalization.
Reference Material Development
Synthesis of Formaldehyde-2,4-Dinitrophenylhydrazine Derivatives and its Qualitative and Quantitative Analysis
WANG Xiangnan, WANG Meiling, REN Danhua, ZHANG Airui, ZHOU Yan, WANG Hai, CHENG Bin
2023, 67(5): 45-51. doi: 10.12338/j.issn.2096-9015.2022.0295
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The monitoring and research of volatile oxygenated organic pollutants, including aldehydes and ketones, have garnered widespread attention. Given the existing shortage of formaldehyde-2,4-dinitrophenylhydrazone standard substances for high-performance liquid chromatography (HPLC)-based formaldehyde measurement, this study embarks on exploring the synthesis method of formaldehyde hydrazone through the derivatization reaction of formaldehyde and 2,4-dinitrophenylhydrazine. It also delves into the qualitative and quantitative analyses of the resulting product. By optimizing reaction parameters such as reaction time, the acidity of the reaction solution, and the number of extractions, the study has identified optimal conditions for the derivatization reaction: a reaction time of 30 minutes, a reaction solution pH of 2, and 6 extraction iterations. Infrared spectroscopy and gas chromatography-mass spectrometry were employed to qualitatively confirm the derivatives, while HPLC was used for quantitative analysis, with a subsequent evaluation of measurement uncertainty. The results indicated that the synthesized formaldehyde-2,4-dinitrophenylhydrazone aligns well with the NIST Standard Spectrum Library, and could achieve a purity of up to 98% and an uncertainty of less than 1%, making it a promising candidate for standard substance formulation. Additionally, the established HPLC method has been proven capable of accurate formaldehyde-2,4-dinitrophenylhydrazone measurements. This study will offer vital insights for the preparation, valuation, and development of standard substances like formaldehyde-2,4-dinitrophenylhydrazone.
Metrology Theory
Analytical Research on Uncertainty of Calibration Equation Coefficient of
MENG Chen, WANG Hao, WU Kun
2023, 67(5): 52-57. doi: 10.12338/j.issn.2096-9015.2022.0276
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The build-up force standard machine, due to its simple and reliable structure as well as its appreciable precision, has found extensive industrial applications. Such machines typically consist of high-precision force transducers complemented by well-engineered structures. The system's output, defined by a force transfer standard calibrated by a deadweight force standard machine, is typically characterized using polynomial expressions. The choice of the calibration equation's order and the associated uncertainty in its coefficients are significant factors influencing the machine's accuracy. However, different countries' regulations and standards do not explicitly prescribe the equation's order. This study, therefore, explores the impact of the calibration equation on force transmission uncertainty. We demonstrate a negative correlation between the uncertainty in calibration equation coefficients and the number of calibration points. By carrying out numerical experiments with polynomial functions of different orders, we compute residuals and uncertainties for the linear coefficient. A comparison of the predicted values from the testing and training datasets suggests that a first-order polynomial function can be reliably used as the calibration equation for force sensors.
Research on Calibration of Resistance Tube Based on Acoustic Simulation
ZHAO Ying, GUO Xinxin, ZHENG Haorui
2023, 67(5): 58-63. doi: 10.12338/j.issn.2096-9015.2023.0002
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The calibration of the measurement error of the sound absorption coefficient, using the impedance tube (transfer function method), employs the standard sample method. The excitation of a plane wave is produced by the broadband sound source within the tube. By measuring the transfer function of the response signals of two transducers, the sound absorption coefficient of the standard sample is determined. The measurement error of the sound absorption coefficient is then deduced by comparing this with the standard value of the standard sample. As the operating frequency range of the impedance tube under calibration may not correspond with the calibration frequency range mentioned in the certificate of the standard sample, it is essential to determine the impedance tube's working frequency range prior to calibration. This further aids in establishing the calibration frequency range, thereby avoiding calibration result inaccuracies. This study encompasses a theoretical analysis and simulation of the cut-off frequency of the plane wave sound field generated within the impedance tube, and a simulation of the sound absorption coefficient of two impedance tubes with distinct diameters (or side lengths) and varied transducer spacing. A mathematical model that establishes a relationship between the tube diameter (or side length), transducer spacing, and frequency range has been derived from these simulations. This model serves as a useful tool providing guidance for the calibration of the measurement error of the impedance tube's sound absorption coefficient.
Measurement Methods and Techniques
A Study on the Methodology for Evaluating the Quality Control Status of VOCs Monitoring Systems through Statistical Analysis
MA Yunyun, CHAI Wenxuan, LI Hongli, ZOU Yingjie, XIE Qian, XIAO Yang, XU Weihong
2023, 67(5): 64-71. doi: 10.12338/j.issn.2096-9015.2023.0063
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Monitoring photochemical precursors in the atmosphere can provide essential data for researching the formation mechanisms of composite pollution from ozone (O3) and fine particulate matter (PM2.5). The quality of the monitoring data significantly influences the accuracy of air pollution control measures. Therefore, executing scientific monitoring is critical for preventive measures and has paramount importance in continually improving China's air quality. Volatile Organic Compounds (VOCs), key precursors to O3 and PM2.5 pollution, participate in photochemical reactions in the atmosphere. This paper introduces the structure and function of VOCs' online monitoring systems in the photochemical monitoring network. After a preliminary analysis of quality control indicators and error sources, potential typical array distribution forms of quality control results were discussed. The paper further explores methods for evaluating the quality control status of the monitoring system through statistical analysis and conducts correlation analyses between residuals and quality control results, as well as between operational duration and component qualification rates. The paper recommends collecting a large sample of quality control data, carrying out systematic and meticulous correlation analyses among quality control indicators, and investigating factors that affect the quality control status of the monitoring system and the quality of measured data.
Measuring Instruments and Systems
Development of a Calibration Device for External Pacemakers
ZHOU Feng, MA Xueran, ZHANG Zhengshu, DING Xiang
2023, 67(5): 72-76. doi: 10.12338/j.issn.2096-9015.2023.0128
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An external pacemaker is a medical device that treats arrhythmia and facilitates cardiac pacing through electrical stimulation. The precision of its key metrics is crucial to patient safety, necessitating regular calibration. Addressing this calibration need, we developed a calibration device for external pacemakers capable of calibrating parameters such as pulse amplitude, pulse width, pulse frequency, sensing sensitivity, and refractory period. This paper presents the working principles and the design methodology of both the software and hardware of the calibration device, and the testing of its key parameters. The results demonstrate that the technical characteristics of the calibration device fulfill the calibration requirements of external pacemakers. The device, compact, user-friendly, and highly accurate, resolves the pivotal issue of the absence of a dedicated calibration device for external pacemakers. It enhances the traceability system of measurement values and contributes to lowering the clinical risk associated with external pacemakers.