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2023 Vol. 44, No. 3
Published: 2023-03-28
 
317 Research Advances and Prospect in Biometrology
DONG Lian-hua,LIU Ya-hui,FU Bo-qiang,ZHANG Yu,DAI Xin-hua
DOI: 10.3969/j.issn.1000-1158.2023.03.01
Biometrology is emerging field in metrology. It mainly focuses on the research of biological reference measurement procedures/methods, reference materials and measurement traceability. The purpose is to achieve the accuracy and consistency of the measured values and nominal properties of biological materials in the national and international scope, and to ensure that the measurement results can be traced to the International System of Units (SI), legal measurement units or internationally recognized units.The research progress and challenges of biometrology are summarized, and countermeasures and suggestions are put forward in order to provide reference for the development of biometrology.
2023 Vol. 44 (3): 317-325 [Abstract] ( 252 ) HTML (1 KB)  PDF (560 KB)  ( 659 )
326 Study on Samples Pretreatment Technology Based on Immunomagnetic Separation for Rapid Detection of Shigella in Food
LI Jing-wen,CHEN Er-ning,KANG Fu-ying,HONG Tian,FU Ying-hui,DU Mei-hong
DOI: 10.3969/j.issn.1000-1158.2023.03.02
Anti-Shigella multi-target immunomagnetic beads were prepared by using Protein A magnetic beads and anti-Shigella mixed serum, and a 25mL immunomagnetic separation system for Shigella was established. Combined with determining the growth curve of Shigella bacteria in representative foods (milk, fruit, bread), a feasible strategy for the pretreatment of food samples was designed, which was integrated with the LAMP technology to conduct rapid detection of Shigella in food. The results showed that the multi-target immunomagnetic beads could simultaneously capture four Shigella species, including flexneri, sonnei, Bowman, and dysentery, with a capture efficiency of 35%~94% and a non-specificity of less than 1% (except for Staphylococcus aureus 10%). Above 102CFU/mL of target Shigella could be obtained when 1~2×101CFU Shigella in 25mL milk/in 25g bear/bread +25mL Shigella enrichent broth base by culturing for 6h following the operation of immunomagnetic separation, the time of samples pretreatment for Shigella detection is shortened from 48h to within 8h, which can meet the requirements of the detection limit of technologies subsequently used to realize the rapid detection of Shigella in food.
2023 Vol. 44 (3): 326-333 [Abstract] ( 164 ) HTML (1 KB)  PDF (2799 KB)  ( 59 )
334 Development of Certified Reference Materials for Evaluation on Protection Performance of Biological Safety Cabinet
WANG Zi-quan,LIU Si-yuan,ZHEN Xiao-xiao,HUNAG Wen-feng,ZHANG Ling,XU Qian,SUI Zhi-wei
DOI: 10.3969/j.issn.1000-1158.2023.03.03
The protection performance of biosafety cabinet not only affects the accuracy and reliability of experimental results, but also relates to the personal safety of laboratory personnel, therefore its protection performance needs to be evaluated and calibrated in time. Bacillus subtilis (B. subtilis) is an indicator of performance evaluation specified in the domestic and international standards of biosafety cabinet, thus development of B. subtilis reference material is necessary. Three reference materials were prepared by freeze-drying B. subtilis spores in the presence of a composite cryoprotectant. The result indicated that the reference materials of B. subtilis spores count bearing excellent homogeneity and could be stored stably for twenty-four months at 4℃. The certified values of three different concentrations of certified reference materials were (5.4±1.3)×108CFU/mL, (5.2±1.3)×106CFU/mL, (5.3±1.4)×104CFU/mL, respectively. The reference materials of B. subtilis spores count could mainly be used to evaluate the staff, product, and cross-contamination protection of the biosafety cabinet.
2023 Vol. 44 (3): 334-340 [Abstract] ( 170 ) HTML (1 KB)  PDF (1585 KB)  ( 85 )
341 Cell Growth and Drug Effect Differences Induced by Inoculum Number Variations and Comparison of Cell Counting Methods
XUE Zhi-chao,ZENG Jia-ming,LI Yong-shu,ZHAO Jia-wei,ZHAO Yang,DAI Xin-hua,GONG Xiao-yun
DOI: 10.3969/j.issn.1000-1158.2023.03.04
Hela cells were used to investigate the changes in cell growth rate and the influence of drug effect induced by the cell number differences at the cell seeding step. The experimental results indicated that the larger the initial number of cells, the higher the density after adhesion, the faster the growth rate, and the lower the inhibitory effect of drugs on its growth. Therefore, the accuracy and efficiency of cell counting are of great importance for in vitro studies. Three commonly used cell counting methods were compared including the cell counting plate method, the cell counting apparatus method, and the flow cytometry method. Their linear regression R2 were 0.9835, 0.9997, and 0.9960 respectively. Under the same condition, the cell counting apparatus method held the highest accuracy. In addition, indirect methods such as crystal violet staining, basal area photography, protein content estimation, and protein reference GAPDH measurement were also evaluated in to provide data reference for cell number measuring in biological experiments.
2023 Vol. 44 (3): 341-349 [Abstract] ( 107 ) HTML (1 KB)  PDF (3942 KB)  ( 358 )
350 Study on Measurement Method of Rhodobacter Sphaeroides Based on Plate Counting
LI Long-quan,WANG Zi-quan,LIU Si-yuan,ZHOU Guo-ping,SUI Zhi-wei,ZHANG Ling,ZHEN Xiao-xiao,HUANG Wen-feng,XU Qian
DOI: 10.3969/j.issn.1000-1158.2023.03.05
Rhodobacter sphaeroides is one of the main microorganisms producing coenzyme Q10. The quantitation detection is of great significance for optimizing the fermentation conditions of Rhodobacter sphaeroides. In this study, the plate counting method of Rhodobacter sphaeroides was optimized by comparing the inoculation method, the inoculation volume, the type of culture medium, and the culture temperature. Additionally, the optimized method was validated by collaborative experiments and uncertainty was analyzed. The final optimization result of the plate counting method is: the inoculation method is coating method, the inoculation amount is 50μL, the culture medium is Nutrient Agar, and the culture temperature is 32℃. The optimized method possessed a good repeatability and reproducibility, of which the RSD of within-laboratory repeatability is 6.0%, and inter-laboratory RSD is 16.4%. With relative expanded uncertainty of 9.2% (k=2), the optimized method could play an important role in the quantitation of Rhodobacter sphaeroides.
2023 Vol. 44 (3): 350-355 [Abstract] ( 194 ) HTML (1 KB)  PDF (763 KB)  ( 60 )
356 Performance Verification and Application of Bioaerosol Monitor by Fluorescence Method
TIAN Ying,ZHANG Guo-cheng,PAN Yi-ting,WU Dan,LIU Jia-qi,SHEN Shang-yi,LI Jing-jing
DOI: 10.3969/j.issn.1000-1158.2023.03.06
The total particle counting efficiency and fluorescence particle counting efficiency were evaluated by the fluorescence bioaerosol monitor, and verified by a variety of microbial aerosols in laboratory and practical application scenarios. By comparing the values of two traditional off-line detection methods, colony counting method and microscope observation method, it was found that the real-time bioaerosol monitoring technology has a good agreement with the traditional detection methods. At the same time, the bioaerosol monitor was used to monitor biological particles in different application scenarios, and the reliability of the detection results was verified.
2023 Vol. 44 (3): 356-360 [Abstract] ( 133 ) HTML (1 KB)  PDF (1790 KB)  ( 62 )
361 Preparation and Characterization of a Simulated Cell Free DNA Positive Quality Control Material
FANG Yan,WANG Xia,DONG Lian-hua,YANG Jing-ya
DOI: 10.3969/j.issn.1000-1158.2023.03.07
By optimizing a new type of enzymatic hydrolysis system with unknown mechanism (reaction system, RS), which directly acts on tumor cell lines SW1573,SNU-C2B and NCI-H1975, with KRAS G12C,KRAS G12D,EGFR L858R and EGFR T790M mutations, by optimizing the action time and cell number of RS system, a kind of positive quality control substance which can highly mimic human plasma free DNA (cfDNA) can be prepared by cleavage of cell genomic DNA. The length of simulated cfDNA fragments detected by chip electrophoresis is (166±16)BP, which is the same as that of normal human plasma cfDNA. Microdrop digital PCR detection show that the cfDNA fragments prepared by RS and gDNA have the same mutation abundance at the target mutation site. The results show that the DNA fragment prepared by RS system can be used as a positive quality control substance of cfDNA.
2023 Vol. 44 (3): 361-367 [Abstract] ( 144 ) HTML (1 KB)  PDF (3512 KB)  ( 169 )
368 Research on Digital PCR Reference Measurement Method of PIK3CA Gene Mutation
WANG Lei-lei,WANG Xia,XING De-chun,DONG Lian-hua,YANG Jing-ya
DOI: 10.3969/j.issn.1000-1158.2023.03.08
PIK3CA mutation detection is an important predictor for realizing individualized treatment of tumors. Therefore, using PIK3CA as the target gene, three hotspot mutations, E542K, E545K, and H1047R, were selected to establish a droplet digital polymerase chain reaction (ddPCR) method for accurate and quantitative detection. The annealing temperature, primer probe concentration and other conditions were optimized, and the specificity, linear range and repeatability of the method were investigated. The results show that the established ddPCR detection method has good precision, the relative standard deviation value is between 0.392%~14.031% in the abundance range of 0.05%~82.75%, and the accuracy is high. The correlation coefficient with gravimetric method reach 99.91%, 99.98%, 99.94%, when the mutation abundance is above 0.2%, the repeatability of the method can reach within 5%, and when the mutation abundance is below 0.2%, the repeatability remains below 15%. The limit of blank of the three hot spot mutations in the 20μL reaction system are 0.03%, 0.04%, 0.04%, and the lower limit of detection and lower limit of quantification are both 0.05%. Therefore, the ddPCR reference measurement of PIK3CA gene E542K, E545K and H1047R mutations has high sensitivity and good repeatability, and has good applications in cancer diagnosis, individualized medication guidance and prognosis.
2023 Vol. 44 (3): 368-376 [Abstract] ( 154 ) HTML (1 KB)  PDF (2866 KB)  ( 262 )
377 Quality Evaluation of Three KRAS Gene Mutation Detection Kits
DONG Lian-hua,WANG Shang-jun,ZHANG Yu-jing,WANG Jing
DOI: 10.3969/j.issn.1000-1158.2023.03.09
In order to understand the quality of the human KRAS gene mutation detection kit, and to guide the selection and use of the kit, three kits commonly available on the market (random numbered A, B and C) were used for quality evaluation. The accuracy, specificity, detection limit and repeatability of the kits were evaluated using standard materials. The positive rate of the seven mutants was 100%, which indicated the accuracy of the kits was good. The specific verification results of the three laboratories showed that the three kits could not meet the negative coincidence rate of 100% mutants, that is, each kit had a false positive result, and the number of mutants with a negative coincidence rate of 100%: 6 for kit A, 6 for kit B, and 3 for kit C. The results of the detection limit showed that the actual detection limits of the seven mutants were not exactly the same as the identified detection limits (1%). And the number of mutants in the three laboratories that were consistent and consistent with the detection limit: 0 for kit A, 3 for kit B, and 5 for kit C. The low level repeatability of all the kits were good (<5%).
2023 Vol. 44 (3): 377-383 [Abstract] ( 124 ) HTML (1 KB)  PDF (527 KB)  ( 67 )
384 The Research of Quantification for HPV16 and HPV18 Pseudovirus Nucleic Acid Reference Materials
LI Hui-jie,CHEN Gui-fang,DONG Lian-hua,YANG Jia-yi,YANG Jing-ya
DOI: 10.3969/j.issn.1000-1158.2023.03.10
Using pseudoviruses containing HPV16 and HPV18 L1 gene sequences as candidate materials, the copy number concentration of L1 gene was detected by digital PCR quantitative method, and the homogeneity and stability of the reference materials were verified. HPV16 and HPV18 pseudovirus nucleic acid reference materials (NIM-RM5213 and NIM-RM5214) were developed. The standard value of copy number and expanded uncertainty (k=2) of the two reference materials are (1.52±0.13) ×103copies/μL, (1.29±0.12) ×103copies/μL。 The calibration results of the two reference materials were verified by multiple testing platforms, and the relative standard deviation of the calibration results was within 5%. The mentioned standard material can provide reference for the quality control of the whole process of HPV detection, help to improve the accuracy and effectiveness of HPV nucleic acid detection process, and has broad application prospects.
2023 Vol. 44 (3): 384-391 [Abstract] ( 150 ) HTML (1 KB)  PDF (1154 KB)  ( 99 )
392 Research of Quantification for IHHNV Pseudovirus Nucleic Acid Reference Materials
DOI: 10.3969/j.issn.1000-1158.2023.03.11
Infectious hypodermal and haematopoietic necrosis virus (IHHNV) infection caused acute infectious diseases, especially to juvenile shrimp. According to the IHHNV gene sequence (AF218266.2) accepted by GenBank, pseudoviruses containing the whole genome sequence of IHHNV have been produced. Referring to GB/T 25878-2010 guidance on IHHNV PCR test, ORF1 gene was aimed to design special primers and probes, digital PCR detection method for IHHNV was established. Then digital PCR method was employed to verify the uniformity and stability of the reference material. The reference values with expanded uncertainty was (1.22±0.15)×103copies/μL (k=2). Multiple dPCR platforms were recruited to validate the values of the reference materials, and the relative standard deviations value was less than 4%, showing good reproducibility. Commercial IHHNV nucleic acid detection kit was used to detect the reference materials, the results were in good agreement with the reference values.
2023 Vol. 44 (3): 392-400 [Abstract] ( 137 ) HTML (1 KB)  PDF (2281 KB)  ( 87 )
401 The Research of Quantification for HPV16 and HPV18(E6/E7) RNA Pseudovirus Nucleic Acid Reference Materials
LI Hui-jie,CHEN Gui-fang,GAO Yun-hua,YANG Jia-yi,DONG Lian-hua
DOI: 10.3969/j.issn.1000-1158.2023.03.12
Pseudoviruses containing E6/E7 RNA sequences of HPV16 and HPV18 were selected as reference materials. One-step reverse transcription digital PCR method was used to quantify content of E6/E7 RNA. HPV16 and HPV18 (E6/E7) RNA pseudoviruses were prepared and certificated (NIM-RM5231 and NIM-RM5232), which showed good uniformity and stability. The reference values with expanded uncertainty of the two reference materials were: (9.7±1.8)×102copies/μL, (5.9±1.1)×102copies/μL. The values were verified by multiple laboratories, and the relative standard deviations of the determination results were all less than 10%. The reference materials can provide reference for the quality control of the related detection of high-risk HPV E6/E7 RNA.
2023 Vol. 44 (3): 401-409 [Abstract] ( 187 ) HTML (1 KB)  PDF (2370 KB)  ( 82 )
410 Purity Analysis of Oligonucleotides Based on Capillary Gel Electrophoresis
WANG Le-le,ZHANG Xiao-xia,LIU Gang
DOI: 10.3969/j.issn.1000-1158.2023.03.13
During the chemical synthesis of oligonucleotides, the key technical challenge at present is that the full-length sequence is generated with single (n-1) and double (n-2) deletions as the major impurities. Due to the only subtle difference between the molecular mass and charge properties of impurities and the full-length sequence, it is difficult to accurately quantify the purity of oligonucleotides. With the advantages of small sample amount, fast speed, high sensitivity, separation effective, and high degree automatization, capillary gel electrophoresis is widely used in the separation and analysis of nucleic acids. Capillary gel electrophoresis was used to analyze the purity of oligonucleotides, which can effectively separate the full-length sequence of oligonucleotides and n-1 impurities. The linearity is good in the concentration range of 0.03 mg/L to 1.00mg/L (R2=0.9988), and the detection limit is about 0.01mg/L (S/N>3).The establishment of the aboved method will provide strong technical support for the purity analysis and quality control of oligonucleotides.
2023 Vol. 44 (3): 410-414 [Abstract] ( 162 ) HTML (1 KB)  PDF (1619 KB)  ( 36 )
415 Development of Digital PCR Absolute Quantification Method for Herbicide-tolerant Genetically Modified Soybean SHZD32-1
ZHENG Zi-fan,WANG Hao-qian,GAO Jia-qi,CHEN Shuo,LIU Fang-fang,ZHANG Xiu-jie,LI Liang
DOI: 10.3969/j.issn.1000-1158.2023.03.14
Based on the digital PCR technology for absolute quantification of DNA single molecule, a droplet digital PCR (ddPCR) dual (transformant-specific gene and soybean internal standard gene) quantitative method for the transformant was established. The main contents include:optimize the double ddPCR primer-probe concentration and annealing temperature, examine the specificity, determine the linear kinetic range and critical parameters such as the limit of detection (3copies/μL) and the limit of quantification (15copies/μL). The genetically modified soybean SHZD32-1 has obtained the production and application safety certificate "Nongjianzhengzi (2019)" No. 293. Its ddPCR quantitative detection method, as an absolute quantitative measurement method, is simple, efficient and accurate, and will provide technical support for the calibration of reference materials, quantitative detection and standardization of the establishment of digital PCR methods in the field of biosafety.
2023 Vol. 44 (3): 415-421 [Abstract] ( 115 ) HTML (1 KB)  PDF (3463 KB)  ( 77 )
422 Construction and Application of Plasmid Reference Molecule pUC57-Papaya for Genetic Modified Papaya
PAN Zhi-wen,CHEN Wei-ting,YAO Juan,WANG Sheng-bin,JIANG Da-gang
DOI: 10.3969/j.issn.1000-1158.2023.03.15
A plasmid pUC57-Papaya including two papaya endogenous reference genes, four screening targets and three event-specific fragments was constructed. After sequencing verification, the applicability of the plasmid reference molecule was tested. The commutability was analyzed by ordinary PCR and real-time fluorescence quantitative PCR. Then the plasmid molecule was used to determine the transgenic contents of 2 samples. The sequencing result showed that all 9 target fragments of the plasmid molecule were arranged according to the design, and the sequence was completely consistent. The ordinary PCR and real-time fluorescence quantitative PCR results showed that the plasmid molecule could correctly amplify and obtain the expected results, which were consistent with genomic DNA. There was no significant difference with the slopes of standard curves constructed by the plasmid molecule and genomic DNA for quantitative tests, and the linear correlation coefficients were greater than 0.99. There was no difference in the intercept of Papain, NOS terminator, YK1601 and 55-1 event specific fragment. The copy numbers of Papain, NOS terminator, YK1601 and 55-1 event-specific fragments and the transgenic contents of two samples were measured by plasmid molecule, the results were consistent with genomic DNA. The sequencing result showed that the ratios of the copy number of each exogenous gene fragments to the copy number of the endogenous reference gene fragments were 1. The plasmid DNA copy number concentration was (2.54±0.10)×106copies/μL. The above results suggested that the constructed standard plasmid molecule could be used as a reference material for qualitative and quantitative detection of transgenic papaya.
2023 Vol. 44 (3): 422-429 [Abstract] ( 110 ) HTML (1 KB)  PDF (3056 KB)  ( 30 )
430 Establishment of Quantitative PCR Methods for the Detection of Genetically Modified Maize MZIR098
WEN Hong-tao,YANG Yang,DING Yi-jia,GUAN Hai-tao,YUAN Ran,ZHANG Rui-ying,LI Ling-yan,LIANG Jin-Gang,WANG Jing
DOI: 10.3969/j.issn.1000-1158.2023.03.16
Primers and probes were designed based on the 5′flanking sequence information of transgenic insect resistant and herbicide tolerant maize MZIR098. Subsequently, a double quantitative assay for the transformant specificity of maize MZIR098 was established through qPCR and 3D-dPCR platforms. After testing, it was found that the repeatability (relative standard deviation) of the two detection methods, qPCR and 3D-dPCR, was less than 25%, which met the relevant standards of transgenic detection methods, and there was no significant difference between the detection limit and the quantification limit. The above results showed that the two methods can meet the basic needs of quantitative detection of transgenic plants, and can provide a new reference method for accurate and efficient detection of maize MZIR098 and its products in the future.
2023 Vol. 44 (3): 430-439 [Abstract] ( 140 ) HTML (1 KB)  PDF (2991 KB)  ( 48 )
440 The Reference Materials System of Forensic Science STR Typing
MO Xiao-ting,MA Wen-hua,ZHANG Jian,ZHAO Xing-chun
DOI: 10.3969/j.issn.1000-1158.2023.03.17
Strengthening the development and application of related certified reference material is of great significance for the establishment of the standard system for DNA analysis in forensic science. At present, new methods for STR typing are constantly emerging and rapidly applied to help in criminal case investigations. The validity and accuracy of existing methods are being challenged. DNA STR typing test is the main basis for individual identification and genetic identification in forensic science now, and the applicable DNA certified reference materials are the standards, enabling the realization of source sharing, as well as accuracy and comparison of DNA STR typing among laboratories. Here, STR typing technology, the standard substances and reference material used in the STR typing process are summarized, and suggestions and prospects for the construction of the standard material system for STR typing in the forensic science are put forward.
2023 Vol. 44 (3): 440-446 [Abstract] ( 135 ) HTML (1 KB)  PDF (803 KB)  ( 39 )
447 Current Progress on Clinical Application and Quantitative Methods of Insulin-like Growth Factor-1
ZHAO Xu,JIN You-xun,WANG Xian-xia,WU Li-qing,LIU Ya-hui
DOI: 10.3969/j.issn.1000-1158.2023.03.18
Insulin-like growth factor-1 (IGF-1) is a peptide hormone composed of 70 amino acids. Clinical studies have found that IGF-1 was closely related to endocrine diseases, cardio-cerebrovascular diseases, cancer tumors, diseases related to brain and nervous system, skin diseases, liver diseases and other diseases. IGF-1 was also found to play an important role in research of COVID-19. Therefore, the changes of serum IGF-1 content can be accurately detected as one of the auxiliary diagnostic indicators of related diseases. At present, the clinical detection methods for IGF-1 mainly include immunological analysis methods based on antigen-antibody specific binding and analysis methods based on mass spectrometry. These methods have different detection characteristics and different measurement accuracy. The relevant research progress of IGF-1 is reviewed, the functional role of IGF-1 in clinical detection and application are summarized, and the characteristics and application scenarios of its detection methods are discussed, the suggestions for further improving the detection ability of IGF-1 are also put forward.
2023 Vol. 44 (3): 447-456 [Abstract] ( 157 ) HTML (1 KB)  PDF (598 KB)  ( 74 )
457 Research Status and Trend of MicrobialReference Materials in Dairy Products
LIU Si-yuan,BAI Zhao-ying,WANG Zi-quan,WANG Meng,LU Lin,LI Hao1,WANG Cheng-long,CHANG Hai-yan,ZHOU Guo-ping,ZHANG Wei,SUI Zhi-wei
DOI: 10.3969/j.issn.1000-1158.2023.03.19
Microbial reference materials (RMs) in dairy products are important tool for developing microbiological measurement techniques, establishing microbial detection standards, and improving the quality supervision system of milk and dairy products, which have broad application prospects. The main characteristics of the microbial RMs, and the main preparation technology that could help with the microbial activity, as well as the measurement techniques of the quantity value and nominal property are introduced. Furthermore, an overview on the development and application of the microbial RMs in dairy products are given. Based on the analysis of the main problems existing in this field, the demand and trend of the RMs are prospected, which can provide more meaningful reference for the subsequent research of microbial RMs.
2023 Vol. 44 (3): 457-463 [Abstract] ( 140 ) HTML (1 KB)  PDF (658 KB)  ( 119 )
464 Development Progress of Nucleic Acid Reference Materials for Foodborne Pathogenic Microorganisms
CHEN Tian-qi,QI Xin,WANG Min,LI Kai,FAN Li,LI Liang
DOI: 10.3969/j.issn.1000-1158.2023.03.20
In order to ensure food safety, microbiological inspection for food hygiene must be attached importance. As the most commonly used microbial detection target, nucleic acid molecules require reference materials to realize traceability and provide a measurement basis. Nucleic acid reference materials are the sample standard to ensure the accuracy and consistency of nucleic acid test results. Here, the development of nucleic acid reference materials of several common foodborne pathogenic microorganisms were reviewed, in order to promote their application in food safety testing, and provide reference for improving the quality control level of microbial test results, ensuring the accuracy and impartiality of test results, and promoting the development of nucleic acid reference materials.
2023 Vol. 44 (3): 464-471 [Abstract] ( 147 ) HTML (1 KB)  PDF (615 KB)  ( 109 )
472 Application of Digital PCR in Development of Food Detection Reference Materials
FAN Hong-bo,CAI Yong-hong,LI Yue-yue,HUANG Man-ying,ZHANG Li-ling,MA Ting-ting,HU Song-qing,HU Liang-yong
DOI: 10.3969/j.issn.1000-1158.2023.03.21
Food detection reference material is a measuring instrument to ensure traceability, mutual recognition and accuracy of food detection value, and its development needs accurate determination methods. Digital PCR is a sensitive, accurate and matrix-resistant method for absolute quantification of nucleic acid, which is widely applied in many fields such as medical diagnosis, genetically modified organism detection and animal disease detection. Digital PCR method and its research progress in the detection of genetically modified foods, animal and plant origin analysis and the development of food-borne pathogenic bacteria detection reference materials is reviewed to provide reference for the development of food detection nucleic acid reference materials.
2023 Vol. 44 (3): 472-478 [Abstract] ( 167 ) HTML (1 KB)  PDF (1289 KB)  ( 459 )
479 The Progress and Future of Human Hemoglobin A1c Certified Reference Materials
LI Jing-jing,ZHAO Hai-bo,LIANG Liang,FAN Pei-lei,ZHAO Yu-jia,WU Li-qing,ZHAI Rui
DOI: 10.3969/j.issn.1000-1158.2023.03.22
As the basis of traceability of measurement, Glycated hemoglobin A1c, (HbA1c) reference material is the direct carrier of value traceability and transfer, which plays an essential role in the quality assurance of clinical test results.It is significant to establish a reference measurement system and the satandardization of clinical tests for HbA1c in China. The preparation process, determination method, reporting units and uncertainty of human HbA1c reference materials at domestic and abroad are briefly reviewed, it can provide reference for the promotion of HbA1c standardization in China. We briefly review the preparation process, determination method, reporting units and uncertainty of human HbA1c reference materials at domestic and abroad for the efficient development of the standardization of HbA1c in China. Through a brief review of the preparation process, calibration method, reporting unit and uncertainty of domestic and foreign reference materials for human HbA1c, it provides reference for the promotion of HbA1c standardization in China.
2023 Vol. 44 (3): 479-487 [Abstract] ( 207 ) HTML (1 KB)  PDF (849 KB)  ( 96 )
488 Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
YANG Jia-yi,NIU Chun-yan,GAO Yun-hua,DONG Lian-hua
DOI: 10.3969/j.issn.1000-1158.2023.03.23
Nucleic acid measurement has been widely used in biosafety, medical health, food safety, environmental monitoring and other fields. Thus, the accuracy and reliability of nucleic acid measurement is crucial. Nucleic acid metrology is a subject about nucleic acid measurement and its application. It is a biometric branch that studies the unity of nucleic acid measurement units and accurate and reliable quantity values. The work done by the Nuclear Acid Analysis Working Group (NAWG) of the Consultative Committee for Amount of Substance Metrology in Chemistry and Biology (CCQM) in improving the accuracy, reliability and comparability of nucleic acid analysis and measurement results is summarized. The NAWG is an international group dedicated to improving the global comparability of nucleic acid measurements; its primary focus is to support the development and maintenance of measurement capabilities. For nearly two decades, NAWG members have conducted a series of research efforts that support reliable, consistent and traceable nucleic acid measurements in various fields.
2023 Vol. 44 (3): 488-494 [Abstract] ( 172 ) HTML (1 KB)  PDF (647 KB)  ( 56 )
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