|
|
Research Advances and Prospect in Biometrology |
DONG Lian-hua,LIU Ya-hui,FU Bo-qiang,ZHANG Yu,DAI Xin-hua |
National Institute of Metrology, Beijing 100029, China |
|
|
Abstract 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.
|
Received: 04 January 2023
Published: 08 March 2023
|
|
Corresponding Authors:
lianhua dong
E-mail: lianhuadong@126.com
|
|
|
|
[13] |
王晶. 生物计量[EB/OL]//《中国大百科全书》第三版网络版. https: //www.zgbk.com/ecph/words?SiteID=1&ID=7477&Type=bkzyb&SubID=80144, 2022-01-20.
|
[60] |
刘瑛颖. 基于显微成像流式细胞技术的白细胞三类群分型和计数方法研究与不确定度评定[J]. 中国计量, 2021 (10): 92-95.
|
[9] |
Mcnutt M. Reproducibility[J]. Science, 2014, 343(6168): 229.
|
[45] |
张庆合, 杨吉双, 焦慧, 等. 基于质量平衡法的有机物纯度测量技术进展[J]. 化学试剂, 2020, 42(8): 931-939.
|
[10] |
Clayton J, ACollins F S. Policy: NIH to balance sex in cell and animal studies[J]. Nature, 2014, 509(7500): 282-283.
|
[44] |
李佳乐, 武利庆, 金有训, 等. 人血清白蛋白纯品含量的同位素稀释质谱方法研究[J]. 计量学报, 2016, 37(3): 328-332.
|
[61] |
刘瑛颖, 张玲, 杨乔斯. 尿沉渣白细胞计数标准物质的研制[J]. 计量学报, 2022, 43(3): 427-432.
|
[75] |
ISO 20391-1: 2018, Biotechnology-Cell counting-Part 1: General guidance on cell counting methods[S].
|
[2] |
Zhu F C, Li Y H, Guan X H, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial[J]. Lancet, 2020, 395(10240): 1845-1854.
|
[4] |
Barkal A A, Brewer R E, Markovic M, et al. CD24 signalling through macrophage Siglec-10 is a target for cancer immunotherapy[J]. Nature, 2019, 572(7769): 392-396.
|
[6] |
Di Pilato M, Kim E Y, Cadilha B L, et al. Targeting the CBM complex causes Treg cells to prime tumours for immune checkpoint therapy[J]. Nature, 2019, 570(7759): 112-116.
|
[12] |
Freedman L P, Cockburn I M, Simcoe T S. The economics of reproducibility in preclinical research[J]. PLoS Biol, 2015, 13(6): e1002165.
|
[74] |
马忠明, 杨波. 我国体外诊断试剂监管现状、面临的新形势及其思考[J]. 中国食品药品监管, 2022(6): 4-9.
|
[82] |
Dong L H, Zhou J B, Niu C Y, et al. Highly accurate and sensitive diagnostic detection of SARS-CoV-2 by digital PCR[J]. Talanta, 2021, 224: 121726.
|
[1] |
Gao Q, Bao L, Mao H, et al. Development of an inactivated vaccine candidate for SARS-CoV-2[J]. Science, 2020, 369(6499): 77-81.
|
[8] |
Baker M. Irreproducible biology research costs put at $28 billion per year[J]. Nature, 2015:533.
|
[11] |
Bradbury A, Plückthun A. Reproducibility: Standardize antibodies used in research[J]. Nature, 2015, 518(7537): 27-29.
|
[14] |
Oconnor G, Dawson C, Woolford A, et al. Quantitation of oligonucleotides by phosphodiesterase digestion followed by isotope dilution mass spectrometry: proof of concept[J]. Anal Chem, 2002, 74(15): 3670-3676.
|
[16] |
Camp C L, Sharp B L, Reid H J, et al. Analysis of mono-phosphate nucleotides as a potential method for quantification of DNA using high performance liquid chromatography-inductively coupled plasma-mass spectrometry[J]. Anal Bioanal Chem, 2012, 402(1): 367-372.
|
[18] |
Hwang H, Kim H, Myong S. Protein induced fluorescence enhancement as a single molecule assay with short distance sensitivity[J]. Proc Natl Acad Sci, 2011, 108(18): 7414-7418.
|
[41] |
武利庆. 什么是蛋白质计量[J]. 计量技术, 2018(9): 1-7.
|
[55] |
Neukammer J, Kammel M, Hckner J, et al. Reference procedure for the measurement of stem cell concentrations in apheresis products[J]. PTB Mitt, 2015, 125: 70-73.
|
[58] |
Shaw M, Zajiczek L, Oholleran K. High speed structured illumination microscopy in optically thick samples[J]. Methods, 2015, 88: 11-19.
|
[65] |
董莲华,孟盈,王晶,等. 质粒DNA定量检测用标准品的制备方法:CN201210541174.XA[P]. 2013-04-24.
|
[7] |
Begley C, Gellis L M. Raise standards for preclinical cancer research[J]. Nature, 2012, 483(7391): 531-533.
|
[17] |
Yoo H, Yang J, Nakamura Y, et al. Fluorescence dynamics of directly meso-meso linked porphyrin rings probed by single molecule spectroscopy[J]. J Am Chem Soc, 2009, 131(4): 1488-1494.
|
[21] |
Ou C Y, Vu T, Grunwald J T, et al. An ultrasensitive test for profiling circulating tumor DNA using integrated comprehensive droplet digital detection[J]. Lab Chip, 2019, 19(6): 993-1005.
|
[22] |
Corbisier P, Vincent S, Schimmel H, et al. CCQM-K86/P113. 1: relative quantification of genomic DNA fragments extracted from a biological tissue[J]. Metrologia, 2012, 49(1A): 08002.
|
[24] |
Dong L H, Sui Z W, Wang J, et al. Final report for CCQM-K86. b relative quantification of Bt63 in GM rice matrix sample[J]. Metrologia, 2018, 55(1A): 08017.
|
[26] |
Milavec M, Cleveland M H, Bae Y K, et al. Metrological framework to support accurate, reliable, and reproducible nucleic acid measurements[J]. Anal Bioanal Chem, 2021, 414(2): 791-806.
|
[27] |
Runov A, Vonsky M, Mikhelson V. DNA methylation level and telomere length as a basis for modeling of the biological aging clock[J]. Cell tissue biol, 2015, 9(4): 261-264.
|
[28] |
National Measurement Institutes demonstrate high accuracy reference measurement system for SARS-CoV-2 testing[EB]. https: //www.bipm.org/en/-/2020-nmi-covid, 2020-12-09.
|
[31] |
Dong L H, Wang S J, Fu B Q, et al. Evaluation of droplet digital PCR and next generation sequencing for characterizing DNA reference material for KRAS mutation detection[J]. Sci Rep, 2018, 8(1): 1-9.
|
[32] |
Dong L H, Wang X, Wang S J, et al. Interlaboratory assessment of droplet digital PCR for quantification of BRAF V600E mutation using a novel DNA reference material[J]. Talanta, 2020, 207: 120293.
|
[63] |
陈敏璠, 傅博强, 林婧, 等. 阴沟肠杆菌定量标准物质的研制[J]. 计量学报, 2017, 38(5): 527-531.
|
[71] |
Spreitzer E, Usluer S, Madl T. Probing surfaces in dynamic Protein interactions[J]. J Mol Biol, 2020, 432(9): 2949-2972.
|
[78] |
杨怡, 杨佳怡, 高运华, 等. DNA甲基化测量技术及准确性评估研究进展[J]. 计量学报, 2022, 43(11): 1524-1532.
|
[5] |
Vodnala S K, Eil R, Kishton R J, et al. T cell stemness and dysfunction in tumors are triggered by a common mechanism[J]. Science, 2019, 363(6434): eaau0135.
|
[15] |
Holden M J, Rabb S A, Tewari Y B, et al. Traceable phosphorus measurements by ICP-OES and HPLC for the quantitation of DNA[J]. Anal Chem, 2007, 79(4): 1536-1541.
|
[19] |
Dong L H, Meng Y, Wang J, et al. Evaluation of droplet digital PCR for characterizing plasmid reference material used for quantifying ammonia oxidizers and denitrifiers[J]. Anal Bioanal Chem, 2014, 406(6): 1701-1712.
|
[25] |
Mester Z, Corbisier P, Ellison S L, et al. Final report of CCQM-K86. c. Relative quantification of genomic DNA fragments extracted from a biological tissue[J]. Metrologia, 2020, 57(1A): 08004.
|
[29] |
Dong L H, Zang C, Wang J, et al. Lambda genomic DNA quantification using ultrasonic treatment followed by liquid chromatography-isotope dilution mass spectrometry[J]. Anal Bioanal Chem, 2012, 402(6): 2079-2088.
|
[34] |
Wenger A M, Peluso P, Rowell W J, et al. Accurate circular consensus long-read sequencing improves variant detection and assembly of a human genome[J]. Nat Biotechnol, 2019, 37(10): 1155-1162.
|
[35] |
Shumate A, Zimin A V, Sherman R M, et al. Assembly and annotation of an Ashkenazi human reference genome[J]. Genome Biol, 2020, 21(1): 1-18.
|
|
Li J L. Wu L Q, Jin Y X, et al. Determination of the mass fraction of pure human serum albumin by HPLC-IDMS[J]. Acta Metrologica Sinica, 2016, 37(3): 328-332.
|
[52] |
Mi W, Josephs R, Melanson J, et al. PAWG Pilot Study on Quantification of SARS-CoV-2 Monoclonal Antibody-Part 1[J]. Metrologia, 2021, 59(1A): 08001.
|
[59] |
Lü W X, Fu B Q, Li M L, et al. Determination of IC 50 values of anticancer drugs on cells by D2O-single cell Raman spectroscopy[J]. Chem Commun, 2022, 58(14): 2355-2358.
|
[69] |
Salit M, Woodcock J. MAQC and the era of genomic medicine[J]. Nat Biotechnol, 2021, 39(9): 1066-1067.
|
[76] |
Stewart N T, Byrne K M, Hosick H L, et al. Traditional and emerging methods for analyzing cell activity in cell culture [J]. Method Cell Sci, 2000, 22: 67-78.
|
[84] |
中国计量科学研究院. 中国计量院为移动方舱提供精准计量支撑[EB]. https: //www.nim.ac.cn/node/1685, 2020-09-21.
|
[3] |
Gillmore J D, Gane E, Taubel J, et al. CRISPR-Cas9 in vivo gene editing for transthyretin amyloidosis[J]. N Engl J Med, 2021, 385(6): 493-502.
|
[23] |
Devonshire A S, Sanders R, Whale A S, et al. An international comparability study on quantification of mRNA gene expression ratios: CCQM-P103. 1[J]. Biomol Detect Quantif, 2016, 8: 15-28.
|
[33] |
Zook J M, Chapman B, Wang J, et al. Integrating human sequence data sets provides a resource of benchmark SNP and indel genotype calls[J]. Nat Biotechnol, 2014, 32(3): 246-251.
|
[43] |
Li M, Josephs R D, Daireaux A, et al. Identification and accurate quantification of structurally related peptide impurities in synthetic human C-peptide by liquid chromatography-high resolution mass spectrometry[J]. Anal Bioanal Chem, 2018, 410(20): 5059-5070.
|
[50] |
Arabi M, Ostovan A, Zhang Z, et al. Label-free SERS detection of Raman-inactive protein biomarkers by Raman reporter indicator: toward ultrasensitivity and universality[J]. Biosens Bioelectron, 2021, 174: 112825.
|
|
Liu Y Y, Zhang L, Yang Q S. Development of reference material for white blood cell count in urine sediment[J]. Acta Metrologica Sinica, 2022, 43(3): 427-432.
|
|
Chen M F, Fu B Q, Lin J, et al. Development of quantitative reference material of Enterobacter cloacae[J]. Acta Metrologica Sinica, 2017, 38(5): 527-531.
|
[67] |
Wang J, Sun N, Lee Y-T, et al. A circulating tumor cell-based digital assay for the detection of EGFR T790M mutation in advanced non-small cell lung cancer[J]. J Mater Chem B, 2020, 8(26): 5636-5644.
|
|
Wang X X, Wu L Q, Yang B, et al. Review on research progress of protein activity metrology technology[J]. Current Biotechnology, 2020,10(6): 607-612.
|
|
Ma M Z, Yang B. Regulation of in vitro diagnostic reagents in China: current status, new trend and considerations[J]. China Food & Drug Administration Magazine, 2022(6): 4-9.
|
[79] |
Josephs R D, Martos G, Li M, et al. Establishment of measurement traceability for peptide and protein quantification through rigorous purity assessment—a review[J]. Metrologia, 2019, 56(4): 044006.
|
[83] |
王迪,王志栋,吴枭, 等. SARS-CoV-2基因组RNA标准物质的研制[J].计量学报,2021,42(2):259-264.
|
[20] |
Bhat S, Herrmann J, Armishaw P, et al. Single molecule detection in nanofluidic digital array enables accurate measurement of DNA copy number[J]. Anal Bioanal Chem, 2009, 394(2): 457-467.
|
[30] |
Gao Y H, Li H F, Li J X, et al. Quantitative Analysis of Fluorescent Dye-labeled DNA by High Resolution Inductively Coupled Plasma Mass Spectrometry[J]. Chem Res Chin Univ, 2010, 31(12): 2360-2365.
|
[40] |
光明日报-光明网. 中华家系1号基因组和转录组标准物质发布—基因测序可靠性有了计量支撑[EB]. https: //epaper.gmw.cn/gmrb/html/202208/27/nw.D110000gmrb_20220827_3-04.htm, 2022-08-27.
|
[48] |
陈琰, 胡志上, 米薇, 等. 电喷雾差分电迁移率分析技术在生物研究中的应用[J]. 分析试验室, 2019, 38(5): 632-636.
|
[57] |
Lin-Gibson S, Sarkar S, Ito Y. Defining quality attributes to enable measurement assurance for cell therapy products[J]. Cytotherapy, 2016, 18(10): 1241-1244.
|
|
Xue L, Sui Z W, Zhang L, et al. Preparation of Staphylococcus aureus reference material[J]. Food Science, 2015, 36(8): 44-48.
|
[73] |
林新文, 廖晓棠, 海乐,等. 体外诊断试剂生产质量管理要点研究[J]. 中国医学工程, 2022, 30(8): 58-62.
|
[80] |
Kessler A. Mass spectrometry-a key technique for traceability in clinical chemistry[J]. Trends Analyt Chem, 2016, 84: 74-79.
|
[36] |
WangY C, Olson N D, Deikus G, et al. High-coverage, long-read sequencing of Han Chinese trio reference samples[J]. Sci Data, 2019, 6(1): 1-5.
|
[37] |
Parikh H, Mohiyuddin M, Lam H Y, et al. svclassify: a method to establish benchmark structural variant calls[J]. BMC Genomics, 2016, 17(1): 1-16.
|
[38] |
Ren L Y, Duan X K, Dong L H, et al. Quartet DNA reference materials and datasets for comprehensively evaluating germline variants calling performance[J]. bioRxiv, 2022, https://doi.org/10.1101/2022.09.28.509844.
|
[39] |
Yu Y, Hou W W, Wang H Y, et al. Quartet RNA reference materials and ratio-based reference datasets for reliable transcriptomic profiling[J]. bioRxiv, 2022, https://doi.org/10.1101/2022.09.26.507265.
|
[42] |
Donnelly D P, Rawlins C M, Dehart C J, et al. Best practices and benchmarks for intact protein analysis for top-down mass spectrometry[J]. Nat Methods, 2019, 16(7): 587-594.
|
|
Zhang Q H, Yang J S, Jiao H, et al. Advancement in organic chemical purity measurement by mass balance method[J]. Chemical Reagents, 2020, 42(8): 931-939.
|
[46] |
Melanson J E, Thibeault M-P, Stocks B B, et al. Purity assignment for peptide certified reference materials by combining qNMR and LC-MS/MS amino acid analysis results: application to angiotensin II[J]. Anal Bioanal Chem, 2018, 410(26): 6719-6731.
|
[47] |
Li M, Tan J, Tarlov M J, et al. Absolute quantification method for protein concentration[J]. Anal Chem, 2014, 86(24): 12130-12137.
|
|
Chen Y, Hu Z S, Mi W, et al. The application of electrospray-differential mobility analysis in the field of biological research[J]. Chinese Journal of Analysis Laboratory, 2019(5): 632-636.
|
[49] |
Luo Y, Wu L Q, Yang, B, et al. A novel potential primary method for quantification of enantiomers by high performance liquid chromatography-circular dichroism[J]. Sci Reports, 2018, 8(1): 1-11.
|
[51] |
Mickert M J, Farka Z K, Kostiv U, et al. Measurement of sub-femtomolar concentrations of prostate-specific antigen through single-molecule counting with an upconversion-linked immunosorbent assay[J]. Anal Chem, 2019, 91(15): 9435-9441.
|
[54] |
Kammel M, Kummrow A, John M, et al. Flow cytometer for reference measurements of blood cell concentrations with low uncertainty[C]// 2015 IEEE International Symposium on Medical Measurements and Applications (MeMeA) Proceedings, Turin, Italy, 2015.
|
[56] |
Lin-Gibson S, Sarkar S, Elliott J, et al. Understanding and managing sources of variability in cell measurements[J]. Cell Gene Ther Insights, 2016, 2(6): 663-673.
|
[64] |
薛蕾, 隋志伟, 张玲, 等. 金黄色葡萄球菌标准物质的研制[J]. 食品科学, 2015, 36(8): 44-48.
|
[53] |
Stebbings R, Wang L, Sutherland J, et al. Quantification of cells with specific phenotypes I: Determination of CD4+ cell count per microliter in reconstituted lyophilized human PBMC prelabeled with anti-CD4 FITC antibody[J]. Cytometry A, 2015, 87(3): 244-253.
|
[62] |
Liu S Y, Wan Z Q, Wang M, et al. Evaluation of volume-based flow cytometry as a potential primary method for quantification of bacterial reference material[J]. Talanta, 2022, 255: 124197.
|
[70] |
Sequencing benchmarked[J]. Nat Biotechnol, 2021, 39: 1027.
|
[77] |
Deveson I W, Gong B, Lai K, et al. Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology[J]. Nat biotechnol, 2021, 39(9): 1115-1128.
|
[66] |
Niu C Y, Wang X, Gao Y H, et al. Accurate quantification of SARS-CoV-2 RNA by isotope dilution mass spectrometry and providing a correction of reverse transcription efficiency in droplet digital PCR[J]. Anal Bioanal Chem, 2022, 414(23): 6771-6777.
|
[68] |
Whale A S, Jones G M, Pavicˇ J, et al. Assessment of digital PCR as a primary reference measurement procedure to support advances in precision medicine[J]. Clin Chem, 2018, 64(9): 1296-1307.
|
[72] |
王仙霞, 武利庆, 杨彬, 等. 蛋白质活性计量技术研究进展[J]. 生物技术进展, 2020, 10(6): 607-612.
|
|
Lin X W, Liao X T, Hai L, et al. Key points of supervision on production of in vitro diagnostic reagents[J]. China Medical Engineering, 2022, 30(8): 58-62.
|
|
Yang Y, Yang J Y, Gao Y H, et al. Research progress of DNA methylation measurement technology and accuracy evaluation[J]. Acta Metrologica Sinica, 2022, 43(11): 1524-1532.
|
[81] |
Tae J Y, Lee H, Lee H, et al. Morphological stability, cellular viability and stem cell marker expression of threedimensional cultures of stem cells from bone marrow and periodontium[J]. Biomed Rep, 2021, 14(1): 1-6.
|
|
Wang D. Wang Z D, Wu X, et al. Development of reference material of SARS-CoV-2 Genomic RNA[J]. Acta Metrologica Sinica, 2021, 42(2):259-264.
|
|
|
|