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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.