Flow cytometry analysis of anti-polyethylene glycol antibodies in human plasma.
Flow cytometry analysis of anti-polyethylene glycol antibodies in human plasma.
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DOI：
10.1016/j.toxrep.2020.12.022
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发表时间：
2021
影响因子：
--
通讯作者：
Roffler SR
中科院分区：
文献类型：
--
作者：
Fang JL;Beland FA;Tang Y;Roffler SR
建立了一种快速、灵敏、特异的流式细胞术检测人血浆中抗PEG IgG和IgM的方法。用该方法对300例健康献血员的血浆标本进行了检测，结果抗PEG IgG或IgM阳性率为65%。使用三种验证试验确认了抗PEG IgG和IgM的存在。抗-IgG和抗-IgM的最高流行率在18-24岁的个体中。抗PEG IgG和IgM浓度之间无相关性。聚乙二醇（PEG）是一种生物相容性聚合物，用于生物治疗，以提高生物利用度，降低给药频率，并优化药代动力学。已在健康个体中检测到抗PEG抗体，其可能降低疗效并改变PEG化治疗剂的药代动力学;然而，抗PEG抗体的患病率尚不清楚。在这项研究中，流式细胞术测定进行了优化，以检测人血浆中的抗PEG IgG和IgM。筛选了来自健康献血者的300份血浆样本;在总人群的65.3%中检测到抗PEG IgG或IgM，其中21.3%具有抗PEG IgG，19.0%具有抗PEG IgM，25.0%具有抗PEG IgG和IgM。使用0.5%Tween-20干扰测定、20 kDa PEG化聚苯乙烯珠结合测定和来自人IgG和IgM纯化柱的纯化血浆的蛋白质印迹法确认抗PEG IgG和IgM的存在。阳性样本中抗PEG IgG和IgM的浓度范围分别为39 ng/mL-18.7 μg/mL和26 ng/mL-11.6 μg/mL。抗-IgG和抗-IgM的最高流行率在18-24岁的个体中。抗PEG IgG和IgM的患病率在女性中往往更高，但在种族之间没有差异。年龄、性别和种族与抗PEG IgG或IgM浓度无关。抗PEG IgG和IgM浓度之间无相关性。我们的研究表明，流式细胞术可用于检测人血浆中的抗PEG IgG和IgM抗体。
A rapid, sensitive, and specific flow cytometry assay was developed to detect anti-PEG IgG and IgM in human blood plasma. Using the method, anti-PEG IgG or IgM were detected in 65% of plasma samples from 300 healthy blood donors. The presence of anti-PEG IgG and IgM was confirmed using three validation assays. The highest prevalence of both anti-IgG and anti-IgM was in individuals 18–24 years of age. No correlation was found between anti-PEG IgG and IgM concentrations. Polyethylene glycol (PEG) is a biocompatible polymer used in biotherapeutics to increase bioavailability, reduce the frequency of administration, and optimize pharmacokinetics. Anti-PEG antibodies have been detected in healthy individuals and may decrease efficacy and alter the pharmacokinetics of PEGylated therapeutics; however, the prevalence of anti-PEG antibodies is unclear. In this study, a flow cytometry assay was optimized to detect anti-PEG IgG and IgM in human blood plasma. Three hundred (300) plasma samples from healthy blood donors were screened; anti-PEG IgG or IgM was detected in 65.3% of the total population, with 21.3% having anti-PEG IgG, 19.0% having anti-PEG IgM, and 25.0% having both anti-PEG IgG and IgM. The presence of anti-PEG IgG and IgM was confirmed using a 0.5% Tween-20 interference assay, a 20 kDa PEGylated polystyrene bead binding assay, and Western blotting of purified plasma from human IgG and IgM purification columns. The concentrations of anti-PEG IgG and IgM in positive samples ranged from 39 ng/mL to 18.7 μg/mL and 26 ng/mL to 11.6 μg/mL, respectively. The highest prevalence of both anti-IgG and anti-IgM was in individuals 18–24 years of age. The prevalence of anti-PEG IgG and IgM tended to be higher in women but did not differ among races. Age, sex, and race were not associated with the concentrations of anti-PEG IgG or IgM. No correlation was found between anti-PEG IgG and IgM concentrations. Our study indicates that flow cytometry can be used to detect anti-PEG IgG and IgM antibodies in human plasma.
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具有未验证抗体的蛋白质印迹不准确：需要蛋白质印迹最小的报告标准（WBMR）。
影响因子：
3.7
作者：
Gilda JE;Ghosh R;Cheah JX;West TM;Bodine SC;Gomes AV
通讯作者：
Gomes AV
影响因子：
168.9
作者：
Longo, Nicola;Harding, Cary O.;Burton, Barbara K.;Grange, Dorothy K.;Vockley, Jerry;Wasserstein, Melissa;Rice, Gregory M.;Dorenbaum, Alejandro;Neuenburg, Jutta K.;Musson, Donald G.;Gu, Zhonghua;Sile, Saba
通讯作者：
Sile, Saba
DOI：
10.1159/000233309
发表时间：
1983-01-01
期刊：
INTERNATIONAL ARCHIVES OF ALLERGY AND APPLIED IMMUNOLOGY
影响因子：
--
作者：
RICHTER, AW;AKERBLOM, E
通讯作者：
AKERBLOM, E
影响因子：
4.7
作者：
Su, Yu-Cheng;Chen, Bing-Mae;Roffler, Steve R.
通讯作者：
Roffler, Steve R.
影响因子：
--
作者：
Sundy, John S.;Ganson, Nancy J.;Hershfield, Michael S.
通讯作者：
Hershfield, Michael S.