Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1.
Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1.
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DOI：
10.1016/j.jim.2013.11.022
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发表时间：
2014-07
影响因子：
2.2
通讯作者：
Montefiori, David C.
中科院分区：
文献类型：
--
作者：
Sarzotti-Kelsoe, Marcella;Bailer, Robert T.;Turk, Ellen;Lin, Chen-li;Bilska, Miroslawa;Greene, Kelli M.;Gao, Hongmei;Todd, Christopher A.;Ozaki, Daniel A.;Seaman, Michael S.;Mascola, John R.;Montefiori, David C.
TZM-bl检测试剂盒可测量抗体介导的HIV-1中和作用，作为Env假型病毒单轮感染后HIV-1 Tat调节的萤火虫荧光素酶（Luc）报告基因表达降低的函数。该检测试剂盒已成为全球越来越多的实验室用于临床前和临床试验样品评估的主要终点中和检测试剂盒。在这里，我们提出的TZM-bl检测的正式优化和验证的结果，按照良好的临床实验室规范（GCLP）的指导方针进行。评价了该试验的专属性、准确度、精密度、检测限和定量限、线性、范围和耐用性。还对经验证的手动TZM-bl试验进行了调整、优化并确认为自动化384孔格式。
The TZM-bl assay measures antibody-mediated neutralization of HIV-1 as a function of reductions in HIV-1 Tat-regulated firefly luciferase (Luc) reporter gene expression after a single round of infection with Env-pseudotyped viruses. This assay has become the main endpoint neutralization assay used for the assessment of preclinical and clinical trial samples by a growing number of laboratories worldwide. Here we present the results of the formal optimization and validation of the TZM-bl assay, performed in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. The assay was evaluated for specificity, accuracy, precision, limits of detection and quantitation, linearity, range and robustness. The validated manual TZM-bl assay was also adapted, optimized and qualified to an automated 384-well format.
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DOI：
10.1093/infdis/jis367
发表时间：
2012-08-01
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
Montefiori DC;Karnasuta C;Huang Y;Ahmed H;Gilbert P;de Souza MS;McLinden R;Tovanabutra S;Laurence-Chenine A;Sanders-Buell E;Moody MA;Bonsignori M;Ochsenbauer C;Kappes J;Tang H;Greene K;Gao H;LaBranche CC;Andrews C;Polonis VR;Rerks-Ngarm S;Pitisuttithum P;Nitayaphan S;Kaewkungwal J;Self SG;Berman PW;Francis D;Sinangil F;Lee C;Tartaglia J;Robb ML;Haynes BF;Michael NL;Kim JH
通讯作者：
Kim JH
DOI：
10.1016/j.bbrc.2006.07.163
发表时间：
2006-09-29
影响因子：
3.1
作者：
Choudhry, Vidita;Zhang, Mei-Yun;Dimitrov, Dimiter S.
通讯作者：
Dimitrov, Dimiter S.
国际艾滋病毒中和试验比较网络：NeutNet 报告。
影响因子：
3.7
作者：
Fenyo, Eva Maria;Heath, Alan;Dispinseri, Stefania;Holmes, Harvey;Lusso, Paolo;Zolla-Pazner, Susan;Donners, Helen;Heyndrickx, Leo;Alcami, Jose;Bongertz, Vera;Jassoy, Christian;Malnati, Mauro;Montefiori, David;Moog, Christiane;Morris, Lynn;Osmanov, Saladin;Polonis, Victoria;Sattentau, Quentin;Schuitemaker, Hanneke;Sutthent, Ruengpung;Wrin, Terri;Scarlatti, Gabriella
通讯作者：
Scarlatti, Gabriella
影响因子：
3.7
作者：
Ozaki, Daniel A.;Gao, Hongmei;Sarzotti-Kelsoe, Marcella
通讯作者：
Sarzotti-Kelsoe, Marcella
影响因子：
3.7
作者：
Choudhry, Vidita;Zhang, Mei-Yun;Dimitrov, Dimiter S.
通讯作者：
Dimitrov, Dimiter S.