Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1

被引：387
作者：
Sarzotti-Kelsoe, Marcella [1 ,2 ]
Bailer, Robert T. [3 ]
Turk, Ellen [3 ]
Lin, Chen-li [3 ]
Bilska, Miroslawa [2 ]
Greene, Kelli M. [2 ]
Gao, Hongmei [2 ]
Todd, Christopher A. [2 ]
Ozaki, Daniel A. [2 ]
Seaman, Michael S. [4 ]
Mascola, John R. [3 ]
Montefiori, David C. [2 ]
机构：
[1] Duke Univ, Med Ctr, Dept Immunol, Durham, NC 27705 USA
[2] Duke Univ, Med Ctr, Dept Surg, Durham, NC 27705 USA
[3] NIH, Vaccine Res Ctr, Bethesda, MD 20892 USA
[4] Harvard Univ, Beth Israel Deaconess Med Ctr, Sch Med, Boston, MA 02215 USA
来源：
JOURNAL OF IMMUNOLOGICAL METHODS | 2014年 / 409卷
基金：
比尔及梅琳达.盖茨基金会;
关键词：
Neutralizing antibody; Assay validation; HIV; TZM-bl cells; GCLP; HUMAN-IMMUNODEFICIENCY-VIRUS; MONOCLONAL-ANTIBODIES; TYPE-1; INFECTION; EFFICACY; CELLS; PANEL; CCR5;
D O I：
10.1016/j.jim.2013.11.022
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
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 pre-clinical 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. (C) 2013 Elsevier B.V. All rights reserved.
引用
收藏
页码：131 / 146
页数：16
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