| Literature DB >> 24291345 |
Marcella Sarzotti-Kelsoe1, Robert T Bailer2, Ellen Turk2, Chen-li Lin2, Miroslawa Bilska3, Kelli M Greene3, Hongmei Gao3, Christopher A Todd3, Daniel A Ozaki3, Michael S Seaman4, John R Mascola2, David C Montefiori3.
Abstract
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.Entities:
Keywords: Assay validation; GCLP; HIV; Neutralizing antibody; TZM-bl cells
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Year: 2013 PMID： 24291345 PMCID： PMC4040342 DOI： 10.1016/j.jim.2013.11.022
Source DB: PubMed Journal: J Immunol Methods ISSN： 0022-1759 Impact factor: 2.303