Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1.
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.
Duke Scholars
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Related Subject Headings
- Transfection
- Time Factors
- Reproducibility of Results
- Quality Control
- Predictive Value of Tests
- Practice Guidelines as Topic
- Observer Variation
- Neutralization Tests
- Limit of Detection
- Immunology
Citation
Published In
DOI
EISSN
Publication Date
Volume
Start / End Page
Location
Related Subject Headings
- Transfection
- Time Factors
- Reproducibility of Results
- Quality Control
- Predictive Value of Tests
- Practice Guidelines as Topic
- Observer Variation
- Neutralization Tests
- Limit of Detection
- Immunology