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Background Recent advances in assay technology led to major improvements in how HIV-1 neutralizing antibodies are measured. A luciferase reporter gene assay performed in TZM-bl (JC53bl-13) cells has been optimized, and many performance parameters of this assay have been validated. Because this assay has been adopted by multiple laboratories world-wide, an external proficiency testing program was developed to qualify laboratories to perform a Good Clinical Laboratory Practice (GCLP) compliant neutralizing antibody assay for HIV/AIDS vaccine clinical trials.

P15-04. Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells