Evaluation of ELISA test for therapeutic monitoring of Nelfinavir in HIV-positive patients.

Therapeutic drug monitoring (TDM) is an important tool in the management of antiretroviral (ARV) therapy. The gold standard for measuring drugs plasma levels in High-Performance Liquid Chromotographic Assay (HPLC) however it is technically-demanding the time-consuming. We evaluated a new immunoendymatic test (TDM-ELISA, Biostrands, Trieste, Italy) for nelfinavir and its active metabolite M8 in comparison with HPLC. A statistically significant difference on Ctrough between the two different tests was demonstrated but this difference was non longer significant when a value of 29%due to M8 aliquot was deleted. This faster TDM-ELISA may have an important role for TDM in HIV patients taking ARVs.