title: Evaluation of Elisa test for therapeutic monitoring of Nelfinavir in HIV-positive patients.
abstract: Therapeutic drug monitoring (TDM) is an important tool in the management of antiretroviral (ARV) therapy. The gold standard for measuring drugs plasma levels is High-Performance Liquid Chromatographic Assay (HPLC) however it is technically-demanding and time-consuming. We evaluated a new immunoenzymatic test (TDM-ELISA, Biostrands, Trieste, Italy) for nelfinavir and its active metabolite M8 in comparison with HPLC. A statistically significant difference in Ctrough between the two different tests was demonstrated but this difference was no 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.
authors.affiliation: Infectious Disease Department University of Pavia, Foundation IRCCS San Matteo Hospital, Pavia, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Uglietti
authors.forename: Francesca
authors.initials: F
authors.lastname: Genco
authors.forename: Elena
authors.initials: E
authors.lastname: Donadel
authors.forename: Serena
authors.initials: S
authors.lastname: Rinaldi
authors.forename: Erica
authors.initials: E
authors.lastname: Bastiani
authors.forename: Renato
authors.initials: R
authors.lastname: Maserati
authors.forename: Valeria
authors.initials: V
authors.lastname: Meroni
mesh_terms: D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D016903:Drug Monitoring; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D019888:Nelfinavir / Q000031:analogs & derivatives / Q000097:blood* / Q000493:pharmacokinetics; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity