Semi-quantification of HIV-1 protease inhibitor concentrations in clinical samples of HIV-infected patients using a gold nanoparticle-based immunochromatographic assay.

Abstract

Individual drug concentration data can be a valuable tool for the clinical management of antiretroviral therapy (ART) for the treatment of HIV infection. High performance liquid chromatography (HPLC) based assays are currently the gold standard for drug measurement but its high cost and requirement of technical expertise limits its widespread use. Simpler user-friendly and inexpensive detection assays are needed. A novel immunochromatographic (IC) strip test to detect HIV-1 protease inhibitors (PIs) was fabricated by combining the proteolysis activity of HIV-protease (PR) and an immunochromatographic reaction. The PIs-IC strip cut-off to detect lopinavir (LPV) concentrations was set at 1,000\u202fng\u202fmL-1. We evaluated this novel PIs-IC strip for the semi-quantification of HIV PIs in plasma samples collected from healthy subjects and HIV-infected patients receiving antiretroviral treatment with and without LPV. LPV plasma drug levels were quantified by HPLC and evaluated (blinded to the HPLC results) using the PIs-IC strip. Results of plasma samples tested using the PIs-IC strip were available within 5\u202fmin. Using the PIs-IC strip test the accuracy, specificity and sensitivity were 97.8%, 97.1%, and 100%, respectively, compare to the gold-standard assay, to detect LPV in human plasma samples. This novel PIs-IC strip test could be used as a simple tool for the rapid monitoring of PIs levels in HIV-infected patients, although further clinical evaluation is needed.