AIDS research and treatment
A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir
By Wei X, Youngpairoj AS, Haaland R and 6 others.
Abstract
Background
Second-generation HIV-1 integrase strand transfer inhibitors (INSTIs)-bictegravir (BIC), cabotegravir (CAB), and dolutegravir (DTG)-are leading components of highly potent antiretroviral therapy, and CAB is also used for long-acting chemoprevention. Rapid detection of clinically relevant INSTI concentrations could support point-of-care assessment and real-time clinical decision-making. We developed a lateral flow assay (LFA) that detects BIC, CAB, and DTG in whole blood and plasma and evaluated its performance against predefined concentration thresholds and high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Methods
A single LFA cassette design was developed using a monoclonal antibody to distinguish BIC, CAB, and DTG concentrations below trough, at minimal-to-moderate trough, and at ideal concentrations. LFA results were read visually at 20 min and were compared with LC-MS/MS-quantified INSTI concentrations for 124 clinical plasma specimens.



