European Multicenter Study on Analytical Performance of Veris HIV-1 Assay

摘要

Monitoring of viral load (VL) levels is an important part of treatment for patients living with human immunodeficiency virus (HIV). With HIV estimated to affect 37 million people worldwide, the number of patients receiving antiretroviral therapy (ART) and therefore requiring VL monitoring topped 17.0 million in 2015 (1). Current guidelines (including those from the World Health Organization [WHO], the Centers for Disease Control and Prevention [CDC], the U.S. Department of Health and Human Services [USDHHS], and the European AIDS Clinical Society [EACS]) recommend starting all HIV-infected people on ART regardless of VL status or immunologic CD4 level (2–5). The goal is to continually expand the numbers of people able to receive treatment by shifting more money to providing ART. Earlier treatment of patients combined with highly active antiretroviral therapy (HAART) has shown improved suppression of HIV viral loads over time and improved long-term survival (2–5). VL testing is recommended not only for monitoring antiviral suppression of VL but also as the preferred method for detection/confirmation of virologic failure, prediction of clinical progression, and identification of treatment adherence problems (3). Additionally, some antiretroviral medications require pretreatment viral load levels of 100,000 copies/ml in order to be used (3). For patients on treatment, “not detected” or “detected, not quantified” results are required, indicating both compliance with therapy and efficacy of the current regimen. Accurate, sensitive, reliable, and automated easy-to-use viral load monitoring is essential for patient management.