CrAg lateral flow assay for cryptococcosis

Abstract

Importance of field: Cryptococcal meningitis is a leading cause of death globally among people with AIDS. In sub-Saharan Africa, cryptococcosis is estimated to kill more people than tuberculosis. Cryptococcosis is also an important infectious disease among immunosuppressed patients in countries with advanced medical care. Early diagnosis is the key to effective treatment, particularly in patients in resource-limited settings. A new lateral flow immunoassay (LFA) for cryptococcal antigen (CrAg) allows for rapid and inexpensive diagnosis of cryptococcosis at or near the point of patient contact. This article reviews the need for improved diagnostics for cryptococcal meningitis and describes the features of an ideal diagnostic. The design of a new LFA for CrAg is described as well as the results of initial clinical evaluation of the CrAg LFA. The CrAg LFA is recommended for use with serum, plasma or CSF for diagnosis of cryptococcal meningitis or non-meningeal cryptococcal disease in symptomatic patients. There is a need for further evaluation of LFA for screening of asymptomatic patients. However, the LFA is emerging as a valuable tool for screening of serum or plasma in ART-naive adults with CD4 counts less than 100 cells/mm(3) in geographic regions with a high prevalence of cryptococcal antigenemia. CrAg screening has the potential to identify patients with asymptomatic cryptococcal infection who should receive preemptive antifungal therapy.