(1–3)-β-D-Glucan Assay: A Review of its Laboratory and Clinical Application

Abstract

A new fungal surrogate marker, (1–3)-β-D glucan, offers a noninvasive method for the potential surveillance and diagnosis of invasive fungal infections. Invasive fungal infections have long been associated with significantly high morbidity and mortality on hematology-oncology wards and recipients of either solid-organ or hematopoietic stem cell transplantation. The diagnoses of invasive fungal infections have historically been made difficult by the need for invasive methods. (1–3)-β-D-glucan testing requires a minimally invasive sample that can be used to aid in the diagnosis of an invasive fungal infection as well as monitor the response to treatment. One disadvantage of (1–3)-β-D-glucan testing is that a positive test alone lacks sufficient sensitivity and specificity for a definitive diagnosis. While formal guidelines for the use of (1–3)-β-D-glucan testing are lacking, this chromogenic assay provides a new opportunity for testing at-risk populations. A review and recommendation for its laboratory and clinical application are provided. * (1–3)-β-D-glucan: : A polysaccharide component of the cell wall of most fungi pyrogen test. An assay used to determine if a pharmaceutical or medical device intended for human use will stimulate fever. * HSCT : hematopoietic stem cell transplant SOT : solid organ transplantation FDA : Food & Drug Administration LAL : limulus amebocyte lysate USP : United States Pharmacopoeia SST : serum separator tube NPV : negative predictive value PPV : positive predictive value PCP : Pneumocystis jirovecii pneumonia IA : invasive Aspergillosis EORTC-IFICG : European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group