Human vs Machine: A Systematic Review of Automated Bead-Based Multiplex Immunoassay Performance

Abstract

Autoimmune diseases are important contributors to morbidity and mortality in the United States. Researchers have identified more than 20 subtypes of antinuclear antibodies (ANAs), which are the hallmark of autoimmune diseases (1). Reliable, rapid ANA tests with acceptable sensitivity and specificity are in high demand for the timely diagnosis and treatment of autoimmune diseases (2,3). The gold standard for ANA detection is manual indirect immunofluorescence (IIF) with Hep-2 cells. This method is highly sensitive but has several flaws. It relies heavily on highly skilled morphologists which may lead to reader bias, and increased inter-laboratory variation (2,4). This study is a systematic review of the currently available multiplexed systems (i.e., Bioplex 2200, AtheNA Multi-Lyte ANA and FIDIS Connective 10) that might serve as alternative methods for detection of ANAs in the diagnosis of autoimmune diseases (5).