Antinuclear Antibody Screening: A Delicate Balance for Clinical Laboratories

In the article in this issue, “Quality monitoring approach for optimizing antinuclear antibody screening cutoffs and testing work flows,” Tacker and Perrotta address an issue faced by many laboratories—how to offer antinuclear antibody (ANA)3 testing that combines optimal clinical performance with realistic laboratory work flows (1). Specifically, Tacker and Perrotta evaluated an ANA enzyme immunoassay (EIA) as a way to decrease the number of manual immunofluorescence assays (IFAs) performed in their laboratory. Maintaining IFA testing is a significant challenge for many clinical laboratories (2, 3). It is usually a manual process with many steps that each have risk for error. In addition, the interpretation is subjective, relying on well-trained clinical technologists for accurate and consistent test results. For years, clinical laboratories have recognized the need for alternatives to IFA that are more automated and less subjective. These alternatives are available in the form of EIAs and multiplex immunoassays (MIAs). EIAs generally use a human epithelial type 2 (HEp-2) cell lysate as the capture antigen, which makes it fairly representative of the IFA method (4). The MIA is a bead-based method in which individual antigens are conjugated to different bead sets (5, 6). Collectively, these beads represent an …