Testing Recommendations Expand as Zika Season Approaches

As warm weather sets in across the southern portion of the United States, public health officials are planning for the 2017 Zika season. This mosquito year experts have a better knowledge about the infection and its natural history, revised testing and laboratory guidance, and more available diagnostics. DTET conducted a comprehensive review of 2016 testing volumes, current clinical testing recommendations, remaining assay development challenges, and expectations for the upcoming season. Zika Testing Volumes There are no commercially available diagnostic tests cleared by U.S. Food and Drug Administration (FDA) for the detecting Zika virus. However, the FDA is working with Zika virus diagnostic developers to accelerate assay development programs. Over the past year there has been a significant increase in the number of Zika diagnostic products the FDA currently allows use of under emergency use authorization (EUA). Given the serious consequences of Zika, particularly during pregnancy, the FDA encourages laboratory developed test developers to submit a request for an EUA. The first Zika diagnostics approved were developed by the U.S. Centers for Disease Control and Prevention (CDC)—the Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (MAC-ELISA; approved Feb. 26, 2016) and Trioplex real-time Reverse Transcription Polymerase Chain Reaction Assay (rtRT-PCR; approved […]