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FDA Clears Gold Standard Diagnostic Lyme Disease Assay

NEW YORK (360Dx) – Gold Standard Diagnostics said today that the US Food and Drug Administration has cleared the company's Borrelia burgdorferi IgG/IgM ELISA assay.

The test is intended for use as the initial screen in the two-step testing process recommended by the US Centers for Disease Control and Prevention for detecting antibodies against B. burgdorferi, a bacterial species that can cause Lyme disease. GSD said that both steps can be performed using the same blood sample.

The test contains B. burgdorferi strain B31 and 2591, and the immunogenic lipoprotein VIsE, and it features a 15-15-15 minute incubation protocol, making it easy to automate, GSD said.

The clearance comes after the CDC last month said that the number of people in the US who have been infected with diseases carried by ticks, as well as mosquitoes and flea bites, have more than tripled in recent years.

Recently, Quidel's Sofia Lyme FIA test was cleared by the FDA to run on the Sofia 2 Fluorescent Immunoassay Analyzer. The CDC also has confirmed a testing workflow that appears to offer improved accuracy and sensitivity, and Reagena launched a point-of-care test for detecting the Lyme-linked chemokine CXCL13 in human cerebrospinal fluid that the company said could be an alternative to ELISAs for Lyme diagnosis.