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NIAID Collaboration Yields New Test for Lyme Disease

A new test developed with funding from the National Institute of Allergy and Infectious Diseases (NIAID) has been shown to be highly accurate and sensitive for detecting antibodies to Lyme disease. Produced by Immunetics, Inc. of Cambridge, Massachusetts, the new assay recently won approval from the Food and Drug Administration (FDA) for use as a diagnostic test for Lyme disease.

It is the first diagnostic tool to use a synthetic product called C6, a hybrid chemical marker based on components derived from the surface of Borrelia burgdorferi, the tick-borne bacterium that causes Lyme disease. The C6 test is sensitive only to antibodies generated during an active infection.

Lyme disease can be difficult to diagnose, especially in later stages of infection when an individual’s antibodies can fall to very low levels. Laboratory testing showed the C6 approach resulted in a high rate of sensitivity to antibodies from both the early and late stages of Lyme disease. The kit also resulted in fewer false positive readings when compared with current screening methods. Significantly, no false positive readings were obtained when the kit was used to test people who had previously received Lymerix®, the Lyme disease vaccine. Another advantage is the test’s ability to detect antibodies specific to both U.S. and European strains of Borrelia.

"The C6 test is the result of years of collaboration in an ongoing effort to improve our ability to diagnose Lyme disease," explains microbiologist Phillip Baker, Ph.D., NIAID’s Lyme disease program officer. "This new approach is an important first step in that direction."

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NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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