Department of Health releases 2014 Lyme disease cases in Allegheny County
Courtesy of wikipedia.org
Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.
These tests are the first to be indicated to follow a new testing paradigm running enzyme immunoassays (EIA) concurrently, not the previous two-step process with the Western blot protein test.
“Lyme disease can have a devastating impact on patients,” said Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “With [this] action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients.”
Transmitted to humans through the bite of an infected tick, the first symptoms of Lyme disease can mimic the flu, but are different due to the presence of a skin rash called erythema migrans.
In order to approve clearance, the FDA reviewed data from four separate clinical studies that used the modified two-tier test and found it was at least as accurate at detecting Borrelia burgdorferi, the causative agent of Lyme disease.
