"Lyme disease can have a devastating impact on patients. With today's 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," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
Lyme disease is caused by Borrelia burgdorferi bacteria which is transmitted to humans by the bite of infected ticks. Symptoms seen are fever, headache, fatigue, skin rash etc.
Lab diagnosis of Lyme disease previously used a two-tier process involving EIA and western blot for diagnosing the presence of antibodies against Borrelia bacteria in the patient's blood. The tests cleared by FDA involve a changed approach that uses only EIA technology-based tests.
The FDA reviewed data from various studies of the ZEUS ELISA Borrelia IgG/IgM Test Systems and concluded that this alternative approach is more reliable compared to existing methods for detecting Lyme disease.
The enzyme immunoassay tests were reviewed through the premarket notification (510(k)) pathway. The FDA granted clearance of the ZEUS ELISA enzyme immunoassay tests to ZEUS Scientific.