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Today, the US Food and Drug Administration has licensed four previously validated tests with new indications to aid the diagnosis of Lyme disease. The tests approved today are the first time that a test follows a new paradigm in which two tests, called Enzyme Immunobadays (EIA), are performed simultaneously or sequentially, instead of the current two-step process in which a separate protein test called a Western Blot must be performed after the initial EIA test.
Lyme disease can have a devastating impact on patients. With today's action, clinicians have a new option for testing Lyme disease, which is easier to interpret by a clinical laboratory because of the simplified method of the test. These tests can improve confidence in the diagnosis of a patient for an illness requiring treatment as early as possible to ensure the best results for patients. "
Tim Stenzel, M.D., Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA Radiation and Equipment Center
Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue and rash called erythema migrans. If it is not treated, the infection can spread to the joints, heart and nervous system. In 2017, the last year for which the Centers for Disease Control and Prevention (CDC) published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported to the CDC, an increase of 17% report to 2016.
Laboratory diagnosis of Lyme disease has traditionally used a two-level process to detect the presence of antibodies to Borrelia burgdorferi in a patient's blood. Antibodies are proteins found in the blood when the body reacts to a specific infection. In the previous two-level approach, different types of tests were used (EIA and Western blots) to confirm a clinical diagnosis. The tests approved today involve a modified approach that uses only tests based on EIA technology.
The FDA reviewed clinical trial data from the Borrelia VlsE1 / pepC10 ZEUS ELISA IgE / IgM baday system, the ELISA Borrelia burgdorferi ZEUS IgE / BIE baday system, the Borrelia burgdorferi IgM baday system, and the ZEUS ELISA Borrelia Screening Test This alternative approach, called the modified two-level test, is as accurate as current methods of detecting antibodies to badess exposure to Borrelia burgdorferi, the causative agent of the disease. Lyme, compared to current methods.
CDC recommendations should be followed for the diagnosis of Lyme disease and to determine when laboratory tests are appropriate.
Enzyme immunobaday tests were reviewed via pre-market notification (510 (k)). A 510 (k) is a pre-market submission to the FDA to demonstrate that the device to be commercialized is at least as safe and effective as it is virtually equivalent to a device marketed legally.
The FDA has authorized ZEUS Scientific to perform ZEUS ELISA Enzyme Immunobadays.
Source:
US Food and Drug Administration
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