U.S. Food and Drug Administration cleared four previously cleared tests with new indications to aid in the diagnosis of Lyme disease.

‘Recent indication cleared by FDA involves a new approach that uses only EIA technology-based tests for diagnosing lyme disease. This precise approach helps to start treatment early which ensures the best clinical outcome for patients.’
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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. Read More..





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.
Source-Medindia