FDA OKs Streamlined Lyme Disease Tests to Aid Earlier Diagnosis

Megan Brooks


July 30, 2019

The US Food and Drug Administration (FDA) has approved a streamlined process for diagnosing Lyme disease that involves use of existing tests already on the market.

Laboratory diagnosis of Lyme disease has traditionally followed a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in blood. The approach involves use of an enzyme immunoassay (EIA) followed by a Western blot to confirm a clinical diagnosis. With the new testing paradigm, two EIAs can be run concurrently or sequentially, the FDA said.

The FDA approved the "modified two-tier" EIA approach on the basis of studies of four EIAs from Zeus Scientific:

  • Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System

  • Zeus ELISA Borrelia burgdorferi IgG/IgM Test System

  • Zeus ELISA Borrelia burgdorferi IgM Test System

  • Zeus ELISA Borrelia burgdorferi IgG Test System

The results showed that using only two EIA tests is as accurate as the EIA/Western blot method for detecting antibodies in assessing exposure to B burgdorferi.

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," Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a news release.

"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," Stenzel said.

In 2017, the last year for which the Centers for Disease Control and Prevention (CDC) has published data, 42,743 confirmed and probable cases of Lyme disease were reported to the CDC, an increase of 17% from 2016.

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