Updated
July 31st, 2019

Lyme Disease Tests Indications Expanded by FDA

Lyme disease tests gain new indications that may help streamline diagnosis

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The U.S. Food and Drug Administration (FDA) cleared for marketing previously approved tests with new indications to assist in the diagnosis of Lyme disease. 

These 4 tests cleared by the FDA on July 29, 2019, is the first time that a test has been indicated to follow a new testing paradigm in which 2 tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current 2-step process in which a separate protein test called a ‘Western Blot’ must be run, after the initial EIA test.

To make this determination, the FDA reviewed clinical study data for the:

  • ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, 
  • ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, 
  • ZEUS ELISA Borrelia burgdorferi IgM Test System, and the,
  • ZEUS ELISA Borrelia burgdorferi IgG Test System that showed this alternative, two-tier test, approach.

“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,” 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.

“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 Dr. Stenzel, in a press release.

The FDA says the Centers for Disease Control and Prevention (CDC) recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.

The CDC says healthcare providers should consider:

  • The signs and symptoms of Lyme disease
  • The likelihood that the patient has been exposed to infected black-legged ticks
  • The possibility that other illnesses may cause similar symptoms
  • Results of laboratory tests, when indicated.

Furthermore, the CDC says most Lyme disease tests are designed to detect antibodies made by the body in response to infection. And, antibodies can take several weeks to develop, so patients may test negative if they were infected recently.

Lyme disease is caused by the bacteria Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue and skin rash called erythema migrans. 

If left untreated, an infection can spread to joints, the heart, and the nervous system.

The CDC reported the bacteria that causes most tickborne diseases in the United States, Borrelia burgdorferi, accounts for 82 percent of reported Lyme disease cases. Infections from other diseases, including some tickborne diseases, or some viral, bacterial, or autoimmune diseases, can result in false-positive test results.

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In 2017, the last year for which the CDC published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported to CDC, which is an increase of 17 percent from 2016.

With 10,001 cases in 2017, Pennsylvania saw the most positive Lyme disease test results of any state in the USA, and nearly as many found in all New England states combined (11,549).

In Europe, an additional 200,000 Lyme disease cases are diagnosed most years.

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In related news, the Infectious Diseases Society of America, American Academy of Neurology, and American Academy of Rheumatology announced in June 2019 that they are now accepting public comments on draft guidelines for the prevention, diagnosis, and treatment of Lyme disease, through August 10, 2019.

Those wishing to provide feedback can view the draft guidelines and submit their comments on the IDSA website.

Lyme disease news

These enzyme immunoassay tests were reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.