ADH says new, cheaper Lyme disease test isn't FDA-approved

New Lyme disease test coming to the Natural State

LITTLE ROCK, Ark. (KTHV) – The Arkansas Department of Health is urging patients to not undergo certain Lyme diseases tests they warn are not FDA-approved.

“Certain tests have not proven to be reliable for use in the diagnosis of Lyme disease and are not recommended by ADH or the Centers for Disease Control and Prevention (CDC), even if they are promoted by some labs or doctors," said the Arkansas Department of Health in a released statement.  

"Tests that have not been approved include: Lyme Polymerase Chain Reaction (PCR) tests, capture assays for antigens in urine, reverse Western Blots, and measurements of antibodies in joint fluid."

Arkansas has some of the highest rates in the nation for tickborne diseases such as Rocky Mountain Spotted Fever (RMSF), Ehrlichiosis, and Tularemia. The state has also cases of Lyme disease and Anaplasmosis. But testing for Lyme and other tick-borne illnesses can be even more frustrating in the Natural State.

Sean Donegan, owner of Any Lab Test Now in West Little Rock, said he gets a lot of calls about Lyme disease and people wanting to get tested. That’s why Any Lab Test Now is bringing a different test to Arkansas. It’s called a PCR test, or Polymerase chain reaction test. It isn’t new, but it is new to the Natural State.

Donegan said he is bringing it to his business because he wanted to have another alternative for patients on a retail level that brings good results.

“Despite recent incorrect reports in Arkansas, the Lyme PCR test is not licensed by the Food and Drug Administration. PCR tests are not recommended due to problems with high numbers of both false positive and false negative results,” warned the ADH. “Proper testing for these diseases is very important for both patient diagnosis and case documentation for surveillance purposes, so ADH encourages health care providers to use reliable, approved tests when diagnosing patients.”

When a doctor suspects a patient has a tickborne disease, the doctor often orders a tickborne disease diagnostic panel, commonly referred to as a tick panel, which tests for the diseases mentioned above using the same blood sample. The tests for RMSF, Ehrlichiosis, Tularemia, and Anaplasmosis are all fairly easy to interpret; however, the recommended test for Lyme disease is more complicated.

According to the ADH, Lyme disease requires a two-tiered testing system. Depending on the lab used, both tests may or may not be included in a tick panel. The second test should only be done if the first test is positive. The first test can either be an Enzyme Immunoassay (EIA) or an Immunofluorescence Assay (IFA). The second test will either be an IgM or an IgG Western Blot test, depending on the time that has passed since symptoms started. They state that the tests must be done in the correct order. 

© 2017 KTHV-TV


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