Lyme Disease
11:29 am
Wed June 18, 2014

Investigative Report Reveals Not All Lyme Disease Tests Are Accurate

An FDA loophole allows for-profit laboratories to sell Lyme disease tests without actually proving they work.
An FDA loophole allows for-profit laboratories to sell Lyme disease tests without actually proving they work.
Credit Jerry Kirkhart / Creative Commons

A new investigative report calls into question thousands of diagnostic tests for Lyme disease.

Lyme is a problematic disease. It can be tough to treat, and even tougher to diagnose. The Food and Drug Administration recommends a test that works fairly well. It identifies about 300,000 new cases of Lyme disease a year, mostly in the northeast. 

The test doesn't catch every case of Lyme disease, however. As investigative reporter Beth Daley discovered, for-profit labs have cropped up, offering their own test for Lyme disease.

"The reason people go to these other tests is that they are really sick," Daley said. "They go for an FDA test, and it is negative. Then they start shopping around to other doctors. There is a group of doctors out there who will diagnose you with Lyme, not using the same criteria that the medical establishment does, and many of them will rely on these tests."

The problem is that because of an FDA loophole, these labs are not required to scientifically prove that their tests actually identify the disease. These tests cost anywhere from $100 to $1,000, and many times are not covered by health insurance. "You have to be very careful," Daley said, "because you don't know which ones are good, and it comes down to you have to trust the lab's word. I don't want to do that. There are unscrupulous people out there, and as a result, I may say, people are being diagnosed with Lyme, or not diagnosed with Lyme, and being given inappropriate treatment."

New York is the only state that requires labs to scientifically prove their Lyme tests work. Beth Daley's report can be found at the New England Center for Investigative Reporting website, necir.org.