Are Lyme disease tests accurately diagnosing patients?

A new report from the New England Center for Investigative Reporting suggests that many labs offering Lyme tests haven’t proved that they actually work. 

A new report from the New England Center for Investigative Reporting suggests that many labs that offer Lyme disease tests haven’t proved that the test actually works.

An exemption in federal regulations allows many labs to offer Lyme tests to patients without proving that the test actually works. The other type of diagnostic test, which is federally recommended, has been vetted and looked at by independent scientists to make sure the test is accurately diagnosing people and screening out people who don’t have the disease.

“The problem is, it’s not perfect,” said Beth Daley, reporter for the New England Center for Investigative Reporting and author of this week’s report. “The federally recommended test, early on in the disease, will not diagnose you with Lyme if you just got it. That’s because your body has to produce enough antibodies for the test to detect. So if you just got bit by a tick and your body hasn’t produced enough antibodies, you’re going to probably test negative.”

It’s a frustrating result for many who are aggressively seeking answers on their condition.

“Many people land in this very parallel medical world to the medical establishment where doctors call themselves ‘Lyme literate,’ where they will diagnose you simply by looking at you or by using one of these tests,” said Daley. “But the problem is, there’s no peer-reviewed process behind that. So you’re really just trusting a doctor’s word or trusting a test that hasn’t gone through the proper scientific review.”

In terms of cost, patients can expect to pay between $127 and $400 for a federally recommended test and anywhere between $100 and $1,000 for an unregulated test.

“The difference is, though, is the patient paying for it themselves? In a lot of the federally recommended tests, it’s covered by insurance for the most part but many insurers do not reimburse for these alternative Lyme tests, so patients have to pay out of pocket for them.”

One lab that provides these alternative tests is Advanced Laboratory Services, located just outside Philadelphia. Regulators and scientists have raised concerns about the validity of their tests and asked for the lab to provide proof of accuracy from an independent third party by this past April but the lab never followed through. 

Beth contacted the company’s spokeswoman, Jen Hoefner, who said validation studies were delayed, but will still be conducted and the company “hopes to have the information published shortly.”

To listen to our full interview with Beth Daley, click on the audio playlist above.