Lyme Disease: Testing & Diagnosis

Summary: Effective diagnostic testing for Lyme has never been reliable. In the absence of an EM rash, there is no way to reliably and consistently diagnose Lyme disease , acute or chronic, using serological testing (testing the blood). Beyond this, Lyme is difficult to diagnose because fewer than half of all patients recall a tick bite or develop the signature bulls-eye (EM) rash, and routine Lyme ELISA screening test has up to a 60% false negativity. Coinfections also have a high rate of false negativity. Overall, the medical literature on diagnostic testing highlight the need for both and improvement and standardization in blood tests for Lyme disease and coinfections.If you find a tick on your body or attached to you, REMOVE IT PROPERLY and SAVE THE TICK. Testing the tick for Lyme (and co-infections) is much easier than testing your blood later on. More on this below.

Tick Submission: The Easiest Route of Diagnosis

So, you've been bitten by a tick. Now what?First, remove the tick properly. I know that they're nasty things, BUT DON'T THROW IT OUT OR FLUSH IT!Instead, put the tick into a small plastic Ziploc bag with with a moist cotton ball or piece of wet paper towel.You have the option to send this sample in for diagnostic testing. Remember, it's much easier and much more accurate to test the tick itself. Here is the company we use:Ticknology: They're not free, but they're affordable.

Diagnosing Lyme: Overview of Blood Tests...And A Litany of Problems

Clinically, Lyme disease is diagnosed based on symptoms: objective physical findings such as EM (erythema migrans, also know as the bulls-eye rash), facial palsy, or arthritis.  Lyme can sometimes be diagnosed using serological blood tests. A serological blood test measures levels of specific antibodies in a patient's blood. The most commonly used serological tests available for Lyme are referred to as a two-tiered test; typically, doctors will order an ELISA antibody test first, and if results are positive, a western blot test will be ordered. Research shows that the ELISA and the western blot are NOT reliable tests; if you look at the research literature on this methodology, the false negative rate is anywhere from 33% to 75%.This being said, the ELISA and the western blot are still considered the "gold-standard" for diagnosing Lyme disease.Wait, WHAT??!! Let's take a closer look. But first - if you're simply not in the mood for the following dry-as-hell details about testing, and the problems inherent to the testing available, just read this succinct overview of current testing, from Columbia University Medical Center.Below, I've listed out the detailed reasons why the "gold-standard" testing for Lyme is inadequate.

1. Measurable amounts of antibodies will not show up for 2-4 weeks after exposure, so if testing happens too quickly after infection, it's possible to test (falsely) negative.
2. Spirochete levels tend to peak at 60 days after infection and then drop to low levels in the system. If tested when they are at low levels, many tests may not detect their presence.
3. Spirochetes can encyst, alter their genetic makeup, and alter their form. This makes testing for Lyme disease difficult. (I know - it sounds like I'm making this up. Spirochetes are creepy and smart. For more on this, see here.)
4. READ THIS:

...a certain percentage of people are lucky enough to mount a robust antibody response and then that shows up on the blood test.  A significant amount of people are not.  And it also has been shown that the longer you’re sick with this and the longer it’s been since you were actually exposed, you’re actually less likely to show an antibody response because of the way the bacteria can evade the immune system.  These are what are called stealth pathogens, and they’re actually remarkably well designed to persist and to hide from the immune system.  So after a while, your body kind of gives up and stops making antibodies...So the two-tiered testing has a pretty high false-negative rate.  And if you do sort of make it through the first gate and you have a positive ELISA and then you do the Western blot, the CDC has set up this criteria wherein certain antibodies that you’re making are considered specific, and certain other ones are not, and they require that you have a certain pattern and a specific number of these different antibodies in order to qualify for a positive test.  And there’s a lot of controversy about which ones they chose and which ones they didn’t.  Back in the ’80s, they had developed a Lyme vaccine, which has been since taken off the market because of some fairly severe side effects that people were developing, but they changed the test once they did that, and they excluded certain bands which would have been positive as a result of the vaccine....And the other problem with the test is that there’s one kit that’s used that has been approved by the FDA and the CDC, and that kit has one strain of the bacteria, and it is the Lyme Connecticut strain.  Worldwide, there are probably 300 different strains of this bacteria, and some really interesting cutting-edge research is coming out of California as we’re seeing what were thought to be only European strains.  We’re seeing them showing up here.  So Borrelia bissettii, Borrelia miyamotoi, and all sorts of other Borrelia bacteria, like Borrelia hermsii, which causes more of a tick-borne relapsing fever picture, which we’re seeing if we know to look for them.  However, that one test kit is not going to pick those up because those antibodies are different.  So there are a number of reasons why the testing is problematic. Sunjya Schweig, MD, from this interview

5. The ELISA test tests blood serum for the presence of Borrelia antibodies. Lyme ELISA testing is useless as a screening tool because of its high incidence false negativity. From Harrod's book, Healing Lyme: "...a significant number of studies have found, and continue to find, that the ELISA test is not all that effective in diagnosing Lyme disease. In general, some 40 percent of people known to have Lyme (because of EM rash) test negative for Lyme infection with ELISA. To make this statistic worse, studies have found ELISA to be negative in 35 percent of people in whom a skin biopsy found cultivatable spirochetes."

6. The Western blot looks for either IgG or IgM, two different antibodies that are produced in response to infection. Western blot evaluation is the best first step in lab evaluation, but it requires knowledge of which bands are reasonably specific for Lyme.

However, it should be noted that "IgM antibodies rise during the third week, peak after four to six weeks and then disappear by week eight - so if you tested after this, they may not show at all. IgG antibodies, which appear between six weeks and three months of infection, can persist for years or decades after successful treatment, and so when tested, people will be found to be positive for the disease even if they do not have it." -Buhner, Healing Lyme (all of the journal articles are listed at the end of this book)

7. Borgermans et al. (2014) sums up the reliance on two tiered-tested: "There is consistent evidence that the two-tier testing lacks sensitivity, cannot distinguish between current and past infection, cannot be used as a marker for treatment, is often dependent on subjectively scored immunoblots, and is considered expensive."

8. Given the unreliability of testing, it's recommended that when diagnosing Lyme disease, practitioners should AT LEAST use a checklist of symptoms along with the western blot assay with at minimum two bands.

"Bands" are borrelial proteins of the same molecular size against which the patient's blood is tested; the more bands, the more specific the diagnosis. Patients should consider, if not offered,  requesting results that include all bands. They should also consider requesting antibody testing for some of the common co-infections like Bartonella and Babesia and Ehrlichia.

9. If you're being tested with the western blot, have your doctor request a complete list of the bands that react with your blood (many labs simple report "negative" or "positive" and do not provide a list of the bands). In some circles, two bands are considered enough to diagnose Lyme: 41kd and another Lyme-specific band.

10. Borrelia bacteria are very, very slow growing (which is why treatment can take so long). That being said, borrelial organisms are best treated when they’re actively replicating. On average, they replicate once a month, which is different than “normal” bacterial infections.

11. IgeneX, Clongen Laboratories, Advanced Testing Laboratories, and Medical Diagnostics Laboratory are preferred labs for Lyme-literate doctors when ordering a western blot, as they test more bands including bands 31 and 34, which are specific to Borrelia burgdorferi (and are the actual bands the vaccine was made from).

12. This post isn't definitive in regards to the tests available - there are many. The point of this was to review the most common tests used in attempt to diagnose Lyme disease. Some tests, notably a blood culture that, so far, seems promising, is still being researched.

13. Chronic Lyme and other tick-borne illness is a clinical diagnosis, meaning it is most often diagnosed by a Lyme literate physician based on history, physical exam, and laboratory testing. Because there is no one perfect test for this condition, and the currently available tests each have their own limitations, practitioners must pull all of the information together - history, exam and testing - to make a clinical diagnosis. You can see ILADS treatment guidelines here.

This is the 3rd post in a 4-series piece on Lyme disease. See the last post here.