LYMEPOLICYWONK: New Lyme Disease Culture Test Could be Game Changer

12th September 2011

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Advanced Laboratory Services Inc. (ALSI) has announced a new culture test for Lyme disease. It is commercially available in all states except California, New York and Florida, which have individual state licensing requirements that must be met before the test can be offered. Direct detection of bacteria through culture is considered the “gold standard” for diagnosis, but this method has not been commercially available for Lyme disease using previous culture methods. The new test is based on research conducted by Dr. Eva Sapi and colleagues, which CALDA helped fund. Results of the research published earlier this year demonstrated the improved culture method for Borrelia burgdorferi, the agent of Lyme disease, and the technique has recently been corroborated using human blood samples. Larger confirmatory studies of the test are now being pursued. Dr. Joseph Burrascano, a pioneer in the treatment of Lyme disease, consulted with ALSI to help make the test commercially available. A sensitive high-quality culture test would not only permit patients to be accurately diagnosed, but would lay to rest much of the controversy surrounding Lyme disease.

One of the primary causes of the Lyme controversy is the lack of a “gold standard” diagnostic test to determine who has the disease, who has persisting disease, and who has cleared the infection.  Currently available Lyme tests rely on indirect methods of detecting the disease using antibodies produced by the patient. The sensitivity of most of these commercially available antibody tests has been so low that they may miss one out of every two people with the disease.

The new test identifies Borrelia burgdorferi using histology and growth characteristics in conjunction with fluorescent immunostaining.  Positive results can be further confirmed using standard molecular biology methods (PCR) based on DNA sequencing. 

The testing is now available for use in all states except California, New York, and Florida, which require a higher level of lab certification for testing. Physicians can obtain lab test kits from ALSI in Pennsylvania.  Contact information about the lab can be obtained from their website.

Those seeking further information may wish to read: 

The Advanced Laboratory Services press release.

Dr. Burrascano’s informal release regarding the testing.

My blog post announcing the in vitro culture results. 

The research study is also available open access (free).  Sapi E, Kaur N, Anyanwu S, Luecke DF, Datar A, Patel S, et al. Evaluation of in-vitro antibiotic susceptibility of different morphological forms of Borrelia burgdorferi. Infect Drug Resist 2011;4:97-113.

 

 

 

 

 

The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is CALDA’s Chief Executive Officer. Contact her at lbjohnson@lymedisease.org.

 

Related posts:

  1. LYMEPOLICYWONK: Odd Couples—CDC, NIH, IDSA, others? “Hey, what are you yelling about? We’re playing a friendly game!”
  2. OPINION: Dear Pennsylvania legislators, Lyme disease isn’t always diagnosed by a test
  3. TOUCHED BY LYME: A whole ’nother ball game
  4. LYMEPOLICYWONK: Mammograms, pap smears and Lyme? Statistical lives vs personal lives. You choose.
  5. LYMEPOLICYWONK: Lyme disease abandoned by Pharma
Comments

5 thoughts on “LYMEPOLICYWONK: New Lyme Disease Culture Test Could be Game Changer

  1. Yes, this could be an important game changer, to be sure.

    However, newbies (very often already financially devastated by Lyme even before diagnosis) must be informed
    that insurance does not cover the borrelia culture test (and maybe not yet)because there have been no studies to satisfy insurance companies.

    I've called the lab and I've spoken with the person in charge of inquiries about the Borrelia Culture test. He's called me back twice. He's says he'll call me back a third time. He has not answered my question about cost: Each test will cost, they estimate, $450-$500. The problem comes because they require several "sets."

    He couldn't answer what "sets" mean, with regard to cost. If several blood draws are taken at the same time, would each one be considered a "set?" That is, would there be a separate charge for each set? He said probably not, but he wasn't sure. In addition, further blood draws on other days could be asked of a patient. I asked if there would be a separate charge for each of those. He said probably.

    I've been waiting for his reply since Monday.

    Exactly how much will the test cost financially strapped newbies? If diagnosis runs into thousands of dollars because of this test, where would many newbies also get money to pay for LLMD visits? For meds? For food and housing?

    Until more is known, newbies need a qualifier along with the announcement of the Borrelia Culture test and it is this: Lyme at any stage is still a CLINICAl diagnoses with a genuine LLMD, as ever.

    People who can afford to fund Borrelia Culture studies by having the test(s) ordered, is fine! Great! But financially strapped and hurting newbies are confused enough, as it is. They need a qualifier, please.

  2. I don't get it. What are you going to culture though? I thought you had to culture the spot of the bite at the time of infection. I thought that the bacteria did not populate the blood supply in the body. Am I wrong? I know that you need to culture it to be sure, but in order to culture something you have to catch it first. I'm not even sure if I have lyme disease or these other people do, but am I missing something? Are they saying 80% of people with lyme like symptoms tested positive and that is how they determined 80% sensitivity? Or did they use a CDC test and then test them with a culture and get 80% positive? I thought the whole problem with regular PCR was that the bacteria was not in the blood, so how do you catch it in there to culture it?

  3. I suspect the "sets" are taken over time so as to capture a sample when the spirochetes are in an active growth state. When they are not in an active growth state, they cannot be detected by any means (the spirochetes won't be in the blood sample), nor are they vulnerable to abx treatment. I too wonder if the fee cited ($600) is for the entire sets or each one. Suspect it is for the whole shot. We need a funding source to make this lab test available to those without resources to cover it (insurance) or adequate personal finances to pay for it directly. Who is working on finding a grant for this similar to the lymetap grant?

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