LabCorp to deny physicians access to western blot tests for Lyme disease

Labcorp will not offer a western blot test for individuals unless they are positive or equivocal for the Enzyme Immunoassay (EIA) or Immunoflorescense (IFA) screening tests for Lyme disease as of August 11, 2014.[1]

img-ldpr2Physicians have been disappointed by the poor sensitivity of the EIA or IFA screening tests for Lyme disease. The sensitivity of the whole-cell enzyme-linked immunosorbent assay (ELISA) to the B31 strain typically falls between 33-49% for patients presenting with an EM.[2-4] The sensitivity of the Food and Drug Administration (FDA) approved complement peptide C6 (C6-peptide) was 37% in 89 clinically well-defined individuals with LD [5] and 66.5% 403 sera from patients with an EM rash.[6]

Physicians have commonly ordered the western blot test for Lyme disease even in the absence of positive or equivocal testing. An IgM Western blot test can persist for at least 2 years in individuals with established Lyme disease infection. A IgM WB can persist for months to years in LD even if an individual is treated with antibiotics.[7-9]  An IgG can be positive in individuals with a negative screening test.

LabCorp’s decision to deny physician assess to western blot test for Lyme disease only makes testing sensitive than it already is.

It important that LabCorp reverse their position and allow physicians to continue to order western blot tests for Lyme disease even if the EIA and/or IFA are negative. Until then, clinicians may have to direct their patients to other labs.

  1. LabCorp newsletter for clients. Lyme disease testing now employs a two-tier antibody standard, Available from https://http://www.labcorp.com/wps/wcm/connect/e831ac0044cfc61b8549dd5dc65848bc/L13226-0714-1.pdf?MOD=AJPERES&CACHEID=046d350044cfb1a59442d7703d82366a  Last accessed 8/16/14.
  2. Aguero-Rosenfeld ME, Nowakowski J, Bittker S, Cooper D, Nadelman RB, Wormser GP. Evolution of the serologic response to Borrelia burgdorferi in treated patients with culture-confirmed erythema migrans. J Clin Microbiol, 34(1), 1-9 (1996).
  3. Trevejo RT, Krause PJ, Sikand VK et al. Evaluation of two-test serodiagnostic method for early Lyme disease in clinical practice. J Infect Dis, 179(4), 931-938 (1999).
  4. Aguero-Rosenfeld ME, Nowakowski J, McKenna DF, Carbonaro CA, Wormser GP. Serodiagnosis in early Lyme disease. J Clin Microbiol, 31(12), 3090-3095 (1993).
  5. Ang CW, Notermans DW, Hommes M, Simoons-Smit AM, Herremans T. Large differences between test strategies for the detection of anti-Borrelia antibodies are revealed by comparing eight ELISAs and five immunoblots. Eur J Clin Microbiol Infect Dis,  (2011).
  6. Wormser GP, Schriefer M, Aguero-Rosenfeld ME et al. Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease. Diagn Microbiol Infect Dis,  (2012).
  7. Steere AC, Hardin JA, Ruddy S, Mummaw JG, Malawista SE. Lyme arthritis: correlation of serum and cryoglobulin IgM with activity, and serum IgG with remission. Arthritis Rheum, 22(5), 471-483 (1979).
  8. Massarotti EM, Luger SW, Rahn DW et al. Treatment of early Lyme disease. Am J Med, 92(4), 396-403 (1992).
  9. Craft JE, Grodzicki RL, Shrestha M, Fischer DK, Garcia-Blanco M, Steere AC. The antibody response in Lyme disease. Yale J Biol Med, 57(4), 561-565 (1984).

 


25 Replies to "LabCorp to deny physicians access to western blot tests for Lyme disease"

  • Donna Falcone
    08/19/2014 (5:19 pm)
    Reply

    LabCorp should be boycotted. Patients can ask their doctors who rely on LapCorp to write them an Rx for blood work and then have it done anywhere else that takes their insurance. This is outrageous.

  • Ashley
    08/19/2014 (5:24 pm)
    Reply

    This is stupid! Why would they deny that kind of testing? I was sooooo sick with RMSF and it took forever for the doctors to even figure it out. Now I have been bitten by a couple ticks again and the doctor is running a test for Lymes and RMSF but if they come back negative, I would want the western blot run because I KNOW something is wrong. I feel the same sickness as I did when I first KNEW something was wrong before. Ugh..this makes me mad. I hope LabCorp changes their minds on this. What other labs will run a western blot?

  • Jerry Seidel
    08/19/2014 (6:13 pm)
    Reply

    I am certain this is due to the CDC’s attempt to take control of ALL testing. They are working on the language for a bill which will give them control of all lab tests. Lab tests(You send them the sample) are currently validated by another government approved method. The CDC doesn’t like that. They only want individuals with Lyme who make tons of antibodies to test positive. They want people who have a weak immune response due to the immunosuppression from Lyme to test negative. Most people have the immunosuppression. Chronic infections which exist below your immune systems radar are worth billions of dollars to the industry. It makes you sick off and on for life. The CDC helps the industry make money because the CDC is part of it. The CDC is allowed to own patents and profit from them. They actually own Lyme disease related patents and we are expected to trust they are looking out for us. The CDC IS BigPharma.

  • Debbie Thompson
    08/19/2014 (10:01 pm)
    Reply

    When I read about this, I called a number that was posted in one of the groups. It turned out to be a billing number, but I was asked what state I was in, and was given another number 800 877-7831 Labcorp Customer Service. The woman I spoke with told me right away that this was not Labcorp’s doing, and that this came from the top. I asked her if ‘from the top’ meant the CDC/IDSA, she said yes. I told her she may be getting more calls about this, because it is known that the ELISA is bogus.

  • Justin Reilly, JD
    08/19/2014 (10:14 pm)
    Reply

    Dr. Cameron, thank you for this excellent, succinct blogpost on such an important topic!

    This is completely outrageous! I’m sputtering here.

    And I knew ELISA was bad, but wasn’t aware it was THAT bad. And these numbers Dr. Camerson cites are for “well-defined” Lyme cases and EM cases, and it’s still only 30 – 70% sensitive! And I thought the state of affairs was insane as it was; now this takes the cake.

    Ashley, before I started going to Dr. Cameron, I was treated for Lyme by Derek Enlander, who runs the ME’cfs’ Center at Mt. Sinai (I have a dx of ME’cfs’ too). He doesn’t bother ordering ELISA because it is such a PoS, he just orders Western Blot and Igenex 2xPCR + Southern Blot. He uses Quest usually, IIRC (and sometimes LabCorp).

    • Ashley
      08/25/2014 (5:49 pm)
      Reply

      Thank you for letting me know! My lyme’s test came back 0 but RMSF test was .54. My doctor thinks both of those tests are negative but I still feel sick after 10 days on Doxy. They won’t even consider that the tests could be wrong. It’s so frustrating. More doctors need to be informed about Tick diseases.

      • Steve
        04/18/2017 (2:16 am)
        Reply

        Please stop writing “lyme’s” or “Lymes.” There is no “s”; it is neither possessive nor plural.

  • Connie
    08/20/2014 (12:27 am)
    Reply

    I don’t understand why a lab would no longer make a superior diagnosing test unavailable. Why are they policing the test? Why can’t the doctors make the decision about appropriate testing? What is the downside to offering? Who benefits from it being off the market? What is in it for Labcorp?

  • Linda Olley
    08/20/2014 (2:20 am)
    Reply

    It is well known the unreliability of the Elisa and the Western Blot, missing over 50 % of patients with Lyme. With this new unconchionable change in practice, patient’s will endure increased harm due to lack of an early diagnosis and failure to treat promptly and appropriately. Who is controlling and practicing medicine in America??!!!!!
    I can only speculate this was not LabCorps decision but an edict from the CDC and/or IDSA.
    There will never be an accurate account of Lyme cases with detrimental decisions like this. Is there a reason some organizations wish the numbers to be inaccurate? Concealed? A question I would like answered.

  • Val
    08/20/2014 (7:16 am)
    Reply

    Who are you working for Lab Corp.? This is as dirty as it gets. I will NEVER use your labs or services again. You are helping the epidemic spread by denying tests that people need. Shame on you!

  • Lori Mattix
    08/20/2014 (9:54 am)
    Reply

    I was misdiagnosed originally because of this Elissa test done at St Johns? Specifically looking for Lyme’s disease? They came back negative? My Dr. Told me I did not have? Even though I had Bullseye, fever and malaise ? I was bit and after a year went to get tested and was told Negative? 4 yrs later 5 bands of Borrelius in western blot? We have to boycot and march? We are back to the 70s? When to only test for Aids was the Western Blot? They are purposely making it difficult to diagnose? Why?

  • Lee
    08/20/2014 (4:19 pm)
    Reply

    We know that indirect tests that only test our immune response (ELISA & Western Blot etc) are less than definitive for diagnosis and that the ELISA is less definitive than the WB and don’t forget…it is also less costly (a factor?) And the whole ELISA/WB system of testing was initially devised for surveillance numbers…not clinical diagnosis. Even back in 1994 at the Dearborn convention when this protocol was established (note with some dissent) they knew the ELISA sucked and limited official case numbers. I would suggest that this was not decreed by LabCorp. (It wouldn’t make sense for them to limit their income by reducing testing)

  • K.C.
    08/20/2014 (5:19 pm)
    Reply

    I called LabCorp to complain about this, and this is MISINFORMATION. The Western Blot is offered as a standalone test. If a doctor orders only the ELISA and it comes back POSITIVE they AUTOMATICALLY RUN THE WESTERN BLOT, instead of waiting on a doctor to requisition it because many doctors fail to follow up with Western Blot. This is an overall IMPROVEMENT in testing… If only the ELISA was ordered, they do not follow with Western Blot if the Elisa is negative. Still a problem, IMO, but their Western Blot is also not sensitive enough, IMO. If doctor orders ELISA AND Western Blot, they run BOTH regardless of the ELISA being pos or neg. I was told that this is the company policy by the customer service person in their lab department who has run these tests herself. If you have had an experience that differs from what I was told was company policy, CALL THEM and complain but have your case number ready and a copy of your lab in hand!

    • K.C.
      08/20/2014 (5:37 pm)
      Reply

      I just read the literature myself…because if I was given wrong information, I am convinced that the lady I talked to was herself misinformed as she was very polite, very understanding of my concern to the point of agreeing with my stance, and logical. This could be a LabCorp CYA public maneuver even though it will certainly cause less people to be properly diagnosed. But regardless I just sent this info to my dad who works in Information Systems at LabCorp and has access and working relationship with people who might be able to do something.

  • K.C.
    08/20/2014 (6:00 pm)
    Reply

    To reach LabCorp Customer Service, Call: 800-762-4344
    Select the option for “Report or result” and then into customer service. They might want a patient number; simply say you are calling as a patient advocate, not as a current patient with a lab you can reference (unless you have one they did this two-tier testing to). Refer to the July 2014 edition of LabHorizons, page 8. Have this saved to your device and offer to email it if they do not have access. Be polite and reasonable. It takes patience and persistence to change policy.

  • NEWS: LabCorp's unwelcome policy change on Lyme testsLymeDisease.org
    08/20/2014 (9:06 pm)
    Reply

    […] Click here for Dr. Dan Cameron’s explanation. […]

  • Paula Shick
    08/20/2014 (11:26 pm)
    Reply

    Ad nausea

  • KarlaL
    08/21/2014 (1:57 am)
    Reply

    I called LabCorp last week and I was told that physicians can still order a stand alone Western blot. What physicians can no longer order is a stand-alone EIA test. If the EIA is positive, then a Western blot will automatically be run, which was not the case before. If the EIA is negative, a Western blot will not be run, but a physician can still order it separately. So my question is, “are different people being told different things about what this new policy means?” Several patients in my online support groups have said that even before this policy was in place, that they were denied Western blots from LabCorp when their EIAs were negative. I for one would like to see LabCorp make a public statement clarifying their new policy.

    In either case, the CDC’s endorsement of the two-tier serology test is the root of the problem here. Patients from Lyme endemic areas already know how the two-tier serology test has failed so many people. Yet the CDC continues to stand behind their flawed studies and support the test. For one, I move to transfer the CDC Lyme office from their isolated enclave in Boulder CO to a Lyme endemic area like Poughkeepsie NY. Then the CDC officers will see for themselves how unreliable the two-tier serology test is, because they will witness their own children, families, friends, and neighbors falling ill with chronic disabling illness, because so few doctors will treat without a positive test.

  • Christine
    08/21/2014 (11:50 am)
    Reply

    My ELISA test was negative, but I was still having terrible symptoms. A few months later, they did the Western Blot and it came back positive. I’m being treated and am getting better. The ELISA test is inaccurate– to say the least!

    • Tonia
      08/25/2014 (6:38 pm)
      Reply

      Agreed!

  • Melisa Young
    08/22/2014 (5:24 pm)
    Reply

    I really feel we should be addressing all of this with the top of the pile…the W.H.O. (World Health Organization) after the SARS “scare” they organized the international infectious disease panel and appointed the USA CDC their position – then in turn the USA CDC appointed the IDSA. If the USA CDC cannot take better control of this situation then their position should be in question with the WHO.

  • Mrs. Hayward
    08/24/2014 (11:53 pm)
    Reply

    Thankfully there is a laboratory in NJ called Medical Diagnostic Labs that does a complete vector borne screening, including PCR/DNA and all co infections They test for the alternative bands in the Lyme Western Blot that lab corp does not check for. They also take insurance and my physician uses them exclusively for all her Lyme patients.

  • Tonia
    08/25/2014 (6:37 pm)
    Reply

    Wow, I just missed the cutoff! My practioner mistakenly ordered Western Blot 1st, which of course came back positive in IgG and IgM. Interestingly enough, my GP, an East Coast Trainned doc didn’t think I had enough bands to warrant the start of treatment, so he secondarily ran the ELISA and I’m sure you can guess what it said? Hmmm… negative. Shocking how inacurate it is! I have been dibilatingly sick for 2 years and had to give up a 27 year carreer which I loved because I am phyisically unable to execute the simnplest tasks required. Please forgive my naiety, but perhaps one test is beter for recent infection (ELISA) and the other for people living with a long term infection (Western Blot)?

  • Charlie
    08/28/2014 (4:12 pm)
    Reply

    Per my in-person conversation with Robert Giguere of IgeneX, Labcorp still does a good job of the Co-infections Testing.
    BTW, the Elisa is 47% accurate, and the FDA Western Blots do not read bands 31 & 34, as mandated by our beloved CDC.
    The ILADS website explains a lot of this. ILADS will help you find a Lyme Literate MD.
    IgeneX does other non-serum tests for people who’ve been partially treated for Lyme Diseases as well as people who are in Stages 2 and 3. This is because the Borrelia breaks through the vascular walls after 48 hours and hides within the neurological, skeletal and cardiological systems where it manifests itself by imitating other diseases and syndromes.

  • Mel T
    08/30/2014 (6:55 pm)
    Reply

    You never needed a pos. test to say you had infections after giving us all the real cause of AIDS immune suppression for decades. Using Antibody tests to detect infections in immune suppression is criminal and will be seen as the worst crimes against humanity ever wrought.
    http://www.lymeneteurope.org/forum/viewtopic.php?f=13&t=5147&start=20


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