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Serologic Tests for Lyme Disease Yield Disparate Results

When serum samples were tested for anti-Borrelia antibodies using eight commercially available ELISAs and five immunoblot assays, intertest agreement was only modest.

Current guidelines for diagnosing Lyme disease include a two-tier testing algorithm: an enzyme-linked immunosorbent assay (ELISA) for detecting anti-Borrelia antibodies, followed by immunoblot confirmation of positive ELISA results. Commercially available tests are based on sonicated whole-cell Borrelia antigens, recombinant antigens, or a mixture of the two.

To compare the performance of these assays, researchers in the Netherlands tested serum samples for anti-Borrelia antibodies using eight commercial ELISAs and five immunoblots (4 commercial, 1 investigator-made). The 89 samples were from 59 patients with suspected Lyme disease, 14 healthy controls, and 16 patients with syphilis or Mycoplasma pneumoniae infection — conditions associated with highly cross-reactive antibodies.

Of the 89 samples, 35 (39%) tested negative — and 16 (18%) tested positive — on all ELISAs. The remaining 38 (43%) tested positive on one to seven ELISAs. The proportion of samples with positive results on any one ELISA ranged from 34% to 59% for patients with suspected Lyme disease and from 0% to 38% for patients with cross-reactive antibodies. Samples from healthy controls almost always had negative ELISA results.

Thirty-one of the samples from patients with suspected Lyme disease were also tested with all immunoblots. Interblot agreement was low (IgG, 30%–84%; IgM, 0%–46%), and it was no higher for recombinant antigens than for whole-cell antigens. Some samples that tested negative on all ELISAs showed blot reactivity; some that tested positive on all ELISAs tested negative on all blots.

Comment: These findings are sobering and, unfortunately, do not facilitate diagnosis of Lyme disease. Clinicians should rely on a precise clinical determination of Lyme disease, interpreting serologic test results with great caution. Clearly, several possible ELISA/blot combinations do not work together very well. Furthermore, there are true Lyme cases with positive ELISA but negative blot results (depending on the test used), and even a few with negative ELISA but positive blot results.

— Thomas Glück, MD

Published in Journal Watch Infectious Diseases August 31, 2011

Citation(s):

Ang CW et al. 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 Aug; 30:1027.

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Review and add to remarks on this article

• ELISA Negative, Blot Positive
  Phyllis C Mervine, 2 Feb 2012 12:32 PM EST
  Specialty: Unspecified
  Liegner and Kochvar presented an abstract supporting the insensitivity of ELISAs at the LDF 10th Annual International Scientific Conference on... [more]
• Serologic Tests for Lyme Disease Yield Disparate Results
  Marina Andrews, 13 Feb 2012 11:29 AM EST
  Specialty: Unspecified
  Thank you Phyllis Mervine for adding additional helpful information for physicians who rely on tests so obviously insensitive.
  
  How tragic... [more]

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