Lyme disease testing

The March edition of Lancet Infectious diseases also published the following letters on Lyme Disease link

Lancet Infectious Diseases
Vol 6 March 2006 pages 122 to 123


Section - Reflection and Reaction

Three letters on the topic of 'Lyme disease testing' published by the Lancet
Infectious Diseases, March 2006.



(*First letter)

In the October 2005 issue of The Lancet Infectious Diseases, Roxanne Nelson
reported(1) about the unreliability of standard testing for Lyme disease.
Paul Mead, an epidemiologist at the US Centers for Disease Control and
Prevention (CDC, Atlanta, GA, USA), expressed concern about newer Lyme
disease assays "whose accuracy and clinical usefulness has not been
adequately established". Mead seems unconcerned that the CDC's reporting
methods miss more than 90% of Lyme cases.(2,3)

Lyme disease, the most prevalent vector-borne illness in the USA, has become
a major health-care problem, not because of laboratories that offer fully
approved testing with increased sensitivity, nor because of physicians who
are willing to treat Lyme patients based on clinical and laboratory
evidence. The problem lies with government agencies like the CDC that
appear to ignore the undisputed need for better testing and criticise the
messengers of Lyme awareness.

Steven E. Phillips, Joseph J. Burrascano, Richard Horowitz, Virginia R.
Savely and Raphael B. Stricker.


RBS is president of the International Lyme and Associated Diseases Society,
Bethesda, MD, USA. JJB, RH, VRS, and SEP are also at the International Lyme
and Associated Diseases Society.
Correspondence to: Dr. Raphael B Stricker, International Lyme and Associated
Diseases Society, PO Box 341461, Bethesda, MD 20827-1461, USA.
rstricker@usmamed.com

1 Nelson R. Controversy brewing over Lyme disease testing. Lancet Infect
Dis 2005; 5:605.

2 Meek JI, Roberts CL, Smith EV, Cartter ML. Underreporting of Lyme
disease by Connecticut physicians, 1992. J Public Health Manag Pract 1996;
2:61-65.

3 Boltri JM, Hash RB, Vogel RL. Patterns of Lyme disease diagnosis and
treatment by family physicians in a southeastern state. J Community Health
2002; 27: 395-402.



(*Third letter)

Roxanne Nelson's Newsdesk article(1) contains misleading statements
regarding the position of the US Centers for Disease Control and Prevention
(CDC).

First, there is a quotation saying: "The CDC says the two-tiered system
works for Lyme victims...who have an erythema migrans rash". In fact, the
CDC does not recommend routine serological testing of patients with erythema
migrans, in part because of low sensitivity at this early stage of
illness.(2) In the appropriate setting, such patients can be diagnosed and
treated without the delay and expense of laboratory testing.(3-5)

Second, the article states that: "In chronic or late stage Lyme disease, the
percentage of positive EIA is much lower (than 70%)". This curious
statement contradicts the preponderance of scientific literature(3-7) as
well as a basic understanding of immune responses.

Finally, there is a quotation stating that: "The CDC claims that the PCR is
not useful in the diagnosis of Lyme because of its low predictive value".
At issue is specifically the testing of blood and urine by PCR.(8) Although
PCR can be highly specific, specificity alone does not determine the
clinical utility of a test. Other factors include sensitivity,
reproducibility, correlation with clinical illness, cost, and whether the
same conclusions can be drawn based on clinical grounds or standard
serological testing. A meta-analysis and recent evaluations have concluded
that the scientific literature (not just the CDC) does not support the
diagnostic utility of blood and urine PCR as a method for diagnosing Lyme
disease.(6,9,10)

Each year the CDC conducts(7) and funds over $1 million in research to
improve Lyme disease testing. As new tests are developed, it is critical
that they be adequately validated. Misdiagnosis is never in a patient's
best interest regardless of whether they have Lyme disease or some other
condition.

Paul Mead


Correspondence to: Dr. Paul Mead, Centers for Disease Control and
Prevention, PO box 2087, Ft Collins, CO 80522, USA.
pmead@cdc.gov

1 Nelson R. Controversy brewing over Lyme disease testing. Lancet Infect
Dis 2005; 5:605.

2 Centers for Disease Control and Prevention. Lyme disease diagnosis.
http://www.cdc.gov/ncidod/dvbid/lyme/
Ld_humandisease_diagnosis.htm (accessed Jam 20, 2006).

3 Anon. Guidelines for laboratory evaluation in the diagnosis of Lyme
disease. American College of Physicians. Ann Intern Med 1997; 127:
1106-08.

4 Steere AC, Coburn J, Glickstein L. The emergence of Lyme disease. J
Clin Invest 2004; 113: 1093-101.

5 Tugwell P, Dennis DT, Weinstein A, et al. Laboratory evaluation in the
diagnosis of Lyme disease. Ann Intern Med 1997; 127:1109-23.

6 Aguero-Rosenfeld ME, Wang G, Schwartz I, Wormser GP. Diagnosis of lyme
borreliosis. Clin Microbiol Rev 2005; 18: 484-509.

7 Bacon RM, Biggerstaff BJ, Schriefer ME, et al. Serodiagnosis of Lyme
disease by kinetic enzyme-linked immunosorbent assay using recombinant VlsE1
or peptide antigens of Borrelia burgdorferi compared with 2-tiered testing
using whole-cell lysates. J Infect Dis 2003; 189: 1187-99.

8 CDC. Notice to readers: caution regarding testing for Lyme disease.
MMWR Morb Martal Wkly Rep 2005; 54:125.

9 Dumler JS. Molecular diagnosis of Lyme disease: review and
meta-analysis. Mol Diagn 2001; 6: 1-11.

10 Rauter C, Mueller M, Diterich I, et al. Critical evaluation of
urine-based PCR assay for diagnosis of Lyme borreliosis. Clin Diagn Lab
Immunol 2005; 12: 910-17.

The LDA also had a letter published in the Lancet, click here.

This was released in response to the article "Controversy brewing over Lyme disease testing."

October 2005 Lancet Infectious Diseases. 2005;5:605 Nelson R Text