Copyright (c) Derek Clontz/4-Page Media, Inc.
Commercial laboratories that conduct testing for Lyme disease have come under fire from the CDC on grounds that the tests may not be accurate even though Canadian and European health authorities use them, too.
The tests include:
- Urine antigen tests.
- Immuno-fluorescent “staining” for cell wall-deficient forms of Borrelia burgdorferi – the bacteria that cause Lyme disease.
- Lymphocyte transformation tests.The U.S. agencies further complain that some labs are performing so-called “polymerase chain reaction tests” for B. burgdorferi DNA on “inappropriate specimens such as blood and urine.”
Either that, or they are interpreting data “using criteria that haven’t been validated and published in peer-reviewed scientific literature,” the CDC and FDA say.
The same tests and criteria are being used to evaluate patients in Canada, Germany, and the United Kingdom.
But as one U.S. health official in Washington, D.C. snidely told National Lyme Report: “Just because the British, Germans and Canadians use them doesn’t mean we’re wrong to question their accuracy – I mean, come on … these people haven’t even figured out how to chill beer. They still drink it hot because their refrigerators are always broken.”
So where does that leave you?
In the United States, the FDA has approved 70 serologic assays to aid in the diagnosis of Lyme disease.
Recommendations for the use and interpretation of these tests include:
1. Initial testing should use an enzyme immunoassay (EIA) or immunofluorescent assay (IFA).
2. Specimens yielding positive or equivocal results should be tested further by using a standardized Western immunoblot assay.
3. Specimens negative by a sensitive EIA or IFA do not need further testing.
Ask your doctor whether his testing for Lyme disease was performed using validated methods and whether results were interpreted using government-approved guidelines.That’s no guarantee that your test results will be accurate. But it puts your doctor on notice that you expect his best work.
References
1. CDC. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR 1995;44:590–1.
2. Consensus Conference on Lyme Disease. Can Dis Wkly Rep 1991; 17:63–70.
3. Wilske B, Zöller L, Brade V, et al. MIQ 12 Lyme-Borreliose. Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik. Munich, Germany: Urban & Fischer Verlag; 2000;1–59. Guidelines available in English at http://nrz-borrelien.lmu.de/miq-lyme/index.html.
4. Robertson J, Guy E, Andrews N, et al. A European multicenter study of immunoblotting in serodiagnosis of Lyme borreliosis. J Clin Microbiol 2000;38:2097–102.
