Controversy brewing over Lyme disease testing.docVIP

Controversy brewing over Lyme disease testing Roxanne Nelson Available online 23 September 2005.  Lyme disease, a bacterial infection transmitted by ticks, is difficult to diagnose because its symptoms mimic those of other disorders. Although diagnostic tests are currently available, there is a growing controversy over the unreliability of standard testing, as well as the use of new testing approaches. The US Centers for Disease Control and Prevention (CDC) has cautioned against using assays whose accuracy and clinical usefulness has not been adequately established. These include urine antigen tests, immunofluorescent staining for cell wall-deficient forms of Borrelia burgdorferi, and PCR tests that are done on inappropriate specimens such as blood and urine. “Based on calls and complaints that we get from patients, and also based on what were hearing from colleagues in Europe, we are concerned that some patients are being misdiagnosed or potentially misdiagnosed and mistreated, as a result of unfounded reliance on these tests”, says Paul Mead, a medical epidemiologist at the CDC. CDC guidelines recommend a two-test approach using a sensitive enzyme immunoassay (EIA) or immunofluorescent assay, to be followed by a western immunoblot if results are positive. But Lyme disease is often mistaken for other ailments, and conversely, serious illnesses such as amyotrophic lateral sclerosis have been misdiagnosed as Lyme disease. Nick Harris, the founder and chief executive of IGeneX, a reference laboratory that does PCR testing for Lyme disease on a variety of specimens, is among those who feel that the CDCs guidelines are actually part of the reason for the high rate of misdiagnosis. “The CDC says the two-tiered system works for Lyme victims within 3 to 4 months of a tick bite and for those who have an erythema migrans rash”, he points out. “But more than 50% of the patients do not remember being bitten by a tick and more than 50% do not get the rash.” Any screenin