nowy test na borelię

http://www.medscape.com/viewarticle/778482?nlid=27501_1048&src=wnl_edit_dail Medical News Lyme Culture Test Causes Uproar Janis C. Kelly Jan 30, 2013 PrintEmail Editors' Recommendations Lyme Disease Recurrences May Be Reinfections, Not Relapses Testing for Lyme Disease: Follow the Steps Chronic Lyme Disease: The Controversies and the Science Topic Alert Receive an email from Medscape whenever new articles on this topic are available. Add Lyme Disease to My Topic Alert Drug & Reference Information Ophthalmic Aspects of Lyme Disease Lyme Disease in Emergency Medicine Lyme Disease A new chapter in the Lyme disease controversy opened in September 2011 when Advanced Laboratory Services, Inc, announced the commercial availability of a new culture test for Borrelia burgdorferi. Some Lyme patient advocacy groups and physicians began encouraging patients to have the $595 test, but others are concerned about the early commercialization of the still-unvalidated test. This concern may result in changes to how the US Food and Drug Administration (FDA) regulates so-called "homebrew" or laboratory-developed tests (LDTs). Physicians on all sides of the Lyme disease arena agree that a reliable culture test for active Borrelia infection would be a breakthrough. They differ on whether it is a good idea to market a blood test to consumers before it has been validated, peer-reviewed, published, reviewed by the FDA, or widely vetted by infectious disease experts with experience in Borrelia infections. Joseph J. Burrascano Jr, MD, senior vice president of medical affairs and medical director for Advanced Research Corporation, voiced the complaint of many in the field that the 2-tier Lyme disease test approved and used by Centers for Disease Control and Prevention (CDC) relies on a serologic assay that can only indicate possible past exposure. "What is very much needed is a direct test that can indicate whether living Borrelia are present in a patient," Dr. Burrascano said. No Published Data Soon after Advanced Laboratory Services' initial public announcements about the new culture test, emails and public statements attributed to Dr. Burrascano began appearing on Lyme-related Internet sites, including comments that the culture test was approximately 94% sensitive and 100% specific. Dr. Burrascano told Medscape Medical News that the validity of the culture test was established using blood samples provided by physicians and that the identity of Borrelia was confirmed by its ability to grow in Borrelia-specific media, by its characteristic appearance on darkfield microscopy, by reacting to published Borrelia-specific polyclonal and monoclonal immunostains, by DNA polymerase chain reaction (PCR) at 2 different loci, and by direct DNA sequencing. These data are so far unpublished. According to Dr. Burrascano, "All clinical samples turned out to be B burgdorferi sensu stricto, which would be expected, as the clinical samples all came from patients who met the strict CDC surveillance case definition as having Lyme.... In addition, when a large number of normal controls were tested (well people), none of them had any positive cultures, meaning that there were no false-positives." Dr. Burrascano said that a paper reporting the data has been submitted for publication and that "2 university-based research labs are each separately well on their way in validating the results of Advanced Labs." Paul Mead, MD, MPH, chief of epidemiology and surveillance activity in the CDC's Bacterial Diseases Branch, Fort Collins, Colorado, told Medscape Medical News, "There is a long history of alternative, poorly validated tests being used to diagnose Lyme disease. Recently, we've been hearing about new blood culture techniques in which patient blood samples are incubated with an unspecified media for up to several months and then tested by polyclonal immunostaining and, in some cases, PCR assays.... We are very concerned about the accuracy of these sorts of tests. The methods are not well-described, and their validity and accuracy have not been documented either in the peer-reviewed literature or through the process of FDA clearance. We are concerned that potentially bogus tests are being marketed directly and at great expense to patients." One of the healthcare providers experiencing a surge in patient requests for the Advanced Laboratory Services test is Gary Green, MD, infectious diseases chief and clinical director of the HIV Team & Travel Clinic at Kaiser Permanente in Santa Rosa, California. Dr. Green told Medscape Medical News that many patients who request the Lyme blood culture test have symptoms they are convinced are a result of chronic Lyme disease even though they test negative on all other standard tests. Dr. Green said, "The problem with a test that has not been validated and not been tested outside the