In a press release, Boulder Diagnostics reported the European market launch of the CE marked SpiroFind in vitro diagnostic test for the detection of active Lyme Borreliosis. The makers of the novel SpiroFind test claim it can detect active Lyme Borreliosis through all stages of disease from early disease to late and persistent manifestation.
The test is based on measuring the cellular immune response to a specific challenge with the Borrelia organism. The effectiveness of the SpiroFind test was confirmed in a clinical study at the Radboud University* Nijmegen Medical Centre, which is submitted for peer-reviewed publication and for presentation at the ECCMID conference in Berlin, Germany in April, 2013.
“We are proud to offer this important new tool for the correct diagnosis of Lyme disease”, comments Dr. Wolfgang Pieken, CEO of Boulder Diagnostics Inc., and adds “the SpiroFind test is the first method to query the trained immunity to Borrelia infection as a signal for active disease”.
“At our clinical laboratory in Mellrichstadt, Germany, we now accept whole blood samples for testing by the SpiroFind method,” states Dr. Anton Waldherr, laboratory physician of Boulder Diagnostics Europe GmbH.
Professor Leo Joosten of Raboud University has been collaborating with Boulder Diagnostics and has worked on a project by Oosten et al which may have shaped the design of this test, "The interaction between NOD2-autophagy pathway and inflammasome activation determines the chronicity of Lyme arthritis" - see this paper's full text on Pubmed. The reason why some patients may develop persisting symptoms is because of a defect in their immune system.
Looking at Dr. Joosten's long list of publications on immune factors involved in infection, one can see that he has accomplished a lot of research on cytokines, Toll-like receptors (TLRs), and biomarkers of infection and inflammation.
It also should be noted here that Raboud University has also been involved in clinical studies on the use of long term antibiotic treatment for chronic Lyme disease as the sponsor of the Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) - perhaps subjects of this study were also used to help assess this new test?
Links:
- The 23rd European Congress of Clinical Microbiology and Infectious Diseases - 2013
- Recognition of Borrelia burgdorferi by NOD2 is central for the induction of an inflammatory reaction.
- Related research news in Dutch: http://www.reumafonds.nl/informatie-voor-doelgroepen/patienten/onderzoek/overig
- Persistent Lyme Empiric Antibiotic Study Europe
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I was trying not to get too excited about this test particularly as it is another antibody test, however I was interested to read your comments and I was also interested that Lyme Disease Action thought it sufficiently interesting to post on their Facebook page.
ReplyDeleteHi Joanne,
ReplyDeleteI am not sure yet what to make of this test either and want to read more about it. I think it's important to review Dr. Joosten's research in relation to development of this test and think more documentation review is needed.
It's clear better tests are needed, and having more specificity in testing is needed if one is looking at antibodies fthat react to different genotypes/genospecies. At the same time, I am concerned that because patients can exhibit an undulating immune response that all any antibody test can provide is a snapshot in time that may not give an accurate picture of the patient's condition. This is one reason why I think retesting when one has ongoing symptoms is important.