Lack of substantiation for claim that patients are often are diagnosed with CLD based on nonstandard interpretations of serology or other testing that has little or no validity
Anthony Murawski, Calm Mind Institute
6 June 2014
Having read the authors' claims that "[c]hronic Lyme disease is a term that describes a constellation of persistent symptoms in patients with or without evidence of previous Borrelia burgdorferi infection," [emphasis added] and that "patients are often are diagnosed with CLD based on nonstandard interpretations of serology or other testing that has little or no validity....," I am struck by the absence of any discussion or relevant references supporting these claims. For the latter claim, the authors cite only the IDSA and ILADS diagnostic and treatment guidelines for Lyme disease, but make no references to any published evidence concerning the accuracy of the serological testing criteria they endorse or reject. The authors' appear to use the CDC's surveillance criteria for serological test interpretation as diagnostic criteria, despite the CDC's explicit caveat that the "surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis." [1] According to the surveillance criteria, on the IgG western blot, out of 25 possible bands, ten bands were selected as reportable (18, 21, 28, 30, 39, 41, 45, 58, 66 and 93 kDa), and five of these ten bands must be positive to obtain a positive test result, whereas two or more of bands 23, 39, 41 KDa on the IgM western blot must be positive. After the CDC adopted these surveillance criteria, a study was conducted to test their accuracy. The study results were presented as an abstract and lecture at The Rheumatology Conference inTexas, chaired by Dr. Alan Steere, MD (1995 Rheumatology Symposia Abstract #1254, Dr. Paul Fawcett, et al.). With the new criteria only 20 of 66 symptomatic, pediatric patients with a history of a tick bite and bull'seyerash who were positive under the old western blot interpretation were considered positive under the new criteria. The false positive results under both criteria were zero percent. Thus, 46 symptomatic children with confirmed Lyme disease were now considered negative and disease-free. The researchers concluded that "the proposed western blot reporting criteria are grossly inadequate, because it excluded 69% of the infected children." Yet these are the very same criteria that the authors of this qualitative study rely upon for Lyme disease diagnosis. For this reason, the evidence demonstrates that the authors' assertions are unfounded.
1. CDC 2011 Case Definition, Lyme disease (Borrelia burdorferi) (http://wwwn.cdc.gov/nndss/script/casedef.aspx?CondYrID=752&DatePub=1/1/2011%2012:00:00%20AM
Lack of substantiation for claim that patients are often are diagnosed with CLD based on nonstandard interpretations of serology or other testing that has little or no validity
6 June 2014
Having read the authors' claims that "[c]hronic Lyme disease is a term that describes a constellation of persistent symptoms in patients with or without evidence of previous Borrelia burgdorferi infection," [emphasis added] and that "patients are often are diagnosed with CLD based on nonstandard interpretations of serology or other testing that has little or no validity....," I am struck by the absence of any discussion or relevant references supporting these claims. For the latter claim, the authors cite only the IDSA and ILADS diagnostic and treatment guidelines for Lyme disease, but make no references to any published evidence concerning the accuracy of the serological testing criteria they endorse or reject. The authors' appear to use the CDC's surveillance criteria for serological test interpretation as diagnostic criteria, despite the CDC's explicit caveat that the "surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis." [1] According to the surveillance criteria, on the IgG western blot, out of 25 possible bands, ten bands were selected as reportable (18, 21, 28, 30, 39, 41, 45, 58, 66 and 93 kDa), and five of these ten bands must be positive to obtain a positive test result, whereas two or more of bands 23, 39, 41 KDa on the IgM western blot must be positive. After the CDC adopted these surveillance criteria, a study was conducted to test their accuracy. The study results were presented as an abstract and lecture at The Rheumatology Conference inTexas, chaired by Dr. Alan Steere, MD (1995 Rheumatology Symposia Abstract #1254, Dr. Paul Fawcett, et al.). With the new criteria only 20 of 66 symptomatic, pediatric patients with a history of a tick bite and bull'seyerash who were positive under the old western blot interpretation were considered positive under the new criteria. The false positive results under both criteria were zero percent. Thus, 46 symptomatic children with confirmed Lyme disease were now considered negative and disease-free. The researchers concluded that "the proposed western blot reporting criteria are grossly inadequate, because it excluded 69% of the infected children." Yet these are the very same criteria that the authors of this qualitative study rely upon for Lyme disease diagnosis. For this reason, the evidence demonstrates that the authors' assertions are unfounded.
1. CDC 2011 Case Definition, Lyme disease (Borrelia burdorferi) (http://wwwn.cdc.gov/nndss/script/casedef.aspx?CondYrID=752&DatePub=1/1/2011%2012:00:00%20AM
Sincerely,
Anthony Murawski
Competing interests
The author has no competing interests.