|
Home
|
|
Symptoms
|
|
Live Discussion
|
|
Diagnosis
|
|
Treatment
|
|
Area Support
|
|
Library
|
|
Research
|
|
Lymelinks
|
|
Contact
|
|
Pets & Lyme
|
|
DONATIONS
|
|
Drug Info
|
|
Medical Dictionary
|
|
Board of Directors
|
|
|
No Warranties or Representations
The data and information presented in this web site are presented in good faith and believed to be accurate. Any and all liability for the content or any omissions including any inaccuracies, errors, or misstatements in such data or information is expressly disclaimed. The web site is compiled for the sole purpose of informing community members of resources and information pertaining to Lyme Borreliosis Disease and its coinfections.
The Canadian Lyme Disease Foundation, Directors and members are not liable for any direct or indirect damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action arising out of or in connection with the use or performance of information available from this website.
Consult a qualified Lyme ( Borreliosis ) Disease literate doctor for medical advice if Lyme Disease is suspect.
|
C6 Peptide ELISA still not the answer
I am responding on behalf of ILADS. The C6 peptide ELISA (see article below) was touted as a
possible "gold standard" for the diagnosis of Lyme disease. What we have
found is that the C6 has about the same sensitivity as all other ELISAs -
about 50% in the chronic Lyme disease population. This is insufficient for
a diagnostic screening test.
The MDL article claims a higher sensitivity (100%) in 52 "characterized
specimens" from Lyme patients. These appear to be acutely infected
patients. However "four false-positive C6 results were identified in
patients that had clinically and microbiologically confirmed Lyme disease
but were not detected by the CDC reference methods".
This statement casts
doubt on the nature of the patient samples because these results should not
be considered "false positive". It appears that the C6 assay works OK with
strongly positive samples, but its utility as a screening test for chronic
Lyme disease remains unproven.
A danger with this test is that physicians
(and insurance companies) will start to deny the clinical diagnosis of Lyme
disease if the C6 test is negative, with disastrous results for patients.
One interesting aspect of this study was the poor results obtained with
commercial Western blots. The results were all over the place, and the
variability shows why "two tier" testing does not work with the current
patented Western blots.
The IGeneX Western blot remains the best diagnostic
screening test for Lyme disease.
Raphael Stricker, MD
President-Elect, ILADS
450 Sutter Street
Suite 1504
San Francisco, CA 94108
Phone: (415) 399-1035
Fax: (415) 399-1057
Clin Diagn Lab Immunol. 2004 Sep;11(5):924-9.
Comparison of Western immunoblotting and the c6 lyme antibody test for
laboratory detection of lyme disease.
Mogilyansky E, Loa CC, Adelson ME, Mordechai E, Tilton RC.
Medical Diagnostic Laboratories, 133 Gaither Dr., Suite C, Mt. Laurel,
NJ 08054. rctilton@mdlab.com
Three commercial Lyme disease Western immunoblotting (WB) kits and the
C6 Borrelia burgdorferi (Lyme) enzyme-linked immunosorbent assay (ELISA)
kit were compared using two commercially available performance panels from
the Centers for Disease Control and Prevention (CDC) and Boston Biomedica
(BBI). Combined, the panels consisted of 52 characterized specimens.
Immunoglobulin G (IgG) sensitivity was similar for the three WB products.
The BBI and Marblot WBs were more specific for IgG antibodies, while the
Virablot was the most sensitive for IgM antibody. The BBI WB was 100%
specific for IgM, while Marblot was 97% and Virablot was 77% specific for
IgM. The C6 ELISA was found to be 100% sensitive.
Four false-positive C6
results were identified in patients that had clinically and
microbiologically confirmed Lyme disease but were not detected by the CDC
reference methods.
No one WB product showed overall superiority. The C6
ELISA shows promise as the first ELISA for Lyme disease that would not
require a supplemental test such as a WB.
PMID: 15358654 [PubMed - in process]
|
| | |
