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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.
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*Note: A misconception about Western Blots is that they have as many false positives as false negatives.
This is not true. False positives based on species specific bands are rare. False negatives are more
prevalent much to the dismay of victims looking for validation.
Wien Klin Wochenschr. 2002 Jul 31;114(13-14):591-600. Related Articles, Links
Quality of Lyme disease serology. Lessons from the German Proficiency Testing Program 1999-2001. A preliminary report.
Hunfeld KP, Stanek G, Straube E, Hagedorn HJ, Schorner C, Muhlschlegel F, Brade V.
Central Laboratory of the German Proficiency Testing Program for Bacteriological Infection Serology, Institute of Medical
Microbiology, University Hospital of Frankfurt/Main, Germany. K.Hunfeld@em.uni-frankfurt.de
OBJECTIVE:
External quality control surveys are an important tool in regulating the quality of infection
serology in general and of borreliosis serology in particular. We report on the results of a Lyme disease proficiency
testing program which is regularly organised twice a year by our institutions in close cooperation with the Institute
of Standardisation in the Medical Laboratory (INSTAND).
METHODS:
From 1999 to 2001, between 226 and 337
microbiological laboratories participated in each of the four surveys that have been held so far. In addition, between
23 and 30 laboratories from 13 other European countries also participated in each trial. In each survey two serum
samples which had been unambiguously characterised by six reference laboratories to contain or not to contain
antibodies against the Lyme disease spirochete were distributed in order to determine the accuracy of the diagnostic
methods used in participating laboratories. The laboratories also reported interpretative statements of whether or not
the test constellation suggested a possible borrelial infection and if an early or late phase of the specific antibody response
was suspected.
RESULTS:
Test results were found to be in part highly variable and clearly correlated with the manufacturers
and the applied test methodology. It was also clear that IgM tests were more difficult to handle than were IgG tests.
ELISA-testing was more reproducible and proved to be more sensitive and specific than IFA and IHA testing.
Quantification of test results and reporting of specific immunoblot bands also showed high variability.
Moreover, for some assays a high number of false positive and false negative test results were reported by the participants.
CONCLUSION:
In view of our results further standardisation of Lyme disease serology is not just desirable but is urgently needed.
Moreover, stronger criteria for the validation of available test kits must be applied.
Publication Types:
* Evaluation Studies
PMID: 12422607 [PubMed - indexed for MEDLINE]
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