Notice to Readers
Recommendations for Test Performance and Interpretation from the
Second National Conference on Serologic Diagnosis of Lyme Disease
The Association of State and Territorial Public Health
Laboratory Directors, CDC, the Food and Drug Administration, the
National Institutes of Health, the Council of State and Territorial
Epidemiologists, and the National Committee for Clinical Laboratory
Standards cosponsored the Second National Conference on Serologic
Diagnosis of Lyme Disease held October 27-29, 1994. Conference
recommendations were grouped into four categories: 1) serologic
test performance and interpretation, 2) quality-assurance
practices, 3) new test evaluation and clearance, and 4)
communication of developments in Lyme disease (LD) testing. This
report presents recommendations for serologic test performance and
interpretation, which included substantial changes in the
recommended tests and their interpretation for the serodiagnosis of
LD.
A two-test approach for active disease and for previous
infection using a sensitive enzyme immunoassay (EIA) or
immunofluorescent assay (IFA) followed by a Western immunoblot was
the algorithm of choice. All specimens positive or equivocal by a
sensitive EIA or IFA should be tested by a standardized Western
immunoblot. Specimens negative by a sensitive EIA or IFA need not
be tested further. When Western immunoblot is used during the first
4 weeks of disease onset (early LD), both immuno- globulin M (IgM)
and immunoglobulin G (IgG) procedures should be performed. A
positive IgM test result alone is not recommended for use in
determining active disease in persons with illness greater than 1
month's duration because the likelihood of a false-positive test
result for a current infection is high for these persons. If a
patient with suspected early LD has a negative serology, serologic
evidence of infection is best obtained by testing of paired acute-
and convalescent-phase serum samples. Serum samples from persons
with disseminated or late-stage LD almost always have a strong IgG
response to Borrelia burgdorferi antigens.
It was recommended that an IgM immunoblot be considered
positive if two of the following three bands are present: 24 kDa
(OspC) * , 39 kDa (BmpA), and 41 kDa (Fla) (1). It was further
recommended that an that IgG immunoblot be considered positive if
five of the following 10 bands are present: 18 kDa, 21 kDa (OspC)
*,
28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa (not
GroEL), 66 kDa, and 93 kDa (2).
The details of both plenary sessions and the work group
deliberations are included in the publication of the proceedings,
which is available from the Association of State and Territorial
Public Health Laboratory Directors; telephone (202) 822-5227.
References
Engstrom SM, Shoop E, Johnson RC. Immunoblot interpretation
criteria for serodiagnosis of early Lyme disease. J Clin Microbiol
1995;33:419-22.
Dressler F, Whelan JA, Reinhart BN, Steere AC. Western blotting
in the serodiagnosis of Lyme disease. J Infect Dis
1993;167:392-400.
The apparent molecular mass of OspC is dependent on the strain of
B. burgdorferi being tested. The 24 kDa and 21 kDa proteins
referred to are the same.
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