[Skip to Content]
[Skip to Content Landing]
Article
April 1990

Serologic Tests for Lyme Disease: Interlaboratory Variability

Author Affiliations
From the Department of Pathology, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, Piscataway, NJ (Dr Krauss). Dr Luger is in private practice, Old Lyme, Conn. Dr Krauss is now with the Medical Center at Princeton (NJ).
Arch Intern Med. 1990;150(4):761-763. doi:10.1001/archinte.1990.00390160039009
Abstract

• The serologic test for the detection of antibodies to Borrelia burgdorferi is the most frequently used laboratory method for the diagnosis of Lyme disease. However, the insensitivity of the assays and the interlaboratory variability are frequent problems. To determine the extent of this variability, one aliquot of serum from each of nine patients with a history of Lyme disease was sent to nine reference laboratories, including national, university, state, and local hospital laboratories. A second aliquot of the original serum was submitted 2 weeks later. Wide variability among laboratories was observed, ranging from a university laboratory that detected antibody to B burgdorferi (IgG or IgM) in 18 of 18 specimens, to a state laboratory that detected antibody in only 8 of 18 specimens. Detection of IgM specific antibodies showed similar variability (range, 2 to 10 of 18). There were eight instances of a fourfold or greater change in titer between the aliquots sent 2 weeks apart, although only three of these were an increase in titer. These results indicate the need for standardization of the assays and the availability of national reference material. It is recommended that the results of serologic testing should not be relied on as the sole criteria in making the diagnosis of Lyme disease.

(Arch Intern Med. 1990;150:761-763)

References
1.
Steere AC, Malawista SE, Snydman DR, et al.  Lyme arthritis: an epidemic of oligoarticular arthritis in children and adults in three Connecticut communities .  Arthritis Rheum . 1977;20:7-17.Crossref
2.
Steere AC, Grodzicki RL, Kornblatt AN, et al.  The spirochetal etiology of Lyme disease .  N Engl J Med . 1983;308:733-740.Crossref
3.
Reik L, Steere AC, Bartenhagen NH, Shope RE, Malawista SE.  Neurologic abnormalities of Lyme disease .  Medicine . 1979;58:281-294.Crossref
4.
Steere AC, Batsford WP, Weinberg M, et al.  Lyme carditis: cardiac abnormalities of Lyme disease .  Ann Intern Med . 1980;93:8-16.Crossref
5.
Steere AC, Gibofsky A, Patarroyo ME, Winchester RJ, Hardin JA, Malawista SE.  Chronic Lyme arthritis: clinical and immunogenetic differentiation from rheumatoid arthritis .  Ann Intern Med . 1979;90:896-901.Crossref
6.
Burgdorfer W, Barbour AGH, Hayes SF, Benach JL, Grunwaldt E, David JP.  Lyme disease: a tick-borne spirochetosis:  Science . 1982;216:1317-1319.Crossref
7.
Centers for Disease Control.  Update: Lyme disease—United States, 1984 .  MMWR . 1984;33:268-270.
8.
Wilkinson HW, Russell H, Sampson JS.  Caveats on using nonstandardized serologic tests for Lyme disease .  J Clin Microbiol . 1985;21:291-292.
9.
Russell H, Sampson JS, Schmid GP, Wilkinson HW, Plikaytis B.  Enzyme-linked immunosorbent assay and indirect immunofluorescence assay for Lyme disease .  J Infect Dis . 1984;149:465-470.Crossref
10.
Hedberg CW, Osterholm MT, MacDonald KL, White KE.  An interlaboratory study of antibody to Borrelia burgdorferi .  J Infect Dis . 1987;155:1325-1327.Crossref
11.
Magnarelli LA, Ryan RW, Rilton RC, et al.  Lyme disease—Connecticut .  JAMA . 1988;259:1147-1148.Crossref
12.
Craft JE, Grodzicki RL, Steere AC.  Antibody response in Lyme disease: evaluation of tests .  J Infect Dis . 1984;149:789-795.Crossref
13.
Grodzicki RL, Steere AC.  Comparison of immunoblotting and indirect enzyme-linked immunosorbent assay using different antigen preparations for diagnosing early Lyme disease .  J Infect Dis . 1988;157:790-797.Crossref
14.
Hansen K, Hindersson P, Strandberg Pedersen N.  Measurement of antibodies to the Borrelia burgdorferi flagellum improves serodiagnosis in Lyme disease .  J Clin Microbiol . 1988;26:338-346.
15.
Berardi VP, Weeks KE, Steere AC.  Serodiagnosis of early Lyme disease: analysis of IgM and IgG antibody responses by using an antibody-capture enzyme immunoassay .  J Infect Dis . 1988;158:754-760.Crossref
×