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Journal of Clinical Microbiology, February 2003, p. 803-809, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.803-809.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Evaluation of Four Commercially Available Rapid Serologic Tests for Diagnosis of Leptospirosis

Mary D. Bajani,1* David A. Ashford,1 Sandra L. Bragg,1 Christopher W. Woods,1,{dagger} Tin Aye,1 Richard A. Spiegel,1,2 Brian D. Plikaytis,2 Bradley A. Perkins,1 Maureen Phelan,2 Paul N. Levett,1 and Robbin S. Weyant1

Meningitis and Special Pathogens Branch,1 Biostatistics and Information Management Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 303332

Received 29 July 2002/ Returned for modification 22 October 2002/ Accepted 22 November 2002

Four rapid tests for the serologic diagnosis of leptospirosis were evaluated, and the performance of each was compared with that of the current standard, the microscopic agglutination test (MAT). The four rapid tests were a microplate immunoglobulin M (IgM)-enzyme-linked immunosorbent assay (ELISA), an indirect hemagglutination assay (IHA), an IgM dipstick assay (LDS), and an IgM dot-ELISA dipstick test (DST). A panel of 276 sera from 133 cases of leptospirosis from four different geographic locations was tested as well as 642 sera from normal individuals or individuals with other infectious or autoimmune diseases. Acute-phase sera from cases (n = 148) were collected <=14 days (median = 6.0) after the onset of symptoms, and convalescent-phase sera (n = 128) were collected >=15 days after onset (median = 29.1). By a traditional method (two-by-two contingency table), the sensitivities for detection of leptospirosis cases were 93.2% by LDS, 92.5% by DST, 86.5% by ELISA, and 79.0% by IHA. Specificity was 98.8% by DST, 97% by ELISA and MAT, 95.8% by IHA, and 89.6% by LDS. With a latent class analysis (LCA) model that included all the rapid tests and the clinical case definition, sensitivity was 95.5% by DST, 94.5% by LDS, 89.9% by ELISA, and 81.1% by IHA. The sensitivity and specificity estimated by the traditional methods were quite close to the LCA estimates. However, LCA allowed estimation of the sensitivity of the MAT (98.2%), which traditional methods do not allow. For acute-phase sera, sensitivity was 52.7% by LDS, 50.0% by DST, 48.7% by MAT and ELISA, and 38.5% by IHA. The sensitivity for convalescent-phase sera was 93.8% by MAT, 84.4% by DST, 83.6% by LDS, 75.0% by ELISA, and 67.2% by IHA. A good overall correlation with the MAT was obtained for each of the assays, with the highest concordance being with the DST (kappa value, 0.85; 95% confidence interval [CI], 0.8 to 0.90). The best correlation was between ELISA and DST (kappa value, 0.86; 95% CI, 0.81 to 0.91). False-positive LDS results were frequent (>=20%) in sera from individuals with Epstein-Barr virus, human immunodeficiency virus, and periodontal disease and from healthy volunteers. The ease of use and significantly high sensitivity and specificity of DST and ELISA make these good choices for diagnostic testing.

* Corresponding author. Mailing address: Meningitis and Special Pathogens Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, M/S G-34, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. Phone: (404) 639-2492. Fax: (404) 639-3022. E-mail: mkb9{at}cdc.gov.

{dagger} Present address: Division of Infectious Diseases, Department of Medicine, Duke University Medical Center, Durham, NC 27710.

{ddagger} Deceased.

Journal of Clinical Microbiology, February 2003, p. 803-809, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.803-809.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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