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Journal of Clinical Microbiology
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Bacteriology

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

Mary D. Bajani, David A. Ashford, Sandra L. Bragg, Christopher W. Woods, Tin Aye, Richard A. Spiegel, Brian D. Plikaytis, Bradley A. Perkins, Maureen Phelan, Paul N. Levett, Robbin S. Weyant
Mary D. Bajani
1Meningitis and Special Pathogens Branch
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  • For correspondence: mkb9@cdc.gov
David A. Ashford
1Meningitis and Special Pathogens Branch
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Sandra L. Bragg
1Meningitis and Special Pathogens Branch
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Christopher W. Woods
1Meningitis and Special Pathogens Branch
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Tin Aye
1Meningitis and Special Pathogens Branch
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Richard A. Spiegel
1Meningitis and Special Pathogens Branch
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Brian D. Plikaytis
2Biostatistics and Information Management Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333
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Bradley A. Perkins
1Meningitis and Special Pathogens Branch
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Maureen Phelan
2Biostatistics and Information Management Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333
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Paul N. Levett
1Meningitis and Special Pathogens Branch
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Robbin S. Weyant
1Meningitis and Special Pathogens Branch
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DOI: 10.1128/JCM.41.2.803-809.2003
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ABSTRACT

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.

  • Copyright © 2003 American Society for Microbiology
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Evaluation of Four Commercially Available Rapid Serologic Tests for Diagnosis of Leptospirosis
Mary D. Bajani, David A. Ashford, Sandra L. Bragg, Christopher W. Woods, Tin Aye, Richard A. Spiegel, Brian D. Plikaytis, Bradley A. Perkins, Maureen Phelan, Paul N. Levett, Robbin S. Weyant
Journal of Clinical Microbiology Feb 2003, 41 (2) 803-809; DOI: 10.1128/JCM.41.2.803-809.2003

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Evaluation of Four Commercially Available Rapid Serologic Tests for Diagnosis of Leptospirosis
Mary D. Bajani, David A. Ashford, Sandra L. Bragg, Christopher W. Woods, Tin Aye, Richard A. Spiegel, Brian D. Plikaytis, Bradley A. Perkins, Maureen Phelan, Paul N. Levett, Robbin S. Weyant
Journal of Clinical Microbiology Feb 2003, 41 (2) 803-809; DOI: 10.1128/JCM.41.2.803-809.2003
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KEYWORDS

Leptospira
Leptospirosis
Reagent Kits, Diagnostic

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