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Journal of Clinical Microbiology, April 2002, p. 1464-1469, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1464-1469.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of Eight Rapid Screening Tests for Acute Leptospirosis in Hawaii

Paul V. Effler,1* April K. Bogard,1 Harry Y. Domen,2 Alan R. Katz,3 Henry Y. Higa,2 and David M. Sasaki1

Epidemiology Branch, Communicable Disease Division, Hawaii State Department of Health, Honolulu, Hawaii 96813 ,1 Medical Microbiology Branch, State Laboratories Division, Hawaii State Department of Health, Pearl City, Hawaii 96782,2 Department of Public Health Sciences and Epidemiology, John A. Burns School of Medicine, University of Hawaii, Honolulu, Hawaii 968223

Received 30 July 2001/ Returned for modification 29 November 2001/ Accepted 30 December 2001

Leptospirosis is a major public health problem throughout the world. Clinical recognition of leptospirosis is challenging, and the definitive serologic diagnostic assay, the microscopic agglutination test, is time-consuming and difficult to conduct. Various serologic screening tests have been developed, but their performance among ill persons in the United States has not been established. Eight screening tests were compared using 379 serum samples obtained in 1998 and 1999 from a series of 236 patients (33 with confirmed infection). The median number of days between illness onset and specimen collection was 9. The overall sensitivity, by specimen, for each test was as follows: indirect hemagglutination assay (MRL Diagnostics, Cypress, Calif.), 29%; INDX Leptospira Dip-S-Tick (PanBio InDx, Inc., Baltimore, Md.), 52%; Biognost IgM IFA test (Bios GmbH Labordiagnostik, Gräfelfing, Germany), 40%; Biolisa IgM ELISA (Bios GmbH, Labordiagnostik), 48%; Leptospira IgM ELISA (PanBio Pty Ltd., Brisbane, Australia), 36%; SERION ELISA classic Leptospira (Institut Virion•Serion GmbH, Würzburg, Germany), 48%; LEPTO Dipstick(Organon-Teknika, Ltd., Amsterdam, The Netherlands), 34%; Biosave latex agglutination test (LATEX; Bios GmbH Labordiagnostik), 86%. Test specificity ranged from 85 to 100% among all tests except LATEX, for which the specificity was significantly lower, at 10%. Test sensitivity was particularly low (<25%) for all tests (except LATEX) on specimens collected during the first week of illness. This is the most comprehensive field trial of leptospirosis screening tests reported to date. The data indicate that immunoglobulin M detection tests have limited utility for diagnosing leptospirosis during the initial evaluation of patients seen in Hawaii, a time when important therapeutic decisions are made. Improved leptospirosis screening tests are needed.

* Corresponding author. Mailing address: Hawaii State Department of Health, 1250 Punchbowl St., Room 444, Honolulu, HI 96813. Phone: (808) 586-4586. Fax: (808) 586-8347. E-mail: pveffler{at}mail.health.state.hi.us.

Journal of Clinical Microbiology, April 2002, p. 1464-1469, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1464-1469.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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