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Am J Trop Med Hyg. 2018 Apr;98(4):1056-1060. doi: 10.4269/ajtmh.17-0702. Epub 2018 Feb 22.

A Prospective Hospital Study to Evaluate the Diagnostic Accuracy of Rapid Diagnostic Tests for the Early Detection of Leptospirosis in Laos.

Author information

1
Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.
2
Microbiology Laboratory, Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Mahosot Hospital, Vientiane, Lao PDR.
3
Queensland Health Forensic and Scientific Service, WHO Collaborating Centre for Reference and Research on Leptospirosis, Brisbane, Australia.
4
Faculty of Science Health, Education and Engineering, University of the Sunshine Coast, Sippy Downs, Australia.
5
Section for Global Health, Department of Public Health, Copenhagen Centre for Disaster Research, University of Copenhagen, Copenhagen, Denmark.
6
Faculty of Health, Queensland University of Technology, Brisbane, Australia.
7
Faculty of Tropical and Infectious Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
8
Faculty of Postgraduate Studies, University of Health Sciences, Vientiane, Lao PDR.
9
National Infection Service (NIS), Public Health England (PHE), London, United Kingdom.

Abstract

Leptospirosis is a globally important cause of acute febrile illness, and a common cause of non-malarial fever in Asia, Africa, and Latin America. Simple rapid diagnostic tests (RDTs) are needed to enable health-care workers, particularly in low resource settings, to diagnose leptospirosis early and give timely targeted treatment. This study compared four commercially available RDTs to detect human IgM against Leptospira spp. in a head-to-head prospective evaluation in Mahosot Hospital, Lao PDR. Patients with an acute febrile illness consistent with leptospirosis (N = 695) were included in the study during the 2014 rainy season. Samples were tested with four RDTs: ("Test-it" [Life Assay, Cape Town, South Africa; N = 418]; "Leptorapide" [Linnodee, Ballyclare, Northern Ireland; N = 492]; "Dual Path Platform" [DPP] [Chembio, Medford, NY; N = 530]; and "SD-IgM" [Standard Diagnostics, Yongin, South Korea; N = 481]). Diagnostic performance characteristics were calculated and compared with a composite reference standard combining polymerase chain reaction (PCR) (rrs), microscopic agglutination tests (MATs), and culture. Of all patients investigated, 39/695 (5.6%) were positive by culture, PCR, or MAT. The sensitivity and specificity of the RDTs ranged greatly from 17.9% to 63.6% and 62.1% to 96.8%, respectively. None of the investigated RDTs reached a sensitivity or specificity of > 90% for detecting Leptospira infections on admission. In conclusion, our investigation highlights the challenges associated with Leptospira diagnostics, particularly in populations with multiple exposures. These findings emphasize the need for extensive prospective evaluations in multiple endemic settings to establish the value of rapid tools for diagnosing fevers to allow targeting of antibiotics.

PMID:
29488460
PMCID:
PMC5928825
DOI:
10.4269/ajtmh.17-0702
[Indexed for MEDLINE]
Free PMC Article

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