title: 'Leptorapide' - a one-step assay for rapid diagnosis of human leptospirosis.
abstract: Leptospirosis is a globally important zoonotic infection caused by spirochaetes of the genus Leptospira. It is transmitted to humans by direct contact with infected animals or indirectly via contaminated water. It is mainly a problem of the resource-poor developing countries of the tropical and sub-tropical regions of the world but outbreaks due to an increase in travel and recreational activities have been reported in developed and more industrialized areas of the world. Current methods of diagnosis are costly, time-consuming and require the use of specialized laboratory equipment and personnel. The purpose of this paper is to report the validation of the 'Leptorapide®' test (Linnodee Ltd, Northern Ireland) for the diagnosis of human leptospirosis. It is a simple one-step latex agglutination assay performed using equal volumes of serum sample and antigen-bound latex beads. Evidence of leptospiral antibodies is determined within minutes. Agglutination is scored on a scale of 1-5 and the results interpreted using a score card provided with the kit. Validation has been performed with a large sample size obtained from individuals originating from various parts of the world including Brazil and India. The test has shown sensitivity and specificity values of 97·1% and 94·0%, respectively, relative to the microscopic agglutination test. The results demonstrate that Leptorapide offers a cost-effective and accurate alternative to the more historical methods of antibody detection.
authors.affiliation: Linnodee Ltd, Ballyclare, Northern Ireland.
authors.forename: T
authors.initials: T
authors.lastname: Brownlow
authors.affiliation: Linnodee Ltd, Ballyclare, Northern Ireland.
authors.forename: O V
authors.initials: OV
authors.lastname: Kavanagh
authors.affiliation: Linnodee Ltd, Ballyclare, Northern Ireland.
authors.forename: E F
authors.initials: EF
authors.lastname: Logan
authors.affiliation: Department of Biomedical Research, Royal Tropical Institute (KIT), Amsterdam, The Netherlands.
authors.forename: R A
authors.initials: RA
authors.lastname: Hartskeerl
authors.affiliation: Linnodee Ltd, Ballyclare, Northern Ireland.
authors.forename: R
authors.initials: R
authors.lastname: Savage
authors.affiliation: Leptospirosis Reference Unit, PHLS Laboratory, County Hospital, Hereford, UK.
authors.forename: M F
authors.initials: MF
authors.lastname: Palmer
authors.affiliation: Zoonoses Centre, UFPRS, Pelotas, CEP 96010-900, Brazil.
authors.forename: M
authors.initials: M
authors.lastname: Krahl
authors.affiliation: Zoonoses Centre, UFPRS, Pelotas, CEP 96010-900, Brazil.
authors.forename: D P
authors.initials: DP
authors.lastname: Mackie
authors.affiliation: OIE Leptospira Reference Laboratory, AFBI Veterinary Sciences Division, Belfast Northern Ireland.
authors.forename: W A
authors.initials: WA
authors.lastname: Ellis
mesh_terms: D006801:Humans; D007841:Latex Fixation Tests / Q000191:economics / Q000379:methods*; D007922:Leptospirosis / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
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