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A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a laser direct-write lateral flow device

A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a laser direct-write lateral flow device
A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a laser direct-write lateral flow device
Visceral Leishmaniasis (VL) causes high morbidity and mortality in low-to-middle-income countries worldwide. In this study, we used Laser Direct-Write (LDW) technology to develop a new Lateral Flow Device (LFD) with double-channel geometry on a low-cost paper platform as a rapid and accurate serodiagnostic assay for human VL. This Duplex VL-LFD was based on a laser-patterned microfluidic device using two recombinant Leishmania proteins, β-tubulin and LiHyp1, as novel diagnostic antigens. The VL-LFD assay was tested with blood/serum samples from patients diagnosed with VL, Tegumentary Leishmaniasis, Leishmaniasis of unknown identity, other parasitic diseases with similar clinical symptoms, i.e. Leprosy Disease and Chagas Disease, and blood from healthy donors, and compared in parallel with commercial rK39 IT-LEISH® Kit. Clinical diagnosis and real-time Polymerase Chain Reaction assay were used as reference standards. VL-LFD Sensitivity (S ± 95% Confidence Intervals (CI)) of 90.9 (78.9-100) and Specificity (Sp ± 95% CI) of 98.7 (96.1-100) outperformed the IT-LEISH® Kit [S = 77.3 (59.8-94.8), Sp = 94.7 (89.6-99.8)]. This is the first study reporting successful development of an LFD assay using the LDW technology and the VL-LFD warrants comparative testing in larger patient cohorts and in areas with endemic VL in order to improve diagnosis and disease management.
1178-1185
Humbert, Maria
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Costa, Lourena Emanuele
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Katis, Ioannis
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Fonseca Ramos, Fernanda
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Sanchez Machado, Amanda
c8ade693-7d20-4447-be3f-cde9b9784bc1
Sones, Collin
9de9d8ee-d394-46a5-80b7-e341c0eed0a8
Ferraz Coelho, Eduardo Antonio
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Christodoulides, Myron
eba99148-620c-452a-a334-c1a52ba94078
Humbert, Maria
82134d25-24b8-4fdd-bd1c-461683b5322e
Costa, Lourena Emanuele
2d7d0941-735d-4e51-8b6c-2093eb417014
Katis, Ioannis
f92dfb8f-610d-4877-83f6-fd26a571df12
Fonseca Ramos, Fernanda
a285abcc-c281-4415-85da-6c99b2dffc02
Sanchez Machado, Amanda
c8ade693-7d20-4447-be3f-cde9b9784bc1
Sones, Collin
9de9d8ee-d394-46a5-80b7-e341c0eed0a8
Ferraz Coelho, Eduardo Antonio
5e5a4bbe-2ad1-499d-aae2-bf3697f72924
Christodoulides, Myron
eba99148-620c-452a-a334-c1a52ba94078

Humbert, Maria, Costa, Lourena Emanuele, Katis, Ioannis, Fonseca Ramos, Fernanda, Sanchez Machado, Amanda, Sones, Collin, Ferraz Coelho, Eduardo Antonio and Christodoulides, Myron (2019) A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a laser direct-write lateral flow device. Emerging Microbes and Infections, 8 (1), 1178-1185. (doi:10.1080/22221751.2019.1635430).

Record type: Article

Abstract

Visceral Leishmaniasis (VL) causes high morbidity and mortality in low-to-middle-income countries worldwide. In this study, we used Laser Direct-Write (LDW) technology to develop a new Lateral Flow Device (LFD) with double-channel geometry on a low-cost paper platform as a rapid and accurate serodiagnostic assay for human VL. This Duplex VL-LFD was based on a laser-patterned microfluidic device using two recombinant Leishmania proteins, β-tubulin and LiHyp1, as novel diagnostic antigens. The VL-LFD assay was tested with blood/serum samples from patients diagnosed with VL, Tegumentary Leishmaniasis, Leishmaniasis of unknown identity, other parasitic diseases with similar clinical symptoms, i.e. Leprosy Disease and Chagas Disease, and blood from healthy donors, and compared in parallel with commercial rK39 IT-LEISH® Kit. Clinical diagnosis and real-time Polymerase Chain Reaction assay were used as reference standards. VL-LFD Sensitivity (S ± 95% Confidence Intervals (CI)) of 90.9 (78.9-100) and Specificity (Sp ± 95% CI) of 98.7 (96.1-100) outperformed the IT-LEISH® Kit [S = 77.3 (59.8-94.8), Sp = 94.7 (89.6-99.8)]. This is the first study reporting successful development of an LFD assay using the LDW technology and the VL-LFD warrants comparative testing in larger patient cohorts and in areas with endemic VL in order to improve diagnosis and disease management.

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Accepted/In Press date: 20 June 2019
e-pub ahead of print date: 5 August 2019
Published date: 2019

Identifiers

Local EPrints ID: 433286
URI: http://eprints.soton.ac.uk/id/eprint/433286
PURE UUID: 11e5de0a-674e-4c28-a46c-6079cb03ac8a
ORCID for Maria Humbert: ORCID iD orcid.org/0000-0002-5728-6981
ORCID for Ioannis Katis: ORCID iD orcid.org/0000-0002-2016-557X
ORCID for Myron Christodoulides: ORCID iD orcid.org/0000-0002-9663-4731

Catalogue record

Date deposited: 13 Aug 2019 16:30
Last modified: 26 Nov 2021 03:02

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Contributors

Author: Maria Humbert ORCID iD
Author: Lourena Emanuele Costa
Author: Ioannis Katis ORCID iD
Author: Fernanda Fonseca Ramos
Author: Amanda Sanchez Machado
Author: Collin Sones
Author: Eduardo Antonio Ferraz Coelho

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