A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device
ABSTRACTVisceral 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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2019-01-01
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| Series: | Emerging Microbes and Infections |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2019.1635430 |
| _version_ | 1797385756838199296 |
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| author | Maria Victoria Humbert Lourena Emanuele Costa Ioannis Katis Fernanda Fonseca Ramos Amanda Sanchéz Machado Collin Sones Eduardo Antonio Ferraz Coelho Myron Christodoulides |
| author_facet | Maria Victoria Humbert Lourena Emanuele Costa Ioannis Katis Fernanda Fonseca Ramos Amanda Sanchéz Machado Collin Sones Eduardo Antonio Ferraz Coelho Myron Christodoulides |
| author_sort | Maria Victoria Humbert |
| collection | DOAJ |
| description | ABSTRACTVisceral 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. |
| first_indexed | 2024-03-08T21:58:52Z |
| format | Article |
| id | doaj.art-4b2de46f793d4934a8035a6ebb192c37 |
| institution | Directory Open Access Journal |
| issn | 2222-1751 |
| language | English |
| last_indexed | 2024-03-08T21:58:52Z |
| publishDate | 2019-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj.art-4b2de46f793d4934a8035a6ebb192c372023-12-19T16:09:58ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512019-01-01811178118510.1080/22221751.2019.1635430A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow DeviceMaria Victoria Humbert0Lourena Emanuele Costa1Ioannis Katis2Fernanda Fonseca Ramos3Amanda Sanchéz Machado4Collin Sones5Eduardo Antonio Ferraz Coelho6Myron Christodoulides7Neisseria Research Group, Molecular Microbiology, School of Clinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton General Hospital, Southampton, EnglandPrograma de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilOptoelectronics Research Centre, University of Southampton, Southampton, EnglandPrograma de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilPrograma de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilOptoelectronics Research Centre, University of Southampton, Southampton, EnglandPrograma de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilNeisseria Research Group, Molecular Microbiology, School of Clinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton General Hospital, Southampton, EnglandABSTRACTVisceral 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.https://www.tandfonline.com/doi/10.1080/22221751.2019.1635430Leishmania infantumVisceral LeishmaniasisLaser Direct-WriteLateral Flow Deviceimmunochromatographic test |
| spellingShingle | Maria Victoria Humbert Lourena Emanuele Costa Ioannis Katis Fernanda Fonseca Ramos Amanda Sanchéz Machado Collin Sones Eduardo Antonio Ferraz Coelho Myron Christodoulides A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device Emerging Microbes and Infections Leishmania infantum Visceral Leishmaniasis Laser Direct-Write Lateral Flow Device immunochromatographic test |
| title | A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device |
| title_full | A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device |
| title_fullStr | A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device |
| title_full_unstemmed | A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device |
| title_short | A rapid diagnostic test for human Visceral Leishmaniasis using novel Leishmania antigens in a Laser Direct-Write Lateral Flow Device |
| title_sort | rapid diagnostic test for human visceral leishmaniasis using novel leishmania antigens in a laser direct write lateral flow device |
| topic | Leishmania infantum Visceral Leishmaniasis Laser Direct-Write Lateral Flow Device immunochromatographic test |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2019.1635430 |
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