Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis.
Background : Leptospirosis is a growing public health concern in many tropical and subtropical countries. However, its diagnosis is difficult because of non-specific symptoms and concurrent other endemic febrile diseases. In many regions, the laboratory diagnosis is not available due to a lack of pr...
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ftdoajarticles:oai:doaj.org/article:c8f15f9976524c0986daf2c6fd007667 2023-05-15T15:15:44+02:00 Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. Cyrille Goarant Pascale Bourhy Eric D'Ortenzio Sylvie Dartevelle Carine Mauron Marie-Estelle Soupé-Gilbert Lilian Bruyère-Ostells Ann-Claire Gourinat Mathieu Picardeau Faridabano Nato Suzanne Chanteau 2013-06-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0002289 https://doaj.org/article/c8f15f9976524c0986daf2c6fd007667 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC3694835?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0002289 https://doaj.org/article/c8f15f9976524c0986daf2c6fd007667 PLoS Neglected Tropical Diseases, Vol 7, Iss 6, p e2289 (2013) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2013 ftdoajarticles https://doi.org/10.1371/journal.pntd.0002289 2022-12-31T15:00:28Z Background : Leptospirosis is a growing public health concern in many tropical and subtropical countries. However, its diagnosis is difficult because of non-specific symptoms and concurrent other endemic febrile diseases. In many regions, the laboratory diagnosis is not available due to a lack of preparedness and simple diagnostic assay or difficult access to reference laboratories. Yet, an early antibiotic treatment is decisive to the outcome. The need for Rapid Diagnostic Tests (RDTs) for bedside diagnosis of leptospirosis has been recognized. We developed a vertical flow immunochromatography strip RDT detecting anti-Leptospira human IgM and evaluated it in patients from New Caledonia, France, and French West Indies. Methodology/Principal Findings : Whole killed Leptospira fainei cells were used as antigen for the test line and purified human IgM as the control line. The mobile phase was made of gold particles conjugated with goat anti-human IgM. Standards for Reporting of Diagnostic Accuracy criteria were used to assess the performance of this RDT. The Microscopic Agglutination Test (MAT) was used as the gold standard with a cut-off titer of ≥400. The sensitivity was 89.8% and the specificity 93.7%. Positive and negative Likelihood Ratios of 14.18 and 0.108 respectively, and a Diagnostic Odds Ratio of 130.737 confirmed its usefulness. This RDT had satisfactory reproducibility, repeatability, thermal tolerance and shelf-life. The comparison with MAT evidenced the earliness of the RDT to detect seroconversion. When compared with other RDT, the Vertical Flow RDT developed displayed good diagnostic performances.This RDT might be used as a point of care diagnostic tool in limited resources countries. An evaluation in field conditions and in other epidemiological contexts should be considered to assess its validity over a wider range of serogroups or when facing different endemic pathogens. It might prove useful in endemic contexts or outbreak situations. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 7 6 e2289 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Cyrille Goarant Pascale Bourhy Eric D'Ortenzio Sylvie Dartevelle Carine Mauron Marie-Estelle Soupé-Gilbert Lilian Bruyère-Ostells Ann-Claire Gourinat Mathieu Picardeau Faridabano Nato Suzanne Chanteau Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Background : Leptospirosis is a growing public health concern in many tropical and subtropical countries. However, its diagnosis is difficult because of non-specific symptoms and concurrent other endemic febrile diseases. In many regions, the laboratory diagnosis is not available due to a lack of preparedness and simple diagnostic assay or difficult access to reference laboratories. Yet, an early antibiotic treatment is decisive to the outcome. The need for Rapid Diagnostic Tests (RDTs) for bedside diagnosis of leptospirosis has been recognized. We developed a vertical flow immunochromatography strip RDT detecting anti-Leptospira human IgM and evaluated it in patients from New Caledonia, France, and French West Indies. Methodology/Principal Findings : Whole killed Leptospira fainei cells were used as antigen for the test line and purified human IgM as the control line. The mobile phase was made of gold particles conjugated with goat anti-human IgM. Standards for Reporting of Diagnostic Accuracy criteria were used to assess the performance of this RDT. The Microscopic Agglutination Test (MAT) was used as the gold standard with a cut-off titer of ≥400. The sensitivity was 89.8% and the specificity 93.7%. Positive and negative Likelihood Ratios of 14.18 and 0.108 respectively, and a Diagnostic Odds Ratio of 130.737 confirmed its usefulness. This RDT had satisfactory reproducibility, repeatability, thermal tolerance and shelf-life. The comparison with MAT evidenced the earliness of the RDT to detect seroconversion. When compared with other RDT, the Vertical Flow RDT developed displayed good diagnostic performances.This RDT might be used as a point of care diagnostic tool in limited resources countries. An evaluation in field conditions and in other epidemiological contexts should be considered to assess its validity over a wider range of serogroups or when facing different endemic pathogens. It might prove useful in endemic contexts or outbreak situations. |
format |
Article in Journal/Newspaper |
author |
Cyrille Goarant Pascale Bourhy Eric D'Ortenzio Sylvie Dartevelle Carine Mauron Marie-Estelle Soupé-Gilbert Lilian Bruyère-Ostells Ann-Claire Gourinat Mathieu Picardeau Faridabano Nato Suzanne Chanteau |
author_facet |
Cyrille Goarant Pascale Bourhy Eric D'Ortenzio Sylvie Dartevelle Carine Mauron Marie-Estelle Soupé-Gilbert Lilian Bruyère-Ostells Ann-Claire Gourinat Mathieu Picardeau Faridabano Nato Suzanne Chanteau |
author_sort |
Cyrille Goarant |
title |
Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
title_short |
Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
title_full |
Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
title_fullStr |
Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
title_full_unstemmed |
Sensitivity and Specificity of a New Vertical Flow Rapid Diagnostic Test for the Serodiagnosis of Human Leptospirosis. |
title_sort |
sensitivity and specificity of a new vertical flow rapid diagnostic test for the serodiagnosis of human leptospirosis. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2013 |
url |
https://doi.org/10.1371/journal.pntd.0002289 https://doaj.org/article/c8f15f9976524c0986daf2c6fd007667 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 7, Iss 6, p e2289 (2013) |
op_relation |
http://europepmc.org/articles/PMC3694835?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0002289 https://doaj.org/article/c8f15f9976524c0986daf2c6fd007667 |
op_doi |
https://doi.org/10.1371/journal.pntd.0002289 |
container_title |
PLoS Neglected Tropical Diseases |
container_volume |
7 |
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6 |
container_start_page |
e2289 |
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1766346081256341504 |