Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis

Abstract Leptospirosis is a common life-threatening disease worldwide. However, its diagnosis is frequently ineffective because the gold standard bacterial culture and microscopic agglutination test (MAT) are usually positive 1–2 weeks after the disease onset. We thus developed an immunochromatograp...

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Autores principales:	Galayanee Doungchawee, Direk Sutdan, Kannika Niwatayakul, Tasanee Inwisai, Athisri Sitthipunya, Naphatsawan Boonsathorn, Titipatima Sakulterdkiat, Worachart Sirawaraporn, Visith Thongboonkerd
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2017
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1510e66f8bee4c3baf68da6262f7f23d
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spelling	oai:doaj.org-article:1510e66f8bee4c3baf68da6262f7f23d2021-12-02T16:07:58ZDevelopment and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis10.1038/s41598-017-02654-82045-2322https://doaj.org/article/1510e66f8bee4c3baf68da6262f7f23d2017-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-02654-8https://doaj.org/toc/2045-2322Abstract Leptospirosis is a common life-threatening disease worldwide. However, its diagnosis is frequently ineffective because the gold standard bacterial culture and microscopic agglutination test (MAT) are usually positive 1–2 weeks after the disease onset. We thus developed an immunochromatographic assay (LEPkit) to detect serum anti-leptospiral lipopolysaccharide (LPS) IgM for rapid diagnosis of acute leptospirosis. Using referenced sera of 77 leptospirosis and 91 non-leptospirosis cases, LEPkit yielded 97.4% sensitivity, 94.5% specificity, 93.8 positive predictive value (PPV), 97.7% negative predictive value (NPV), and 95.8% accuracy. The stability of this kit stored for up to 18 months and its reproducibility were confirmed. Testing in 74 new cases using samples at admission-phase and subsequent paired samples (total n = 135), overall sensitivity was 98.5%, whereas that of culture and single MAT (≥1:400) was 15.6% and 35.6%, respectively. When only the samples at admission-phase were used (n = 74), the sensitivity remained at 98.7%, whereas that of culture and single MAT (≥1:400) was 28.4% and 13.5%, respectively. In summary, our LEPkit was far more effective than any conventional methods for the diagnosis of acute leptospirosis, especially within the first few days after the disease onset. The ease of use, stability and reproducibility further enhance its feasibility for clinical use on-site.Galayanee DoungchaweeDirek SutdanKannika NiwatayakulTasanee InwisaiAthisri SitthipunyaNaphatsawan BoonsathornTitipatima SakulterdkiatWorachart SirawarapornVisith ThongboonkerdNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-9 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Galayanee Doungchawee Direk Sutdan Kannika Niwatayakul Tasanee Inwisai Athisri Sitthipunya Naphatsawan Boonsathorn Titipatima Sakulterdkiat Worachart Sirawaraporn Visith Thongboonkerd Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
description	Abstract Leptospirosis is a common life-threatening disease worldwide. However, its diagnosis is frequently ineffective because the gold standard bacterial culture and microscopic agglutination test (MAT) are usually positive 1–2 weeks after the disease onset. We thus developed an immunochromatographic assay (LEPkit) to detect serum anti-leptospiral lipopolysaccharide (LPS) IgM for rapid diagnosis of acute leptospirosis. Using referenced sera of 77 leptospirosis and 91 non-leptospirosis cases, LEPkit yielded 97.4% sensitivity, 94.5% specificity, 93.8 positive predictive value (PPV), 97.7% negative predictive value (NPV), and 95.8% accuracy. The stability of this kit stored for up to 18 months and its reproducibility were confirmed. Testing in 74 new cases using samples at admission-phase and subsequent paired samples (total n = 135), overall sensitivity was 98.5%, whereas that of culture and single MAT (≥1:400) was 15.6% and 35.6%, respectively. When only the samples at admission-phase were used (n = 74), the sensitivity remained at 98.7%, whereas that of culture and single MAT (≥1:400) was 28.4% and 13.5%, respectively. In summary, our LEPkit was far more effective than any conventional methods for the diagnosis of acute leptospirosis, especially within the first few days after the disease onset. The ease of use, stability and reproducibility further enhance its feasibility for clinical use on-site.
format	article
author	Galayanee Doungchawee Direk Sutdan Kannika Niwatayakul Tasanee Inwisai Athisri Sitthipunya Naphatsawan Boonsathorn Titipatima Sakulterdkiat Worachart Sirawaraporn Visith Thongboonkerd
author_facet	Galayanee Doungchawee Direk Sutdan Kannika Niwatayakul Tasanee Inwisai Athisri Sitthipunya Naphatsawan Boonsathorn Titipatima Sakulterdkiat Worachart Sirawaraporn Visith Thongboonkerd
author_sort	Galayanee Doungchawee
title	Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
title_short	Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
title_full	Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
title_fullStr	Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
title_full_unstemmed	Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis
title_sort	development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide igm in acute leptospirosis
publisher	Nature Portfolio
publishDate	2017
url	https://doaj.org/article/1510e66f8bee4c3baf68da6262f7f23d
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Development and evaluation of an immunochromatographic assay to detect serum anti-leptospiral lipopolysaccharide IgM in acute leptospirosis

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