Diagnostic accuracy of the Leishmania OligoC-TesT and NASBA-Oligochromatography for diagnosis of leishmaniasis in Sudan

The Leishmania OligoC-TesT and NASBA-Oligochromatography (OC) were recently developed for simplified and standardised molecular detection of Leishmania parasites in clinical specimens. We here present the phase II evaluation of both tests for diagnosis of visceral leishmaniasis (VL), cutaneous leish...

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Veröffentlicht in:PLoS neglected tropical diseases 2010-08, Vol.4 (8), p.e776-e776
Hauptverfasser: Saad, Alfarazdeg A, Ahmed, Nuha G, Osman, Osman S, Al-Basheer, Ahmed Almustafa, Hamad, Awad, Deborggraeve, Stijn, Büscher, Philippe, Schoone, Gerard J, Schallig, Henk D, Laurent, Thierry, Haleem, Ahmed, Osman, Omran F, Eltom, Ahmed Mohamedain, Elbashir, Mustafa I, El-Safi, Sayda
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container_issue 8
container_start_page e776
container_title PLoS neglected tropical diseases
container_volume 4
creator Saad, Alfarazdeg A
Ahmed, Nuha G
Osman, Osman S
Al-Basheer, Ahmed Almustafa
Hamad, Awad
Deborggraeve, Stijn
Büscher, Philippe
Schoone, Gerard J
Schallig, Henk D
Laurent, Thierry
Haleem, Ahmed
Osman, Omran F
Eltom, Ahmed Mohamedain
Elbashir, Mustafa I
El-Safi, Sayda
description The Leishmania OligoC-TesT and NASBA-Oligochromatography (OC) were recently developed for simplified and standardised molecular detection of Leishmania parasites in clinical specimens. We here present the phase II evaluation of both tests for diagnosis of visceral leishmaniasis (VL), cutaneous leishmaniasis (CL) and post kala-azar dermal leishmaniasis (PKDL) in Sudan. The diagnostic accuracy of the tests was evaluated on 90 confirmed and 90 suspected VL cases, 7 confirmed and 8 suspected CL cases, 2 confirmed PKDL cases and 50 healthy endemic controls from Gedarif state and Khartoum state in Sudan. The OligoC-TesT as well as the NASBA-OC showed a sensitivity of 96.8% (95% CI: 83.8%-99.4%) on lymph node aspirates and of 96.2% (95% CI: 89.4%-98.7%) on blood from the confirmed VL cases. The sensitivity on bone marrow was 96.9% (95% CI: 89.3%-99.1%) and 95.3% (95% CI: 87.1%-98.4%) for the OligoC-TesT and NASBA-OC, respectively. All confirmed CL and PKDL cases were positive with both tests. On the suspected VL cases, we observed a positive OligoC-TesT and NASBA-OC result in 37.1% (95% CI: 23.2%-53.7%) and 34.3% (95% CI: 20.8%-50.9%) on lymph, in 72.7% (95% CI: 55.8%-84.9%) and 63.6% (95% CI: 46.6%-77.8%) on bone marrow and in 76.9% (95% CI: 49.7%-91.8%) and 69.2% (95% CI: 42.4%-87.3%) on blood. Seven out of 8 CL suspected cases were positive with both tests. The specificity on the healthy endemic controls was 90% (95% CI: 78.6%-95.7%) for the OligoC-TesT and 100% (95% CI: 92.9%-100.0%) for the NASBA-OC test. Both tests showed high sensitivity on lymph, blood and tissue scrapings for diagnosis of VL, CL and PKDL in Sudan, but the specificity for clinical VL was significantly higher with NASBA-OC.
doi_str_mv 10.1371/journal.pntd.0000776
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On the suspected VL cases, we observed a positive OligoC-TesT and NASBA-OC result in 37.1% (95% CI: 23.2%-53.7%) and 34.3% (95% CI: 20.8%-50.9%) on lymph, in 72.7% (95% CI: 55.8%-84.9%) and 63.6% (95% CI: 46.6%-77.8%) on bone marrow and in 76.9% (95% CI: 49.7%-91.8%) and 69.2% (95% CI: 42.4%-87.3%) on blood. Seven out of 8 CL suspected cases were positive with both tests. The specificity on the healthy endemic controls was 90% (95% CI: 78.6%-95.7%) for the OligoC-TesT and 100% (95% CI: 92.9%-100.0%) for the NASBA-OC test. Both tests showed high sensitivity on lymph, blood and tissue scrapings for diagnosis of VL, CL and PKDL in Sudan, but the specificity for clinical VL was significantly higher with NASBA-OC.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0000776</identifier><identifier>PMID: 20689822</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Animals ; Blood ; Blood - parasitology ; Bone marrow ; Bone Marrow - parasitology ; Disease ; Health facilities ; Humans ; Infectious Diseases/Protozoal Infections ; Leishmania ; Leishmania - isolation &amp; purification ; Leishmaniasis - diagnosis ; Lymph Nodes - parasitology ; Molecular Diagnostic Techniques - methods ; Nucleic Acid Amplification Techniques - methods ; Parasites ; Parasitic diseases ; Parasitology - methods ; Polymerase chain reaction ; Primary care ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Sudan ; Tropical diseases ; Vector-borne diseases</subject><ispartof>PLoS neglected tropical diseases, 2010-08, Vol.4 (8), p.e776-e776</ispartof><rights>2010 Saad et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Saad AA, Ahmed NG, Osman OS, Al-Basheer AA, Hamad A, et al. (2010) Diagnostic Accuracy of the Leishmania OligoC-TesT and NASBA-Oligochromatography for Diagnosis of Leishmaniasis in Sudan. 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On the suspected VL cases, we observed a positive OligoC-TesT and NASBA-OC result in 37.1% (95% CI: 23.2%-53.7%) and 34.3% (95% CI: 20.8%-50.9%) on lymph, in 72.7% (95% CI: 55.8%-84.9%) and 63.6% (95% CI: 46.6%-77.8%) on bone marrow and in 76.9% (95% CI: 49.7%-91.8%) and 69.2% (95% CI: 42.4%-87.3%) on blood. Seven out of 8 CL suspected cases were positive with both tests. The specificity on the healthy endemic controls was 90% (95% CI: 78.6%-95.7%) for the OligoC-TesT and 100% (95% CI: 92.9%-100.0%) for the NASBA-OC test. 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Fisheries Abstracts (ASFA) 1: Biological Sciences &amp; Living Resources</collection><collection>Aquatic Science &amp; Fisheries Abstracts (ASFA) 3: Aquatic Pollution &amp; Environmental Quality</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Aquatic Science &amp; Fisheries Abstracts (ASFA) Professional</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PLoS neglected tropical diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saad, Alfarazdeg A</au><au>Ahmed, Nuha G</au><au>Osman, Osman S</au><au>Al-Basheer, Ahmed Almustafa</au><au>Hamad, Awad</au><au>Deborggraeve, Stijn</au><au>Büscher, Philippe</au><au>Schoone, Gerard J</au><au>Schallig, Henk D</au><au>Laurent, Thierry</au><au>Haleem, Ahmed</au><au>Osman, Omran F</au><au>Eltom, Ahmed Mohamedain</au><au>Elbashir, Mustafa I</au><au>El-Safi, Sayda</au><au>Bates, Paul Andrew</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic accuracy of the Leishmania OligoC-TesT and NASBA-Oligochromatography for diagnosis of leishmaniasis in Sudan</atitle><jtitle>PLoS neglected tropical diseases</jtitle><addtitle>PLoS Negl Trop Dis</addtitle><date>2010-08-03</date><risdate>2010</risdate><volume>4</volume><issue>8</issue><spage>e776</spage><epage>e776</epage><pages>e776-e776</pages><issn>1935-2735</issn><issn>1935-2727</issn><eissn>1935-2735</eissn><abstract>The Leishmania OligoC-TesT and NASBA-Oligochromatography (OC) were recently developed for simplified and standardised molecular detection of Leishmania parasites in clinical specimens. We here present the phase II evaluation of both tests for diagnosis of visceral leishmaniasis (VL), cutaneous leishmaniasis (CL) and post kala-azar dermal leishmaniasis (PKDL) in Sudan. The diagnostic accuracy of the tests was evaluated on 90 confirmed and 90 suspected VL cases, 7 confirmed and 8 suspected CL cases, 2 confirmed PKDL cases and 50 healthy endemic controls from Gedarif state and Khartoum state in Sudan. The OligoC-TesT as well as the NASBA-OC showed a sensitivity of 96.8% (95% CI: 83.8%-99.4%) on lymph node aspirates and of 96.2% (95% CI: 89.4%-98.7%) on blood from the confirmed VL cases. The sensitivity on bone marrow was 96.9% (95% CI: 89.3%-99.1%) and 95.3% (95% CI: 87.1%-98.4%) for the OligoC-TesT and NASBA-OC, respectively. All confirmed CL and PKDL cases were positive with both tests. On the suspected VL cases, we observed a positive OligoC-TesT and NASBA-OC result in 37.1% (95% CI: 23.2%-53.7%) and 34.3% (95% CI: 20.8%-50.9%) on lymph, in 72.7% (95% CI: 55.8%-84.9%) and 63.6% (95% CI: 46.6%-77.8%) on bone marrow and in 76.9% (95% CI: 49.7%-91.8%) and 69.2% (95% CI: 42.4%-87.3%) on blood. Seven out of 8 CL suspected cases were positive with both tests. The specificity on the healthy endemic controls was 90% (95% CI: 78.6%-95.7%) for the OligoC-TesT and 100% (95% CI: 92.9%-100.0%) for the NASBA-OC test. Both tests showed high sensitivity on lymph, blood and tissue scrapings for diagnosis of VL, CL and PKDL in Sudan, but the specificity for clinical VL was significantly higher with NASBA-OC.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>20689822</pmid><doi>10.1371/journal.pntd.0000776</doi><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1935-2735
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issn 1935-2735
1935-2727
1935-2735
language eng
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source PubMed (Medline); MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central Open Access; Public Library of Science (PLoS)
subjects Accuracy
Animals
Blood
Blood - parasitology
Bone marrow
Bone Marrow - parasitology
Disease
Health facilities
Humans
Infectious Diseases/Protozoal Infections
Leishmania
Leishmania - isolation & purification
Leishmaniasis - diagnosis
Lymph Nodes - parasitology
Molecular Diagnostic Techniques - methods
Nucleic Acid Amplification Techniques - methods
Parasites
Parasitic diseases
Parasitology - methods
Polymerase chain reaction
Primary care
Reagent Kits, Diagnostic
Sensitivity and Specificity
Sudan
Tropical diseases
Vector-borne diseases
title Diagnostic accuracy of the Leishmania OligoC-TesT and NASBA-Oligochromatography for diagnosis of leishmaniasis in Sudan
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