Validation of Two Rapid Diagnostic Tests for Visceral Leishmaniasis in Kenya
Publication Date
September 26, 2013
Journal
PLOS Neglected Tropical Diseases
Authors
Jane Mbui, Monique Wasunna, Manica Balasegaram, Adrian Laussermayer, et al
Volume
7
Issue
9
Pages
e2441
DOI
https://dx.plos.org/10.1371/journal.pntd.0002441
Publisher URL
http://journals.plos.org/plosntds/article?id=10.1371%2Fjournal.pntd.0002441
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/24086782
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3784478
Europe PMC
http://europepmc.org/abstract/MED/24086782
Web of Science
000324920800045
Scopus
84884693534
Mendeley
http://www.mendeley.com/research/validation-two-rapid-diagnostic-tests-visceral-leishmaniasis-kenya
Events
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Mendeley | Further Information

{"title"=>"Validation of Two Rapid Diagnostic Tests for Visceral Leishmaniasis in Kenya", "type"=>"journal", "authors"=>[{"first_name"=>"Jane", "last_name"=>"Mbui", "scopus_author_id"=>"9434981500"}, {"first_name"=>"Monique", "last_name"=>"Wasunna", "scopus_author_id"=>"6506541162"}, {"first_name"=>"Manica", "last_name"=>"Balasegaram", "scopus_author_id"=>"56228152600"}, {"first_name"=>"Adrian", "last_name"=>"Laussermayer", "scopus_author_id"=>"55866170300"}, {"first_name"=>"Rashid", "last_name"=>"Juma", "scopus_author_id"=>"6508069241"}, {"first_name"=>"Simon Njoroge", "last_name"=>"Njenga", "scopus_author_id"=>"57190304317"}, {"first_name"=>"George", "last_name"=>"Kirigi", "scopus_author_id"=>"6602236509"}, {"first_name"=>"Mark", "last_name"=>"Riongoita", "scopus_author_id"=>"55865743800"}, {"first_name"=>"Roberto", "last_name"=>"de la Tour", "scopus_author_id"=>"6506646282"}, {"first_name"=>"Joke", "last_name"=>"van Peteghem", "scopus_author_id"=>"18839153100"}, {"first_name"=>"Raymond", "last_name"=>"Omollo", "scopus_author_id"=>"36492111100"}, {"first_name"=>"François", "last_name"=>"Chappuis", "scopus_author_id"=>"7004412392"}], "year"=>2013, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"issn"=>"19352735", "scopus"=>"2-s2.0-84884693534", "pui"=>"369904069", "doi"=>"10.1371/journal.pntd.0002441", "isbn"=>"1935-2735 (Electronic)\\r1935-2727 (Linking)", "sgr"=>"84884693534", "pmid"=>"24086782"}, "id"=>"79a6bd7b-da3b-380c-806f-de288ef26475", "abstract"=>"BACKGROUND: Visceral leishmaniasis (VL) is a systemic parasitic disease that is fatal unless treated. In Kenya, national VL guidelines rely on microscopic examination of spleen aspirate to confirm diagnosis. As this procedure is invasive, it cannot be safely implemented in peripheral health structures, where non-invasive, accurate, easy to use diagnostic tests are needed.\\n\\nMETHODOLOGY: We evaluated the sensitivity, specificity and predictive values of two rapid diagnostic tests (RDT), DiaMed IT LEISH and Signal-KA, among consecutive patients with clinical suspicion of VL in two treatment centres located in Baringo and North Pokot District, Rift Valley province, Kenya. Microscopic examination of spleen aspirate was the reference diagnostic standard. Patients were prospectively recruited between May 2010 and July 2011.\\n\\nPRINCIPAL FINDINGS: Of 251 eligible patients, 219 patients were analyzed, including 131 VL and 88 non-VL patients. The median age of VL patients was 16 years with predominance of males (66%). None of the tested VL patients were co-infected with HIV. Sensitivity and specificity of the DiaMed IT LEISH were 89.3% (95%CI: 82.7-94%) and 89.8% (95%CI: 81.5-95.2%), respectively. The Signal KA showed trends towards lower sensitivity (77.1%; 95%CI: 68.9-84%) and higher specificity (95.5%; 95%CI: 88.7-98.7%). Combining the tests did not improve the overall diagnostic performance, as all patients with a positive Signal KA were also positive with the DiaMed IT LEISH.\\n\\nCONCLUSION/SIGNIFICANCE: The DiaMed IT LEISH can be used to diagnose VL in Kenyan peripheral health facilities where microscopic examination of spleen aspirate or sophisticated serological techniques are not feasible. There is a crucial need for an improved RDT for VL diagnosis in East Africa.", "link"=>"http://www.mendeley.com/research/validation-two-rapid-diagnostic-tests-visceral-leishmaniasis-kenya", "reader_count"=>37, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Student > Doctoral Student"=>4, "Researcher"=>4, "Student > Ph. D. Student"=>9, "Student > Postgraduate"=>2, "Student > Master"=>10, "Other"=>1, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Student > Doctoral Student"=>4, "Researcher"=>4, "Student > Ph. D. Student"=>9, "Student > Postgraduate"=>2, "Student > Master"=>10, "Other"=>1, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Mathematics"=>2, "Agricultural and Biological Sciences"=>12, "Medicine and Dentistry"=>11, "Veterinary Science and Veterinary Medicine"=>3, "Business, Management and Accounting"=>1, "Chemistry"=>1, "Social Sciences"=>2, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>11}, "Chemistry"=>{"Chemistry"=>1}, "Social Sciences"=>{"Social Sciences"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>12}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Mathematics"=>{"Mathematics"=>2}, "Unspecified"=>{"Unspecified"=>1}, "Environmental Science"=>{"Environmental Science"=>1}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>3}}, "reader_count_by_country"=>{"Brazil"=>1, "Malaysia"=>1, "Switzerland"=>1}, "group_count"=>5}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1217099"], "description"=>"<p>Abbreviations: PPV = positive predictive value, NPV = negative predictive value, CI = Confidence Interval.</p>", "links"=>[], "tags"=>["predictive", "diamed", "it-leish", "ka", "vl", "kacheliba", "rift"], "article_id"=>809123, "categories"=>["Biological Sciences"], "users"=>["Jane Mbui", "Monique Wasunna", "Manica Balasegaram", "Adrian Laussermayer", "Rashid Juma", "Simon Njoroge Njenga", "George Kirigi", "Mark Riongoita", "Roberto de la Tour", "Joke van Peteghem", "Raymond Omollo", "François Chappuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002441.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sensitivity_specificity_negative_and_positive_predictive_values_of_the_DiaMed_IT_LEISH_and_the_Signal_KA_for_VL_diagnosis_in_Kacheliba_and_Kimalel_Rift_Valley_province_Kenya_/809123", "title"=>"Sensitivity, specificity, negative and positive predictive values of the DiaMed IT-LEISH and the Signal KA for VL diagnosis in Kacheliba and Kimalel, Rift Valley province, Kenya.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-09-26 02:07:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/1217100"], "description"=>"<p>IQR = inter-quartile range.</p>*<p>p-value from t-test or Kruskal-Wallis test for continuous variables and Chi-square or Fisher Exact test for categorical variables.</p>**<p>measured between tip of spleen and left costal margin (at anterior axillary line level).</p>", "links"=>[], "tags"=>["vl", "non-vl", "patients", "kacheliba", "rift"], "article_id"=>809124, "categories"=>["Biological Sciences"], "users"=>["Jane Mbui", "Monique Wasunna", "Manica Balasegaram", "Adrian Laussermayer", "Rashid Juma", "Simon Njoroge Njenga", "George Kirigi", "Mark Riongoita", "Roberto de la Tour", "Joke van Peteghem", "Raymond Omollo", "François Chappuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002441.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_demographic_and_laboratory_characteristics_between_VL_and_non_VL_patients_in_Kacheliba_and_Kimalel_Rift_Valley_province_Kenya_/809124", "title"=>"Comparison of demographic and laboratory characteristics between VL and non-VL patients in Kacheliba and Kimalel, Rift Valley province, Kenya.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-09-26 02:07:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/1217102", "https://ndownloader.figshare.com/files/1217103"], "description"=>"<div><p>Background</p><p>Visceral leishmaniasis (VL) is a systemic parasitic disease that is fatal unless treated. In Kenya, national VL guidelines rely on microscopic examination of spleen aspirate to confirm diagnosis. As this procedure is invasive, it cannot be safely implemented in peripheral health structures, where non-invasive, accurate, easy to use diagnostic tests are needed.</p><p>Methodology</p><p>We evaluated the sensitivity, specificity and predictive values of two rapid diagnostic tests (RDT), DiaMed IT LEISH and Signal-KA, among consecutive patients with clinical suspicion of VL in two treatment centres located in Baringo and North Pokot District, Rift Valley province, Kenya. Microscopic examination of spleen aspirate was the reference diagnostic standard. Patients were prospectively recruited between May 2010 and July 2011.</p><p>Principal Findings</p><p>Of 251 eligible patients, 219 patients were analyzed, including 131 VL and 88 non-VL patients. The median age of VL patients was 16 years with predominance of males (66%). None of the tested VL patients were co-infected with HIV. Sensitivity and specificity of the DiaMed IT LEISH were 89.3% (95%CI: 82.7–94%) and 89.8% (95%CI: 81.5–95.2%), respectively. The Signal KA showed trends towards lower sensitivity (77.1%; 95%CI: 68.9–84%) and higher specificity (95.5%; 95%CI: 88.7–98.7%). Combining the tests did not improve the overall diagnostic performance, as all patients with a positive Signal KA were also positive with the DiaMed IT LEISH.</p><p>Conclusion/Significance</p><p>The DiaMed IT LEISH can be used to diagnose VL in Kenyan peripheral health facilities where microscopic examination of spleen aspirate or sophisticated serological techniques are not feasible. There is a crucial need for an improved RDT for VL diagnosis in East Africa.</p></div>", "links"=>[], "tags"=>["diagnostic", "visceral", "leishmaniasis"], "article_id"=>809126, "categories"=>["Biological Sciences"], "users"=>["Jane Mbui", "Monique Wasunna", "Manica Balasegaram", "Adrian Laussermayer", "Rashid Juma", "Simon Njoroge Njenga", "George Kirigi", "Mark Riongoita", "Roberto de la Tour", "Joke van Peteghem", "Raymond Omollo", "François Chappuis"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002441.s001", "https://dx.doi.org/10.1371/journal.pntd.0002441.s002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Validation_of_Two_Rapid_Diagnostic_Tests_for_Visceral_Leishmaniasis_in_Kenya_/809126", "title"=>"Validation of Two Rapid Diagnostic Tests for Visceral Leishmaniasis in Kenya", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2013-09-26 02:07:46"}

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