{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T17:15:42Z","timestamp":1790270142218,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2006,11,27]],"date-time":"2006-11-27T00:00:00Z","timestamp":1164585600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2007,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>In this phase III trial for diagnostics for visceral leishmaniasis (VL) in India, we compared parasitological diagnosis with several serological tests: direct agglutination test (freeze dried; DAT\u2010FD), rK\u201039 strip test, rK\u201026 strip test and a latex agglutination test for antigen detection in urine (KAtex) in 452 subjects from the endemic regions of Bihar, India. The subjects were segregated into four categories: 230 confirmed patients, 52 probable cases, 70 non\u2010cases and 100 healthy endemic controls. The first two groups were used for estimating sensitivity, the latter two for specificity. Sensitivity of DAT\u2010FD was 98.9%, rK\u201039: 98.9%, KAtex: 67.0% and rK\u201026: 21.3%. Sensitivity of DAT\u2010FD on blood taken on filter paper (DAT\u2010FDF) was 99.3%, which was comparable with that using serum. Specificity of serological tests was comparable and high (DAT\u2010FD and DAT\u2010FDF: 94%, rK\u201039 strip test: 97%, KAtex: 99% and rK\u201026 strip test: 100%). The classical \u2018gold standard\u2019 parasitological demonstration in splenic smear performed poorly as it missed 18.4% of cases that benefited from VL treatment. Reproducibility of the serological tests between field and central laboratories was excellent (<jats:italic>\u03ba<\/jats:italic>\u2003=\u20031.0, 0.99, 0.96 and 0.94 respectively for microscopy, DAT\u2010FD, rK\u201039 strip test and rK\u201026 strip test). A high degree of agreement was observed between DAT\u2010FD and rK\u201039 strip test (<jats:italic>\u03ba<\/jats:italic>\u2003=\u20030.986). Although DAT\u2010FD and rK\u201039 strip test were highly sensitive with excellent specificity, the ease of use of the latter makes it most suitable for the diagnosis of VL in the field conditions.<\/jats:p>","DOI":"10.1111\/j.1365-3156.2006.01775.x","type":"journal-article","created":{"date-parts":[[2006,11,27]],"date-time":"2006-11-27T19:52:31Z","timestamp":1164657151000},"page":"284-289","source":"Crossref","is-referenced-by-count":64,"title":["Comparative evaluation of parasitology and serological tests in the diagnosis of visceral leishmaniasis in India: a phase III diagnostic accuracy study"],"prefix":"10.1111","volume":"12","author":[{"given":"S.","family":"Sundar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. K.","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. 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D.","family":"Manandhar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Boelaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Rai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2006,11,27]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19991130)18:22<2987::AID-SIM205>3.0.CO;2-B"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0001-706X(00)00155-8"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0166-6851(99)00098-5"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.1983.32.475"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1179\/000349804225011488"},{"key":"e_1_2_6_7_1","first-page":"759","article-title":"K39 strip test \u2013 easy, reliable and cost\u2010effective field diagnosis for visceral leishmaniasis in India","volume":"51","author":"Goswami RP","year":"2003","journal-title":"Journal of the Association of Physicians of India"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(02)00347-X"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1179\/000349802125000475"},{"key":"e_1_2_6_10_1","first-page":"73","article-title":"Fine needle aspiration cytology of the spleen in visceral leishmaniasis","volume":"37","author":"Haque I","year":"1993","journal-title":"Acta Cytologica"},{"key":"e_1_2_6_11_1","first-page":"503","article-title":"Katex for the diagnosis of human visceral leishmaniasis","volume":"61","author":"Hommel M","year":"2001","journal-title":"M\u00e9decine Tropicale: Revue du Corps de Sant\u00e9 Colonial"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.2307\/2529310"},{"key":"e_1_2_6_13_1","doi-asserted-by":"crossref","first-page":"296","DOI":"10.4269\/ajtmh.1983.32.296","article-title":"Comparison of microscopy and culture in the detection of Leishmania donovani from splenic aspirates","volume":"32","author":"Lightner LK","year":"1983","journal-title":"American Journal of Tropical Medicine and Hygiene"},{"key":"e_1_2_6_14_1","doi-asserted-by":"crossref","first-page":"1742","DOI":"10.1128\/jcm.33.7.1742-1745.1995","article-title":"Leish\u2010KIT, a stable direct agglutination test based on freeze\u2010dried antigen for serodiagnosis of visceral leishmaniasis","volume":"33","author":"Meredith SE","year":"1995","journal-title":"Journal of Clinical Microbiology"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-3156.2004.01251.x"},{"key":"e_1_2_6_16_1","first-page":"951","article-title":"Laboratory diagnosis of visceral leishmaniasis","volume":"9","author":"Sundar S","year":"2002","journal-title":"Clinical and Diagnostic Laboratory Immunology"},{"key":"e_1_2_6_17_1","first-page":"651","article-title":"Diagnostic lag period in kala\u2010azar: test for early diagnosis needed","volume":"39","author":"Sundar S","year":"1991","journal-title":"Journal of the Association of Physicians of India"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(97)04350-X"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)04367-0"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trstmh.2005.08.018"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.44.1.251-253.2006"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trstmh.2005.08.018"},{"key":"e_1_2_6_23_1","volume-title":"Press release: elimination of kala\u2010azar from endemic countries in the south\u2010east Asia region","author":"TDR","year":"2005"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-3156.2003.00996.x"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470317082"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/0035-9203(91)90224-M"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/0035-9203(92)90086-R"}],"container-title":["Tropical Medicine &amp; 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