{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T22:29:08Z","timestamp":1791325748893,"version":"4.3.1"},"update-to":[{"DOI":"10.1371\/journal.pntd.0012774","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T00:00:00Z","timestamp":1752192000000}}],"reference-count":37,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T00:00:00Z","timestamp":1751846400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004385","name":"Universiteit Gent","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004385","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003130","name":"Research Foundation Flanders","doi-asserted-by":"crossref","award":["G0F4320N"],"award-info":[{"award-number":["G0F4320N"]}],"id":[{"id":"10.13039\/501100003130","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"<jats:sec id=\"sec020\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The World Health Organization calls for the development of new diagnostics to support large-scale deworming programs against strongyloidiasis. To better steer research and development (R&amp;D) of new diagnostics, it is imperative to identify the minimal requirements that new diagnostics should meet, the so-called target product profiles (TPPs). While diagnostic TPPs exist for other major soil-transmitted helminthiases, none exist for strongyloidiasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec021\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We investigated a range of potential diagnostic TPPs using our previously developed simulation framework for the effect of imperfect diagnostics on the cost and correctness of program decisions. With this framework, we studied the minimum requirements for diagnostic performance, cost per test and sample throughput for future assays while comparing the survey costs with those of the reference Baermann method. As potential assay platforms, we considered antibody (Ab)-detecting assays, including a point-of-care lateral flow assay (LFA) and a laboratory-based Ab-ELISA. We also determined cost-efficient school-based survey designs for two currently available assays: Bordier Ab-ELISA and a prototype NIE-LFA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec022\">\n                    <jats:title>Principal findings<\/jats:title>\n                    <jats:p>Our findings highlighted that (i) specificity rather than sensitivity is a critical parameter to consider for R&amp;D of new diagnostic methods for monitoring control programs; (ii) the requirements for diagnostic performance became less stringent with an increasing sample size and when higher risks of incorrect decision-making were accepted. When focusing on the assay formats, the LFA resulted in lower survey costs compared to the Baermann method. Ab-ELISA was cost-efficient only if the diagnostic performance was nearly perfect combined with low cost per test and high sample throughput. Of all the three assays considered here, the prototype NIE-LFA allowed for the most cost-efficient survey designs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec023\">\n                    <jats:title>Conclusion\/significance<\/jats:title>\n                    <jats:p>R&amp;D should focus on developing point-of-care assays with high specificity. The prototype NIE-LFA is a cost-efficient alternative to Baermann to support control programs for strongyloidiasis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pntd.0012774","type":"journal-article","created":{"date-parts":[[2025,7,7]],"date-time":"2025-07-07T14:06:24Z","timestamp":1751897184000},"page":"e0012774","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Target product profiles for new diagnostics to inform strongyloidiasis control programs"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6093-9648","authenticated-orcid":true,"given":"Adama","family":"Kazienga","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc E.","family":"Coffeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Roose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sake J.","family":"de Vlas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dora","family":"Buonfrate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Scarso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Tamarozzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Levecke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,7,7]]},"reference":[{"key":"pntd.0012774.ref001","author":"World Health Organization","year":"2021"},{"issue":"10117","key":"pntd.0012774.ref002","doi-asserted-by":"crossref","first-page":"252","DOI":"10.1016\/S0140-6736(17)31930-X","article-title":"Soil-transmitted helminth infections","volume":"391","author":"PM Jourdan","year":"2018","journal-title":"Lancet"},{"key":"pntd.0012774.ref003"},{"issue":"4","key":"pntd.0012774.ref004","doi-asserted-by":"crossref","DOI":"10.1128\/cmr.00033-23","article-title":"Human strongyloidiasis: complexities and pathways forward","volume":"36","author":"D Buonfrate","year":"2023","journal-title":"Clin Microbiol Rev"},{"key":"pntd.0012774.ref005","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/bs.apar.2022.07.001","article-title":"The diagnosis of human and companion animal Strongyloides stercoralis infection: Challenges and solutions. A scoping review","volume":"118","author":"D Buonfrate","year":"2022","journal-title":"Adv Parasitol"},{"issue":"6","key":"pntd.0012774.ref006","doi-asserted-by":"crossref","first-page":"468","DOI":"10.3390\/pathogens9060468","article-title":"The Global Prevalence of Strongyloides stercoralis Infection","volume":"9","author":"D Buonfrate","year":"2020","journal-title":"Pathogens"},{"key":"pntd.0012774.ref007"},{"issue":"3","key":"pntd.0012774.ref008","article-title":"Review of the WHO guideline on preventive chemotherapy for public health control of strongyloidiasis","volume":"25","author":"NC Lo","year":"2025","journal-title":"Lancet Infect Dis"},{"issue":"5","key":"pntd.0012774.ref009","doi-asserted-by":"crossref","DOI":"10.1016\/S2214-109X(23)00108-0","article-title":"Accuracy, acceptability, and feasibility of diagnostic tests for the screening of Strongyloides stercoralis in the field (ESTRELLA): a cross-sectional study in Ecuador","volume":"11","author":"F Tamarozzi","year":"2023","journal-title":"Lancet Glob Health"},{"issue":"2","key":"pntd.0012774.ref010","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0009076","article-title":"Performance evaluation of Baermann techniques: The quest for developing a microscopy reference standard for the diagnosis of Strongyloides stercoralis","volume":"15","author":"W Gelaye","year":"2021","journal-title":"PLoS Negl Trop Dis"},{"issue":"6","key":"pntd.0012774.ref011","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1016\/j.cmi.2015.04.001","article-title":"Novel approaches to the diagnosis of Strongyloides stercoralis infection","volume":"21","author":"D Buonfrate","year":"2015","journal-title":"Clin Microbiol Infect"},{"issue":"1","key":"pntd.0012774.ref012","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0002002","article-title":"The laboratory diagnosis and follow up of strongyloidiasis: a systematic review","volume":"7","author":"A Requena-M\u00e9ndez","year":"2013","journal-title":"PLoS Negl Trop Dis"},{"issue":"4","key":"pntd.0012774.ref013","doi-asserted-by":"crossref","first-page":"863","DOI":"10.4269\/ajtmh.16-0414","article-title":"Improved detection of strongyloides stercoralis in modified agar plate cultures","volume":"96","author":"LA Pocaterra","year":"2017","journal-title":"Am J Trop Med Hyg"},{"issue":"1","key":"pntd.0012774.ref014","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1038\/s41564-018-0295-3","article-title":"REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes","volume":"4","author":"KJ Land","year":"2019","journal-title":"Nat Microbiol"},{"issue":"2","key":"pntd.0012774.ref015","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1093\/trstmh\/traa118","article-title":"Diagnostics and the neglected tropical diseases roadmap: setting the agenda for 2030","volume":"115","author":"AA Souza","year":"2021","journal-title":"Trans R Soc Trop Med Hyg"},{"key":"pntd.0012774.ref016","author":"WHO"},{"key":"pntd.0012774.ref017","author":"WHO"},{"key":"pntd.0012774.ref018","author":"WHO"},{"key":"pntd.0012774.ref019","author":"WHO"},{"key":"pntd.0012774.ref020"},{"key":"pntd.0012774.ref021"},{"key":"pntd.0012774.ref022"},{"key":"pntd.0012774.ref023"},{"key":"pntd.0012774.ref024"},{"issue":"10","key":"pntd.0012774.ref025","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0010824","article-title":"Comparison of coproprevalence and seroprevalence to guide decision-making in national soil-transmitted helminthiasis control programs: Ethiopia as a case study","volume":"16","author":"S Roose","year":"2022","journal-title":"PLoS Negl Trop Dis"},{"issue":"4","key":"pntd.0012774.ref026","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0010353","article-title":"Two-stage lot quality assurance sampling framework for monitoring and evaluation of neglected tropical diseases, allowing for imperfect diagnostics and spatial heterogeneity","volume":"16","author":"A Kazienga","year":"2022","journal-title":"PLoS Negl Trop Dis"},{"issue":"9","key":"pntd.0012774.ref027","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0009740","article-title":"Assessment of the required performance and the development of corresponding program decision rules for neglected tropical diseases diagnostic tests: Monitoring and evaluation of soil-transmitted helminthiasis control programs as a case study","volume":"15","author":"B Levecke","year":"2021","journal-title":"PLoS Negl Trop Dis"},{"key":"pntd.0012774.ref028","doi-asserted-by":"crossref","first-page":"105986","DOI":"10.1016\/j.actatropica.2021.105986","article-title":"A new antigen detection ELISA for the diagnosis of Strongyloides infection","volume":"221","author":"D Balachandra","year":"2021","journal-title":"Acta Trop"},{"issue":"2","key":"pntd.0012774.ref029","doi-asserted-by":"crossref","first-page":"432","DOI":"10.4269\/ajtmh.19-0053","article-title":"Lateral Flow Dipstick Test for Serodiagnosis of Strongyloidiasis","volume":"101","author":"MH Yunus","year":"2019","journal-title":"Am J Trop Med Hyg"},{"key":"pntd.0012774.ref030","doi-asserted-by":"crossref","first-page":"106251","DOI":"10.1016\/j.actatropica.2021.106251","article-title":"A point-of-care cassette test for detection of Strongyloides stercoralis","volume":"226","author":"R Noordin","year":"2022","journal-title":"Acta Trop"},{"issue":"1","key":"pntd.0012774.ref031","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1186\/s13071-022-05249-z","article-title":"The accuracy of a recombinant antigen immunochromatographic test for the detection of Strongyloides stercoralis infection in migrants from sub-Saharan Africa","volume":"15","author":"F Tamarozzi","year":"2022","journal-title":"Parasit Vectors"},{"key":"pntd.0012774.ref032","doi-asserted-by":"crossref","first-page":"465","DOI":"10.1007\/s10096-019-03745-2","article-title":"Development of immunochromatographic device as a point-of-care tool for serodiagnosis of human strongyloidiasis cases","volume":"39","author":"L Sadaow","year":"2020","journal-title":"Eur J Clin Microbiol Infect Dis"},{"issue":"9","key":"pntd.0012774.ref033","doi-asserted-by":"crossref","first-page":"615","DOI":"10.3390\/diagnostics10090615","article-title":"Effectiveness of Strongyloides Recombinant IgG Immunoreactive Antigen in Detecting IgG and IgG4 Subclass Antibodies for Diagnosis of Human Strongyloidiasis Using Rapid Immunochromatographic Tests","volume":"10","author":"P Boonroumkaew","year":"2020","journal-title":"Diagnostics (Basel)"},{"key":"pntd.0012774.ref034","article-title":"Examination of diagnostic performance of new IgG4 rapid test compared with IgG-and IgG4-ELISAs to investigate epidemiology of strongyloidiasis in Northeast Thailand","author":"P Wongphutorn","year":"2024","journal-title":"Am J Trop Med Hyg"},{"issue":"1","key":"pntd.0012774.ref035","doi-asserted-by":"crossref","first-page":"166","DOI":"10.4269\/ajtmh.16-0857","article-title":"Serologic Monitoring of Public Health Interventions against Strongyloides stercoralis","volume":"97","author":"P Vargas","year":"2017","journal-title":"Am J Trop Med Hyg"},{"issue":"7","key":"pntd.0012774.ref036","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0011473","article-title":"Impact of preventive chemotherapy on Strongyloides stercoralis: A systematic review and meta-analysis","volume":"17","author":"G Stroffolini","year":"2023","journal-title":"PLoS Negl Trop Dis"},{"issue":"8","key":"pntd.0012774.ref037","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1016\/j.tibtech.2017.03.013","article-title":"Multiplexed Point-of-Care Testing - xPOCT","volume":"35","author":"C Dincer","year":"2017","journal-title":"Trends Biotechnol"}],"updated-by":[{"DOI":"10.1371\/journal.pntd.0012774","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T00:00:00Z","timestamp":1752192000000}}],"container-title":["PLOS Neglected Tropical Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0012774","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,11]],"date-time":"2025-07-11T18:04:21Z","timestamp":1752257061000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0012774"}},"subtitle":[],"editor":[{"given":"Feng","family":"Xue","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,7,7]]},"references-count":37,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7,7]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pntd.0012774","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2024.12.12.24318904","asserted-by":"object"}]},"ISSN":["1935-2735"],"issn-type":[{"value":"1935-2735","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,7]]}}}