{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T18:01:35Z","timestamp":1791396095076,"version":"4.3.3"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T00:00:00Z","timestamp":1767744000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The diagnosis of talaromycosis, a life-threatening invasive fungal disease endemic in Southeast Asia, still relies on protracted culture methods. We report the development and clinical evaluation of a novel lateral flow assay (LFA) for the rapid diagnosis of talaromycosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The LFA used 2 novel monoclonal antibodies targeting the Talaromyces marneffei-specific protein Mp1p. In a retrospective, case-cohort study, we evaluated the diagnostic performance of the Mp1p LFA against the reference standard of culture-proven talaromycosis from any clinical specimens, and compared to our validated Mp1p enzyme immunoassay (EIA) in paired plasma and urine samples from 239 talaromycosis and 160 non-talaromycosis participants randomly selected from cohorts of hospitalized adults with advanced human immunodeficiency virus (HIV) disease from 5 centers across Vietnam.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The Mp1p LFA demonstrated an analytical limit-of-detection of 400\u2005pg\/mL, comparable to the EIA. No cross-reactivity with 16 common human fungal pathogens was observed. Clinical sensitivity was higher in urine compared to plasma (95.4% vs 88.7%, P &amp;lt; .01), and clinical specificity was &amp;gt;95% in both specimen types. Clinical performance was similar to the EIA: sensitivity 95.4% versus 97.1%, P = .87 and specificity 95.6% versus 97.5%, P =1.0. Both the LFA and EIA were substantially more sensitive than conventional blood culture collected at the same time (95.4% vs 97.1% vs 77.8%, P &amp;lt; .01).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Mp1p LFA has excellent diagnostic performance, comparable to the EIA, is superior to blood culture, and has the potential to rapidly rule in and rule out talaromycosis at the point-of-care within 15\u2005minutes without need for laboratory infrastructure.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag004","type":"journal-article","created":{"date-parts":[[2026,1,5]],"date-time":"2026-01-05T12:20:53Z","timestamp":1767615653000},"page":"e495-e504","source":"Crossref","is-referenced-by-count":0,"title":["Development and Clinical Evaluation of a Novel\n                    <i>Talaromyces marneffei<\/i>\n                    Mp1p Lateral Flow Assay for Rapid Diagnosis of Talaromycosis"],"prefix":"10.1093","volume":"83","author":[{"given":"Nguyen Thi Mai","family":"Thu","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]},{"name":"Tropical Medicine Research Center for Talaromycosis, Centre for Biomedical Research, Pham Ngoc Thach University of Medicine, Ho Chi Minh City ,","place":["Vietnam"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9896-8682","authenticated-orcid":false,"given":"Lottie","family":"Brown","sequence":"additional","affiliation":[{"name":"Clinical Infection Unit, St George's Hospital, St George's NHS Foundation Trust , London ,","place":["United Kingdom"]},{"name":"School of Health and Medical Sciences, Institute of Infection and Immunity, City St George's University of London , London ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4685-1305","authenticated-orcid":false,"given":"Oriana","family":"Hawkins","sequence":"additional","affiliation":[{"name":"Immuno-Mycologics, Inc. (IMMY) , Norman, Oklahoma ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konner","family":"Bloss","sequence":"additional","affiliation":[{"name":"Immuno-Mycologics, Inc. (IMMY) , Norman, Oklahoma ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5577-4120","authenticated-orcid":false,"given":"Sruthi","family":"Venugopalan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University of Nevada Reno School of Medicine , Reno, Nevada ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6506-189X","authenticated-orcid":false,"given":"Meredith","family":"Brown","sequence":"additional","affiliation":[{"name":"Immuno-Mycologics, Inc. (IMMY) , Norman, Oklahoma ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Fenhaus","sequence":"additional","affiliation":[{"name":"Immuno-Mycologics, Inc. (IMMY) , Norman, Oklahoma ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-8729-6121","authenticated-orcid":false,"given":"Heera Natesan","family":"Sambath","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3645-0089","authenticated-orcid":false,"given":"Jialin","family":"Liu","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyla","family":"Clancy","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, 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Microbiology, The University of Hong Kong-Shenzhen Hospital , Shenzhen, Guangdong Province ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K Y","family":"Yuen","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Emerging Infectious Diseases, Carol Yu Center for Infection, Department of Microbiology, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong , Pokfulam, Hong Kong Special Administrative Region ,","place":["China"]},{"name":"Department of Infectious Diseases and Microbiology, The University of Hong Kong-Shenzhen Hospital , Shenzhen, Guangdong Province ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-9577-3926","authenticated-orcid":false,"given":"Vo Trieu","family":"Ly","sequence":"additional","affiliation":[{"name":"Tropical Medicine Research Center for Talaromycosis, Centre for Biomedical Research, Pham Ngoc Thach 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