{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T21:12:42Z","timestamp":1792530762328,"version":"4.5.0"},"reference-count":29,"publisher":"American Society for Microbiology","issue":"2","license":[{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,2,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>Developing rapid, non-sputum-based tests is a global priority to improve the diagnosis and timely treatment of tuberculosis (TB). In this study, we evaluated the detection limit, precision, stability, and lot-to-lot variation of a next-generation rapid diagnostic test (RDT), the plasmonic fluor (PF)-enhanced urinary lipoarabinomannan lateral flow assay (PF-LAM). We also assessed the diagnostic performance of PF-LAM, Alere Determine TB LAM Ag (AlereLAM), and electrochemiluminescence LAM assay (EclLAM), a highly sensitive laboratory-based test by comparing with microbiology reference standard (MRS) that includes molecular testing (Xpert MTB\/RIF) and culture. Two sub-studies were conducted using banked urine samples. First, a preclinical study involving 399 well-characterized urine samples was conducted to determine assay cutoff and assess PF-LAM performance compared with Alere LAM. Second, a diagnostic accuracy assessment study was conducted using 77 blinded samples to compare the performance of PF-LAM to EclLAM. In the preclinical study, when compared with MRS, the AlereLAM showed a sensitivity of 5.5% (95% CI: 3.1%\u20139.6%) and a specificity of 98.5% (95% CI: 95.6%\u201399.6%), while PF-LAM exhibited a sensitivity of 33.8% (95% CI: 27.4%\u201340.6%) and the same specificity of 98.5% (95% CI: 95.6%\u201399.6%). In the diagnostic accuracy study, when compared with MRS, PF-LAM achieved a sensitivity of 58% (95% CI: 41%\u201373%) and a specificity of 98% (95% CI: 88%\u2013100%), while EclLAM showed a sensitivity of 42% (95% CI: 27%\u201359%) and a specificity of 95% (95% CI: 85%\u201399%). Overall, PF-LAM demonstrated better analytical and diagnostic sensitivity compared with EclLAM and significantly better performance compared with AlereLAM, while exhibiting high precision and minimal lot-to-lot variability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>To the best of our knowledge, this study uniquely reports a rapid diagnostic test, plasmonic fluor-enhanced urinary lipoarabinomannan lateral flow assay (PF-LAM), outperforming an electrochemiluminescence-based laboratory assay. PF-LAM demonstrated promising analytical and diagnostic performance with minimal lot-to-lot variability, positioning it as a helpful tool for non-sputum tuberculosis diagnostics.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.03042-25","type":"journal-article","created":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T14:22:54Z","timestamp":1767190974000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Rapid urinary lipoarabinomannan test with laboratory-level sensitivity for tuberculosis detection: a performance evaluation"],"prefix":"10.1128","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-2909-7884","authenticated-orcid":true,"given":"Qisheng","family":"Jiang","sequence":"first","affiliation":[{"name":"Brightest Bio","place":["Saint Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harisha","family":"Ramachandraiah","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tcsqz68","id-type":"ROR","asserted-by":"publisher"}],"name":"FIND, the global alliance for diagnostics","place":["Geneva, Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Duncan","sequence":"additional","affiliation":[{"name":"Brightest Bio","place":["Saint Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1482-0854","authenticated-orcid":true,"given":"Sumanth","family":"Gandra","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine","place":["St. Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ige A.","family":"George","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine","place":["St. Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingyi","family":"Luan","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/048sx0r50","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Mechanical and Aerospace Engineering, University of Houston","place":["Houston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcos","family":"Perez","sequence":"additional","affiliation":[{"name":"PATH","place":["Seattle, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorraine","family":"Lillis","sequence":"additional","affiliation":[{"name":"PATH","place":["Seattle, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David S.","family":"Boyle","sequence":"additional","affiliation":[{"name":"PATH","place":["Seattle, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Crick","sequence":"additional","affiliation":[{"name":"Brightest Bio","place":["Saint Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Ruhwald","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tcsqz68","id-type":"ROR","asserted-by":"publisher"}],"name":"FIND, the global alliance for diagnostics","place":["Geneva, Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7203-2613","authenticated-orcid":false,"given":"Srikanth","family":"Singamaneni","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01yc7t268","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Mechanical Engineering and Materials Science, Institute of Materials Science and Engineering, Washington University in St. Louis","place":["St. Louis, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","unstructured":"WHO. 2024. Global tuberculosis report 2024. Geneva: World Health Organization (2024) Licence: CC BY-NC-SA 3.0 IGO. 2024"},{"key":"e_1_3_4_3_2","unstructured":"WHO. 2024. Target product profiles for tuberculosis diagnosis and detection of drug resistance. Geneva: World Health Organization. Licence: CC BY-NC-SA 3.0 IGO"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiz097"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41564-019-0380-2"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD011420.pub3"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aal2807"},{"key":"e_1_3_4_8_2","doi-asserted-by":"crossref","unstructured":"WHO. 2019. Lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis of active tuberculosis in people living with HIV U. n. d. h. w. w. i. WHO (2019) Lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis of active tuberculosis in people living with HIV","DOI":"10.1002\/14651858.CD011420.pub3"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01338-18"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(22)00513-7"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1172\/JCI140461"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(19)30001-5"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0303846"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000004213"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaf079"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.5588\/ijtldopen.24.0449"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.21203\/rs.3.rs-5386988\/v2"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaf081"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41551-020-0547-4"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41551-022-01001-1"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1021\/acsinfecdis.3c00423"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1039\/d4nh00226a"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0254156"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2024.105353"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pgph.0003891"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(19)30475-X"},{"key":"e_1_3_4_27_2","unstructured":"Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine. Geneva: World Health Organization. (Technical specifications series for submission to WHO prequalification \u2013 diagnostic assessment TSS23). Licence: CC BY-NC-SA 3.0 IGO. 2024"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2025.105885"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0274415"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.11613\/BM.2016.034"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.03042-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.03042-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:48:28Z","timestamp":1788223708000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.03042-25"}},"subtitle":[],"editor":[{"given":"Michael Gordon","family":"Whitfield","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,2,3]]},"references-count":29,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2,3]]}},"alternative-id":["10.1128\/spectrum.03042-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.03042-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,3]]},"assertion":[{"value":"2025-09-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e03042-25"}}