{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T02:27:46Z","timestamp":1790908066134,"version":"4.1.0"},"reference-count":86,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"6","license":[{"start":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T00:00:00Z","timestamp":1780444800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,3]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>\n                    Definitively diagnosing Hansen\u2019s disease (HD) is challenging, but molecular methods can provide species identification of the causative mycobacteria (\n                    <jats:italic>Mycobacterium leprae<\/jats:italic>\n                    and\n                    <jats:italic>Mycobacterium lepromatosis<\/jats:italic>\n                    ). Most studies have investigated targeted assays, and the performance of broad-range molecular approaches remains unknown. This study evaluated a multilocus (\n                    <jats:italic>hsp65<\/jats:italic>\n                    , 16S ribosomal RNA, and\n                    <jats:italic>rpoB<\/jats:italic>\n                    ) broad-range polymerase chain reaction (PCR) assay in detecting HD-associated mycobacteria at a single large reference laboratory in the United States from 2009 to 2024. We identified 148 positive samples from 137 patients submitted from 26 states.\n                    <jats:italic>Mycobacterium lepromatosis<\/jats:italic>\n                    was identified in 8 of 137 patients (5.8%), and\n                    <jats:italic>M. leprae<\/jats:italic>\n                    was identified in the rest. Although most samples were skin biopsies (\u223c90%), 10 samples (7.9%) represented atypical locations, including bone marrow and liver. Half of all samples were identified by only a single target (\n                    <jats:italic>n<\/jats:italic>\n                    = 72\/146 samples, 49.3%), and\n                    <jats:italic>rpoB<\/jats:italic>\n                    was the most likely to be positive (\n                    <jats:italic>n<\/jats:italic>\n                    = 123\/146 samples, 84.2%). Overall, broad-range PCR successfully identified HD-associated mycobacteria, including\n                    <jats:italic>M. lepromatosis<\/jats:italic>\n                    , from skin and atypical anatomic sites, and it should be considered more frequently in the evaluation of suspected cases.\n                  <\/jats:p>","DOI":"10.4269\/ajtmh.25-0379","type":"journal-article","created":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T18:09:04Z","timestamp":1776794944000},"page":"1082-1088","source":"Crossref","is-referenced-by-count":1,"title":["Identification of Mycobacterium leprae and Mycobacterium lepromatosis Cases with Broad-Range Molecular Assays at a Single Large Reference Laboratory"],"prefix":"10.4269","volume":"114","author":[{"given":"Gregory S.","family":"Olson","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khalil","family":"Deveaux","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Chiller","sequence":"additional","affiliation":[{"name":"School of Medicine, Tulane University, New Orleans, Louisiana, USA;"},{"name":"School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhruba","family":"SenGupta","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brad T.","family":"Cookson","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason D.","family":"Simmons","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Washington, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua A.","family":"Lieberman","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"issue":"2","key":"b1","series-title":"PLoS Negl Trop Dis","first-page":"e2544","article-title":"On the age of leprosy","volume":"8","author":"Han","year":"2014"},{"issue":"1","key":"b2","series-title":"Nat Rev Dis Primers","first-page":"90","article-title":"Leprosy","volume":"10","author":"Grijsen","year":"2024"},{"key":"b3","article-title":"National Hansen\u2019s Disease (Leprosy) Program. Caring and Curing Since 1984","year":"2024"},{"issue":"2","key":"b4","series-title":"Public Health Rep","first-page":"278","article-title":"Epidemiology of leprosy (Hansen disease) in Washington state, 2001\u20132023","volume":"141","author":"Bennett","year":"2026"},{"issue":"4","key":"b5","series-title":"Oral Surg Oral Med Oral Pathol Oral Radiol","first-page":"362","article-title":"Prevalence of oral manifestations of leprosy: A systematic review and meta-analysis","volume":"137","author":"Mezaiko","year":"2024"},{"issue":"10","key":"b6","series-title":"Eur J Clin Microbiol Infect Dis","first-page":"1863","article-title":"Early detection of M. leprae by qPCR in untreated patients and their contacts: Results for nasal swab and palate mucosa scraping","volume":"37","author":"Carvalho","year":"2018"},{"issue":"7","key":"b7","series-title":"Indian J Ophthalmol","first-page":"2673","article-title":"Commentary: Ocular lesions in leprosy\u2014Should we forget?","volume":"70","author":"Biswas","year":"2022"},{"key":"b8","series-title":"Int J Infect Dis","first-page":"60","article-title":"Frequent testicular involvement in multibacillary leprosy","volume":"90","author":"Gunawan","year":"2020"},{"issue":"3","key":"b9","series-title":"J Am Acad Dermatol","first-page":"722","article-title":"Impact of Mycobacterium leprae and Mycobacterium lepromatosis on immune reactions and clinical outcomes in Hansen\u2019s disease: A single-center retrospective analysis","volume":"88","author":"Khan","year":"2023"},{"issue":"6","key":"b10","series-title":"Am J Clin Pathol","first-page":"856","article-title":"A new Mycobacterium species causing diffuse lepromatous leprosy","volume":"130","author":"Han","year":"2008"},{"issue":"7","key":"b11","series-title":"Emerg Infect Dis","first-page":"1376","article-title":"Systematic review of Hansen disease attributed to Mycobacterium lepromatosis.","volume":"29","author":"Collin","year":"2023"},{"issue":"8","key":"b12","series-title":"Clin Infect Dis","first-page":"e262","article-title":"Isolation of Mycobacterium lepromatosis and development of molecular diagnostic assays to distinguish Mycobacterium leprae and M. lepromatosis.","volume":"71","author":"Sharma","year":"2020"},{"issue":"1","key":"b13","series-title":"J Am Acad Dermatol","first-page":"1","article-title":"Leprosy: Clinical aspects and diagnostic techniques","volume":"83","author":"Maymone","year":"2020"},{"issue":"1","key":"b14","series-title":"Sci Rep","first-page":"16675","article-title":"Quantitative PCR for leprosy diagnosis and monitoring in household contacts: A follow-up study, 2011\u20132018","volume":"9","author":"Manta","year":"2019"},{"issue":"2","key":"b15","series-title":"Pathog Glob Health","first-page":"72","article-title":"Evaluation of 16S rRNA qPCR for detection of Mycobacterium leprae DNA in nasal secretion and skin biopsy samples from multibacillary and paucibacillary leprosy cases","volume":"112","author":"Marques","year":"2018"},{"issue":"1","key":"b16","series-title":"Mol Biol Res Commun","first-page":"17","article-title":"Molecular detection of Mycobacterium leprae using RLEP-PCR in post elimination era of leprosy","volume":"9","author":"Mohanty","year":"2020"},{"issue":"2","key":"b17","series-title":"PLoS Negl Trop Dis","first-page":"e0009850","article-title":"Development and validation of a multiplex real-time qPCR assay using GMP-grade reagents for leprosy diagnosis","volume":"16","author":"Manta","year":"2022"},{"issue":"12","key":"b18","series-title":"J Dermatol","first-page":"1936","article-title":"Simultaneous detection and differentiation between Mycobacterium leprae and Mycobacterium lepromatosis using novel polymerase chain reaction primers","volume":"48","author":"Dwivedi","year":"2021"},{"issue":"11","key":"b19","series-title":"Open Forum Infect 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identification","volume":"39","author":"Carlos","year":"2012"},{"issue":"11","key":"b23","series-title":"J Clin Microbiol","first-page":"e0095521","article-title":"High clinical impact of broad-range fungal PCR in suspected fungal sinusitis","volume":"59","author":"Lieberman","year":"2021"},{"issue":"3","key":"b24","series-title":"J Mol Biol","first-page":"403","article-title":"Basic local alignment search tool","volume":"215","author":"Altschul","year":"1990"},{"issue":"1","key":"b25","series-title":"Cold Spring Harb Mol Case Stud","first-page":"a005876","article-title":"Identification of Leptotrichia goodfellowii infective endocarditis by next-generation sequencing of 16S rDNA amplicons","volume":"7","author":"Lieberman","year":"2021"},{"issue":"11","key":"b26","series-title":"Clin Chem","first-page":"1465","article-title":"Clinical next generation sequencing outperforms standard microbiological culture for characterizing polymicrobial 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southeastern United States","volume":"21","author":"Sharma","year":"2015"},{"issue":"17","key":"b33","series-title":"N Engl J Med","first-page":"1626","article-title":"Probable zoonotic leprosy in the southern United States","volume":"364","author":"Truman","year":"2011"},{"issue":"11","key":"b34","series-title":"Emerg Infect Dis","first-page":"1928","article-title":"Autochthonous leprosy without armadillo exposure, eastern United States","volume":"23","author":"Rendini","year":"2017"},{"issue":"9","key":"b35","series-title":"JAMA","first-page":"798","article-title":"Mounting evidence suggests leprosy is endemic in Florida","volume":"330","author":"Harris","year":"2023"},{"key":"b36","series-title":"JAAD Case Rep","first-page":"21","article-title":"Lepromatous leprosy infection from Mycobacterium lepromatosis without known risk factors or exposures in the Upper Midwest United States","volume":"45","author":"Fleischmann","year":"2024"},{"issue":"4","key":"b37","series-title":"J Hematop","first-page":"251","article-title":"Bridging dermatology and hematology: A case of lepromatous leprosy with bone marrow involvement and pancytopenia","volume":"17","author":"Saini","year":"2024"},{"issue":"9","key":"b38","series-title":"Cureus","first-page":"e69223","article-title":"A Rare cause of pancytopenia from lepromatous leprosy diagnosed in bone marrow aspiration: A bolt from the blue","volume":"16","author":"Shine","year":"2024"},{"issue":"8","key":"b39","series-title":"Int J Dermatol","first-page":"952","article-title":"The leprosy agents Mycobacterium lepromatosis and Mycobacterium leprae in Mexico","volume":"51","author":"Han","year":"2012"},{"issue":"6758","key":"b40","series-title":"Science","first-page":"eadu7144","article-title":"Pre-European contact leprosy in the Americas and its current persistence","volume":"389","author":"Lopopolo","year":"2025"},{"issue":"9","key":"b41","series-title":"Nat Ecol Evol","first-page":"1685","article-title":"4,000-year-old Mycobacterium lepromatosis genomes from Chile reveal long establishment of Hansen\u2019s disease in the Americas","volume":"9","author":"Ramirez","year":"2025"},{"issue":"6","key":"b42","series-title":"J Clin Microbiol","first-page":"1997","article-title":"Molecular epidemiology of Mycobacterium leprae as determined by structure-neighbor clustering","volume":"48","author":"Hall","year":"2010"},{"issue":"19","key":"b43","series-title":"J Bacteriol","first-page":"6067","article-title":"Comparative sequence analysis of Mycobacterium leprae and the new leprosy-causing Mycobacterium lepromatosis.","volume":"191","author":"Han","year":"2009"},{"issue":"2","key":"b1","series-title":"PLoS Negl Trop Dis","first-page":"e2544","article-title":"On the age of leprosy","volume":"8","author":"Han","year":"2014"},{"issue":"1","key":"b2","series-title":"Nat Rev Dis Primers","first-page":"90","article-title":"Leprosy","volume":"10","author":"Grijsen","year":"2024"},{"key":"b3","article-title":"National Hansen\u2019s Disease (Leprosy) Program. Caring and Curing Since 1984","year":"2024"},{"issue":"2","key":"b4","series-title":"Public Health Rep","first-page":"278","article-title":"Epidemiology of leprosy (Hansen disease) in Washington state, 2001\u20132023","volume":"141","author":"Bennett","year":"2026"},{"issue":"4","key":"b5","series-title":"Oral Surg Oral Med Oral Pathol Oral Radiol","first-page":"362","article-title":"Prevalence of oral manifestations of leprosy: A systematic review and meta-analysis","volume":"137","author":"Mezaiko","year":"2024"},{"issue":"10","key":"b6","series-title":"Eur J Clin Microbiol Infect Dis","first-page":"1863","article-title":"Early detection of M. leprae by qPCR in untreated patients and their contacts: Results for nasal swab and palate mucosa scraping","volume":"37","author":"Carvalho","year":"2018"},{"issue":"7","key":"b7","series-title":"Indian J Ophthalmol","first-page":"2673","article-title":"Commentary: Ocular lesions in leprosy\u2014Should we forget?","volume":"70","author":"Biswas","year":"2022"},{"key":"b8","series-title":"Int J Infect Dis","first-page":"60","article-title":"Frequent testicular involvement in multibacillary leprosy","volume":"90","author":"Gunawan","year":"2020"},{"issue":"3","key":"b9","series-title":"J Am Acad Dermatol","first-page":"722","article-title":"Impact of Mycobacterium leprae and Mycobacterium lepromatosis on immune reactions and clinical outcomes in Hansen\u2019s disease: A single-center retrospective analysis","volume":"88","author":"Khan","year":"2023"},{"issue":"6","key":"b10","series-title":"Am J Clin Pathol","first-page":"856","article-title":"A new Mycobacterium species causing diffuse lepromatous leprosy","volume":"130","author":"Han","year":"2008"},{"issue":"7","key":"b11","series-title":"Emerg Infect Dis","first-page":"1376","article-title":"Systematic review of Hansen disease attributed to Mycobacterium lepromatosis.","volume":"29","author":"Collin","year":"2023"},{"issue":"8","key":"b12","series-title":"Clin Infect Dis","first-page":"e262","article-title":"Isolation of Mycobacterium lepromatosis and development of molecular diagnostic assays to distinguish Mycobacterium leprae and M. lepromatosis.","volume":"71","author":"Sharma","year":"2020"},{"issue":"1","key":"b13","series-title":"J Am Acad Dermatol","first-page":"1","article-title":"Leprosy: Clinical aspects and diagnostic techniques","volume":"83","author":"Maymone","year":"2020"},{"issue":"1","key":"b14","series-title":"Sci Rep","first-page":"16675","article-title":"Quantitative PCR for leprosy diagnosis and monitoring in household contacts: A follow-up study, 2011\u20132018","volume":"9","author":"Manta","year":"2019"},{"issue":"2","key":"b15","series-title":"Pathog Glob Health","first-page":"72","article-title":"Evaluation of 16S rRNA qPCR for detection of Mycobacterium leprae DNA in nasal secretion and skin biopsy samples from multibacillary and paucibacillary leprosy cases","volume":"112","author":"Marques","year":"2018"},{"issue":"1","key":"b16","series-title":"Mol Biol Res Commun","first-page":"17","article-title":"Molecular detection of Mycobacterium leprae using RLEP-PCR in post elimination era of leprosy","volume":"9","author":"Mohanty","year":"2020"},{"issue":"2","key":"b17","series-title":"PLoS Negl Trop Dis","first-page":"e0009850","article-title":"Development and validation of a multiplex real-time qPCR assay using GMP-grade reagents for leprosy diagnosis","volume":"16","author":"Manta","year":"2022"},{"issue":"12","key":"b18","series-title":"J Dermatol","first-page":"1936","article-title":"Simultaneous detection and differentiation between Mycobacterium leprae and Mycobacterium lepromatosis using novel polymerase chain reaction primers","volume":"48","author":"Dwivedi","year":"2021"},{"issue":"11","key":"b19","series-title":"Open Forum Infect Dis","first-page":"ofy257","article-title":"Microbial identification using DNA target amplification and sequencing: Clinical utility and impact on patient management","volume":"5","author":"Basein","year":"2018"},{"issue":"3","key":"b20","series-title":"Emerg Infect Dis","first-page":"467","article-title":"Bartonella spp. Infections identified by molecular methods, United States","volume":"29","author":"McCormick","year":"2023"},{"issue":"10","key":"b21","series-title":"Eur J Clin Microbiol Infect Dis","first-page":"1873","article-title":"Added diagnostic value of 16S rRNA gene pan-mycobacterial PCR for nontuberculous mycobacterial infections: A 10-year retrospective study","volume":"38","author":"Simon","year":"2019"},{"key":"b22","series-title":"J Cutan Pathol","first-page":"795","article-title":"Mycobacterial infection identified with broad-range PCR amplification and suspension array identification","volume":"39","author":"Carlos","year":"2012"},{"issue":"11","key":"b23","series-title":"J Clin Microbiol","first-page":"e0095521","article-title":"High clinical impact of broad-range fungal PCR in suspected fungal sinusitis","volume":"59","author":"Lieberman","year":"2021"},{"issue":"3","key":"b24","series-title":"J Mol Biol","first-page":"403","article-title":"Basic local alignment search tool","volume":"215","author":"Altschul","year":"1990"},{"issue":"1","key":"b25","series-title":"Cold Spring Harb Mol Case Stud","first-page":"a005876","article-title":"Identification of Leptotrichia goodfellowii infective endocarditis by next-generation sequencing of 16S rDNA amplicons","volume":"7","author":"Lieberman","year":"2021"},{"issue":"11","key":"b26","series-title":"Clin Chem","first-page":"1465","article-title":"Clinical next generation sequencing outperforms standard microbiological culture for characterizing polymicrobial 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Mycobacterium lepromatosis genomes from Chile reveal long establishment of Hansen\u2019s disease in the Americas","volume":"9","author":"Ramirez","year":"2025"},{"issue":"6","key":"b42","series-title":"J Clin Microbiol","first-page":"1997","article-title":"Molecular epidemiology of Mycobacterium leprae as determined by structure-neighbor clustering","volume":"48","author":"Hall","year":"2010"},{"issue":"19","key":"b43","series-title":"J Bacteriol","first-page":"6067","article-title":"Comparative sequence analysis of Mycobacterium leprae and the new leprosy-causing Mycobacterium lepromatosis.","volume":"191","author":"Han","year":"2009"}],"container-title":["The American Journal of Tropical Medicine and 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