{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T00:43:27Z","timestamp":1792197807983,"version":"4.4.0"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"1","license":[{"start":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T00:00:00Z","timestamp":1704931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T00:00:00Z","timestamp":1704931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"crossref","award":["OPP1213504"],"award-info":[{"award-number":["OPP1213504"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"crossref","award":["INV-028115"],"award-info":[{"award-number":["INV-028115"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2024,1,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Sputum collection and testing for tuberculosis (TB) have been problematic due to the potential for aerosolization, difficulty in generating a quality sample, and complex DNA extraction methods. Tongue swabs are inexpensive, minimally invasive, and a promising alternative to sputum collection. We investigated the diagnostic accuracy of tongue swabs for TB diagnosis using the Truenat MTB Plus assay from Molbio Diagnostics with a direct to PCR processing method. Four tongue swabs were collected per participant using two nylon-flocked swabs and two spun polyester swabs. Following tongue swab sample collection, participants also provided two sputum samples, which were tested by Cepheid Xpert MTB\/RIF Ultra or culture. Of the 81 participants enrolled, 24 (30%) were positive for TB disease by sputum Ultra. Using the Truenat MTB Plus test, tongue swabs had 54% (52\/96) sensitivity and 99% (218\/220) specificity compared to sputum Ultra. Crude lysate was also tested using an in-house qPCR assay, which allowed for increased sample input. Using this method, tongue swabs had 70% (67\/96) sensitivity and 94% (216\/224) specificity.\n            <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n            (MTB) sample quantification using digital PCR yielded between 20 copies (minimum) and 34,000 copies (maximum) of MTB per swab. In addition, serially collected tongue swabs resulted in similar levels of detected MTB, and spun polyester swabs performed equivalently to nylon-flocked swabs. Overall, this study demonstrates that tongue swab samples are compatible with the Truenat MTB testing platform and that a direct to PCR method is a viable diagnostic solution.\n          <\/jats:p>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>Tuberculosis (TB) remains one of the world\u2019s leading infectious disease killers, despite available treatments. Although highly sensitive molecular diagnostics are available, expensive equipment and poor infrastructure have hindered their implementation in low-resource settings. Furthermore, the collection of sputum poses challenges as it is difficult for patients to produce and creates dangerous aerosols. This manuscript explores tongue swabs as a promising alternative to sputum collection. While previous studies have explored the sensitivity of tongue swabs as compared to sputum, existing literature has not addressed the need to standardize and simplify laboratory processing for easy implementation in high TB burden areas. This manuscript provides the first evidence that detection of TB from a tongue swab is possible without the use of DNA extraction or purification steps. The data provided in this manuscript will improve the collection and testing of tongue swabs for the diagnosis of TB disease.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/spectrum.03107-23","type":"journal-article","created":{"date-parts":[[2023,12,8]],"date-time":"2023-12-08T14:00:17Z","timestamp":1702044017000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":9,"title":["No extraction? No problem. Direct to PCR processing of tongue swabs for diagnosis of tuberculosis disease as an alternative to sputum collection"],"prefix":"10.1128","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-1416-6289","authenticated-orcid":false,"given":"Charlotte L.","family":"Ahls","sequence":"first","affiliation":[{"name":"Quantigen LLC , Fishers, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duncan","family":"Emsweller","sequence":"additional","affiliation":[{"name":"Quantigen LLC , Fishers, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth J.","family":"Helfers","sequence":"additional","affiliation":[{"name":"Quantigen LLC , Fishers, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Niu","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington , Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Wilson","sequence":"additional","affiliation":[{"name":"Umkhuseli Innovation and Research Management , Pietermaritzburg, South Africa"},{"name":"Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal , Pietermaritzburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leah R.","family":"Padgett","sequence":"additional","affiliation":[{"name":"Quantigen LLC , Fishers, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9569-4097","authenticated-orcid":false,"given":"Paul K.","family":"Drain","sequence":"additional","affiliation":[{"name":"Department of Global Health, University of Washington , Seattle, Washington, USA"},{"name":"Department of Medicine, University of Washington , Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","volume-title":"Global tuberculosis report","author":"World Health Organization","year":"2021","unstructured":"World Health Organization . 2021. Global tuberculosis report. World Health Organization, Geneva, Switzerland."},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.17-0999"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(11)70257-2"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics8040078"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.5588\/ijtld.11.0392"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2019.00034"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/sji.12567"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2334-14-S1-S5"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01743-13"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1038\/srep08668"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0251422"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-019-47302-5"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.3390\/jcm9124124"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01847-18"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13104-019-4385-y"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciac332"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00421-22"},{"key":"e_1_3_3_19_2","volume-title":"WHO Consolidated guidelines on tuberculosis. Module 3: Diagnosis - rapid diagnostics for tuberculosis detection","author":"World Health Organization","year":"2021","unstructured":"World Health Organization . 2021. WHO Consolidated guidelines on tuberculosis. Module 3: Diagnosis - rapid diagnostics for tuberculosis detection. , Geneva, Switzerland."},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00526-2021"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1136\/jcp.55.10.778"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01778-18"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(13)70250-0"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1472-765X.2008.02372.x"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02171-10"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0245423"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.03107-23","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.03107-23","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T14:20:30Z","timestamp":1704982830000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.03107-23"}},"subtitle":[],"editor":[{"given":"Susan","family":"Realegeno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,1,11]]},"references-count":26,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1,11]]}},"alternative-id":["10.1128\/spectrum.03107-23"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.03107-23","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,11]]},"assertion":[{"value":"2023-10-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e03107-23"}}