{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T09:14:58Z","timestamp":1785402898659,"version":"3.56.0"},"posted":{"date-parts":[[2026,7,27]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":18,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:00:00Z","timestamp":1785110400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,7,27]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:p>\n                  Sample preparation remains a barrier for decentralized, swab-based molecular testing of tuberculosis (TB). Extraction-free workflows offer a simpler alternative, but systematic benchmarking against standard methods is lacking. We evaluated five novel lysis devices, BLINK Shaker Prototype, nPOC-BB, SPS-1, Truelyse, and Thermolyse, against a heat- and bead-beating reference method using contrived\n                  <jats:italic>M. tuberculosis<\/jats:italic>\n                  -spiked tongue and sputum swabs. The primary outcome was lysis efficiency, measured as the relative DNA recovery compared with the reference workflow. Secondary outcomes included nuclease inactivation, biosafety, and usability. In the reference buffer, lysis efficiencies ranged from 51\u201363% to 95\u2013 154% on tongue swabs and 12\u201354% to 280\u2013644% on sputum swabs across the five devices. In proprietary buffers, performance varied more widely, with lysis efficiencies of 2\u20134% to 64\u2013 80% on tongue swabs and 1% to 94\u2013398% on sputum swabs. Complete biosafety inactivation was achieved by three devices; two showed residual growth (&lt;0.02%). Lysis efficiency of several devices met or exceeded the reference, supporting the feasibility of extraction-free workflows for TB diagnosis, with further optimization of buffer compatibility and biosafety profiles expected to enhance performance.\n                <\/jats:p>","DOI":"10.64898\/2026.07.24.26358841","type":"posted-content","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T16:15:22Z","timestamp":1785168922000},"source":"Crossref","is-referenced-by-count":0,"title":["Analytical benchmarking of extraction-free lysis devices for molecular detection of tuberculosis"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3252-1727","authenticated-orcid":false,"given":"Sonal","family":"Jain","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg 69120, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexey","family":"Ball","sequence":"additional","affiliation":[{"name":"Global Health Labs, Inc., Bellevue, WA 98007, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin","family":"Anderson","sequence":"additional","affiliation":[{"name":"Global Health Labs, Inc., Bellevue, WA 98007, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adithya","family":"Cattamanchi","sequence":"additional","affiliation":[{"name":"Center for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA 94143, USA"},{"name":"Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, CA 92697, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7216-7067","authenticated-orcid":false,"given":"Claudia M.","family":"Denkinger","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg 69120, Germany"},{"name":"German Center for Infection Research, Partner Site Heidelberg University Hospital, Heidelberg 69120, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5605-1240","authenticated-orcid":false,"given":"Amy","family":"Steadman","sequence":"additional","affiliation":[{"name":"Global Health Labs, Inc., Bellevue, WA 98007, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seda","family":"Yerlikaya","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Tropical Medicine, Heidelberg University Hospital and Faculty of Medicine, Heidelberg University, Heidelberg 69120, Germany"},{"name":"German Center for Infection Research, Partner Site Heidelberg University Hospital, Heidelberg 69120, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2026073001450818000_2026.07.24.26358841v1.1","unstructured":"World Health Organization. Global tuberculosis report 2025. Published online 2025. Accessed December 15, 2025. https:\/\/www.who.int\/publications\/i\/item\/9789240116924"},{"key":"2026073001450818000_2026.07.24.26358841v1.2","unstructured":"World Health Organization. Near point-of-care nucleic acid amplification tests (NPOC-NAATs) as a new diagnostic class for diagnosis of TB using sputum and tongue swabs. Accessed March 5, 2026. https:\/\/www.who.int\/teams\/global-programme-on-tuberculosis-and-lung-health\/diagnosis-treatment\/npoc-tongue-swabs-and-sputum-pooling-for-tb\/npoc-naats"},{"key":"2026073001450818000_2026.07.24.26358841v1.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.mimet.2012.09.002"},{"key":"2026073001450818000_2026.07.24.26358841v1.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(06)70602-8"},{"key":"2026073001450818000_2026.07.24.26358841v1.5","doi-asserted-by":"publisher","DOI":"10.1016\/J.MIMET.2024.107053"},{"key":"2026073001450818000_2026.07.24.26358841v1.6","doi-asserted-by":"publisher","DOI":"10.1038\/srep19541"},{"key":"2026073001450818000_2026.07.24.26358841v1.7","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.00765-25"},{"key":"2026073001450818000_2026.07.24.26358841v1.8","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2018.02341"},{"key":"2026073001450818000_2026.07.24.26358841v1.9","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciag342"},{"key":"2026073001450818000_2026.07.24.26358841v1.10","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.03107-23"},{"key":"2026073001450818000_2026.07.24.26358841v1.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2025.105991"},{"key":"2026073001450818000_2026.07.24.26358841v1.12","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae041"},{"key":"2026073001450818000_2026.07.24.26358841v1.13","doi-asserted-by":"crossref","unstructured":"Andama A , Steadman AE , Ahls C , et al. Consensus standard operating procedure for collection of tongue swabs for TB diagnostics. Published online July 29, 2024. Accessed January 23, 2026. https:\/\/www.protocols.io\/view\/consensus-standard-operating-procedure-for-collect-dfhy3j7w","DOI":"10.17504\/protocols.io.kxygxyw54l8j\/v1"},{"key":"2026073001450818000_2026.07.24.26358841v1.14","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics11071283"},{"key":"2026073001450818000_2026.07.24.26358841v1.15","doi-asserted-by":"publisher","DOI":"10.4103\/jdrntruhs.jdrntruhs_188_20"},{"key":"2026073001450818000_2026.07.24.26358841v1.16","doi-asserted-by":"publisher","DOI":"10.1038\/s41368-022-00163-7"},{"key":"2026073001450818000_2026.07.24.26358841v1.17","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2509761"},{"key":"2026073001450818000_2026.07.24.26358841v1.18","unstructured":"World Health Organization. Target product profile for tuberculosis diagnosis and detection of drug resistance. Target product profile for tuberculosis diagnosis and detection of drug resistance. 2024. Accessed April 26, 2026. https:\/\/www.who.int\/publications\/i\/item\/9789240097698"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.64898\/2026.07.24.26358841","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T08:45:12Z","timestamp":1785401112000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.64898\/2026.07.24.26358841"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,27]]},"references-count":18,"URL":"https:\/\/doi.org\/10.64898\/2026.07.24.26358841","relation":{},"subject":[],"published":{"date-parts":[[2026,7,27]]},"subtype":"preprint"}}