{"doi":"10.1093/cid/ciae614","title":"Diagnostic Accuracy of LiquidArray MTB-XDR VER 1.0 for the Detection of <i>Mycobacterium tuberculosis</i> Complex, Fluoroquinolone, Amikacin, Ethambutol, and Linezolid Susceptibility","abstract":"BACKGROUND: Drug susceptibility testing (DST) is essential for starting people on effective tuberculosis (TB) regimens. No published data exist for the high-throughput LiquidArray MTB-XDR (LA-XDR) test, which detects Mycobacterium tuberculosis complex (MTBC) and fluoroquinolone, amikacin, ethambutol, and linezolid susceptibility (the latter 2 have no rapid DSTs available). METHODS: We enrolled people (N = 720) with presumptive TB who provided 2 sputum samples for an Xpert MTB/RIF Ultra assay and a culture (MTBC reference standard). Phenotypic DST and Sanger sequencing were the composite reference standards. LA-XDR on the manual FluoroLyse and automated GenoXtract fleXT (fleXT) DNA extraction methods were compared. RESULTS: For MTBC, LA-XDR had similar sensitivities (85%-87%) and specificities (99%) using each extraction method. Drug susceptibility sensitivities (95% confidence interval) varied: 94% (86%-98%) for fluoroquinolones, 64% (45%-80%) for amikacin, and 88% (79%-93%) for ethambutol (specificities of 97%-100%). Six of 7 (86%) resistant linezolid isolates were detected. LA-XDR with fleXT had indeterminate proportions of 21/251 (8%), 2/251 (1%), 63/251 (25%), and 93/251 (37%) for fluoroquinolones, ethambutol, amikacin, and linezolid, respectively (amikacin and linezolid indeterminates were higher with FluoroLyse-extracted DNA). In a hypothetical population of 100 smear-negative people with fluoroquinolone-resistant TB undergoing fleXT DNA extraction, 25 (25%) would be missed (1 extraction error, 2 invalid results, 15 MTBC-negative, 6 fluoroquinolone-indeterminate, and 1 false-susceptible). CONCLUSIONS: LA-XDR met the minimum World Health Organization target product profile for a next-generation, sputum-based, moderate-complexity DST with high fluoroquinolone and ethambutol resistance sensitivity, moderate amikacin resistance sensitivity, and promise for linezolid resistance, for which more data are needed. Improved LA-XDR MTBC detection would reduce missed resistance.","journal":"Clinical Infectious Diseases","year":2024,"id":461742,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9594,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":994319,"name":"Rencia Alberts","orcid":"0000-0003-2251-5534","position":1,"is_corresponding":false},{"id":523477,"name":"Brigitta Derendinger","orcid":"0000-0001-7208-2154","position":2,"is_corresponding":false},{"id":523475,"name":"Rouxjeane Venter","orcid":"0000-0002-8710-8166","position":3,"is_corresponding":false},{"id":594910,"name":"Elizabeth M. Streicher","orcid":"0000-0003-3901-1981","position":4,"is_corresponding":false},{"id":787760,"name":"Samantha Pillay","orcid":"0000-0002-4659-4364","position":5,"is_corresponding":false},{"id":826254,"name":"Yonas Ghebrekristos","orcid":"0000-0003-2002-5240","position":6,"is_corresponding":false},{"id":1290669,"name":"Moses Mburu","orcid":"0000-0001-7281-583X","position":7,"is_corresponding":false},{"id":302718,"name":"Morten Rühwald","orcid":"0000-0002-1597-441X","position":8,"is_corresponding":false},{"id":89652,"name":"Robin M. Warren","orcid":"0000-0001-5741-7358","position":9,"is_corresponding":false},{"id":252288,"name":"Adam Penn‐Nicholson","orcid":"0000-0002-1883-0059","position":10,"is_corresponding":false},{"id":244855,"name":"Grant Theron","orcid":"0000-0002-9216-2415","position":11,"is_corresponding":false},{"id":523478,"name":"Margaretha de Vos","orcid":"0000-0003-3059-2986","position":12,"is_corresponding":false},{"id":1267528,"name":"Erick Auma","orcid":"0000-0001-7076-4944","position":0,"is_corresponding":true}],"reference_count":19,"raw_metadata":null,"created_at":"2026-07-19T02:04:16.410510Z","pmid":"39663850","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}