{"doi":"10.1093/cid/ciab839","title":"Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results","abstract":"BACKGROUND: The development of a fast and accurate, non-sputum-based point-of-care triage test for tuberculosis (TB) would have a major impact on combating the TB burden worldwide. A new fingerstick blood test has been developed by Cepheid (the Xpert MTB Host Response [MTB-HR] prototype), which generates a \"TB score\" based on messenger RNA (mRNA) expression of 3 genes. Here we describe the first prospective findings of the MTB-HR prototype. METHODS: Fingerstick blood from adults presenting with symptoms compatible with TB in South Africa, The Gambia, Uganda, and Vietnam was analyzed using the Cepheid GeneXpert MTB-HR prototype. Accuracy of the Xpert MTB-HR cartridge was determined in relation to GeneXpert Ultra results and a composite microbiological score (GeneXpert Ultra and liquid culture) with patients classified as having TB or other respiratory diseases (ORD). RESULTS: When data from all sites (n = 75 TB, 120 ORD) were analyzed, the TB score discriminated between TB and ORD with an area under the curve (AUC) of 0.94 (95% confidence interval [CI], .91-.97), sensitivity of 87% (95% CI, 77-93%) and specificity of 94% (88-97%). When sensitivity was set at 90% for a triage test, specificity was 86% (95% CI, 75-97%). These results were not influenced by human immunodeficiency virus (HIV) status or geographical location. When evaluated against a composite microbiological score (n = 80 TB, 111 ORD), the TB score was able to discriminate between TB and ORD with an AUC of 0.88 (95% CI, .83-.94), 80% sensitivity (95% CI, 76-85%) and 94% specificity (95% CI, 91-96%). CONCLUSIONS: Our interim data indicate the Cepheid MTB-HR cartridge reaches the minimal target product profile for a point of care triage test for TB using fingerstick blood, regardless of geographic area or HIV infection status.","journal":"Clinical Infectious Diseases","year":2021,"id":149040,"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":114,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9524,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":252315,"name":"Gian van der Spuy","orcid":"0000-0002-9067-5903","position":1,"is_corresponding":false},{"id":635408,"name":"Awa Gindeh","orcid":null,"position":2,"is_corresponding":false},{"id":418474,"name":"Nguyễn Thụy Thương Thương","orcid":"0000-0001-8733-692X","position":3,"is_corresponding":false},{"id":635409,"name":"AnnRitah Namuganga","orcid":null,"position":4,"is_corresponding":false},{"id":634217,"name":"Olumuyiwa Owolabi","orcid":"0000-0003-4316-5123","position":5,"is_corresponding":false},{"id":459416,"name":"Harriet Mayanja‐Kizza","orcid":"0000-0002-9297-6208","position":6,"is_corresponding":false},{"id":253371,"name":"Mary Nsereko","orcid":null,"position":7,"is_corresponding":false},{"id":320907,"name":"Guy Thwaites","orcid":"0000-0002-2858-2087","position":8,"is_corresponding":false},{"id":252297,"name":"Jill Winter","orcid":"0000-0003-1345-3546","position":9,"is_corresponding":false},{"id":252329,"name":"Hazel M. Dockrell","orcid":"0000-0003-1869-9107","position":10,"is_corresponding":false},{"id":252307,"name":"Thomas J. Scriba","orcid":"0000-0002-0641-1359","position":11,"is_corresponding":false},{"id":398101,"name":"Annemieke Geluk","orcid":"0000-0001-8555-2872","position":12,"is_corresponding":false},{"id":512956,"name":"Paul L. A. M. Corstjens","orcid":"0000-0002-0004-0526","position":13,"is_corresponding":false},{"id":253362,"name":"Kim Stanley","orcid":null,"position":14,"is_corresponding":false},{"id":635410,"name":"Tracy Richardson","orcid":null,"position":15,"is_corresponding":false},{"id":81825,"name":"Jane Shaw","orcid":"0000-0002-9893-3073","position":16,"is_corresponding":false},{"id":253365,"name":"Bronwyn Smith","orcid":null,"position":17,"is_corresponding":false},{"id":252293,"name":"Stephanus T. 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