{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T04:48:37Z","timestamp":1785905317077,"version":"3.56.0"},"reference-count":43,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100020249","name":"Immunexpress, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100020249","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["75A50120C00125"],"award-info":[{"award-number":["75A50120C00125"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]},{"award":["75A50120C00125"],"award-info":[{"award-number":["75A50120C00125"]}],"id":[{"id":"https:\/\/ror.org\/029y69023","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Overview: SeptiCyte RAPID is an FDA-cleared gene expression test that quantifies host immune response to aid in the diagnosis of sepsis. The test yields a score (the SeptiScore) ranging from 0\u201315, distributed across four bands (1\u20134) based on increased likelihood of sepsis. Each band can be characterized by average positive and negative likelihood ratios (LR+ and LR\u2212, respectively) for the discrimination of sepsis versus the non-infectious systemic inflammatory response syndrome (SIRS). Methods: A retrospective analysis of prospectively collected data from a combined cohort of critically ill patients suspected of sepsis (n = 889), recruited across 19 hospitals in the USA and Europe. The analysis quantified the LR+ and LR\u2212 parameters as a function of SeptiScore, for discrimination of sepsis vs. SIRS in patients admitted to ICU. Hypotheses: (1) The likelihood ratio (LR) framework provides a clinically useful interpretive approach that complements the previously used SeptiScore banding scheme; (2) Low Band 1 SeptiScores are associated with sufficiently small LR\u2212 to support the use of SeptiCyte RAPID as a rule-out test for sepsis; (3) High Band 4 SeptiScores are associated with sufficiently large LR+ to support the use of SeptiCyte RAPID as a rule-in test for sepsis; and (4) SeptiScore-derived LR+ and LR\u2212 values can be combined with estimates of pre-test probability (derived from patient characteristics and\/or other diagnostic tests) to generate individualized, patient-specific post-test probabilities of sepsis. Results: The SeptiCyte RAPID test demonstrates strong diagnostic performance in distinguishing sepsis from SIRS. The likelihood ratios across different score bands provide clear clinical utility: the median LR+ was 3.26 (range 2.57\u20134.24) for Band 3, and 6.97 (range 4.35\u201315.57) for Band 4, providing evidence toward ruling in sepsis at high SeptiScores. Conversely, the median LR\u2212 was 0.16 (range 0.14\u20130.20) for Band 2 and 0.085 (range 0.014\u20130.16) for Band 1, providing evidence toward ruling out sepsis at low SeptiScores. A higher-resolution analysis of SeptiCyte RAPID performance confirmed these trends by evaluating LR+ and LR\u2212 at specific values within each band. The sepsis group was further stratified according to whether patients were classified as blood culture positive (BC+) or blood culture negative (BC\u2212), and the detailed LR+ and LR\u2212 analyses were repeated. A monotonic increase in likelihood ratio with increasing SeptiScore was consistently observed, independent of whether sepsis patients were culture-positive, culture-negative, or unstratified with respect to blood culture status. Conclusions: High SeptiScores have correspondingly high LR+ values, and low SeptiScores have correspondingly low LR\u2212 values, both of which may have clinical utility. High likelihood ratios for Band 4 SeptiScores, which precede traditional microbiology results, may provide clinicians with early confidence of a sepsis diagnosis and microbiology diagnostic stewardship. Low likelihood ratios for Band 1 SeptiScores may prompt clinicians to consider an alternate diagnosis to sepsis. These are diagnostic-performance-based observations; whether they translate into fewer missed diagnoses or more efficient use of hospital resources has not been directly assessed in this study and will require dedicated clinical outcome studies.<\/jats:p>","DOI":"10.3390\/diagnostics16152450","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T14:16:27Z","timestamp":1785766587000},"page":"2450","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Ruling In and Ruling Out Sepsis Using Likelihood Ratios of a Host Response Assay"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4751-6130","authenticated-orcid":false,"given":"Krupa Arun","family":"Navalkar","sequence":"first","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prashant","family":"Wani","sequence":"additional","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roy F.","family":"Davis","sequence":"additional","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Cermelli","sequence":"additional","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0960-038X","authenticated-orcid":false,"given":"Maximilian","family":"Dietrich","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Medical Faculty Heidelberg, Heidelberg University, Im Neuenheimer Feld 420, 69120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5381-6535","authenticated-orcid":false,"given":"Maik","family":"von der Forst","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Medical Faculty Heidelberg, Heidelberg University, Im Neuenheimer Feld 420, 69120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3634-8802","authenticated-orcid":false,"given":"S\u00f6ren L.","family":"Becker","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology and Hygiene, Saarland University, 66421 Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophia","family":"Benthien","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology and Hygiene, Saarland University, 66421 Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Baumann","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology and Hygiene, Saarland University, 66421 Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9464-1010","authenticated-orcid":false,"given":"Carsten","family":"Zeiner","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine V, Pneumology and Intensive Care Medicine, Saarland University, 66421 Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp M.","family":"Lepper","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Pneumology and Intensive Care Medicine, University Hospital OWL Campus Bethel, University of Bielefeld, 33617 Bielefeld, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2542-7601","authenticated-orcid":false,"given":"Jos\u00e9","family":"Garnacho-Montero","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hospital Universitario Virgen del Roc\u00edo, 41013 Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1024-2954","authenticated-orcid":false,"given":"Mar\u00eda Luisa","family":"Cant\u00f3n-Bulnes","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hospital Universitario Virgen Macarena, 41009 Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adela","family":"Fern\u00e1ndez-Galilea","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hospital Universitario Virgen del Roc\u00edo, 41013 Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1443-9236","authenticated-orcid":false,"given":"Jose Luis","family":"Garc\u00eda-Garmendia","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hospital San Juan de Dios del Aljarafe, 41930 Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1ngel","family":"Estella","sequence":"additional","affiliation":[{"name":"Intensive Care Unit, Hospital Universitario de Jerez de la Frontera, 11407 C\u00e1diz, Spain"},{"name":"Instituto de Investigaci\u00f3n e Innovaci\u00f3n Biom\u00e9dica de C\u00e1diz (INiBICA), Department of Medicine and Surgery, University of C\u00e1diz, 11003 C\u00e1diz, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"Russell R.","family":"Miller","sequence":"additional","affiliation":[{"name":"Department of Critical Care Medicine, FirstHealth of the Carolinas, Pinehurst, NC 28374, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3969-7792","authenticated-orcid":false,"given":"Marcus J.","family":"Schultz","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia, General Intensive Care and Pain Management, Division of Cardiothoracic and Vascular Anaesthesia & Critical Care Medicine, Medical University Wien, 1090 Vienna, Austria"},{"name":"Department of Anaesthesiology, Rescue and Pain Medicine, Cantonal Hospital St. Gallen, HOCH Health Ostschweiz, 9007 St. Gallen, Switzerland"},{"name":"Nuffield Department of Medicine, University of Oxford, Oxford OX3 7BN, UK"},{"name":"Mahidol\u2013Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok 10400, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Rothman","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Burke","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Intermountain Medical Center, Murray, UT 84107, USA"},{"name":"School of Medicine, University of Utah, Salt Lake City, UT 84132, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gourang","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Services, University of Chicago Medicine, Chicago, IL 60637, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Parada","sequence":"additional","affiliation":[{"name":"Infectious Disease, Loyola University Medical Center, Maywood, IL 60153, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2341-2353","authenticated-orcid":false,"given":"Thomas D.","family":"Yager","sequence":"additional","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Brandon","sequence":"additional","affiliation":[{"name":"Immunexpress Inc., Seattle, WA 98109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Balk, R., Esper, A.M., Martin, G.S., Miller, R.R., Lopansri, B.K., Burke, J.P., Levy, M., Opal, S., Rothman, R.E., and D\u2019Alessio, F.R. 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