Evidence map›Paper›PMID 41028541›Full record

Observational studyNature medicine2025

Clinical validation of an AI-based blood testing device for diagnosis and prognosis of acute infection and sepsis.

Oliver Liesenfeld, Sanjay Arora, Tom P Aufderheide, Casey M Clements, Elizabeth DeVos, Miriam Fischer, Evangelos J Giamarellos-Bourboulis, Stacey House, Roger L Humphries, Jasreen Kaur Gill and 24 more

Abstract readObservational StudyValidation StudyValidation Study
In one paragraph

Observational study in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Oliver LiesenfeldClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA. oliver.liesenfeld@gmail.com.ORCID http://orcid.org/0000-0002-4348-5509
Sanjay AroraDepartment of Emergency Medicine, University of Southern California, Los Angeles, CA, USA.
Tom P AufderheideDepartment of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
Casey M ClementsDepartment of Emergency Medicine, Mayo Clinic, Rochester, MN, USA.
Elizabeth DeVosDepartment of Emergency Medicine, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.
Miriam FischerDepartment of Emergency Medicine, Georgetown University School of Medicine, Medstar Washington Hospital Center, Washington, DC, USA.
Evangelos J Giamarellos-Bourboulis4th Department of Internal Medicine, National and Kapodistrian University of Athens Medical School, Athens, Greece.ORCID http://orcid.org/0000-0003-4713-3911
Stacey HouseDepartment of Emergency Medicine, Washington University, St. Louis, MO, USA.
Roger L HumphriesDepartment of Emergency Medicine, University of Kentucky, Lexington, KY, USA.
Jasreen Kaur GillDepartment of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.ORCID http://orcid.org/0000-0002-1703-5379
Edward LiuDepartment of Emergency Medicine, Hackensack Meridian Health, Jersey Shore University Medical Center HOPE Tower, Neptune, NJ, USA.
Sharon E MaceDepartment of Emergency Medicine, Cleveland Clinic, Cleveland, OH, USA.
Larissa MayDepartment of Emergency Medicine, University of California, Davis, Davis, CA, USA.
Edward MichelsonDepartment of Emergency Medicine, Texas Tech University Health Sciences Center El Paso, El Paso, TX, USA.
Tiffany M OsbornDepartment of Emergency Medicine, Washington University, St. Louis, MO, USA.
Edward PanacekUniversity of South Alabama, Mobile, AL, USA.
Richard E RothmanDepartment of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.
Wesley H SelfDepartment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID http://orcid.org/0000-0002-9300-3045
Howard A SmithlineUniversity of Massachusetts Chan Medical School-Baystate, Springfield, MA, USA.
Jay SteingrubUniversity of Massachusetts Chan Medical School-Baystate, Springfield, MA, USA.
Paul Van HeukelomDepartment of Emergency Medicine, University of Iowa, Iowa City, IA, USA.
Alexandra WeissmanDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Matthew WilsonDepartment of Emergency Medicine, Georgetown University School of Medicine, Medstar Washington Hospital Center, Washington, DC, USA.
Donna M WolkGeisinger Diagnostic Medicine Institute, Geisinger Commonwealth School of Medicine, Danville, PA, USA.ORCID http://orcid.org/0000-0003-2828-5135
David W WrightDepartment of Emergency Medicine, Emory University School of Medicine, Grady Memorial Hospital, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-7145-9105
Ljubomir ButurovicClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.ORCID http://orcid.org/0000-0003-1732-4338
Yehudit Hasin-BrumshteinClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.
Nandita DamarajuClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.
Cici LuClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.
Joshua R ShakClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.
Natalie N WhitfieldClinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.ORCID http://orcid.org/0000-0001-9937-9687
Purvesh Khatri *Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA, USA.ORCID http://orcid.org/0000-0002-4143-4708
Timothy E Sweeney *Clinical Affairs, Inflammatix, Inc., Sunnyvale, CA, USA.ORCID http://orcid.org/0000-0002-3596-1093
Nathan I Shapiro *Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Funding

Using a tonsil organoid system to probe conditions for the induction of protective antibody and T cell responses to influenza.U19AI057229 · NIAID · STANFORD UNIVERSITY · PI Mark Morris Davis · 2003 to 2026
$88.5M
Translational Incubator CoreU19AI109662 · NIAID · STANFORD UNIVERSITY · PI GLENN, JEFFREY S · 2014 to 2019
$28.6M
NIAID NIH HHS U19 AI057229NIAID NIH HHS U19 AI109662U.S. Department of Health & Human Services | Biomedical Advanced Research and Development Authority (BARDA) 75A50119C00034, 75A50119C00044, and 75A50122C00069
6 · The paper itself

Abstract

Lack of reliable diagnostics for the presence, type and severity of infection in patients presenting to emergency departments with non-specific symptoms poses considerable challenges. We developed TriVerity, which uses isothermal amplification of 29 mRNAs and machine learning algorithms on the Myrna instrument to determine likelihoods of bacterial infection, viral infection and need for critical care interventions within 7 days. To validate TriVerity, the SEPSIS-SHIELD study enrolled 1,222 patients with clinically adjudicated infection status and need for critical care intervention within 7 days as endpoints. The TriVerity Bacterial and Viral scores had higher accuracy than C-reactive protein, procalcitonin or white blood cell count for the diagnosis of bacterial infection with area under the receiver operating characteristic (AUROC) of 0.83, and viral infection (AUROC = 0.91). The TriVerity Severity score had an AUROC of 0.78 for predicting illness severity and allowed reclassification of risk for critical care interventions compared to clinical assessment (quick Sequential Organ Failure Assessment) alone. Each of the three scores had rule-in specificity >92% and rule-out sensitivity >95%. Comparison of antibiotics administration at presentation with post-follow-up adjudication found that TriVerity could potentially reduce false positives and false negatives for inappropriate antibiotics use by 60-70%. Further clinical testing in an interventional setting is needed to prove actionability and clinical benefit of TriVerity.

Indexed as

Artificial IntelligenceBacterial InfectionsSepsisAdolescentAdultAgedAged, 80 and overAlgorithmsBiomarkersFemaleHumansMaleMiddle AgedProcalcitoninPrognosisRNA, MessengerBiomarkersProcalcitoninRNA, Messenger

Identifiers

PMID41028541
PMCPMC12705421

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.