Evidence map›Paper›PMID 42746312›Full record

ArticleLancet regional health. Americas2026

Whole-blood point-of-care glial fibrillary acidic protein and ubiquitin C-terminal hydrolase L1 biomarkers after traumatic brain injury in the US: a prospective diagnostic prediction of intracranial injury on head CT.

Ava M Puccio, Michael A McCrea, David O Okonkwo, Swati Pradhan-Bhatt, Kenneth Curley, Adam Moss, Manish Gupta, Erica Wyse, Deeksha Pahwa, Damien Hoffman and 10 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Lancet regional health. Americas, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04171960 (Clinical Evaluation of the i-STAT TBI Test), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04171960 completednot on this map

Clinical Evaluation of the i-STAT TBI Test

TypeobservationalSponsorAbbott Point of CareRan2020 to 2023Enrolled1,106ConditionsTraumatic Brain InjuryArmsBlood draw, Outcome assessments
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Ava M PuccioDepartment of Neurological Surgery, University of Pittsburgh, Pittsburgh, PA, USA.
Michael A McCreaDepartment of Neurosurgery, Medical College of Wisconsin, Milwaukee, WI, USA.
David O OkonkwoDepartment of Neurological Surgery, University of Pittsburgh, Pittsburgh, PA, USA.
Swati Pradhan-BhattAbbott Laboratories, Abbott Park, IL, USA.
Kenneth CurleyIatrikos Research and Development Strategies, Allied Technologies and Consulting (ATC) Supporting Defense Health Agency, Operational Medical Systems (OPMED), Fort Detrick, MD, USA.
Adam MossAbbott Laboratories, Abbott Park, IL, USA.
Manish GuptaAbbott Laboratories, Abbott Park, IL, USA.
Erica WyseAbbott Laboratories, Abbott Park, IL, USA.
Deeksha PahwaAbbott Laboratories, Abbott Park, IL, USA.
Damien HoffmanDefense Health Agency, Operational Medical Systems (OPMED), Fort Detrick, MD, USA.
Claudia RobertsonDepartment of Neurosurgery, Baylor College of Medicine, Houston, TX, USA.
Joseph GiacinoDepartment of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.
Ramon Diaz-ArrastiaDepartment of Neurology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.
Nancy TemkinDepartments of Neurological Surgery and Biostatistics, University of Washington, Seattle, WA, USA.
Esther YuhDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Pratik MukherjeeDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Raj ChandranAbbott Laboratories, Abbott Park, IL, USA.
Geoffrey T ManleyDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Krista CaudleDefense Health Agency, Operational Medical Systems (OPMED), Fort Detrick, MD, USA.
Beth McQuistonAbbott Laboratories, Abbott Park, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Biomarkers like glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) are being globally recommended as a valuable component in the evaluation of acute TBI. Having a regulatory-approved whole-blood test is imperative to provide consistent and democratized approach to healthcare. This prospective, national multicenter cohort trial (NCT04171960) evaluated the performance of a whole-blood, point-of-care (POC) GFAP/UCH-L1 panel in determining need for head computed tomography (CT) in adult patients presenting to the emergency department (ED) with suspected traumatic brain injury (TBI). Methods: Adults presenting to the ED with suspected TBI, Glasgow Coma Scale score 13-15, completed head CT scan, and blood collected within 24 h of injury were included. GFAP and UCH-L1 measured in whole-blood through a POC TBI biomarker test were analyzed using prespecified cutoffs and combined into a single test result and compared with CT findings. Findings: 970 enrolled participants [mean age 46.8 (18-97); 36%female; 69%White, 18%Black; 19%Hispanic/Latino] were analyzed. 683 participants (70.4%) had 'elevated' and 287 (29.6%) had 'not elevated' TBI blood test result. For detection of CT intracranial injury, the whole-blood TBI test had sensitivity of 96.5% (95%CI 93.6-98.1%) and NPV 96.5% (95%CI 93.7-98.1%). Interpretation: The GFAP/UCH-L1 whole-blood test had high sensitivity and NPV for prediction of intracranial injury within 24 h of TBI. The platform received U.S.-FDA clearance and expands clinical use of the TBI test beyond the laboratory. This test provides results in 15 min; supporting rapid triage and decision-making in suspected TBI. Funding: Defense Health Agency (DHA) under Contract No. W81XWH19C0071.

Indexed as

Acute presentation of TBIBiomarkersConcussion guidelinesCT risksDiagnostic TBI testingGFAPGlasgow Coma ScaleGuidelinesHealth economics and outcomes of TBIImagingIntracranial lesionsNeurological outcomePoint-of-care TBI testingTBITBI blood testTBI consensusTBI guidelinesTBI policyUCH-L1

Identifiers

PMID42746312
PMCPMC13575800

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Registered trials

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.