Evidence mapPaperPMID 40650780Full record

ArticleCellular and molecular neurobiology2025

A Technical Assessment of a Commercial GFAP Lateral Flow Assay to Establish Proof-of-Concept for Use in Traumatic Brain Injury.

Daniel P Whitehouse, Edward J Needham, Joshua D Bernstock, Edoardo Gaude, Liam Barrett, Soraya Ebrahimi, David K Menon, Virginia F J Newcombe

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Article in Cellular and molecular neurobiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

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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

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No citing paper in PubMed yet.

4 · The record

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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

8 authors.

Daniel P Whitehouse *Department of Medicine: Perioperative, Acute, Critical Care and Emergency Medicine (PACE) Section, University of Cambridge, Cambridge, UK. dw555@cam.ac.uk.ORCID http://orcid.org/0000-0002-0216-1866
Edward J Needham *Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0001-7042-7462
Joshua D BernstockDepartment of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-7814-3867
Edoardo GaudeCRUK Cambridge Institute, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0001-8523-7792
Liam BarrettRadcliffe Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-3358-3233
Soraya EbrahimiDepartment of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
David K MenonDepartment of Medicine: Perioperative, Acute, Critical Care and Emergency Medicine (PACE) Section, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0002-3228-9692
Virginia F J NewcombeDepartment of Medicine: Perioperative, Acute, Critical Care and Emergency Medicine (PACE) Section, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0001-6044-9035

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glial fibrillary acidic protein (GFAP) is an emerging biomarker for the detection of acute intracranial pathology following acute brain injuries such as traumatic brain injury (TBI), stroke, and hypoxic-ischaemic encephalopathy. We undertake a proof-of-concept technical assessment of a commercial lateral flow test (LFT) for the detection of GFAP [the Upfront DX LVOne GFAP lateral flow assay (LFA)], against GFAP concentrations measured using a gold-standard assay [Single Molecule Arrays (Simoa®)-based Human Neurology 4-Plex B assay] in a TBI population. The ability of the LVOne GFAP LFA for identification of samples with GFAP concentrations above the manufacturer's reported lower limit of detection (≥ 0.2 ng/ml) was assessed, with further assessment of the association between the LVOne and a gold-standard assay made using Spearman's rank correlation coefficient and linear-mixed-effects modelling. Of the 50 samples, 39 had serum GFAP concentrations exceeding the reported lower limit of detection, with the LVOne GFAP LFA having a 95% (95% CI: 83%, 99%) sensitivity and a 64% (95% CI: 31%, 89%) specificity for detecting a serum GFAP concentrations over this lower limit. There was a significant positive correlation (Rho = 0.94, p < 0.001) between the Quanterix Simoa® GFAP level and the LVOne semiquantitative score, with a significant positive association seen using a linear-mixed-effects model (p < 0.001). In conclusion, the Upfront DX LVOne GFAP LFA is sensitive for the detection of elevated serum GFAP levels, and as such, may be a useful adjunct to the care of patients with acute brain injuries in the pre-hospital setting.

Indexed as

Brain Injuries, TraumaticGlial Fibrillary Acidic ProteinProof of Concept StudyAdultAgedBiomarkersFemaleHumansMaleMiddle AgedYoung AdultBiomarkersGFAP protein, humanGlial Fibrillary Acidic ProteinBiomarkersGlial fibrillary acidic protein (GFAP)Point-of-care (PoC) systemsTraumatic brain injuries (TBI)

Identifiers

PMID40650780
PMCPMC12255627

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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 Socratic graph.