TBICheck: A Rapid Test to Rule-Out CT scans in Mild Traumatic Brain Injury Patients

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Published Oct 4, 2023
DOI: https://doi.org/10.18103/mra.v11i9.4297

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Main Article Content

Azurmendi L.
Department of Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland
Cancelliere N.
Intensive Care Unit, Hospital Universitario La Paz, Madrid, Spain
Sempere L.
Neurovascular Research Laboratory, Instituto de Biomedicina de Sevilla-IBiS, Sevilla, Spain
Schena A.
ABCDx SA, Genève, Switzerland
Chocano E.
Vall d'Hebron Institut de Recerca
Diez Naz A.
Emergency Department, Virgen del Rocio Hospital, Seville, Spain
Chinchilla Palomares E.
Emergency Department, Virgen del Rocio Hospital, Seville, Spain
Perez Torres I.
Emergency Department, Virgen del Rocio Hospital, Seville, Spain
Cancelliere N.
Intensive Care Unit, Hospital Universitario La Paz, Madrid, Spain
Quintana Diaz M.
Intensive Care Unit, Hospital Universitario La Paz, Madrid, Spain
Menendez B.
Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
Garcia Armengol R.
Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
Laguna Carrero L.
Emergency Department, La Mancha Centro General Hospital
Placer López de Alda A
Servicio de Urgencias, Hospital Clínic i Provincial, Universitat de Barcelona
Perea M.
Servicio de Urgencias, Hospital Clínic i Provincial, Universitat de Barcelona
Montaner j.
Department of Neurology, Hospital Universitario Virgen Macarena, Sevilla, Spain; Neurovascular Research Laboratory, Instituto de Biomedicina de Sevilla-IBiS, Sevilla, Spain
Sanchez J-C
Department of Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland

Abstract

Introduction: The TBICheckTM Rapid test is an immunochromatographic rapid test capable of assisting in the triage of patients with mild Traumatic Brain Injury suspected of brain lesions. It quantitatively determines heart-type Fatty Acid Binding Protein (H-FABP) levels in whole blood, serum, or plasma. The aim of the present study was to evaluate its technical performance and test it in two different cohorts of mTBI patients as a potential diagnostic tool for detecting brain lesions in patients with mTBI.


Material and methods: Description of the assay: Linearity and low limit of quantification of TBICheckTM lateral flow assay were determined using serial dilution of standardized samples. Results were read using the TBICheckTM Reader, a mobile photometric immunoassay analyzer based on reflectance measurements to capture the optical density. Obtained results were compared to classical ELISA assays, Meso Scale Diagnostics. Patient cohorts: Two different cohorts of adult mTBI patients were included: a retrospective one including 82 patients and a prospective one including 65 patients. Values of H-FABP area under the curve, specificity, sensitivity were calculated.


Results: The H-FABP dose response fitted a linear regression within the range of 0.5-25 ng/mL. LLOQ in blood was 0.5 ng/mL. High Spearman correlation was found (ρ=0.933, p<0.001) when MSD ELISA and TBICheckTM concentrations were compared.


In the retrospective cohort, when the clinical sensitivity was set at 100%, a specificity value of 32.9% was obtained. In the prospective cohort, the SP value raised to 66.1% with 100% SE, meaning that 6 out of 10 patients might be discharged on the basis of their serum H-FABP concentration at hospital admission.


Conclusions: The quantification of H-FABP by using the TBICheckTM Rapid test on adult mTBI patients may allow to rule out the need of a CT-scan reducing the radiation exposure and avoiding the long waiting times in emergency units. It may lead to savings in hospital resources and assists medical doctors to provide the most appropriate treatment to the patients.


 

Article Details

How to Cite
L., Azurmendi et al. TBICheck: A Rapid Test to Rule-Out CT scans in Mild Traumatic Brain Injury Patients. Medical Research Archives, [S.l.], v. 11, n. 9, oct. 2023. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/4297>. Date accessed: 03 dec. 2024. doi: https://doi.org/10.18103/mra.v11i9.4297.
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Issue
Vol 11 No 9 (2023): September Issue, Vol.11, Issue 9
Section
Research Articles

The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.

 

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