Increased specificity of the "GFAP/UCH-L1" mTBI rule-out test by age dependent cut-offs.

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-11-27 DOI:10.1515/cclm-2024-1034
Aurélie Ladang, George Vavoulis, Ioulia Trifonidi, Emma Calluy, Katerina Karagianni, Athanasios Mitropoulos, Konstantinos Vlachos, Etienne Cavalier, Konstantinos Makris
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Abstract

Objectives: Mild traumatic brain injury (mTBI) remains challenging to diagnose effectively in the emergency department. Abbott has developed the "GFAP/UCH-L1" mTBI test, to guide the clinical decision to perform a computed tomography (CT) head scan by ruling out the presence of mTBI. We evaluated the diagnostic accuracy of the "GFAP/UCH-L1" mTBI test in a Greek cohort and established age-dependent cut-offs.

Methods: A total of 362 subjects with suspected mTBI and admitted to the Emergency department of the KAT General Hospital of Athens, Greece were recruited for the study. All subjects underwent a CT head scan to establish the diagnosis of mTBI. GFAP and UCH-L1 were measured using Alinity I (Abbott). 163 healthy subjects served as controls.

Results: Using the manufacturer's cut-offs (35 ng/L for GFAP and 400 ng/L for UCH-L1), the "GFAP/UCH-L1" mTBI test had a sensitivity of 99.1 % and a specificity of 40.6 %. However, the specificity dropped to 14.9 % in patients older than 65 years old. By defining a new cut-off of 115 ng/L for GFAP and 335 ng/L specifically for patients older than 65 years, specificity was increased up to 30.6 % without changing test sensitivity and the number of CT head scans avoided was doubled in this subgroup.

Conclusions: The "GFAP/UCH-L1" mTBI test is an efficient "rule-out test" to exclude patients suffering from mTBI. By adjusting the cut-offs in patients older than 65 years old, we could significantly increase the number of CT head scans avoided without affecting the sensitivity. These new cut-offs should be externally validated.

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通过与年龄相关的临界值提高 "GFAP/UCH-L1 "mTBI 排除测试的特异性。
目的:在急诊科有效诊断轻度创伤性脑损伤(mTBI)仍然具有挑战性。雅培开发了 "GFAP/UCH-L1 "mTBI 测试,通过排除是否存在 mTBI 来指导临床决定是否进行计算机断层扫描(CT)头部扫描。我们在希腊队列中评估了 "GFAP/UCH-L1 "mTBI 检测的诊断准确性,并确定了与年龄相关的临界值:研究共招募了 362 名疑似 mTBI 受试者,他们均在希腊雅典 KAT 综合医院急诊科住院。所有受试者均接受了头部 CT 扫描,以确诊为 mTBI。使用 Alinity I(雅培)测量 GFAP 和 UCH-L1。163名健康受试者作为对照组:使用制造商提供的临界值(GFAP 为 35 ng/L,UCH-L1 为 400 ng/L),"GFAP/UCH-L1 "mTBI 检测的灵敏度为 99.1%,特异性为 40.6%。但在 65 岁以上的患者中,特异性降至 14.9%。通过将 GFAP 的临界值定为 115 纳克/升,65 岁以上患者的临界值定为 335 纳克/升,在不改变检测灵敏度的情况下,特异性提高到了 30.6%,而且该亚组避免的头部 CT 扫描次数增加了一倍:结论:"GFAP/UCH-L1 "mTBI 检测是排除 mTBI 患者的有效 "排除检测"。通过调整 65 岁以上患者的临界值,我们可以在不影响灵敏度的情况下显著增加避免 CT 头部扫描的次数。这些新的临界值应经过外部验证。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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