Aurélie Ladang, George Vavoulis, Ioulia Trifonidi, Emma Calluy, Katerina Karagianni, Athanasios Mitropoulos, Konstantinos Vlachos, Etienne Cavalier, Konstantinos Makris
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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Increased specificity of the \\\"GFAP/UCH-L1\\\" mTBI rule-out test by age dependent cut-offs.\",\"authors\":\"Aurélie Ladang, George Vavoulis, Ioulia Trifonidi, Emma Calluy, Katerina Karagianni, Athanasios Mitropoulos, Konstantinos Vlachos, Etienne Cavalier, Konstantinos Makris\",\"doi\":\"10.1515/cclm-2024-1034\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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Increased specificity of the "GFAP/UCH-L1" mTBI rule-out test by age dependent cut-offs.
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.
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
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