Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection

Abstract Objective To find an adequate cut‐off point for beta trace protein (β‐TP) in nasal secretion (NS) and validate this diagnostic test with a large sample of patients. Likewise, we evaluated β‐TP test efficacy to confirm the cerebrospinal fluid (CSF) leakage closure after treatment. Methods We...

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Main Authors: María‐Teresa Almela, Javier Navarro‐Zaragoza, María‐Luisa Laorden, Fernando Sánchez‐Celemín, Pilar Almela
Format: Article
Language:English
Published: Wiley 2023-10-01
Series:Laryngoscope Investigative Otolaryngology
Subjects:
Online Access:https://doi.org/10.1002/lio2.1150
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author María‐Teresa Almela
Javier Navarro‐Zaragoza
María‐Luisa Laorden
Fernando Sánchez‐Celemín
Pilar Almela
author_facet María‐Teresa Almela
Javier Navarro‐Zaragoza
María‐Luisa Laorden
Fernando Sánchez‐Celemín
Pilar Almela
author_sort María‐Teresa Almela
collection DOAJ
description Abstract Objective To find an adequate cut‐off point for beta trace protein (β‐TP) in nasal secretion (NS) and validate this diagnostic test with a large sample of patients. Likewise, we evaluated β‐TP test efficacy to confirm the cerebrospinal fluid (CSF) leakage closure after treatment. Methods We performed a retrospective analysis with 207 samples from 162 patients with suspected CSF leakage received in the Hospital Universitario Virgen de la Arrixaca between 2010 and 2016. Twenty‐five samples were included in the control group. Samples were obtained from NS through a swab to determine β‐TP using a nephelometry‐based assay. Sensitivity, specificity, and area under the curve (AUC) for β‐TP in NS were assessed using the receiver operator characteristic (ROC) analysis. Results Using imaging techniques, the diagnosis of CSF leak was confirmed in 57 patients (35.19%), while 105 had a negative diagnosis (64.81%). Patients with CSF leakage had significantly higher β‐TP values in NS (16.07 ± 16.94 mg/L, p < .001) than the control group (0.33 ± 0.12 mg/L) and patients without CSF leakage (0.61 ± 2.34 mg/L). Applying a 1 mg/L cut‐off point resulted in 96.5% sensitivity and 97.1% specificity. Positive and negative predictive values (PPV and NPV) at this cut‐off were 94.9% and 98.6%, respectively. Finally, this cut‐off point yields a test efficacy for CSF leak diagnosis of 97% (95% CI 92.9–98.9). Conclusion Our study has established a 1 mg/L β‐TP concentration in NS as a cut‐off point for CSF leakage diagnosis with high sensibility and specificity. These results suggest that β‐TP analysis could be useful to check CSF leak resolution. Level of Evidence 4.
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spelling doaj.art-730b949d13114a0890fe0ce489f28c072023-10-26T12:36:34ZengWileyLaryngoscope Investigative Otolaryngology2378-80382023-10-01851233123910.1002/lio2.1150Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detectionMaría‐Teresa Almela0Javier Navarro‐Zaragoza1María‐Luisa Laorden2Fernando Sánchez‐Celemín3Pilar Almela4Hospital Universitario Los Arcos del Mar Menor Murcia SpainInstitute of Biomedical Research of Murcia (IMIB), Campus de Ciencias de la Salud Murcia SpainInstitute of Biomedical Research of Murcia (IMIB), Campus de Ciencias de la Salud Murcia SpainInstitute of Biomedical Research of Murcia (IMIB), Campus de Ciencias de la Salud Murcia SpainInstitute of Biomedical Research of Murcia (IMIB), Campus de Ciencias de la Salud Murcia SpainAbstract Objective To find an adequate cut‐off point for beta trace protein (β‐TP) in nasal secretion (NS) and validate this diagnostic test with a large sample of patients. Likewise, we evaluated β‐TP test efficacy to confirm the cerebrospinal fluid (CSF) leakage closure after treatment. Methods We performed a retrospective analysis with 207 samples from 162 patients with suspected CSF leakage received in the Hospital Universitario Virgen de la Arrixaca between 2010 and 2016. Twenty‐five samples were included in the control group. Samples were obtained from NS through a swab to determine β‐TP using a nephelometry‐based assay. Sensitivity, specificity, and area under the curve (AUC) for β‐TP in NS were assessed using the receiver operator characteristic (ROC) analysis. Results Using imaging techniques, the diagnosis of CSF leak was confirmed in 57 patients (35.19%), while 105 had a negative diagnosis (64.81%). Patients with CSF leakage had significantly higher β‐TP values in NS (16.07 ± 16.94 mg/L, p < .001) than the control group (0.33 ± 0.12 mg/L) and patients without CSF leakage (0.61 ± 2.34 mg/L). Applying a 1 mg/L cut‐off point resulted in 96.5% sensitivity and 97.1% specificity. Positive and negative predictive values (PPV and NPV) at this cut‐off were 94.9% and 98.6%, respectively. Finally, this cut‐off point yields a test efficacy for CSF leak diagnosis of 97% (95% CI 92.9–98.9). Conclusion Our study has established a 1 mg/L β‐TP concentration in NS as a cut‐off point for CSF leakage diagnosis with high sensibility and specificity. These results suggest that β‐TP analysis could be useful to check CSF leak resolution. Level of Evidence 4.https://doi.org/10.1002/lio2.1150cerebrospinal fluid leakagecut‐offnephelometryrhinorreaβ‐trace protein
spellingShingle María‐Teresa Almela
Javier Navarro‐Zaragoza
María‐Luisa Laorden
Fernando Sánchez‐Celemín
Pilar Almela
Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
Laryngoscope Investigative Otolaryngology
cerebrospinal fluid leakage
cut‐off
nephelometry
rhinorrea
β‐trace protein
title Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
title_full Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
title_fullStr Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
title_full_unstemmed Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
title_short Cut‐off value for β‐trace protein (β‐TP) as a rapid diagnostic of cerebrospinal fluid (CSF) leak detection
title_sort cut off value for β trace protein β tp as a rapid diagnostic of cerebrospinal fluid csf leak detection
topic cerebrospinal fluid leakage
cut‐off
nephelometry
rhinorrea
β‐trace protein
url https://doi.org/10.1002/lio2.1150
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