array:22 [ "pii" => "S021057052400284X" "issn" => "02105705" "doi" => "10.1016/j.gastrohep.2024.502277" "estado" => "S100" "fechaPublicacion" => "2024-10-31" "aid" => "502277" "copyright" => "Elsevier España, S.L.U.. All rights reserved" "copyrightAnyo" => "2024" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "itemSiguiente" => array:17 [ "pii" => "S0210570524002851" "issn" => "02105705" "doi" => "10.1016/j.gastrohep.2024.502278" "estado" => "S100" "fechaPublicacion" => "2024-10-31" "aid" => "502278" "copyright" => "Elsevier España, S.L.U." "documento" => "simple-article" "crossmark" => 0 "subdocumento" => "crp" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "es" => array:10 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Carta científica</span>" "titulo" => "Neoplasia papilar oncocítica intraductal de páncreas" "tienePdf" => "es" "tieneTextoCompleto" => "es" "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Intraductal oncocytic papillary neoplasm of the pancreas" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figura 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1229 "Ancho" => 1400 "Tamanyo" => 421814 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Resonancia magnética abdominal con lesión nodular exofítica de 3,5<span class="elsevierStyleHsp" style=""></span>cm en cara anterior de cuerpo pancreático, inespecífica, con márgenes bien definidos, cápsula y centro heterogéneo con realce progresivo (A). Aspecto endosonográfico de la lesión sólida pancreática (B-C). Ecoendoscopio radial (B). Ecoendoscopio lineal y punción (C). Citología (Diff Quick 10×) del material obtenido mediante punción por ecoendoscopia con imágenes sugestivas de neoplasia pancreática de patrón glandular y papilar (D). Enucleación laparoscópica de tumoración en cara anterior pancreática, en contacto con pared gástrica posterior (transcavidad de los epiplones) (E). Hallazgos histológicos del espécimen resecado (F-G). Hematoxilina y eosina 20× muestra células atípicas con un citoplasma oncocítico (F). Inmunohistoquímica positiva para MUC6 (G).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Guillermo Castillo-López, Santiago González Vazquez, Beatriz Merchán Gómez, Maite Alonso-Sierra, César Prieto de Frías, Fernando Lapuente Sastre, Fernando Rotellar, Carolina Areán Cuns, Pilar López-Ferrer, José María Riesco López" "autores" => array:10 [ 0 => array:2 [ "nombre" => "Guillermo" "apellidos" => "Castillo-López" ] 1 => array:2 [ "nombre" => "Santiago" "apellidos" => "González Vazquez" ] 2 => array:2 [ "nombre" => "Beatriz" "apellidos" => "Merchán Gómez" ] 3 => array:2 [ "nombre" => "Maite" "apellidos" => "Alonso-Sierra" ] 4 => array:2 [ "nombre" => "César" "apellidos" => "Prieto de Frías" ] 5 => array:2 [ "nombre" => "Fernando" "apellidos" => "Lapuente Sastre" ] 6 => array:2 [ "nombre" => "Fernando" "apellidos" => "Rotellar" ] 7 => array:2 [ "nombre" => "Carolina" "apellidos" => "Areán Cuns" ] 8 => array:2 [ "nombre" => "Pilar" "apellidos" => "López-Ferrer" ] 9 => array:2 [ "nombre" => "José María" "apellidos" => "Riesco López" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210570524002851?idApp=UINPBA00004N" "url" => "/02105705/unassign/S0210570524002851/v1_202410310622/es/main.assets" ] "itemAnterior" => array:17 [ "pii" => "S0210570520302533" "issn" => "02105705" "doi" => "10.1016/j.gastrohep.2020.05.020" "estado" => "S200" "fechaPublicacion" => "2020-09-04" "aid" => "1593" "copyright" => "Elsevier España, S.L.U." "documento" => "simple-article" "crossmark" => 0 "subdocumento" => "ret" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:8 [ "idiomaDefecto" => true "titulo" => "WITHDRAWN: Higher appendicular skeletal muscle mass percentage is an independent protective factor for non-alcoholic steatohepatitis and significant fibrosis in male with NAFLD" "tienePdf" => "en" "tieneTextoCompleto" => 0 "tieneResumen" => "en" "contieneResumen" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Yilun Xu, Yaqi Guan, Wenyi Jin, Li Ding, Jinming Wu" "autores" => array:5 [ 0 => array:2 [ "nombre" => "Yilun" "apellidos" => "Xu" ] 1 => array:2 [ "nombre" => "Yaqi" "apellidos" => "Guan" ] 2 => array:2 [ "nombre" => "Wenyi" "apellidos" => "Jin" ] 3 => array:2 [ "nombre" => "Li" "apellidos" => "Ding" ] 4 => array:2 [ "nombre" => "Jinming" "apellidos" => "Wu" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210570520302533?idApp=UINPBA00004N" "url" => "/02105705/unassign/S0210570520302533/v2_202101310608/en/main.assets" ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original article</span>" "titulo" => "Comparative evaluation of point of care assay with ELISA techniques for quantifying serum concentrations of ustekinumab in inflammatory bowel disease patients" "tieneTextoCompleto" => true "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Carles Iniesta-Navalón, Manuel Ríos-Saorín, Lorena Rentero-Redondo, Rebeca Añez-Castaño, Elena Urbieta-Sanz" "autores" => array:5 [ 0 => array:4 [ "nombre" => "Carles" "apellidos" => "Iniesta-Navalón" "email" => array:1 [ 0 => "carles.iniesta@carm.es" ] "referencia" => array:4 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 3 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Manuel" "apellidos" => "Ríos-Saorín" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Lorena" "apellidos" => "Rentero-Redondo" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 3 => array:3 [ "nombre" => "Rebeca" "apellidos" => "Añez-Castaño" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 4 => array:3 [ "nombre" => "Elena" "apellidos" => "Urbieta-Sanz" "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Department of Hospital Pharmacy, Reina Sofia Hospital of Murcia, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Clinical Pharmacokinetics and Applied Pharmacotherapy Group, Biomedical Research Institute of Murcia (IMIB-Pascual Parrilla), Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Department of Pharmacology, School of Medicine, University of Murcia, Murcia, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Evaluación comparativa de un ensayo Point of Care y técnicas ELISA para la determinación de concentraciones séricas de ustekinumab en pacientes con enfermedad inflamatoria intestinal" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1738 "Ancho" => 2050 "Tamanyo" => 228306 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Correlation and Bland–Altman analysis of ustekinumab concentrations measured by different assays. Panels A–C: Scatter plots comparing ustekinumab concentrations measured by POC-AFIAS, ELISA-PRO, and ELISA-RDSC assays. The line of best fit is shown with the corresponding equation and <span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span> value, indicating the degree of correlation between the methods. Panels D–F: Bland–Altman plots showing the agreement between the assays. The solid line represents the mean difference (bias) between the two assays, while the dashed lines represent the upper and lower limits of agreement (LOA), calculated as the mean difference<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.96 times the standard deviation of the differences.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Ustekinumab (UST), a monoclonal antibody that blocks the p40 subunits of interleukins 12 and 23,<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">1,2</span></a> has demonstrated efficacy in inducing and maintaining clinical remission in patients with Crohn's disease (CD)<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">3,4</span></a> and ulcerative colitis (UC).<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">5</span></a> Data from trials UNITI-1 and UNITI-2 in CD confirm the relationship between UST exposure and clinical efficacy. For CD, the reference levels at week 8 are 3.9<span class="elsevierStyleHsp" style=""></span>μg/mL (range 2–7.3<span class="elsevierStyleHsp" style=""></span>μg/mL) for clinical remission and greater than 11.1<span class="elsevierStyleHsp" style=""></span>μg/mL for endoscopic remission.<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">6–8</span></a> In patients with UC, the trough concentration associated with clinical response at week 8 is ≥3.7<span class="elsevierStyleHsp" style=""></span>μg/mL.<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">8,9</span></a> For maintenance therapy, recommended UST trough levels are between 1.5 and 3<span class="elsevierStyleHsp" style=""></span>μg/mL for clinical remission and greater than 4.5<span class="elsevierStyleHsp" style=""></span>μg/mL for endoscopic response.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">UST, like other biological drugs, exhibit high interindividual variability, significantly affecting their clearance and, consequently, drug exposure.<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">10</span></a> Several factors are associated with increased UST clearance in IBD patients, including higher body weight, low serum albumin levels, immunogenicity, previous exposure to biologics, increased fat-free mass, male gender, Asian race, and elevated C-reactive protein (CRP) levels. In patients with inflammatory bowel disease (IBD), this variability can lead to drug underexposure, increasing the risk of therapeutic failure.<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">9,11–14</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Therapeutic drug monitoring (TDM) for biological drugs involves measuring blood drug concentrations and adjusting doses to maintain therapeutic levels.<a class="elsevierStyleCrossRefs" href="#bib0210"><span class="elsevierStyleSup">15–17</span></a> It uses pharmacokinetic and pharmacodynamic (PK/PD) analyses, integrating population data with individual patient data via Bayesian estimators and decision algorithms.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">8</span></a> A critical step in TDM is the analytical quantification of drug concentration in blood. The accuracy and precision of these analytical methods are essential, as they provide the necessary data for PK/PD analyses that guide personalized dosing, ensuring adequate drug exposure and optimizing therapeutic outcomes.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Various analytical techniques are employed to measure serum drug concentrations and anti-drug antibodies. The enzyme-linked immunosorbent assay (ELISA) is often considered the gold standard due to its established accuracy and precision in quantifying biologic drug levels.<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">18,19</span></a> However, ELISA has limitations, including a longer turnaround time (4–8<span class="elsevierStyleHsp" style=""></span>h), which can delay clinical decision-making. Alternatives like chemiluminescence immunoassays (CLIA) and electrochemiluminescence immunoassays (ECLIA) offer faster results and have shown strong correlation and agreement with ELISA in several studies.<a class="elsevierStyleCrossRefs" href="#bib0235"><span class="elsevierStyleSup">20–22</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Point-of-care (POC) assays offer several significant advantages in TDM of biological drugs. One primary benefit is the rapid turnaround time, with results available within 15–20<span class="elsevierStyleHsp" style=""></span>min compared to the several hours required for ELISA tests. This speed enables immediate clinical decision-making, facilitating prompt adjustments to therapy during the same patient visit. Additionally, POC assays are designed to analyze single samples efficiently, which contrasts with ELISA assays that typically require batch processing for cost-effectiveness. This characteristic of POC assays can reduce delays in obtaining test results, enhancing the responsiveness of patient management.<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">22</span></a> Despite some limitations, such as slightly lower sensitivity and the need for external and internal quality controls, the convenience and immediacy of POC assays make them a valuable tool in clinical practice. Moreover, it is crucial to evaluate their comparability with established ELISA methods. Previous studies have shown good agreement between various POC assays and ELISA for monitoring infliximab and adalimumab, though discrepancies have been noted at higher drug concentrations.<a class="elsevierStyleCrossRefs" href="#bib0250"><span class="elsevierStyleSup">23–25</span></a> However, to our knowledge, there are no studies comparing POC-AFIAS for UST with ELISA-based techniques.</p><p id="par0030" class="elsevierStylePara elsevierViewall">For this reason, the objective of this study was to evaluate the analytical performance and clinical utility of the POC-AFIAS assay, a newly introduced rapid test. This evaluation was conducted in comparison with two established assays: the Promonitor® ELISA assay (ELISA-PRO) and the ELISA Ridascreen® (ELISA-RDSC), for quantifying serum concentrations of UST.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study period and sample collection</span><p id="par0035" class="elsevierStylePara elsevierViewall">A prospective study was conducted from October 2023 to April 2024. The study was conducted at a referral hospital in the Murcia region of Spain. Consecutive serum samples from adult patients undergoing treatment with UST were included. These samples were collected as part of routine monitoring to ensure optimal therapeutic drug levels. The research was approved by the local Ethical Research Committee. Informed consent was obtained from all subjects involved in the study.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Three analytical techniques were compared for the quantification of UST serum concentrations: POC-AFIAS, ELISA-PRO, ELISA-RDSC assays.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Sample extraction and processing</span><p id="par0045" class="elsevierStylePara elsevierViewall">The sample extraction process was conducted at the hospital's pharmacy service for subcutaneously administered drugs. Serum samples were collected from patients at trough levels, both during the induction and maintenance phase, prior to the next scheduled dose. Prior to analysis, the samples were centrifuged at 1500<span class="elsevierStyleHsp" style=""></span>g for 8<span class="elsevierStyleHsp" style=""></span>min, and two aliquots of each serum were extracted. Serum samples were processed immediately after collection using the POC technique. For the ELISA assay, samples were stored frozen at −20<span class="elsevierStyleHsp" style=""></span>°C until they were processed (within 30 days maximum of sample extraction).</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Analytical determination</span><p id="par0050" class="elsevierStylePara elsevierViewall">The analytical determinations were conducted at the Clinical Pharmacokinetics Unit of the hospital's Pharmacy Service. The POC-AFIAS assay was performed using a commercial kit provided by Boditech® in accordance with the manufacturer's instructions, utilizing the AFIAS-10® analyzer (Menarini®). The measurement range for UST concentrations using the POC technique is between 0.2 and 20<span class="elsevierStyleHsp" style=""></span>μg/mL<span class="elsevierStyleHsp" style=""></span>cg/mL.</p><p id="par0055" class="elsevierStylePara elsevierViewall">The ELISA assay was performed using Promonitor® kits (ELISA-PRO) and Radiascreen® (ELISA-RDSC) following the manufacturer's protocols. For the quantification serum concentration of UST samples were diluted 1:200. With this dilution, the measurement range for UST concentrations is between 0.62 and 20<span class="elsevierStyleHsp" style=""></span>μg/mL for ELISA-PRO and between 0.5 and 24<span class="elsevierStyleHsp" style=""></span>μg/mL for ELISA-RDSC. In cases where a sample's concentration exceeded the upper detection limit of the assay, the corresponding upper limit value for each technique was considered. This approach ensured that all data points were consistently represented within the established measurement range of each assay, facilitating accurate comparison and analysis across different techniques.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Therapeutic range</span><p id="par0060" class="elsevierStylePara elsevierViewall">To evaluate the serum concentrations of UST, three specific therapeutic ranges were defined: less than 1<span class="elsevierStyleHsp" style=""></span>μg/mL (<1<span class="elsevierStyleHsp" style=""></span>μg/mL), between 1 and 4.5<span class="elsevierStyleHsp" style=""></span>μg/mL (1–4.5<span class="elsevierStyleHsp" style=""></span>μg/mL), and greater than 4.5<span class="elsevierStyleHsp" style=""></span>μg/mL (>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL). These ranges were used to categorize and compare the UST concentrations obtained using the three analytical techniques and to assess their suitability for monitoring and adjusting patient treatment.<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">22</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical analysis</span><p id="par0065" class="elsevierStylePara elsevierViewall">Median and interquartile range (IQR) were calculated for UST concentrations measured by both techniques. Mean differences between the methods were also determined. The comparison of means was performed using the Kruskal–Wallis test. To identify which pairs of techniques exhibited significant differences, post hoc comparisons were performed using the Mann–Whitney <span class="elsevierStyleItalic">U</span> test. Due to the multiple comparisons, the Bonferroni correction was applied to control the type I error, resulting in an adjusted significance level of 0.0167 for each Mann–Whitney <span class="elsevierStyleItalic">U</span> test.</p><p id="par0070" class="elsevierStylePara elsevierViewall">The Pearson correlation coefficient was used to evaluate the linear relationship between concentrations measured by POC and ELISA assays. The intra-class correlation coefficient (ICC) was calculated to assess the reliability and consistency between the two methods. To assess the agreement between the 2 methods in terms of quantification, Bland–Altman analysis was performed by examining the mean difference and establishing limits of agreement (LOA). Limits of agreement were calculated as the mean difference<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.96 times the standard deviation of the differences. The Kappa statistic was used to evaluate the agreement in classifying samples within therapeutic ranges defined for UST. A <span class="elsevierStyleItalic">p</span>-value of <0.05 was considered statistically significant. All statistical analyses were performed using SPSS for Windows (version 23.0; SPSS Inc., Chicago, IL, USA).</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><p id="par0075" class="elsevierStylePara elsevierViewall">A total of 104 patients were included in the study, with 51.9% being male. The mean age of the evaluated population was 46.4 years (SD<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>15.1). Among the patients, 78.8% were diagnosed with CD, with the most common disease location being ileal (50.0%), followed by ileocolic (35.4%). Additionally, 22 patients (21.2%) were diagnosed with UC, with 68.2% presenting pancolitis. Regarding the treatment period, 87.5% of patients were in the maintenance phase, while 12.5% were in the induction phase (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall">In the comparative analysis of the three analytical techniques for determining serum concentrations of UST, significant differences were observed. The median concentration of UST by POC-AFIAS was 5.22<span class="elsevierStyleHsp" style=""></span>μg/mL (IQR: 4.41), the ELISA-PRO method showed a median of 3.99<span class="elsevierStyleHsp" style=""></span>μg/mL (IQR: 2.78), and the ELISA-RDSC had a median of 4.50<span class="elsevierStyleHsp" style=""></span>μg/mL (IQR: 3.39), with significant differences found only between AFIAS and ELISA-PRO (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.009).</p><p id="par0085" class="elsevierStylePara elsevierViewall">Furthermore, Pearson correlation analyses revealed strong correlations between the techniques. The correlation between POC-AFIAS and ELISA-PRO was 0.921 between POC-AFIAS and ELISA-RDSC was 0.940, and between ELISA-PRO and ELISA-RDSC was 0.976, all with a significance of <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001. These results are supported by scatter plots, which show high correlations and strong linear fits (<span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.8489 for POC-AFIAS vs. ELISA-PRO, <span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.8574 for POC-AFIAS vs. ELISA-RDSC, and <span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.9525 for ELISA-PRO vs. ELISA-RDSC) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). The ICC analysis provided a robust evaluation of the comparability between the analytical methods compared. For POC-AFIAS and ELISA-PRO, the ICC for single measurements was remarkably high at 0.884 (95% CI: 0.832–0.920), indicating excellent reliability. This reliability was further enhanced in average measurements, with an ICC of 0.938 (95% CI: 0.908–0.958). Similarly, POC-AFIAS and ELISA-RDSC showed an ICC of 0.936 (95% CI: 0.903–0.958) for single measurements and 0.967 (95% CI: 0.949–0.978) for average measurements. Lastly, the comparison between the two ELISA methods demonstrated an ICC for single measurements of 0.962 (95% CI: 0.942–0.975) and an ICC for average measurements of 0.981 (95% CI: 0.970–0.987), indicating an exceptionally high level of reliability.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0090" class="elsevierStylePara elsevierViewall">Bland–Altman's analysis was conducted to complete the comparison between the methods, revealing a bias difference of 1.81<span class="elsevierStyleHsp" style=""></span>μg/mL (SD: 2.11) between POC-AFIAS and ELISA-PRO. In the comparison between POC-AFIAS and ELISA-RDSC, the mean difference was 1.27<span class="elsevierStyleHsp" style=""></span>μg/mL (SD: 1.89). Six values above the 95% limit of agreement were identified for the comparison between POC-AFIAS and ELISA-PRO, as well as between POC-AFIAS and ELISA-RDSC. Finally, in the comparison between ELISA-PRO and ELISA-RDSC, the mean difference was −0.54<span class="elsevierStyleHsp" style=""></span>μg/mL (SD: 1.10), 9 samples exceeded the limits of agreement (LOA) in this comparison (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><p id="par0095" class="elsevierStylePara elsevierViewall">Stratifying results into sub-therapeutic, supra-therapeutic, and therapeutic ranges was necessary due to their clinical importance and significance (<a class="elsevierStyleCrossRefs" href="#tbl0010">Tables 2 and 3</a>). Overall, the qualitative agreement between POC-AFIAS and ELISA-PRO and ELISA-RDSC was 83.7% (87/104). The Kappa coefficient, indicating the strength of agreement, was 0.698 for both comparisons. In the comparison between POC-AFIAS and the two ELISA techniques, the highest level of agreement was observed for samples classified within the therapeutic range, with an agreement of 97.3 (36/37). In contrast, for samples classified as above the therapeutic range, the level of agreement was lower, at 74.6% (47/63). Regarding the induction samples (<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>13), the percentage of samples with levels above the therapeutic range was 76.9% (10/13) for the comparison between POC-AFIAS and ELISA-PRO, and 92.3% (12/13) for the comparison between POC-AFIAS and ELISA-RDSC, respectively. The ELISA-PRO results were concordant with the ELISA-RDSC assay results in 92.4% (96/104) of patients. Overall, the Kappa value was 0.856, indicating a moderate level of agreement. Regarding the comparison between the two ELISA techniques, a high level of agreement was observed for samples classified within the therapeutic range, with an agreement of 92.3% (48/52). Conversely, for samples classified as above the therapeutic range, the level of agreement was slightly lower, at 44/48 (91.7%). For the induction samples, the percentage of samples with levels within and above the therapeutic range was 100% (1/1) and 83.3% (10/12), respectively, for the comparison between ELISA-PRO and ELISA-RDSC.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Discussion</span><p id="par0100" class="elsevierStylePara elsevierViewall">To the best of our knowledge, this is the first study that compares the new POC-AFIAS assay for quantifying serum concentrations of UST with two established ELISA techniques in patients with IBD. POC assays, like AFIAS, belong to a group of TDM trials that allow for rapid results and immediate clinical decisions. Therefore, it is necessary to evaluate whether the results from this newly introduced rapid test are comparable with the established gold-standard techniques.</p><p id="par0105" class="elsevierStylePara elsevierViewall">The correlation analysis, as indicated by the Pearson correlation coefficients, demonstrated strong and statistically significant relationships among the different assays. The results suggest that POC-AFIAS, ELISA-PRO, and ELISA-RDSC produce consistent and comparable measurements of serum UST concentrations. Notably, the correlation between the ELISA techniques (ELISA-PRO and ELISA-RDSC) was stronger than between the POC-AFIAS assay and either ELISA method.</p><p id="par0110" class="elsevierStylePara elsevierViewall">The Bland–Altman analysis revealed that the POC-AFIAS assay exhibited a higher bias compared to the ELISA techniques. Specifically, the bias difference between AFIAS and ELISA-PRO was 1.81<span class="elsevierStyleHsp" style=""></span>μg/mL, and between AFIAS and ELISA-RDSC it was 1.27<span class="elsevierStyleHsp" style=""></span>μg/mL. These values indicate that the AFIAS-10® POC assay tends to produce higher serum UST concentrations compared to both ELISA methods. In contrast, the comparison between ELISA-PRO and ELISA-RDSC showed a much smaller mean difference of −0.54<span class="elsevierStyleHsp" style=""></span>μg/mL, suggesting closer agreement between the two ELISA techniques. Thus, while the ELISA methods demonstrate better consistency and reliability, the POC-AFIAS assay may introduce a positive bias, leading to higher concentration readings.</p><p id="par0115" class="elsevierStylePara elsevierViewall">A recent study<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">22</span></a> comparing CLIA with ELISA for UST found significant discrepancies between the methods. The i-TRACK CLIA method tended to underestimate UST concentrations compared to the TRITURUS ELISA, with a mean difference of −1.46<span class="elsevierStyleHsp" style=""></span>μg/mL. This underestimation was more pronounced at higher concentrations (>7<span class="elsevierStyleHsp" style=""></span>μg/mL). In addition, the techniques demonstrated “moderate concordance”, assessed using the Kappa index (0.424). The agreement within the therapeutic range was 65.6%, and for concentrations above 4.5<span class="elsevierStyleHsp" style=""></span>μg/mL, the agreement was 52.6%, both of which were inferior to the agreement observed in our study.</p><p id="par0120" class="elsevierStylePara elsevierViewall">Other study have demonstrated strong agreement between the ECLIA and ELISA assays for UST and antibodies-to-UST, showing high specificity, accuracy, and precision in detecting UST concentrations.<a class="elsevierStyleCrossRef" href="#bib0265"><span class="elsevierStyleSup">26</span></a> In another study that compared the drug-tolerant homogeneous mobility shift assay (HMSA) technique with two commercial ELISA techniques, the HMSA (Prometheus®) technique showed a modest correlation with the ELISA techniques, specifically ELISA (Progenika®) and ELISA (Theradiag®), with ICC of 0.649 and 0.671, respectively. In contrast, a strong correlation was observed between the two ELISA techniques, ELISA (Progenika®) and ELISA (Theradiag®), with an ICC of 0.958.<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">27</span></a></p><p id="par0125" class="elsevierStylePara elsevierViewall">In addition to the technical evaluation of the different methodologies, it is essential to consider how these differences impact practical implementation and accessibility in real clinical settings. Regarding the economic limitations of implementing POC techniques, these methods allow results to be obtained from a single sample without the need to batch multiple samples as required by ELISA, providing greater speed and flexibility in clinical practice. Furthermore, POC allows for immediate therapeutic adjustments during patient visits, optimizing treatment without delays. Although the initial cost may be higher, the benefits of rapid adjustment and effective patient management could compensate for these costs in the long term.</p><p id="par0130" class="elsevierStylePara elsevierViewall">An important consideration in our study is that the correlation between assays was lower at higher drug concentrations, indicating increased variability and reduced agreement between the techniques when measuring elevated levels of UST. Consistent with previous studies,<span class="elsevierStyleSup">28–30</span> significant discrepancies were observed at higher concentrations, suggesting that, although POC methods can be reliable, they do not always match ELISA results, especially at extreme concentrations. While no previous studies have specifically evaluated POC assays for UST, significant discrepancies at higher concentrations have been documented for infliximab and adalimumab.<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">24,25</span></a> The POC-AFIAS results for values above 4.5<span class="elsevierStyleHsp" style=""></span>μg/mL should be interpreted within the clinical context of the patient, considering their specific circumstances, such as clinical remission or suboptimal response. In these cases, a close follow-up is recommended, with careful monitoring and cautious therapeutic adjustments, particularly when considering de-escalation. In this situation, we propose that a follow-up TDM assessment could be conducted after approximately three months to confirm UST serum levels and to provide further support for therapeutic decision-making. This patient-centred approach facilitates timely and effective therapeutic decisions, optimizing treatment outcomes without compromising safety.</p><p id="par0135" class="elsevierStylePara elsevierViewall">However, when analyzing the degree of agreement by therapeutic intervals, the agreement between the different assay techniques varied. For samples classified within the therapeutic range, the highest level of agreement was observed between POC-AFIAS and the ELISA techniques, with an agreement rate of 96.6%. For samples classified above the therapeutic range, the agreement rate was significantly lower at 73.1%. Similarly, when comparing the two ELISA techniques, a high agreement rate of 90.5% was observed for samples within the therapeutic range, whereas for samples above the therapeutic range, the agreement rate was slightly lower at 89.7%. Despite these differences, particularly at supratherapeutic levels, they did not represent a significant limitation in clinical decision-making. It is important to consider that therapeutic ranges inherently carry the concept of probability and should be adjusted for each patient based on their pathology, disease phenotype, and clinical situation. Clinical decisions should be individualized, taking into account not only serum concentration levels but also the patient's clinical status, any potential missed doses, and the patient's serum concentration history over the follow-up period.</p><p id="par0140" class="elsevierStylePara elsevierViewall">This study has several limitations. Firstly, the number of samples included in our study may be a limiting factor in accurately determining the dispersion and correlation between both assays. A larger sample size, particularly with more supratherapeutic samples, would provide a more robust analysis and better quantify the variability observed at higher drug concentrations. This would enhance the reliability of our findings and their applicability in clinical settings. The second limitation is that our study did not determine the presence of anti-UST antibodies, although it is important to note the limited number of samples susceptible to this determination in our study. The third limitation is related to the different upper and lower measurement ranges of the three techniques analyzed: POC-AFIAS (0.5–20<span class="elsevierStyleHsp" style=""></span>μg/mL), ELISA-Prom (0.62–20<span class="elsevierStyleHsp" style=""></span>μg/mL), and ELISA-RDSC (0.5–24<span class="elsevierStyleHsp" style=""></span>μg/mL). This may have affected the correlation discrepancies at elevated concentrations.</p><p id="par0145" class="elsevierStylePara elsevierViewall">Despite the aforementioned limitations, a key strength of our study is that, to our knowledge, it is the first to compare the recently introduced POC-AFIAS method with two ELISA techniques. This provides robust evidence of the comparability and utility of the AFIAS-10® POC assay. Additionally, the inclusion of samples spanning a wide range of concentrations enables the assessment of how both techniques correlate across lower and higher concentration ranges. The use of POC assays such as the AFIAS can offer significant advantages in daily clinical practice, particularly in the rapid monitoring and dose adjustment. This is especially important in patients with suspected therapeutic failure (primary or secondary) or pharmacokinetic failure (mediated or not by antibodies). The ability to obtain near real-time results can improve patient care efficiency, allowing immediate dose adjustments or avoiding unnecessary doses, and potentially enhancing clinical outcomes.<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">18,19,22,23,25,26</span></a> Furthermore, the simplicity and speed of the POC method make it suitable for use in clinical settings where time and resources are limited.</p><p id="par0150" class="elsevierStylePara elsevierViewall">Future research should focus primarily on two main areas: evaluating the correlation between different assays and establishing optimal therapeutic ranges with each assay to determine the interchangeability between the different methods. This will ensure that UST concentrations measured by various techniques are comparable and reliable, thereby facilitating more effective and personalized treatment strategies in clinical practice. Additionally, longitudinal studies are needed to evaluate the clinical impact of using POC assays in the long-term management of patients with immune-mediated diseases, providing valuable insights into the therapeutic and economic benefits of this approach.</p><p id="par0155" class="elsevierStylePara elsevierViewall">In conclusion, this is the first study to compare the new POC-AFIAS method with two ELISA methods, demonstrating that it provides comparable results for quantifying serum concentrations of UST. The findings indicate that POC-AFIAS assay showed a high correlation and concordance with two ELISA methods for the quantification of UST concentrations. These findings support the use of POC assays in daily clinical practice, offering a rapid and reliable tool for TDM of these drugs. Future studies should focus on determining the precision and accuracy of POC assays, particularly at supra-therapeutic levels, to ensure that they provide consistent and dependable results. Additionally, it is crucial to explore the integration of POC assays with other diagnostic tools and clinical data to enhance decision-making processes and ultimately improve patient outcomes.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Authors’ contributions</span><p id="par0160" class="elsevierStylePara elsevierViewall">CIN: conception and design of the study, acquisition, analysis and interpretation of data, drafting of the article and review and final approval of the version.</p><p id="par0165" class="elsevierStylePara elsevierViewall">MRS and RAC: acquisition, conception and design of the study, drafting of the article and review and final approval of the version.</p><p id="par0170" class="elsevierStylePara elsevierViewall">LRR and EUS: drafting of the article and review and final approval of the version.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Ethical approval</span><p id="par0175" class="elsevierStylePara elsevierViewall">The study was approved by Research Ethics Committee of Area VII (Murcia-East) of the Murcian Health Service.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Funding</span><p id="par0180" class="elsevierStylePara elsevierViewall">None.</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conflict of interest</span><p id="par0185" class="elsevierStylePara elsevierViewall">CIN declares that he have received fees from Janssen for participating as a speaker at scientific events. This financial support has not influenced the design, conduct, results, or interpretation of this study. The other authors declared no conflict of interest.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Availability of data and material</span><p id="par0190" class="elsevierStylePara elsevierViewall">The data that support the findings of this study are available upon reasonable request to the corresponding author.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:16 [ 0 => array:3 [ "identificador" => "xres2287632" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1902432" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xpalclavsec1902433" "titulo" => "Abbreviations" ] 3 => array:3 [ "identificador" => "xres2287633" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusión" ] ] ] 4 => array:2 [ "identificador" => "xpalclavsec1902434" "titulo" => "Palabras clave" ] 5 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 6 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study period and sample collection" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Sample extraction and processing" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Analytical determination" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Therapeutic range" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Statistical analysis" ] ] ] 7 => array:2 [ "identificador" => "sec0040" "titulo" => "Results" ] 8 => array:2 [ "identificador" => "sec0045" "titulo" => "Discussion" ] 9 => array:2 [ "identificador" => "sec0050" "titulo" => "Authors’ contributions" ] 10 => array:2 [ "identificador" => "sec0055" "titulo" => "Ethical approval" ] 11 => array:2 [ "identificador" => "sec0060" "titulo" => "Funding" ] 12 => array:2 [ "identificador" => "sec0065" "titulo" => "Conflict of interest" ] 13 => array:2 [ "identificador" => "sec0070" "titulo" => "Availability of data and material" ] 14 => array:2 [ "identificador" => "xack785810" "titulo" => "Acknowledgments" ] 15 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2024-08-05" "fechaAceptado" => "2024-10-14" "PalabrasClave" => array:2 [ "en" => array:2 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1902432" "palabras" => array:4 [ 0 => "Ustekinumab" 1 => "Therapeutic drug monitoring" 2 => "Point-of-care assay" 3 => "Enzyme-linked immunosorbent assays" ] ] 1 => array:4 [ "clase" => "abr" "titulo" => "Abbreviations" "identificador" => "xpalclavsec1902433" "palabras" => array:18 [ 0 => "CD" 1 => "CLIA" 2 => "CRP" 3 => "ECLIA" 4 => "ELISA" 5 => "ELISA-PRO" 6 => "ELISA-RDSC" 7 => "FCP" 8 => "IBD" 9 => "ICC" 10 => "IQR" 11 => "LOA" 12 => "PK/PD" 13 => "POC" 14 => "SD" 15 => "TDM" 16 => "UC" 17 => "UST" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1902434" "palabras" => array:4 [ 0 => "Ustekinumab" 1 => "Monitorización farmacocinética" 2 => "Point of care" 3 => "ELISA, Enfermedad inflamatoria intestinal" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To evaluate the analytical performance and clinical utility of the POC-AFIAS assay in comparison with two ELISA established assays for quantifying serum concentrations of ustekinumab.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A prospective study was conducted. Consecutive serum samples from adult patients undergoing treatment with ustekinumab were collected. Three analytical techniques were compared for the quantification of ustekinumab serum concentrations: the AFIAS-10® POC assay (POC-AFIAS), the Promonitor® ELISA assay (ELISA-PRO), and the ELISA Ridascreen® assay (ELISA-RDSC). Ustekinumab concentrations were evaluated within three therapeutic ranges: <1<span class="elsevierStyleHsp" style=""></span>μg/mL, 1–4.5<span class="elsevierStyleHsp" style=""></span>μg/mL, and >4.5<span class="elsevierStyleHsp" style=""></span>μg/mL. Statistical analysis included Pearson correlation, intra-class correlation coefficient, and Bland–Altman analysis.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A total of 104 patients were included in the study. The median ustekinumab concentrations measured were 5.22<span class="elsevierStyleHsp" style=""></span>μg/mL (POC-AFIAS), 3.99<span class="elsevierStyleHsp" style=""></span>μg/mL (ELISA-PRO), and 4.50<span class="elsevierStyleHsp" style=""></span>μg/mL (ELISA-RDSC). Strong correlations were observed between techniques (POC-AFIAS and ELISA-PRO: <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.921, POC-AFIAS and ELISA-RDSC: <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.940, ELISA-PRO and ELISA-RDSC: <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.976). The Bland–Altman analysis revealed a bias difference of 1.81<span class="elsevierStyleHsp" style=""></span>μg/mL between POC-AFIAS and ELISA-PRO, and 1.27<span class="elsevierStyleHsp" style=""></span>μg/mL between POC-AFIAS and ELISA-RDSC. Agreement rates varied by therapeutic range, with the highest agreement observed within the therapeutic range (97.3%) and lower agreement for supra-therapeutic concentrations (74.6%).</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">This study demonstrated that the POC-AFIAS assay provides comparable results to established ELISA techniques for quantifying serum concentrations of ustekinumab, particularly within the therapeutic range. The findings suggest that the POC-AFIAS assay offers a rapid and effective tool for managing ustekinumab therapy in clinical practice.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Evaluar el rendimiento analítico y la utilidad clínica del ensayo POC-AFIAS en comparación con 2 ensayos ELISA establecidos para la cuantificación de concentraciones séricas de ustekinumab.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se realizó un estudio prospectivo en el que se recolectaron muestras de suero de pacientes adultos en tratamiento con ustekinumab. Se compararon 3 técnicas analíticas: el ensayo POC-AFIAS, el ensayo Promonitor® ELISA (ELISA-PRO) y el ensayo ELISA Ridascreen® (ELISA-RDSC). Las concentraciones de ustekinumab se evaluaron en 3 rangos terapéuticos: <1, 1-4,5 y >4,5<span class="elsevierStyleHsp" style=""></span>μg/ml. El análisis estadístico incluyó la correlación de Pearson, el coeficiente de correlación intraclase y el análisis de Bland-Altman.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 104 pacientes en el estudio. La mediana de las concentraciones séricas de ustekinumab fue de 5,22<span class="elsevierStyleHsp" style=""></span>μg/ml (POC-AFIAS), 3,99<span class="elsevierStyleHsp" style=""></span>μg/ml (ELISA-PRO) y 4,50<span class="elsevierStyleHsp" style=""></span>μg/ml (ELISA-RDSC). Se observaron fuertes correlaciones entre las técnicas (POC-AFIAS y ELISA-PRO: r<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,921, POC-AFIAS y ELISA-RDSC: r<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,940, ELISA-PRO y ELISA-RDSC: r<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,976). El análisis de Bland-Altman reveló una diferencia de sesgo de 1,81<span class="elsevierStyleHsp" style=""></span>μg/ml entre POC-AFIAS y ELISA-PRO, y de 1,27<span class="elsevierStyleHsp" style=""></span>μg/ml entre POC-AFIAS y ELISA-RDSC. Las tasas de concordancia variaron según el rango terapéutico, siendo la más alta dentro del rango terapéutico (97,3%) y menor para concentraciones supra-terapéuticas (74,6%).</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusión</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Este estudio demostró que el ensayo POC-AFIAS proporciona resultados comparables a las técnicas ELISA establecidas para cuantificar las concentraciones séricas de ustekinumab, especialmente dentro del rango terapéutico. Los hallazgos sugieren que el ensayo POC-AFIAS ofrece una herramienta rápida y efectiva para la gestión de la terapia con ustekinumab en la práctica clínica.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusión" ] ] ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1738 "Ancho" => 2050 "Tamanyo" => 228306 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Correlation and Bland–Altman analysis of ustekinumab concentrations measured by different assays. Panels A–C: Scatter plots comparing ustekinumab concentrations measured by POC-AFIAS, ELISA-PRO, and ELISA-RDSC assays. The line of best fit is shown with the corresponding equation and <span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span> value, indicating the degree of correlation between the methods. Panels D–F: Bland–Altman plots showing the agreement between the assays. The solid line represents the mean difference (bias) between the two assays, while the dashed lines represent the upper and lower limits of agreement (LOA), calculated as the mean difference<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.96 times the standard deviation of the differences.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">BMI: body mass index; CD: Crohn's disease; CRP: C-reactive protein; FCP: faecal calprotectin; UC: ulcerative colitis; SD: standard deviation.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="2" align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Patients</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Age, mean (SD)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">46.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(15.13) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Duration of disease at first UST (years), median (IQR)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4.5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(8.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Weight (kg), mean (SD)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">73.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(16.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">BMI, mean (SD)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25.8 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(4.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Male</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">54 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(51.9) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">CD, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">82 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(78.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">CD location, n (%)</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>L1 (ileal) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">41 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(50.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>L2 (colonic) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(2.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>L3 (ileocolonic) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">29 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(35.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">CD behaviour, n (%)</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>B1 (inflammatory) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(26.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>B2 (stricturing) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">31 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(37.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>B3 (penetrating) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">18 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(21.9) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Ulcerative colitis, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(21.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">UC location, n</span> (%)</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>E2 (left-sided colitis) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(31.8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>E3 (pancolitis) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(68.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Perianal disease, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(12.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Surgery previous, n (%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(23.1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Previous biological therapy,</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">98 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(94.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Period treatment, n (%)</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Maintenance \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">90 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(86.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Induction \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(12.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Dosage regimen</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>90<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>sc/8 weeks \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">34 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(32.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>90<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>sc/6 weeks \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(15.4) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>90<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>sc/4 weeks \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">21 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(20.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>130<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>iv/4 weeks \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(6.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Others \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(25.0) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Biochemical parameters</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>CRP (mg/dl), median (IQR) (<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>75) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(0.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>FCP (μg/g), median (IQR) (<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>67) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">186.0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(339.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3708999.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Demographic and clinical characteristics of the study population (<span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>104).</p>" ] ] 2 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at2" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">ELISA-PROM: enzyme-linked immunosorbent assay Promonitor® kit; ELISA-RSDC: enzyme-linked immunosorbent assay Radiascreen® kit; POC: point of care; UST: ustekinumab.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">POC-AFIAS UST concentration \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="3" align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ELISA-PROM UST concentration</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Total \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="3" align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ELISA-RDSK UST concentration</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Total \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"><1<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">(1–4.5) μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"><1<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">(1–4.5) μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><1<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(1–4.5) μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">36 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">37 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">36 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">37 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">47 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">63 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">47 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">63 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="9" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Total</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3709000.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Data agreement between POC-AFIAS and ELISA-PRO and ELISA-RDSK values for ustekinumab.</p>" ] ] 3 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at3" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">ELISA-PROM: enzyme-linked immunosorbent assay Promonitor® kit; ELISA-RSDC: enzyme-linked immunosorbent assay Radiascreen® kit; POC: point of care, UST: ustekinumab.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">ELISA-PROM UST concentration \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="3" align="center" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">ELISA-RDSK UST concentration</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Total \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"><1<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">(1–4.5) μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><1<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">(1–4.5) μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">>4.5<span class="elsevierStyleHsp" style=""></span>μg/mL \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">44 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="5" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Total \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3708998.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Data agreement between ELISA Promonitor and ELISA Radiascreen values for ustekinumab.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:27 [ 0 => array:3 [ "identificador" => "bib0140" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J.M. 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Comparative evaluation of point of care assay with ELISA techniques for quantifying serum concentrations of ustekinumab in inflammatory bowel disease patients
Evaluación comparativa de un ensayo Point of Care y técnicas ELISA para la determinación de concentraciones séricas de ustekinumab en pacientes con enfermedad inflamatoria intestinal