The strong individuality observed supports the preferential use of RCVs rather than population-based reference intervals in elderly people. For most of the analytes studied, data from the young population can be applied to elderly people, but the specific elderly coefficients of BV and RCVs are a recommended option.

Objective To assess concordance between two point‐of‐care testing (POCT) devices and the standard laboratory method in screening for gestational diabetes mellitus (GDM) in Huesca. Methods Pregnant women who met criteria for an oral glucose tolerance test (OGTT) and attended the laboratory between October 2017 and November 2018 were recruited in this prospective observational study. Glucose was measured in venous (laboratory) and capillary blood (Accu‐Chek or Contour Next glucometers). GDM was diagnosed attending to NDDG criteria for venous samples or capillary‐specific cut‐off. Linear regression, Passing–Bablok, Bland–Altman, and the kappa coefficient were used to study concordance between POCT and laboratory method. Results Data from 109 women were analyzed (57 for Accu‐Chek, 52 for Contour Next). Statistical analyses showed good agreement between both POCT and laboratory method. There were no statistical differences in fasting glucose measurements between capillary and venous samples and both POCT devices meet the ISO 15197 standard. Accu‐Chek showed good agreement (k=0.629) regarding the laboratory method in classifying GDM, with an acceptable inter‐evaluator bias of 3.5% (P<0.001). Conclusion POCT can be used to obtain fasting values and reduce overall waiting times for patients. Additionally, Accu‐Chek can be used to diagnose GDM in remote areas applying specific cut‐off values.

ObjectivesChosen cutoff for cytokeratin 19 fragment antigen (CYFRA 21-1) as a tumor biomarker considerably influences its diagnostic and prognostic usefulness. The aim of the present study is to determine an optimal cutoff value for diagnostic validity of CYFRA 21-1 by Lumipulse® technology in patients with suspected cancer and also to determine if CYFRA 21-1 levels provide prognostic value.MethodsA consecutive 284 patients suggestive of malignant disease from six hospitals of Madrid were enrolled in a retrospective design. Optimal CYFRA 21-1 cutoff value was obtained by receiver operating characteristic curve and Youden test. The diagnostic validity was evaluated according to sensitivity, specificity, predictive values and likelihood ratios. The prognostic value of CYFRA 21-1 was checked using multiple logistic regression. Thirty-two diagnostic cancers were confirmed.ResultsThe most optimal cutoff was 3.15 ng/mL. This cutoff showed a better specificity 93.63% (95% confidence interval [CI], 89.66–96.16), positive predictive value 60.98% (95% CI, 44.54–75.38) and positive likelihood ratio 12.65 (95% CI, 7.64–20.95) than the cutoff recommended by Fujirebio® (1.8 ng/mL) (specificity: 73.71% [95% CI, 67.72–78.95], positive predictive value: 29.79% [95% CI, 21.02–40.23] and positive likelihood ratio 3.43 [95% CI, 2.71–4.35]), improving the current diagnostic accuracy. In multivariate analysis, elevated levels of CYFRA 21-1 (>3.15 ng/mL) was confirmed as an unfavorable prognostic factor.ConclusionsThe best cutoff for CYFRA 21-1 obtained was 3.15 ng/mL in patients with suspected cancer. This new cutoff decreases the false positive rate and improves the diagnostic efficacy of CYFRA 21-1 as a tumor marker as well as its association with death events.

ResumenObjetivosEl punto de corte utilizado del CYFRA 21-1 como marcador tumoral influye considerablemente en su utilidad diagnóstica y pronóstica. El objetivo de este estudio es establecer un punto de corte óptimo de CYFRA 21-1 que tenga validez diagnóstica, determinado con la tecnología Lumipulse® en pacientes con sospecha de cáncer. El objetivo secundario de este estudio es determinar si los niveles de CYFRA 21-1 tienen valor pronóstico.MétodosSe llevó a cabo un estudio retrospectivo en una muestra compuesta por 284 pacientes con sospecha de enfermedad maligna procedentes de seis hospitales de Madrid. El punto de corte se obtuvo mediante la curva ROC y el test de Youden. La validez diagnóstica se evaluó de acuerdo con la sensibilidad, especificidad, valores predictivos y ratios de probabilidad. El valor pronóstico de CYFRA 21-1 se determinó por medio de la regresión logística múltiple. Se confirmaron un total de 32 casos de cáncer.ResultadosEl punto de corte más óptimo fue 3,15 ng/mL. Este punto de corte mostró mejor especifidad, de 93,63% (89,66–96,16; IC 95%), Valor Predictivo Positivo (44,54–75,38; IC 95%) y Razón de Probabilidad Positiva 12,65 (7,64–20,95; IC 95%) que el punto de corte recomendado por Fujirebio® (1,8 ng/mL); con una especifidad de 73,71% (67,72–78,95; IC 95%), Valor Predictivo Positivo: 29,79% (21,02–40,23; IC 95%) y una Razón de Probabilidad Positiva de 3,43 (2,71–4,35; IC 95%), mejorando la precisión diagnóstica actual. En el análisis multivariante, se confirmó que los niveles elevados de CYFRA 21-1 (>3,15 ng/mL) son un factor pronóstico desfavorable.ConclusionesEl mejor punto de corte obtenido para CYFRA 21-1 fue de 3,15 ng/mL en pacientes con sospecha de cáncer. Este nuevo punto de corte reduce la tasa de falsos positivos y mejora la eficacia diagnóstica de CYFRA 21-1 como marcador tumoral, así como su asociación con la mortalidad.