Capacidad del qSOFA1-lactato para predecir mortalidad a 30 días en los pacientes atendidos por infección en urgencias / Ability of qSOFA1-lactate to predict 30-day mortality in patients seen for infection in the Emergency Department

Objetivo. Evaluar y comparar la capacidad del lactato y del quick Sepsis-related Organ Failure Assessment (qSOFA) para predecir mortalidad a 30 días en los pacientes que acuden al servicio de urgencias (SU) por un episodio de sospecha de infección.Método. Estudio observacional de cohortes, multicéntrico, prospectivo. Se incluyó por oportunidad a pacientes ≥18 años atendidos por sospecha de infección en 71 SU españoles del 01/10/2019 al 31/03/2020. Se analizó la capacidad predictiva con el área bajo la curva (ABC) de la característica operativa del receptor (COR) y los valores de sensibilidad (Se), especificidad (Es), valor predictivo positivo (VPP) y negativo (VPN). Resultados. Se incluyeron 4.439 pacientes con edad media de 67 (DE:18) años, 2.648 (59,7%) fueron hombres y fallecieron a los 30 días 459 (10,3%). Para la mortalidad a 30 días el ABC-COR obtenida con el modelo qSOFA=1 más lactato 2 mmol/l fue de 0,66 (IC 95%: 0,63-0,69) con una Se:68%, Es:70% y VPN:92%, mientras que qSOFA=1 obtuvo ABC-COR de 0,52 (IC 9%: 0,49-0,55) con una Se:42%, Es:64% y VPN:90%.Conclusiones. Para predecir mortalidad a los 30 días en los pacientes que acuden al SU por un episodio de infección, el modelo qSOFA=1 + lactato≥2 mmol/L mejora significativamente el poder predictivo conseguido de forma individual por qSOFA1 y llega a ser muy similiar al de qSOFA≥2 (AU)

Objectives. To evaluate lactate and the Quick Sepsis-Related Organ Failure Assessment (qSOFA) and compare their ability to predict 30-day mortality in patients treated for infection in emergency departments (ED). Methods. Prospective multicenter observational cohort study. We enrolled a convenience sample of patients aged 18 years or older attended in 71 Spanish ED from October 1, 2019, to March 31, 2020. Each model’s predictive power was analyzed with the area under the receiver operating characteristic curve (AUC), and its values of sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative (NPV). Results. A total of 4439 patients with a mean (SD) age of 18 years were studied; 2648 (59.7%) were men and 459 (10.3%) died within 30 days. For 30-day mortality, the AUC-COR obtained with the qSOFA = 1 model plus 2 mmol/l lactate was 0.66 (95% CI, 0.63-0.69) with Se: 68%, Es: 70% and NPV:92%, while qSOFA = 1 obtained AUC-COR of 0.52 (95% CI, 0.49-0.55) with a Se:42%, Es:64% and NPV:90%. Conclusions. To predict 30-day mortality in patients presenting to the ED due to an episode of infection, the qSOFA =1 + lactate≥2 mmol/L model significantly improves the predictive power achieved individually by qSOFA1 and becomes very similar to qSOFA≥2 (AU)

Ability of lactate, procalcitonin, and criteria defining sepsis to predict 30-day mortality, bacteremia, and microbiologically confirmed infection in patients with infection suspicion treated in emergency departments. / Capacidad del lactato, procalcitonina y de los criterios definitorios de sepsis para predecir mortalidad a 30 días, bacteriemia o infección confirmada microbiológicamente en los pacientes atendidos por sospecha de infección en urgencias.

OBJECTIVES: To evaluate lactate, procalcitonin, criteria defining systemic inflammatory response syndrome (SIRS), and the Quick Sepsis-Related Organ Failure Assessment (qSOFA) and compare their ability to predict 30-day mortality, infection with microbiologic confirmation, and true bacteremia in patients treated for infection in hospital emergency departments. MATERIAL AND METHODS: Prospective multicenter observational cohort study. We enrolled a convenience sample of patients aged 18 years or older attended in 71 Spanish emergency departments from October 1, 2019, to March 31, 2020. Each model's predictive power was analyzed with the area under the receiver operating characteristic curve (AUC), and predetermined decision points were assessed. RESULTS: A total of 4439 patients with a mean (SD) age of 18 years were studied; 2648 (59.7%) were men and 459 (10.3%) died within 30 days. True bacteremia was detected in 899 (20.25%), and microbiologic confirmation was on record for 2057 (46.3%). The model that included the qSOFA score (2) and lactate concentration (0.738 mmol/L; 95% CI, 0.711-0.765 mmol/L) proved to be the best predictor of 30-day mortality, with an AUC of 0.890 (95% CI, 0.880-0.901). The model that included the SIRS score (2) and procalcitonin concentration (0.51 ng/mL) proved to be the best predictor of true bacteremia and microbiologic confirmation, with an AUC of 0.713 (95% CI, 0.698-0.728). CONCLUSION: A qSOFA score of 2 or more plus lactate concentration (0.738 mmol/L) predict 30-day mortality better than the combination of a SIRS score of 2 or more and procalcitonin concentration. A SIRS score of 2 or more plus procalcitonin concentration (0.51 ng/mL) predict true bacteremia and microbiologic confirmation.

OBJETIVO: Evaluar y comparar la capacidad del lactato, la procalcitonina (PCT) y de los criterios definitorios de sepsis (síndrome de respuesta inflamatoria sistémica ­SRIS­ y del quick Sepsis-related Organ Failure Assessment ­qSOFA­) para predecir mortalidad a 30 días, o infección ­con confirmación microbiológica o bacteriemia verdadera (BV)­ en los pacientes que acuden al servicio de urgencias hospitalario (SUH) por un episodio de sospecha de infección. METODO: Estudio observacional de cohortes, multicéntrico, prospectivo. Se incluyó por oportunidad a pacientes 18 años atendidos por sospecha de infección en 71 SUH españoles desde el 01/10/2019 al 31/03/2020. Se analizó la capacidad predictiva con el área bajo la curva (ABC) de la característica operativa del receptor (COR) y puntos de decisión predeterminados. RESULTADOS: Se incluyeron 4.439 pacientes con edad media de 67 (18) años, 2.648 (59,7%) fueron hombres, fallecieron a los 30 días 459 (10,3%), se consideraron BV 899 (20,2%) y se consiguió confirmación microbiológica en 2.057 (46,3%). Para la mortalidad a 30 días la mejor ABC-COR fue la obtenida con el modelo qSOFA 2 más lactato 2 mmol/l con un ABC-COR de 0,738 (0,711-0,765). Para predecir BV y confirmación microbiológica el mejor rendimiento se obtuvo con el modelo de SRIS 2 más PCT 0,51 ng/ml, con un ABC-COR de 0,890 (0,880-0,901) y 0,713 (0,698-0,728), respectivamente. CONCLUSIONES: Para la predicción de mortalidad a 30 días, el qSOFA 2 es superior al SRIS 2 y el mejor rendimiento lo consigue el modelo qSOFA 2 más lactato 2 mmol/l. Para predecir BV y confirmación microbiológica, la PCT es superior al lactato y el mejor rendimiento lo obtiene el modelo SRIS 2 más PCT 0,51 ng/ml.

Utilidad del modelo 5MPB-Toledo para predecir bacteriemia en el paciente anciano / Usefulness of the 5MPB-Toledo model to predict bacteremia in the elderly patient

Resumen Objetivo: Analizar la utilidad del modelo predictivo de bacteriemia (5MPB-Toledo) en los mayores de 65 años atendidos por infección en el servicio de urgencias (SU). Material y Método: Estudio observacional prospectivo y multicéntrico de los hemocultivos (HC) obtenidos en pacientes mayores de 65 años atendidos por infección en 66 SU españoles desde el 1 de diciembre de 2019 hasta el 30 de abril de 2020. Se analizó la capacidad predictiva del modelo con el área bajo la curva (ABC) de la característica operativa del receptor (COR) y se calculó el rendimiento diagnóstico de los puntos de corte (PC) del modelo elegido con los cálculos de la sensibilidad, la especificidad, el valor predictivo positivo y el valor predictivo negativo. Resultados: Se incluyeron 2.401 episodios de HC extraídos. De ellos, se consideró como bacteriemia verdadera a 579 (24,11%) y como HC negativo a 1.822 (75,89%). Entre los negativos, 138 (5,74%) se consideraron contaminados. Se categorizó a los pacientes en bajo (0-2 puntos), moderado (3-5 puntos) y alto (6-8 puntos) riesgo, con una probabilidad de bacteriemia de 1,2%, 18,1% y 80,7%, respectivamente. El ABC-COR del modelo tras remuestreo fue de 0,908 (IC 95%: 0,897-0,924). El rendimiento diagnóstico del modelo, considerando un PC ≥ 5 puntos, obtiene una sensibilidad de 94% (IC 95%:92-96), especificidad de 77% (IC 95%:76-79) y un valor predictivo negativo de 97% (IC 95%:96-98). Conclusión: El modelo 5MPB-Toledo es de utilidad para predecir bacteriemia en los mayores de 65 años atendidos en el SU por un episodio de infección.

Abstract Objective: To analyse a risk score to predict bacteremia (MPB5-Toledo) in the patients aged older 65 years seen in the emergency departments (ED) due to infections. Patients and Methods: Prospective and multicenter observational cohort study of the blood cultures (BC) ordered in 66 Spanish ED for patients aged older 65 years seen from December 1, 2019, to April 30, 2020. The predictive ability of the model was analyzed with the area under the Receiver Operating Characteristic curve (AUC-ROC). The prognostic performance for true bacteremia was calculated with the cut-off values chosen for getting the sensitivity, specificity, positive predictive value and negative predictive value. Results: A total of 2.401 blood samples wered cultured. True cases of bacteremia were confirmed in 579 (24.11%). The remaining 1.822 cultures (75.89%) wered negative. And, 138 (5.74%) were judged to be contaminated. Low risk for bacteremia was indicated by a score of 0 to 2 points, intermediate risk by 3 to 5 points, and high risk by 6 to 8 points. Bacteremia in these 3 risk groups was predicted for 1.2%, 18.1%, and 80.7%, respectively. The model´s area under the receiver ope rating characteristic curve was 0.908 (95% CI, 0.897-0.924). The prognostic performance with a model´s cut-off value of ≥ 5 points achieved 94% (95% CI: 92-96) sensitivity, 77% (95% CI: 76-79) specificity, and negative predictive value of 97% (95% CI: 96-98). Conclusion: The 5MPB-Toledo score is useful for predicting bacteremia in the patients aged older 65 years seen in the emergency departments due to infections.

Capacidad del lactato, procalcitonina y de los criterios definitorios de sepsis para predecir mortalidad a 30 días, bacteriemia o infección confirmada microbiológicamente en los pacientes atendidos por sospecha de infección en urgencias / Ability of lactate, procalcitonin, and criteria defining sepsis to predict 30-day mortality, bacteremia, and microbiologically confirmed infection in patients with infection suspicion treated in emergency departments

Objetivo. Evaluar y comparar la capacidad del lactato, la procalcitonina (PCT) y de los criterios definitorios de sepsis (síndrome de respuesta inflamatoria sistémica –SRIS– y del quick Sepsis-related Organ Failure Assessment –qSOFA–) para predecir mortalidad a 30 días, o infección –con confirmación microbiológica o bacteriemia verdadera (BV)– en los pa- cientes que acuden al servicio de urgencias hospitalario (SUH) por un episodio de sospecha de infección. Método. Estudio observacional de cohortes, multicéntrico, prospectivo. Se incluyó por oportunidad a pacientes $ 18 años atendidos por sospecha de infección en 71 SUH españoles desde el 01/10/2019 al 31/03/2020. Se analizó la capacidad predictiva con el área bajo la curva (ABC) de la característica operativa del receptor (COR) y puntos de de- cisión predeterminados. Resultados. Se incluyeron 4.439 pacientes con edad media de 67 (18) años, 2.648 (59,7%) fueron hombres, fallecie- ron a los 30 días 459 (10,3%), se consideraron BV 899 (20,2%) y se consiguió confirmación microbiológica en 2.057 (46,3%). Para la mortalidad a 30 días la mejor ABC-COR fue la obtenida con el modelo qSOFA $ 2 más lactato $ 2 mmol/l con un ABC-COR de 0,738 (0,711-0,765). Para predecir BV y confirmación microbiológica el mejor rendi- miento se obtuvo con el modelo de SRIS $ 2 más PCT $ 0,51 ng/ml, con un ABC-COR de 0,890 (0,880-0,901) y 0,713 (0,698-0,728), respectivamente. Conclusiones. Para la predicción de mortalidad a 30 días, el qSOFA $ 2 es superior al SRIS $ 2 y el mejor rendimien- to lo consigue el modelo qSOFA $ 2 más lactato $ 2 mmol/l. Para predecir BV y confirmación microbiológica, la PCT es superior al lactato y el mejor rendimiento lo obtiene el modelo SRIS $ 2 más PCT $ 0,51 ng/ml.

Objectives. To evaluate lactate, procalcitonin, criteria defining systemic inflammatory response syndrome (SIRS), and the Quick Sepsis-Related Organ Failure Assessment (qSOFA) and compare their ability to predict 30-day mortality, infection with microbiologic confirmation, and true bacteremia in patients treated for infection in hospital emergency departments. Methods. Prospective multicenter observational cohort study. We enrolled a convenience sample of patients aged 18 years or older attended in 71 Spanish emergency departments from October 1, 2019, to March 31, 2020. Each model’s predictive power was analyzed with the area under the receiver operating characteristic curve (AUC), and predetermined decision points were assessed. Results. A total of 4439 patients with a mean (SD) age of 18 years were studied; 2648 (59.7%) were men and 459 (10.3%) died within 30 days. True bacteremia was detected in 899 (20.25%), and microbiologic confirmation was on record for 2057 (46.3%). The model that included the qSOFA score ($ 2) and lactate concentration ($ 0.738 mmol/L; 95% CI, 0.711-0.765 mmol/L) proved to be the best predictor of 30-day mortality, with an AUC of 0.890 (95% CI, 0.880-0.901). The model that included the SIRS score ($ 2) and procalcitonin concentration ($ 0.51 ng/mL) proved to be the best predictor of true bacteremia and microbiologic confirmation, with an AUC of 0.713 (95% CI, 0.698-0.728). Conclusions. A qSOFA score of 2 or more plus lactate concentration ($ 0.738 mmol/L) predict 30-day mortality better than the combination of a SIRS score of 2 or more and procalcitonin concentration. A SIRS score of 2 or more plus procalcitonin concentration ($ 0.51 ng/mL) predict true bacteremia and microbiologic confirmation.

Validation of a predictive model for bacteraemia (MPB5-Toledo) in the patients seen in emergency departments due to infections.

OBJECTIVE: To validate a simple risk score to predict bacteremia (MPB5-Toledo) in patients seen in the emergency departments (ED) due to infections. METHODS: Prospective and multicenter observational cohort study of the blood cultures (BC) ordered in 74 Spanish ED for adults (aged 18 or older) seen from October 1, 2019, to February 29, 2020. The predictive ability of the model was analyzed with the area under the Receiver Operating Characteristic curve (AUC-ROC). The prognostic performance for true bacteremia was calculated with the cut-off values chosen for getting the sensitivity, specificity, positive predictive value and negative predictive value. RESULTS: A total of 3.843 blood samples wered cultured. True cases of bacteremia were confirmed in 839 (21.83%). The remaining 3.004 cultures (78.17%) were negative. Among the negative, 172 (4.47%) were judged to be contaminated. Low risk for bacteremia was indicated by a score of 0-2 points, intermediate risk by 3-5 points, and high risk by 6-8 points. Bacteremia in these 3 risk groups was predicted for 1.5%, 16.8%, and 81.6%, respectively. The model's area under the receiver operating characteristic curve was 0.930 (95% CI, 0.916-0.948). The prognostic performance with a model's cut-off value of ≥5 points achieved 94.76% (95% CI: 92.97-96.12) sensitivity, 81.56% (95% CI: 80.11-82.92) specificity, and negative predictive value of 98.24% (95% CI: 97.62-98.70). CONCLUSION: The 5MPB-Toledo score is useful for predicting bacteremia in patients attended in hospital emergency departments for infection.

A bacteraemia risk prediction model: development and validation in an emergency medicine population.

OBJECTIVE: Design a risk model to predict bacteraemia in patients attended in emergency departments (ED) for an episode of infection. METHODS: This was a national, prospective, multicentre, observational cohort study of blood cultures (BC) collected from adult patients (≥ 18 years) attended in 71 Spanish EDs from October 1 2019 to March 31, 2020. Variables with a p value < 0.05 were introduced in the univariate analysis together with those of clinical significance. The final selection of variables for the scoring scale was made by logistic regression with selection by introduction. The results obtained were internally validated by dividing the sample in a derivation and a validation cohort. RESULTS: A total of 4,439 infectious episodes were included. Of these, 899 (20.25%) were considered as true bacteraemia. A predictive model for bacteraemia was defined with seven variables according to the Bacteraemia Prediction Model of the INFURG-SEMES group (MPB-INFURG-SEMES). The model achieved an area under the curve-receiver operating curve of 0.924 (CI 95%:0.914-0.934) in the derivation cohort, and 0.926 (CI 95%: 0.910-0.942) in the validation cohort. Patients were then split into ten risk categories, and had the following rates of risk: 0.2%(0 points), 0.4%(1 point), 0.9%(2 points), 1.8%(3 points), 4.7%(4 points), 19.1% (5 points), 39.1% (6 points), 56.8% (7 points), 71.1% (8 points), 82.7% (9 points) and 90.1% (10 points). Findings were similar in the validation cohort. The cut-off point of five points provided the best precision with a sensitivity of 95.94%, specificity of 76.28%, positive predictive value of 53.63% and negative predictive value of 98.50%. CONCLUSION: The MPB-INFURG-SEMES model may be useful for the stratification of risk of bacteraemia in adult patients with infection in EDs, together with clinical judgement and other variables independent of the process and the patient.

Validation of a predictive model for bacteraemia (MPB5-Toledo) in the patients seen in emergency departments due to infections. / Validación del modelo predictivo de bacteriemia (5MPB-Toledo) en los pacientes atendidos en el servicio de urgencias por infección.

OBJECTIVE: To validate a simple risk score to predict bacteremia (MPB5-Toledo) in patients seen in the emergency departments (ED) due to infections. METHODS: Prospective and multicenter observational cohort study of the blood cultures (BC) ordered in 74 Spanish ED for adults (aged 18 or older) seen from from October 1, 2019, to February 29, 2020. The predictive ability of the model was analyzed with the area under the Receiver Operating Characteristic curve (AUC-ROC). The prognostic performance for true bacteremia was calculated with the cut-off values chosen for getting the sensitivity, specificity, positive predictive value and negative predictive value. RESULTS: A total of 3.843 blood samples wered cultured. True cases of bacteremia were confirmed in 839 (21.83%). The remaining 3.004 cultures (78.17%) were negative. Among the negative, 172 (4.47%) were judged to be contaminated. Low risk for bacteremia was indicated by a score of 0 to 2 points, intermediate risk by 3 to 5 points, and high risk by 6 to 8 points. Bacteremia in these 3 risk groups was predicted for 1.5%, 16.8%, and 81.6%, respectively. The model's area under the receiver operating characteristic curve was 0.930 (95% CI, 0.916-0.948). The prognostic performance with a model's cut-off value of ≥ 5 points achieved 94.76% (95% CI: 92.97-96.12) sensitivity, 81.56% (95% CI: 80.11-82.92) specificity, and negative predictive value of 98.24% (95% CI: 97.62-98.70). CONCLUSION: The 5MPB-Toledo score is useful for predicting bacteremia in patients attended in hospital emergency departments for infection.

Recomendaciones para el diseño e implementación de un programa de aseguramiento de la calidad de la fase preanalítica / Recommendations for the design and implementation of a Pre-analytical Phase Quality Assurance Program

El aseguramiento de la calidad de la fase preanalítica se orienta hacia 2 aspectos clave: la gestión de los errores preanalíticos desde la perspectiva de la seguridad del paciente, y la mejora y armonización de los procedimientos, basada en la aplicación de normativa además de recomendaciones profesionales. Al igual que el resto de las fases, debe incluir un programa interno de aseguramiento y la participación en programas de intercomparación entre laboratorios. El control de calidad interno debe basarse fundamentalmente en la identificación de riesgos, detección sistemática de errores y establecimiento de indicadores. La selección de los indicadores priorizando el impacto en el paciente, la forma de detectar y registrar los errores de forma sistemática y fácilmente explotable, así como las variables utilizadas en su cálculo, son aspectos importantes para medir la eficacia de las acciones de mejora y permitir la comparabilidad entre laboratorios. En este sentido, los programas externos de la calidad de la fase preanalítica basados en la comparación de indicadores, son una herramienta útil para el diseño e implantación de un programa de aseguramiento de la calidad. Este documento pretende servir de apoyo para que cada laboratorio seleccione, implante y evalúe sus propios indicadores, de acuerdo a las características individuales de sus procedimientos preanalíticos, pero sin perder de vista la armonización entre laboratorios

The quality assurance of the pre-analytical phase is oriented towards two key aspects; the management of pre-analytical errors from the perspective of patient safety, and the improvement and harmonisation of procedures, based on the application of regulations and professional recommendations. Like the rest of the phases, it should include an internal quality assurance program, as well as the participation in external quality assurance programs. The internal quality control should mainly be based on the identification of risks, systematic detection of errors, and establishment of indicators. The selection of indicators prioritising the impact on the patient, the way to detect and record errors in a systematic and easily exploitable manner, and also the variables used in the calculations, are important aspects to measure the effectiveness of improvement actions and to allow comparability between laboratories. In this sense, the external quality assurance programs of the pre-analytical phase based on the comparison of indicators are a useful tool for the design and implementation of a quality assurance program. This document is intended as a support for each laboratory to select, implement, and evaluate its own indicators, according to the individual characteristics of its pre-analytical procedures, but without losing sight of the harmonisation between laboratories

Gestión de los procesos preanalíticos en los laboratorios clínicos según los requisitos de la Norma UNE-EN ISO 15189: 2013. Recomendación (2015) / Management of pre-analytical processes in clinical laboratories as required by Rule UNE-EN ISO 15189: 2013. Recommendation (2015)

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Prevalence and Distribution of High-Risk Genotypes of HPV in Women with Severe Cervical Lesions in Madrid, Spain: Importance of Detecting Genotype 16 and Other High-Risk Genotypes.

Background. Persistent infection with high-risk human papillomavirus (HR-HPV) has been demonstrated to be the necessary causal factor for developing cervical cancer. To know the most prevalent HR-HPV in different geographical areas is important to design diagnostic tests and implementation of vaccines. Objectives. The goal of this study is to evaluate the prevalence of HR-HPV in a total of 1001 patients, 198 with normal cytology results, 498 with low-grade squamous intraepithelial lesion (LSIL), and 205 with high-grade squamous intraepithelial lesion (HSIL) who attended our gynaecology department for opportunistic screening of HPV infection. Study design. Cervical samples were taken in a PreservCyt vial (Cytyc Corporation, Boxborough, MA). Hybrid capture assay was carried out following the manufacturer's instructions (Digene Corp., Gaithersburg, MD). All samples were further studied with polymerase chain reaction (PCR) (Linear Array HPV Genotyping Test, Roche Diagnostics, Mannheim, Germany). Results. Genotype 16 was the most prevalent HR-HPV in the three groups, 17.8% in the patients with normal cytology results, 22.3% in the LSIL group, and 60% in the HSIL group. Genotype 18 had a very low prevalence in all groups. Other HR-HPV genotypes such as genotype 31, genotype 58 and genotype 52 were found in significant numbers in HSIL patients. Discussion. Our data show that genotypes 16, 31, 58, and 52 are the most prevalent HR-HPV in cervical samples with severe intraepithelial lesion in Spain. There may be some geographical variation in prevalence of carcinogenic types, and it must be considered for designing diagnostic tests and vaccine.

Evaluación de un sistema de PCR a tiempo real (cobas 4800) para la detección separada de los genotipos 16 y 18 y otros genotipos de alto riesgo del virus del papiloma humano en la prevención del cáncer cervical / Evaluation of a prototype real-time PCR assay for the separate detection of human papilloma virus genotypes 16 and 18 and other high risk human papillomavirus in cervical cancer screening

Introducción Se ha demostrado que la detección del ADN del virus del papiloma humano (VPH) es más útil que la citología en la prevención del cáncer cervical especialmente si se identifican los genotipos 16 y 18. Cobas 4800 es un sistema automatizado de PCR a tiempo real que detecta separadamente los genotipos 16 y 18, además de otros 12 genotipos de alto riesgo (AR-VPH)Objetivos Evaluar la detección de AR-VPH con cobas 4800, especialmente los genotipos 16 y 18 y comparar estos resultados con los obtenidos mediante captura de híbridos (HC2). También se evalúa la sensibilidad clínica del cobas 4800 para detectar lesiones >CIN2. Materiales y métodos Se han estudiado 412 muestras cervicales con cobas 4800 y HC2 utilizándose como técnica de referencia una PCR convencional (LA). También se han recogido los resultados citológicos e histológicos de las pacientes Resultados En 376/412 muestras los resultados fueron concordantes (kappa 0,85). En la mayoría de las muestras con resultado positivo por HC2 y negativo por cobas 4800 se detectaron genotipos de bajo riesgo con LA. La sensibilidad y especificidad para la detección de lesiones > CIN2 fueron 92,5 y 44% con cobas 4800 y 88 y 51% con HC2.Conclusión Hay una gran concordancia entre los resultados obtenidos por ambas técnicas. Sin embargo, la CH2 es más inespecífica por tener reactividad cruzada con genotipos de bajo riesgo oncogénico, especialmente el 53. Cobas 4800 presenta la ventaja de identificar los genotipos 16 y 18, además de ser totalmente automatizada y no tener reactividad cruzada con otros genotipos (AU)

Background: It has recently been confirmed that detection of DNA of human papilloma virus (HPV) is more useful than cytology in the screening for cervical cancer, especially if genotypes 16 and 18 are identified. Cobas 4800 is an automated system that detects 14 high risk HPV genotypes: genotypes 16 and 18 separately and 12 other high-risk genotypes pooled.Objectives: The aim of this study is to compare the performance of the cobas 4800 HPV test against the hybrid capture 2 (HC2) and particularly in women in whom >CIN2 lesions are detected Patients and methods: Aliquots from 412 cervical specimens have been studied with three different as says,real time PCR (cobas 4800), Linear Array HPV test, and HC2. Cytological and histological results were also available. Results: There was good agreement between the cobas 4800 and HC2 results in 376 of the 412 women(kappa 0.85). Where there was not good agreement, low-risk HPV genotypes were detected by linear arrayin the majority of samples positive by HC2 and negative by the cobas 4800. Sensitivity and specificity fordetecting >CIN2 lesions were 92.5 and 44%, respectively, by cobas 4800, and 88 and 51% by hybrid capture.Conclusions: In this evaluation the cobas 4800 HPV test was shown to have a similar performance to the HC2 test. However HC2 was less specific due to cross reactivity with low risk genotypes, mainlygenotype 53. Cobas 4800 is very reliable in the detection of high-risk genotypes, with the advantage of simultaneously providing information regarding genotype 16 and 18 infections (AU)

[Evaluation of a prototype real-time PCR assay for the separate detection of human papilloma virus genotypes 16 and 18 and other high risk human papillomavirus in cervical cancer screening]. / Evaluación de un sistema de PCR a tiempo real (cobas 4800) para la detección separada de los genotipos 16 y 18 y otros genotipos de alto riesgo del virus del papiloma humano en la prevención del cáncer cervical.

BACKGROUND: It has recently been confirmed that detection of DNA of human papilloma virus (HPV) is more useful than cytology in the screening for cervical cancer, especially if genotypes 16 and 18 are identified. Cobas 4800 is an automated system that detects 14 high risk HPV genotypes: genotypes 16 and 18 separately and 12 other high-risk genotypes pooled. OBJECTIVES: The aim of this study is to compare the performance of the cobas 4800 HPV test against the hybrid capture 2 (HC2) and particularly in women in whom>CIN2 lesions are detected. PATIENTS AND METHODS: Aliquots from 412 cervical specimens have been studied with three different assays, real time PCR (cobas 4800), Linear Array HPV test, and HC2. Cytological and histological results were also available. RESULTS: There was good agreement between the cobas 4800 and HC2 results in 376 of the 412 women (kappa 0.85). Where there was not good agreement, low-risk HPV genotypes were detected by linear array in the majority of samples positive by HC2 and negative by the cobas 4800. Sensitivity and specificity for detecting>CIN2 lesions were 92.5 and 44%, respectively, by cobas 4800, and 88 and 51% by hybrid capture. CONCLUSIONS: In this evaluation the cobas 4800 HPV test was shown to have a similar performance to the HC2 test. However HC2 was less specific due to cross reactivity with low risk genotypes, mainly genotype 53. Cobas 4800 is very reliable in the detection of high-risk genotypes, with the advantage of simultaneously providing information regarding genotype16 and 18 infections.