Implementación generalizada del diagnóstico en un solo paso (DUSP) de la hepatitis C en Galicia: resultados para la reflexión / Generalized implementation of reflex testing of hepatitis C in Galicia: Results for reflection

Introducción: La implementación del diagnóstico en un solo paso (DUSP) de la infección activa por virus de la hepatitis C (VHC) conjuntamente con la incorporación de alertas informativas ha demostrado que reduce de forma significativa, respecto al diagnóstico tradicional, la cifra de pacientes que no eran remitidos para valoración terapéutica. Métodos: A partir de la implementación en 2018 del DUSP en los servicios de microbiología de los hospitales del Servicio Gallego de Salud (SERGAS), se identifican y caracterizan de manera retrospectiva los nuevos diagnósticos de infección activa por VHC. Resultados: En 2018 se identificaron mediante DUSP un total de 258 pacientes con infección activa por VHC desconocida (70,2% hombres, mediana de edad de 52 años) procedentes de consultas de unidades de atención primaria y especializada en un 54,8% y 39,8%, respectivamente, así como de otras localizaciones en un 5,4%. De los 258 pacientes, el 81,0% fueron derivados para valoración terapéutica, con una mediana de 54 días desde su diagnóstico. En el 58,3% de los casos se determinó el DUSP mediante carga viral, el genotipo predominante fue el 1a (30,7%), un 52,1% fue tratado y se observó una respuesta viral sostenida en el 93,7% de estos. Conclusión: La implementación en toda Galicia del DUSP de la hepatitis C conjuntamente con alertas informativas ha permitido obtener, en conjunto, tasas de derivación para tratamiento similares a las obtenidas en otros estudios. Sin embargo, existe una amplia variabilidad entre los distintos centros, que exigen la incorporación de mejoras, como la formación o la utilización de medidas de rescate para su optimización.(AU)

Introduction: The implementation of reflex testing of active hepatitis C virus (HCV) infection, together with the incorporation of informative alerts in the reports, has shown that it significantly reduces the number of patients who were not referred for therapeutic evaluation. Methods: Since the implementation in 2018 of the DUSP in the microbiology services of the Galician Health Service hospitals (SERGAS), new diagnoses of active HCV infection have been retrospectively identified and characterized. Results: In 2018, a total of 258 patients with unknown active HCV infection (70,2% men, middle age 52 years) were identified through by reflex testing from consultations of primary and specialized care units in 54.8% and 39.8% respectively, as well as from other locations by 5.4%. Of the 258 patients, 81.0% were referred for therapeutic evaluation, with a median of 54 days from their diagnosis. In 58.3% of the cases the reflex testing was determined by viral load, the predominant genotype was 1a (30,7%) and 52,1% were treated, observing sustained viral response in 93.7% of these. Conclusion: The generalized implementation of the HCV reflex testing together with informative alerts in Galicia has allowed us to obtain referral rates for treatment similar to those obtained in other studies. However, there is a wide variability between the different centers that require the incorporation of improvements, such as training or the use of rescue measures for optimization.(AU)

Generalized implementation of reflex testing of hepatitis C in Galicia: Results for reflection.

INTRODUCTION: The implementation of reflex testing of active hepatitis C virus (HCV) infection, together with the incorporation of informative alerts in the reports, has shown that it significantly reduces the number of patients who were not referred for therapeutic evaluation. METHODS: Since the implementation in 2018 of the DUSP in the Microbiology Services of the Galician Health Service hospitals (SERGAS), new diagnoses of active HCV infection have been retrospectively identified and characterized. RESULTS: In 2018, a total of 258 patients with unknown active HCV infection (70,2% men, middle age 52 years) were identified through by reflex testing from consultations of primary and specialized care units in 54.8% and 39.8% respectively, as well as from other locations by 5.4%. Of the 258 patients, 81.0% were referred for therapeutic evaluation, with a median of 54 days from their diagnosis. In 58.3% of the cases the reflex testing was determined by viral load, the predominant genotype was 1a (30,7%) and 52,1% were treated, observing sustained viral response (SVR) in 93.7 % of these. CONCLUSION: The generalized implementation of the HCV reflex testing together with informative alerts in Galicia has allowed us to obtain referral rates for treatment similar to those obtained in other studies. However, there is a wide variability between the different centers that require the incorporation of improvements, such as training or the use of rescue measures for optimization.

Safety and Immunogenicity of SARS-CoV-2 vaccines in people with HIV.

OBJECTIVE: To evaluate the safety and the serological response after two doses of mRNA-based SARS-CoV-2 vaccination in people with HIV (PWH). METHODS: Participants were evaluated 4 weeks after the second dose of mRNA-1273 or BNT162b2 vaccine. Tolerability was evaluated with a specific adverse event questionnaire. Patient's sera were analysed using LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin). RESULTS: One-hundred PWH were included, 75% of them men, with a mean age of 44 ±â€Š11 years old, all receiving antiretroviral treatment and mostly with controlled viral loads (98% with HIV RNA <50 copies/ml) and 96% had >200 CD4+/µl. All patients seroconverted after vaccination (antibody concentration ≥33.8 binding antibody units [BAU]/ml). Only 3% of the patients had a low antibody concentration (<520 BAU/ml), whereas 67% of them had concentrations above the assay's detection range (>2080 BAU/ml). Fifty-six patients had local or systemic symptoms, with mild arthromyalgia being the most common systemic symptom. No severe adverse events were reported. CONCLUSIONS: Vaccination with two doses of mRNA-1273 or BNT162b2 is well tolerated in PWH under effective antiretroviral treatment and it leads to a successful antibody response.

Generalized implementation of reflex testing of hepatitis C in Galicia: Results for reflection. / Implementación generalizada del diagnóstico en un solo paso (DUSP) de la hepatitis C en Galicia: resultados para la reflexión.

INTRODUCTION: The implementation of reflex testing of active hepatitis C virus (HCV) infection, together with the incorporation of informative alerts in the reports, has shown that it significantly reduces the number of patients who were not referred for therapeutic evaluation. METHODS: Since the implementation in 2018 of the DUSP in the microbiology services of the Galician Health Service hospitals (SERGAS), new diagnoses of active HCV infection have been retrospectively identified and characterized. RESULTS: In 2018, a total of 258 patients with unknown active HCV infection (70,2% men, middle age 52 years) were identified through by reflex testing from consultations of primary and specialized care units in 54.8% and 39.8% respectively, as well as from other locations by 5.4%. Of the 258 patients, 81.0% were referred for therapeutic evaluation, with a median of 54 days from their diagnosis. In 58.3% of the cases the reflex testing was determined by viral load, the predominant genotype was 1a (30,7%) and 52,1% were treated, observing sustained viral response in 93.7% of these. CONCLUSION: The generalized implementation of the HCV reflex testing together with informative alerts in Galicia has allowed us to obtain referral rates for treatment similar to those obtained in other studies. However, there is a wide variability between the different centers that require the incorporation of improvements, such as training or the use of rescue measures for optimization.

Seroprevalence of HCV and HIV infections by year of birth in Spain: impact of US CDC and USPSTF recommendations for HCV and HIV testing.

BACKGROUND: The US Centers for Disease Control and Prevention (CDC) recently add the advice of one-time testing of HCV infection in persons born during 1945-1965. Moreover, the US Preventive Services Task Force (USPSTF) newly recommended one-time HIV testing for persons aged 15-65. Herein, we evaluate the potential impact of these recommendations in a reference medical area of Spain. METHODS: All assays results entries for HCV and HIV serological markers ordered at a reference lab from primary care and specialized physicians between 2008 and 2012 were recorded in a medical area which covers 501,526 citizens in Northern Spain. The year of birth were also documented. RESULTS: A total of 108,159 anti-HCV-Ab results were generated during the study period. The global rate of anti-HCV-Ab+ was 7.7% (95% CI: 7.6%-7.9%), being more prevalent in men than women (8.6% vs. 4.5%). By year of birth, the highest prevalence was found in persons born between 1955 and 1970. HCV genotype 1 was the most prevalent (59.7%) followed by genotype 3 (22.7%). Regard HIV infection, among 65,279 anti-HIV results generated the prevalence of anti-HIV+ was 1.1% (95% CI: 1.0%-1.2%), being more frequent in men (2% vs 0.5%). The years of birth with highest rates of HIV infection exactly match with those for HCV infection. CONCLUSIONS: The highest rates of HCV and HIV infections are found between 1960 and 1965. Different historical and social circumstances such as the huge intravenous drug use epidemic in the eighties in Spain, might explain it. Therefore, each country needs to determine its own HCV and HIV seroprevalences by year of birth to establish the proper recommendations for the screening of both infections.

Comparación entre las pruebas para la detección de betalactamasas de espectro extendido de los sistemas Vitek 2 y Phoenix / Comparative assessment of the Vitek 2 and Phoenix systems for detection of extended-spectrum beta-lactamases

Introducción La detección de la multirresistencia a betalactámicos en Escherichia coli y Klebsiella pneumoniae es una cuestión clínicamente relevante. Por otro lado, es interesante diferenciar entre la producción de betalactamasas de espectro extendido (BLEE) y otros mecanismos de resistencia para evitar el tratamiento inadecuado de infecciones causadas por este tipo de cepas. El objetivo del presente estudio fue comparar la capacidad de las pruebas confirmatorias de los sistemas automatizados Vitek 2 y Phoenix para detectar la producción de BLEE en E. coli y K. pneumoniae. Material y métodos Se ensayaron 193 aislamientos clínicos fenotípicamente productores de BLEE (174 E. coli y 19K. pneumoniae) por Vitek 2 y BD Phoenix System y se utilizaron las tarjetas AST-N058 y los paneles UNMIC/ID-62, respectivamente. Se consideraron métodos fenotípicos de referencia la prueba de sinergia con doble disco y Etest. Como controles positivos y negativos se ensayaron 12 cepas genotípicamente caracterizadas. Resultados En el caso de los aislamientos clínicos, la sensibilidad fue del 99,5% para Vitek 2 y del 95,3% para Phoenix. En las cepas control no hubo diferencias entre ambos sistemas. La ejecución del sistema experto elevó la sensibilidad del Phoenix al 100%. Sin embargo, el sistema experto de Vitek 2 consideró incoherentes los resultados obtenidos en 7 aislamientos con la prueba para BLEE positiva. Conclusión La sensibilidad de la prueba confirmatoria para la producción de BLEE es superior en las tarjetas N-058 de Vitek. No obstante, la actuación de los sistemas expertos sitúa a ambos sistemas a la misma altura en su capacidad de detección de BLEE en E. coli y K. pneumoniae (AU)

Introduction and Purpose Detection of beta-lactam resistance in Escherichia coli and Klebsiella pneumoniae strains is clinically relevant. Moreover, it is important to differentiate between extended-spectrum beta-lactamase (ESBL) production and other mechanisms of resistance to avoid inadequate treatment of infection caused by these strains. The aim of this study was to compare the performance of the Vitek 2 and BD Phoenix automated systems for confirmatory testing of ESBL production. Material and Methods A total of 193 clinical isolates of phenotypically confirmed ESBL producers (174 E. coli and 19 K. pneumoniae) were assayed by the Vitek 2 and BD Phoenix systems using AST-N058 cards and UNMIC/ID-62 panels, respectively. The double-disk synergy test and the Etest were used as phenotype reference methods. Twelve strains characterized by genotyping were used as positive and negative controls. Results In the clinical isolates, the sensitivity of the tests was 99.5% for Vitek and 95.3% for Phoenix. There were no significant differences between the 2 systems in the control strains. Execution of the expert system raised the sensitivity of Phoenix to 100%. However, the Vitek 2 expert system considered the results obtained in 7 strains with ESBL-positive tests to be incoherent. Conclusion Confirmatory testing for ESBL production with the Vitek 2 system (AST-N058 card) showed higher sensitivity than the Phoenix (UNMIC-ID 62 panel) system. Nevertheless, the performance of the expert systems in the 2 automated tests was similar for ESBL detection in E. coli and K. pneumonia (AU)

[Comparative assessment of the Vitek 2 and Phoenix systems for detection of extended-spectrum beta-lactamases]. / Comparación entre las pruebas para la detección de betalactamasas de espectro extendido de los sistemas Vitek 2 y Phoenix.

INTRODUCTION AND PURPOSE: Detection of beta-lactam resistance in Escherichia coli and Klebsiella pneumoniae strains is clinically relevant. Moreover, it is important to differentiate between extended-spectrum beta-lactamase (ESBL) production and other mechanisms of resistance to avoid inadequate treatment of infection caused by these strains. The aim of this study was to compare the performance of the Vitek 2 and BD Phoenix automated systems for confirmatory testing of ESBL production. MATERIAL AND METHODS: A total of 193 clinical isolates of phenotypically confirmed ESBL producers (174 E. coli and 19 K. pneumoniae) were assayed by the Vitek 2 and BD Phoenix systems using AST-N058 cards and UNMIC/ID-62 panels, respectively. The double-disk synergy test and the Etest were used as phenotype reference methods. Twelve strains characterized by genotyping were used as positive and negative controls. RESULTS: In the clinical isolates, the sensitivity of the tests was 99.5% for Vitek and 95.3% for Phoenix. There were no significant differences between the 2 systems in the control strains. Execution of the expert system raised the sensitivity of Phoenix to 100%. However, the Vitek 2 expert system considered the results obtained in 7 strains with ESBL-positive tests to be incoherent. CONCLUSION: Confirmatory testing for ESBL production with the Vitek 2 system (AST-N058 card) showed higher sensitivity than the Phoenix (UNMIC-ID 62 panel) system. Nevertheless, the performance of the expert systems in the 2 automated tests was similar for ESBL detection in E. coli and K. pneumoniae.