RESUMO
OBJECTIVES: The investigation of Candida auris outbreaks is needed to provide insights into its population structure and transmission dynamics. We genotypically and phenotypically characterised a C. auris nosocomial outbreak occurred in Consorcio Hospital General Universitario de Valencia (CHGUV), Spain. METHODS: Data and isolates were collected from CHGUV from September 2017 (first case) until September 2021. Thirty-five isolates, including one from an environmental source, were randomly selected for whole genome sequencing (WGS), and the genomes were analysed along with a database with 335 publicly available genomes, assigning them to one of the five major clades. In order to identify polymorphisms associated with drug resistance, we used the fully susceptible GCA_003014415.1 strain as reference sequence. Known mutations in genes ERG11 and FKS1 conferring resistance to fluconazole and echinocandins, respectively, were investigated. Isolates were classified into aggregating or non-aggregating. RESULTS: All isolates belonged to clade III and were from an outbreak with a single origin. They clustered close to three publicly available genomes from a hospital from where the first patient was transferred, being the probable origin. The mutation VF125AL in the ERG11 gene, conferring resistance to fluconazole, was present in all the isolates and one isolate also carried the mutation S639Y in the FKS1 gene. All the isolates had a non-aggregating phenotype (potentially more virulent). CONCLUSIONS: Isolates are genotypically related and phenotypically identical but one with resistance to echinocandins, which seems to indicate that they all belong to an outbreak originated from a single isolate, remaining largely invariable over the years. This result stresses the importance of implementing infection control practices as soon as the first case is detected or when a patient is transferred from a setting with known cases.
Assuntos
Antifúngicos , Candida auris , Candidíase , Infecção Hospitalar , Surtos de Doenças , Farmacorresistência Fúngica , Genótipo , Fenótipo , Sequenciamento Completo do Genoma , Humanos , Espanha/epidemiologia , Infecção Hospitalar/microbiologia , Infecção Hospitalar/epidemiologia , Candidíase/microbiologia , Candidíase/epidemiologia , Antifúngicos/farmacologia , Candida auris/genética , Candida auris/efeitos dos fármacos , Farmacorresistência Fúngica/genética , Testes de Sensibilidade Microbiana , Mutação , Masculino , Fluconazol/farmacologia , Feminino , Equinocandinas/farmacologia , Pessoa de Meia-Idade , Candida/genética , Candida/efeitos dos fármacos , Candida/classificação , Candida/isolamento & purificaçãoRESUMO
BACKGROUND: Candida auris has become a worrisome multi-drug resistant healthcare-associated pathogen due to its capacity to colonise patients and surfaces and to cause outbreaks of invasive infections in critically ill patients. OBJECTIVES: This study evaluated the outbreak in our setting in a 4-year period, reporting the risk factors for developing candidemia in previously colonised patients, the therapeutic measures for candidemia and the outcome of candidemia and colonisation cases among all C. auris isolates and their susceptibility to antifungals. METHODS: Data were retrospectively collected from patients admitted to Consorcio Hospital General Universitario de Valencia (Spain) from September 2017 to September 2021. A retrospective case-control study was designed to identify risk factors for developing C. auris candidemia in previously colonised patients. RESULTS: C. auris affected 550 patients, of which 210 (38.2%) had some clinical sample positive. Isolates were uniformly resistant to fluconazole, 20 isolates were resistant to echinocandins (2.8%) and four isolates were resistant to ampfotericin B (0.6%). There were 86 candidemia cases. APACHE II, digestive disease and catheter isolate were proven to be independent risk factors for developing candidemia in previously colonised patients. Thirty-day mortality rate for C. auris candidemia cases was 32.6%, while for colonisation cases was 33.7%. CONCLUSIONS: Candidemia was one of the most frequent and severe infections caused by C. auris. The risk factors identified in this study should help to detect patients who are at more risk of developing candidemia, as long as an adequate surveillance of C. auris colonisation is performed.
Assuntos
Candidemia , Humanos , Candidemia/tratamento farmacológico , Candidemia/epidemiologia , Candida auris , Estudos Retrospectivos , Candida , Estudos de Casos e Controles , Testes de Sensibilidade Microbiana , Antifúngicos/farmacologia , Antifúngicos/uso terapêuticoRESUMO
A method to identify molecular scaffolds potentially active against the Mycobacterium tuberculosis complex (MTBC) is developed. A set of structurally heterogeneous agents against MTBC was used to obtain a mathematical model based on topological descriptors. This model was statistically validated through a Leave-n-Out test. It successfully discriminated between active or inactive compounds over 86% in database sets. It was also useful to select new potential antituberculosis compounds in external databases. The selection of new substituted pyrimidines, pyrimidones and triazolo[1,5-a]pyrimidines was particularly interesting because these structures could provide new scaffolds in this field. The seven selected candidates were synthesized and six of them showed activity in vitro.
Assuntos
Antituberculosos , Relação Quantitativa Estrutura-Atividade , Antituberculosos/farmacologia , Antituberculosos/química , Estrutura Molecular , Desenho de Fármacos , Bases de Dados FactuaisRESUMO
Candida auris es una levadura multirresistente emergente que causa infecciones invasivas graves y brotes con una alta mortalidad. El control de C. auris es un reto. Laboratorios, clínicos e instituciones sanitarias deben trabajar conjuntamente para mejorar la identificación y el tratamiento de la infección, así como el control de la transmisión. Esta revisión describe los aspectos generales de la biología, diagnóstico y tratamiento de C. auris, al igual que las recomendaciones publicadas recientemente por un grupo de expertos. También se presenta la experiencia de un brote de C. auris en el Consorcio Hospital General Universitario de Valencia desde septiembre de 2017 hasta agosto de 2019. Se detectaron un total de 203 pacientes infectados y/o colonizados por C. auris. Se diagnosticaron 30 infecciones invasivas (29 candidemias y 1 meningitis). El 32% de las candidemias del año 2018 fueron por C. auris. Todas las cepas fueron resistentes a fluconazol
Candida auris is an emerging multidrug-resistant yeast that causes serious invasive infections and outbreaks with high mortality. Controlling C. auris is a challenge in which laboratories, clinicians and public health agencies are needed to identify and treat infections and prevent transmission. This review describes the general aspects of the biology, diagnosis and treatment of C. auris infection, as well as the main recommendations recently published by expert groups. We also present our experience of the C. auris outbreak at the Consorcio Hospital General Universitario de Valencia from September 2017 to August 2019. A total of 203 patients were colonised and/or infected by C. auris. Thirty invasive infections (29 blood cultures and one case of meningitis) were diagnosed. In all, 32% cases of candidemia were caused by C. auris in 2018. All strains were resistant to fluconazole
Assuntos
Humanos , Candidíase Invasiva/microbiologia , Candidíase Invasiva/epidemiologia , Candida/isolamento & purificação , Candida/classificação , Candidíase Invasiva/tratamento farmacológico , Candidíase Invasiva/diagnóstico , Surtos de DoençasRESUMO
Se presenta el análisis anual de los resultados remitidos durante el año 2017 por los participantes inscritos en el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), que incluye las áreas de bacteriología, serología, micología, parasitología, micobacterias, virología, microbiología molecular y de detección genotípica de mecanismos de resistencia bacteriana. Los resultados obtenidos por los centros participantes resaltan, de nuevo, la adecuada capacitación de la inmensa mayoría de los laboratorios españoles de microbiología clínica, como ya venía sucediendo en los últimos años. Sin embargo, el programa muestra de nuevo que es posible obtener un resultado erróneo, incluso en determinaciones de la mayor trascendencia y en cualquier laboratorio. Una vez más, se destaca la importancia de complementar el control interno que cada laboratorio lleve a cabo con estudios de intercomparación externos, como los que ofrece el Programa SEIMC
This article provides an analysis of the results obtained in 2017 by the participants inscribed in the External Quality Control Programme of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), which includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology, and genotypic bacterial resistance. The results obtained in 2017 confirm the excellent skill and good technical standards found in previous editions. However, the programme again showed that erroneous results can be obtained in any laboratory and even in clinically relevant determinations. Once again, the results of this program highlight the need to implement both internal and external controls, as in the SEIMC programme
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , Doenças Transmissíveis/diagnóstico , Controle de Qualidade , Avaliação de Programas e Projetos de Saúde , Sociedades Médicas , Microbiologia , EspanhaRESUMO
Se presenta el análisis anual de los resultados remitidos durante el año 2018 por los participantes inscritos en el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), que incluye las áreas de bacteriología, serología, micología, parasitología, micobacterias, virología, microbiología molecular y detección genotípica de mecanismos de resistencia bacteriana. Los resultados obtenidos por los centros participantes resaltan significativamente la adecuada capacitación de la inmensa mayoría de los laboratorios españoles de microbiología clínica, tal como ya venía evidenciándose en los últimos años. Sin embargo, el Programa muestra de nuevo que es posible obtener un resultado erróneo, incluso en determinaciones de la mayor trascendencia y en cualquier laboratorio. Una vez más, se destaca la importancia de complementar el control interno que cada laboratorio lleve a cabo con estudios de intercomparación externos, como los que ofrece el Programa SEIMC
This article provides an analysis of the results obtained in 2018 by the participants inscribed in the External Quality Control Programme of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), which includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology, and genotypic bacterial resistance. The results obtained in 2018 confirm the excellent skill and good technical standards found in the vast majority of Spanish clinical microbiology laboratories, as shown in previous editions. However, the programme again shows that erroneous results can be obtained in any laboratory and even in clinically relevant determinations. Once again, the results of this programme highlight the need to implement both internal and external controls, as in the SEIMC programme
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , Doenças Transmissíveis/diagnóstico , Controle de Qualidade , Avaliação de Programas e Projetos de Saúde , Sociedades Médicas , Microbiologia , EspanhaRESUMO
FUNDAMENTOS: Las determinaciones microbiológicas de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados, entre ellas se encuentran los programas de intercomparación externos, como es el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de estos virus, incluyendo el genotipado del VHC, realizado durante el año 2017. MÉTODOS Y RESULTADOS: En el control de VIH-1 se remitieron 5 estándares, de los que uno (plasma humano seronegativo) no contenía el virus, y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones entre 2-5 log10 copias/ml. Una parte significativa de los laboratorios obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 35% de los centros. La repetibilidad fue buena, y más del 94% de los laboratorios obtuvieron resultados aceptables (D < 0,5 log10 copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, un 82% en el caso del VHC y un 87% en el del VHB, obtuvo ambos resultados dentro de los límites de la media±1,96 DE log10 UI/ml. CONCLUSIONES: Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos. Debido a la variabilidad interlaboratorio observada, es aconsejable utilizar el mismo método y laboratorio en el seguimiento de los pacientes
BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarised the results obtained from the 2017 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads and HCV genotyping. METHODS AND RESULTS: In the HIV-1 programme, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (35% on average) obtained values outside the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was good, with up to 94% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV programme consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 87% in that of HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory. Due to the marked interlaboratory variability observed, it is advisable to use the same method and laboratory for patient follow-up
Assuntos
Humanos , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Técnicas de Laboratório Clínico/normas , Controle de Qualidade , Carga Viral/normas , Sociedades Médicas , Avaliação de Programas e Projetos de Saúde , EspanhaRESUMO
FUNDAMENTOS: Las determinaciones microbiológicas de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados, entre ellas se encuentran los programas de intercomparación externos, como el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En el presente artículo se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de estos virus y el genotipado del VHC realizado durante el año 2018. MÉTODOS Y RESULTADOS: En el control de VIH-1 se remitieron 5 estándares, de los que uno (plasma humano seronegativo) no contenía el virus, y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones entre 2-5 log10 copias/ml. Una parte significativa de los laboratorios participantes obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 26% de los centros. La repetibilidad fue buena, y la mayoría de los laboratorios obtuvieron resultados aceptables (D < 0,5 log10 copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, un 87% en el caso del VHC y un 88% en el del VHB, obtuvo ambos resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml. CONCLUSIONES: Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos. Debido a la variabilidad interlaboratorio, es aconsejable utilizar un mismo método y el mismo laboratorio en el seguimiento de los pacientes
BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarised the results obtained from the 2018 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads and HCV genotyping. METHODS AND RESULTS: In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (28% on average) obtained values outside the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was good, with most laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV programme consisted of two standards with different viral load contents. Most of the participants, 87% in the case of HCV and 88% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory. Due to the marked interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow-up
Assuntos
Humanos , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Técnicas de Laboratório Clínico/normas , Controle de Qualidade , Carga Viral/normas , Sociedades Médicas , Avaliação de Programas e Projetos de Saúde , EspanhaRESUMO
Se presenta el análisis anual de los resultados remitidos durante el año 2016 por los participantes inscritos en el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), que incluye las áreas de bacteriología, serología, micología, parasitología, micobacterias, virología, microbiología molecular y genotipos de resistencia bacteriana. Los resultados obtenidos por los centros participantes destacan, de nuevo, la adecuada capacitación de la inmensa mayoría de los laboratorios españoles de microbiología clínica, como ya iba sucediendo en los últimos años. Sin embargo, el programa muestra que es posible obtener un resultado erróneo, incluso en determinaciones de la mayor trascendencia y en cualquier laboratorio. Una vez más, se resalta la importancia de complementar el control interno que lleva a cabo cada laboratorio con estudios de intercomparación externos, como los que ofrece el Programa de Control de Calidad SEIMC. Información sobre el suplemento: este artículo forma parte del suplemento titulado "Programa de Control de Calidad Externo SEIMC. Año 2016", que ha sido patrocinado por Roche, Vircell Microbiologists, Abbott Molecular y Francisco Soria Melguizo, S.A
The External Quality Control Programme of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology, and genotypic bacterial resistance. As in previous years, the results obtained in 2016 confirm the excellent skill and good technical standards in the vast majority of clinical microbiology laboratories in Spain. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of this programme highlight the need to implement both internal and external controls. Supplement information: This article is part of a supplement entitled "SEIMC External Quality Control Programme. Year 2016", which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A
Assuntos
Humanos , Avaliação de Resultados em Cuidados de Saúde/normas , Sociedades Médicas/normas , Controle de Qualidade , Análise de Dados , Sorologia/normas , Biologia Molecular , Bacteriologia/normas , Técnicas Bacteriológicas/normas , Virologia/normasRESUMO
FUNDAMENTOS: Las determinaciones microbiológicas de la carga viral de los virus de la inmunodeficiencia humana de tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados; entre ellas se encuentran los programas de intercomparación externos, como el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En este artículo se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de Carga Viral de estos virus, incluyendo el genotipado del VHC, realizado durante el año 2016. Métodos y resultados: En el control del VIH-1 se remitieron 5 estándares, de los cuales uno (plasma humano seronegativo) no contenía el virus y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones entre 2 y 5 log10 copias/ml. Una parte considerable de los laboratorios obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml), en función del estándar y del método empleado, con un término medio del 40% de los centros. En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, el 86,5% en el caso del VHC y el 85,6% en el del VHB, obtuvo ambos resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml. CONCLUSIONES: Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos. Debido a la variabilidad interlaboratorio, es aconsejable utilizar el mismo método y el mismo laboratorio en el seguimiento de los pacientes. Información sobre el suplemento: Este artículo forma parte del suplemento titulado "Programa de Control de Calidad Externo SEIMC. Año 2016", que ha sido patrocinado por Roche, Vircell Microbiologists, Abbott Molecular y Francisco Soria Melguizo, S.A
BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. Microbiology laboratories have a variety of tools to ensure the accuracy of the results obtained, including external quality control programmes such as that of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC). This article summarises the results of the 2016 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. Methods and results: In the HIV-1 programme, a total of 5 standards were sent. One standard consisted of seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL. A significant proportion of the laboratories (40% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. The HBV and HCV programme consisted of 2 standards with different viral load contents. Most of the participants, 86.5% in the case of HCV and 85.6% in the case of HBV, obtained results that were all within the accepted range (mean ± 1.96 SD log10 UI/mL). CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory. Due to the marked interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow-up. Supplement information: This article is part of a supplement entitled "SEIMC External Quality Control Programme. Year 2016", which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A
Assuntos
Humanos , Infecções por HIV/epidemiologia , HIV-1 , Hepacivirus , Vírus da Hepatite B , Sociedades Médicas/normas , Controle de Qualidade , Avaliação de Resultados em Cuidados de Saúde/normasRESUMO
Human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarizes the results obtained from the 2014 SEIMC (Spanish Society of Infectious Diseases and Clinical Microbiology) External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of 5 standards were sent. One standard consisted in seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL; 2 of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (30.8% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 95.8% of laboratories reporting results within the limits (Δ < 0.5 log10 copies/mL). The HBV and HCV program consisted of 2 standards with different viral load contents. Most of the participants, 83.7% in the case of HCV and 87.9% in the HBV, obtained all the results within the accepted range (mean ± 1.96 standard deviations log10 IU/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up.
Assuntos
HIV-1 , Hepacivirus , Vírus da Hepatite B , Laboratórios/normas , Controle de Qualidade , Carga Viral/normas , Humanos , EspanhaRESUMO
Las determinaciones de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son marcadores microbiológicos fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados; entre ellas se encuentran los programas de intercomparación externos, como es el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de estos virus, incluyendo el genotipado del VHC realizado durante el año 2013. En el control del VIH-1 se remitieron 5 estándares, de los que 1 (plasma humano seronegativo) no contenía el virus, y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones entre 2-5 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetibilidad. Una parte significativa de los laboratorios obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml) dependiendo del estándar y del método empleado, en promedio el 25% de los centros. La repetibilidad fue excelente y más del 98,9% de los laboratorios obtuvo resultados aceptables (D < 0,5 log10 copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, alrededor del 82% en el caso del VHC y del 78% en el del VHB, obtuvo ambos resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml. Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos, incluyendo la fase postanalítica. Debido a la variabilidad interlaboratorio es aconsejable utilizar un mismo método y el mismo laboratorio en el seguimiento de los pacientes
Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load HCV determinations are among the most relevant markers for the follow up of patients infected with these HIV-1 viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2013 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (25% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 78% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up
Assuntos
Feminino , Humanos , Masculino , Carga Viral/métodos , Carga Viral , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Vírus da Hepatite B/patogenicidade , Controle de Qualidade , Reprodutibilidade dos Testes , Carga Viral/tendências , Anticorpos Anti-Hepatite C , Resultado do TratamentoRESUMO
Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2012 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (22.3% on average) obtained values out of the accepted range (mean±0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (Δ < 0.5 log10 copias/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 84% in the case of HCV and 88% in the HBV, obtained all the results within the accepted range (mean±1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up.
Assuntos
HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Controle de Qualidade , Carga Viral/normas , HumanosRESUMO
Las determinaciones de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son marcadores microbiológicos fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados; entre ellas se encuentran los programas de intercomparación externos, como el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de estos virus, incluyendo el genotipado del VHC, realizado durante el año 2012. En el control de VIH-1 se remitieron 5 estándares, de los que 1 (plasma humano seronegativo) no contenía el virus y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones de entre 2-5 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetibilidad. Una parte significativa de los laboratorios obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 22,3% de los centros. La repetibilidad fue excelente y más del 98,9% de los laboratorios obtuvo resultados aceptables (Δ < 0,5 log10 copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, alrededor del 84% en el caso del VHC y del 88% en el del VHB, obtuvo ambos resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml. Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos, incluyendo la fase postanalítica. Debido a la variabilidad interlaboratorio es aconsejable utilizar un mismo método y el mismo laboratorio en el seguimiento de los pacientes
Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2012 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (22.3% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (Δ < 0.5 log10 copias/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 84% in the case of HCV and 88% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up
Assuntos
Humanos , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Controle de Qualidade , Carga Viral/normasRESUMO
Las determinaciones de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1), de la hepatitis C (VHC) y de la hepatitis B (VHB) son marcadores microbiológicos fundamentales para el seguimiento y control de los pacientes infectados por estos virus. Los laboratorios de microbiología disponen de herramientas que garantizan la fiabilidad de sus resultados; entre ellas se encuentran los programas de intercomparación externos, como el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de estos virus, incluyendo el genotipado del VHC, realizado durante el año 2012.En el control de VIH-1 se remitieron 5 estándares, de los que 1 (plasma humano seronegativo) no contenía el virus y los otros 4 consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones de entre 2-5 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetibilidad. Una parte significativa de los laboratorios obtuvo de uno a varios resultados fuera de los límites aceptables (media ± 0,25 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 22,3% de los centros. La repetibilidad fue excelente y más del 98,9% de los laboratorios obtuvo resultados aceptables (Δ < 0,5 log10 copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, alrededor del 84% en el caso del VHC y del 88% en el del VHB, obtuvo ambos resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml. Los resultados obtenidos ponen de manifiesto la utilidad de los controles externos para asegurar la calidad de los resultados analíticos, incluyendo la fase postanalítica. Debido a la variabilidad interlaboratorio es aconsejable utilizar un mismo método y el mismo laboratorio en el seguimiento de los pacientes
Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2012 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (22.3% on average) obtained values out of the accepted range (mean±0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (Δ < 0.5 log10 copias/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 84% in the case of HCV and 88% in the HBV, obtained all the results within the accepted range (mean±1.96 SD log10 UI/mL).Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up (AU)
Assuntos
Humanos , Carga Viral/instrumentação , Virologia/normas , Infecções por HIV/microbiologia , Hepatite B Crônica/microbiologia , Hepatite C Crônica/microbiologia , Vírus da Hepatite B/isolamento & purificação , Hepacivirus/isolamento & purificação , Controle de Qualidade , Ensaio de Proficiência LaboratorialRESUMO
Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers in the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarizes the results of the 2011 SEIMC External Quality Control Program for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients in the range of 2-5 log10 copies/mL; to determine repeatability, two of these standards were identical. A significant proportion of the laboratories (52.1% on average) obtained values outside the accepted range (mean ± 0,25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 94.9% of laboratories reporting results within the accepted range (Δ<0,5 log10 copies/ mL). The HBV and HCV program consisted of two standards with different viral load contents. In most of the participating laboratories (90% in the case of HCV and 86% in that of HBV), all the results were within the accepted range (mean ± 1.96 SD log10UI/mL). Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to the marked interlaboratory variability found, use of the same method and the same laboratory for patient follow-up is advisable.
Assuntos
HIV-1 , Hepacivirus , Vírus da Hepatite B , Técnicas Microbiológicas/normas , Carga Viral , Humanos , Controle de Qualidade , Sociedades Médicas , EspanhaRESUMO
El Programa Externo de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) incluye las áreas de serología, bacteriología, virología, parasitología, micología y micobacterias, entre otras. En este manuscrito se presenta un análisis general de los resultados remitidos por los participantes en los distintos controles del año 2008. Los resultados obtenidos por los centros participantes confirman el buen nivel general de los laboratorios españoles de microbiología clínica de años anteriores. A pesar de ello, el programa demuestra que se producen resultados erróneos, incluso en determinaciones de la mayor trascendencia y en cualquier laboratorio. Una vez más, se resalta la importancia de complementar el control interno que cada laboratorio lleva a cabo con estudios de intercomparación externos, como los que ofrece el Programa SEIMC
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria and virology. This article present the most relevant conclusions and lessons from the 2008 controls. As a whole, the results obtained in 2008 confirm the excellent skill and good technical standards of the microbiology laboratories in Spain found in previous editions. However, a few deviations can be obtained in any laboratory, even in clinically relevant determinations. Once again, the results of this program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , Laboratórios/normas , Microbiologia/organização & administração , Controle de Qualidade , Infectologia/organização & administração , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Infecções/diagnóstico , Infecções/microbiologia , Infecções/parasitologia , Laboratórios/estatística & dados numéricosRESUMO
Fundamentos: Las determinaciones de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1) y de la hepatitis C (VHC) son marcadores fundamentales para el seguimiento y el control de los pacientes infectados por estos virus. Es crucial que los laboratorios de microbiología dispongan de herramientas que garanticen la fiabilidad de sus resultados. En el presente número se muestra el análisis del Programa de Control de Calidad SEIMC de carga viral de ambos virus, realizados durante el año 2008. Métodos y resultados: En el control del VIH-1 se remitieron cinco estándares, de los que uno (plasma humano seronegativo) no contenía el virus, y los otros cuatro consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones entre 2-5 log10 copias/ml; dos de ellos eran idénticos, con el fi n de analizar la repetitividad. La especificidad fue muy buena para todos los métodos comerciales, ya que no se detectaron resultados falsamente positivos. Una parte significativa de los laboratorios obtuvo resultados fuera de los límites aceptables (media ± 0,2 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 24%. La repetitividad fue muy buena, y más del 95% de los laboratorios obtuvieron resultados aceptables (D < 0,5 log10 copias/ml). En el control del VHC se remitieron dos estándares con diferente contenido del virus. La mayor parte de los participantes (88,7%) obtuvo resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml, aunque este porcentaje fue considerablemente inferior al del año anterior (94,6%). Se detectaron errores postanalíticos de transcripción de los resultados para el VHC, aunque no para el VIH-1. Conclusiones: Los resultados obtenidos refuerzan la utilidad de los controles externos para asegurar la calidad de los resultados analíticos, incluyendo la fase postanalítica. Debido a la variabilidad interlaboratorio, es aconsejable utilizar un mismo método y el mismo laboratorio en el seguimiento de los pacientes
Background: Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2008 SEIMC External Quality Control Program for HIV-1 and HCV viral loads. Methods and results: In the HIV-1 program, a total of fi ve standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. The specificity was complete for all commercial methods, and no false positive results were reported by the participants. A significant proportion of the laboratories (24% on average) obtained values out of the accepted range (mean ± 0.2 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (D < 0.5 log10 copias/mL). The HCV program consisted of two standards with different viral load contents. Most of the participants (88,7%) obtained results within the accepted range (mean ± 1.96 SD log10 UI/mL). Post-analytical errors due to mistranscription of the results were detected for HCV, but not for the HIV-1 program. Conclusions: Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Laboratórios/normas , Microbiologia/organização & administração , Controle de Qualidade , Carga Viral , Infectologia/organização & administração , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Reações Falso-Negativas , Infecções por HIV/sangue , Infecções por HIV/virologia , Hepatite C/virologia , Microbiologia/normas , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase ReversaRESUMO
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons drawn from the 2007 controls. As a whole, the results obtained in 2007 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. A few deviations were observed in some controls, calling for critical reflection. Once again, the results of this program highlighted the need to complement internal with external controls, such as those offered by the SEIMC program.
Assuntos
Estudos de Avaliação como Assunto , Infectologia , Laboratórios/normas , Microbiologia , Garantia da Qualidade dos Cuidados de Saúde , Sociedades Médicas , Adulto , Bacteriologia/normas , Erros de Diagnóstico , Feminino , Humanos , Laboratórios/estatística & dados numéricos , Masculino , Prontuários Médicos , Microbiologia/normas , Parasitologia/normas , Competência Profissional , Avaliação de Programas e Projetos de Saúde , Controle de Qualidade , Padrões de Referência , Reprodutibilidade dos Testes , Sorologia/normas , Espanha , Virologia/normas , Adulto JovemRESUMO
BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most important tasks performed in the molecular microbiology laboratory, due to their importance in patient follow-up. Quality control tools are crucial in these laboratories to ensure the accuracy of the results. This article presents the analysis of the results obtained in 2007 from the SEIMC External Quality Control Program for HIV-1 and HCV viral loads. METHODS AND RESULTS: In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in a range of 2-5 log(10) copies/mL; to analyze repeatability, two of these standards were identical. The specificity was good for all the methods used by the participants, and only two out of 75 results were considered to be false positive results. A substantial proportion of the laboratories (20% on average) obtained values outside the accepted range (mean +/-0.2 log(10) copies/mL), depending on the standard and on the method used for quantification. A few errors were due to the transcription of the analytical result. Repeatability was also acceptable but approximately 15% of laboratories failed this evaluation. The HCV program consisted of two standards with different viral load contents. Most of the participants (94.6%) obtained results within the accepted range (mean +/-1.96 SD log(10) UI/mL), and interlaboratory variability was <0.5 log units for both standards and all techniques. CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to wide interlaboratory variability, the use of the same method and the same laboratory for patient follow-up is advisable.