RESUMO
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 2016¼, which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A. © 2019 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
Assuntos
Técnicas de Laboratório Clínico/normas , Infecções/diagnóstico , Controle de Qualidade , Humanos , Microbiologia , Avaliação de Programas e Projetos de Saúde , Sociedades Médicas , EspanhaRESUMO
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 2016¼, which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A. © 2019 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
Assuntos
Técnicas de Laboratório Clínico/normas , HIV-1 , Hepacivirus , Vírus da Hepatite B , Controle de Qualidade , Carga Viral , Genótipo , Hepacivirus/genética , Humanos , Infecções , Microbiologia , Avaliação de Programas e Projetos de Saúde , Sociedades Médicas , EspanhaRESUMO
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 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
Infecções por HIV/sangue , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/isolamento & purificação , Hepatite B/sangue , Hepatite C/sangue , Ensaio de Proficiência Laboratorial , Carga Viral , Viremia/virologia , Infecções por HIV/virologia , Hepatite B/virologia , Hepatite C/virologia , Humanos , Infectologia/organização & administração , Ensaio de Proficiência Laboratorial/normas , Microbiologia/organização & administração , Padrões de Referência , Reprodutibilidade dos Testes , Sociedades Médicas/normas , 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 deben disponer de herramientas que garanticen la fiabilidad de sus resultados; entre ellas se encuentran los programas de intercomparación externos. En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de los 3 virus y del genotipado del VHC, realizados durante el año 2010.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 entre 35 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetibilidad. 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 22,6%. La repetibilidad fue muy buena y más del 95% de los laboratorios obtuvo resultados aceptables (Δ<0 5 log 10copias/ml). En los controles de VHC y VHB se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes, 86,1% en el caso del VHC y 87,1% en el del VHB, obtuvo ambos resultados dentro de los límites de la media±1,96 desviación estándar log10UI/ml. Se detectaron errores postanalíticos de transcripción de los resultados en estos controles. 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(AU)
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. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarized the results obtained in the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads and HCV genotyping.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 35 log10 copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (22.6% on average) obtained values out of the accepted range (mean±0.2 log10copies/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 (Δ<0 5 log 10copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 86.1% in the case of HCV and 87.1% in HBV, obtained all the results within the accepted range (mean±1.96 SD log10UI/mL). Post-analytical errors due to mistranscription of the results were detected in these controls. 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 interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable(AU)
Assuntos
Humanos , Carga Viral/métodos , Ensaio de Proficiência Laboratorial , Técnicas Microbiológicas/normas , HIV-1/patogenicidade , Hepacivirus/patogenicidade , Vírus da Hepatite B/patogenicidade , Controle de QualidadeRESUMO
Human immunodeficiency virus type 1 (HIV-1) and hepatitis 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 obtained from the SEIMC's External Quality Control Program for HIV-1 and HCV viral loads in 2009. 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 log(10) copies/mL; two of these standards were identical, aiming to determine repeatability. A significant proportion of the laboratories (21.5% 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. Repeatability was very good, with up to 95 % of laboratories reporting results within the accepted limits (Δ<0.5 log10 copies/mL). Post-analytical errors due to mistranscription of the results were detected for HIV-1. The HCV program consisted of two standards with different viral load contents. Most of the participants (79.7%) obtained results within the accepted range (mean ± 1.96 SD log(10) UI/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 marked interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable.
Assuntos
HIV-1/fisiologia , Hepacivirus/fisiologia , Controle de Qualidade , Sociedades Científicas , Carga Viral , Virologia/normas , Humanos , EspanhaRESUMO
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 control de los pacientes infectados por estos virus. Los laboratorios de microbiología deben disponer de herramientas que garanticen la fiabilidad de sus resultados, entre ellas se encuentran los programas de intercomparación externos. En el presente número se muestra el análisis de resultados del Programa de Control de Calidad SEIMC de carga viral de ambos virus y del genotipado del VHC, realizados durante el año 2009.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 25 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetibilidad. 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 (..) (AU)
Human immunodeficiency virus type 1 (HIV-1) and hepatitis 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 obtained from the SEIMCs External Quality Control Program for HIV-1and HCV viral loads in 2009.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 of2-5 log10 copies/mL; two of these standards were identical, aiming to determine repeatability. A significant proportion of the laboratories (21.5% on average) obtained values outside 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 accepted (..) (AU)
