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
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2014 controls. As a whole, the results obtained in 2014 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of the SEIMC program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests.
Assuntos
Doenças Transmissíveis/diagnóstico , Laboratórios/normas , Controle de Qualidade , Bacteriologia/normas , Micologia/normas , Padrões de Referência , Espanha , Virologia/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
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology and HIV-1, HCV and HBV viral loads. This manuscript presents the analysis of results obtained of the participants from the 2013 SEIMC External Quality Control Programme, except viral loads controls, that they are summarized in a manuscript abroad. As a whole, the results obtained in 2013 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and 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
Ensaio de Proficiência Laboratorial , Técnicas Microbiológicas/normas , Parasitologia/métodos , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Adulto , Erros de Diagnóstico , Feminino , Humanos , Infectologia/organização & administração , Ensaio de Proficiência Laboratorial/organização & administração , Ensaio de Proficiência Laboratorial/normas , Ensaio de Proficiência Laboratorial/estatística & dados numéricos , Masculino , Microbiologia/organização & administração , Pessoa de Meia-Idade , Padrões de Referência , 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
El Programa de Control Externo de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC) incluye las áreas de bacteriología, serología, micología, parasitología, micobacterias, virología y microbiología molecular. En este manuscrito se presenta el análisis de los resultados enviados por los participantes en los controles remitidos durante el año 2010. Los resultados obtenidos confirman de nuevo la buena capacitación general de los laboratorios españoles de microbiología clínica de años anteriores. A pesar de ello, el programa muestra que es posible obtener un resultado erróneo, incluso en determinaciones de gran trascendencia y en cualquier laboratorio. Resaltamos 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 (AU)
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecularmicrobiology. This article presents the most important conclusions and lessons of the 2010 controls. As awhole, the results obtained in 2010 confirm the excellent skill and good technical standards found inprevious years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and externalcontrols to ensure maximal quality of microbiological tests (AU)
Assuntos
Humanos , Técnicas de Laboratório Clínico/normas , Ensaio de Proficiência Laboratorial/métodos , Controle de Qualidade , Laboratório Oficial , Manejo de Espécimes/normas , Preservação de Amostras de Água/métodosRESUMO
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
FUNDAMENTOS. La determinación de la carga viral de losvirus de la inmunodeficiencia humana tipo 1 (VIH-1) y de lahepatitis C (VHC) constituye una labor primordial dellaboratorio de microbiología molecular, por su valorpronóstico y como guía en el tratamiento. Es crucial que ellaboratorio disponga de herramientas para garantizar lafiabilidad de sus resultados. Se presentan el análisis delPrograma de Control de Calidad SEIMC de carga viral deambos virus remitido durante el año 2007.MÉTODOS Y RESULTADOS. En el control de VIH se remitieron 5estándares, de los que uno (plasma humano seronegativo)no contenía el virus, y los otros consistían en plasma de 3pacientes virémicos distintos en un intervalo deconcentraciones de 2-5 log10 copias/ml; 2 de ellos eranidénticos, con el fin de analizar la repetitividad. Laespecificidad fue buena por todos los métodoscomerciales, y sólo 2 de 75 resultados fueron falsospositivos. Una parte importante de los laboratorios obtuvoresultados fuera de límites (media ± 0,2 log10 copias/ml),dependiendo del estándar y del método empleado, enpromedio el 20%. Se detectaron errores atribuibles a latranscripción de los resultados analíticos. La repetitividadtambién fue aceptable, pero en torno al 15% de loslaboratorios no superó esta evaluación. En el control deVHC se remitieron 2 estándares con diferente contenidodel virus. La mayor parte de los participantes (94,6%)obtuvo resultados dentro de los límites de la media ± 1,96DE log10 UI/ml, y la variabilidad interlaboratorio fue inferiora 0,5 unidades logarítmicas para ambos estándares y conlos distintos métodos.CONCLUSIONES. Estos resultados refuerzan la utilidad de loscontroles externos para asegurar la calidad de losresultados analíticos, incluyendo la fase postanalítica.Debido a la notable variabilidad interlaboratorio, es aconsejable utilizar un mismo método y el mismolaboratorio en el seguimiento de los pacientes(AU)
BACKGROUND. Human immunodeficiency virus type 1 (HIV-1)and hepatitis C virus (HCV) viral load determinations areamong the most important tasks performed in themolecular microbiology laboratory, due to theirimportance in patient follow-up. Quality control tools arecrucial in these laboratories to ensure the accuracy of theresults. This article presents the analysis of the resultsobtained in 2007 from the SEIMC External Quality ControlProgram for HIV-1 and HCV viral loads.METHODS AND RESULTS. In the HIV-1 program, a total of fivestandards were sent. One standard consisted ofseronegative human plasma, while the remaining fourcontained plasma from three different viremic patients, in arange of 2-5 log10 copies/mL; to analyze repeatability, two ofthese standards were identical. The specificity was good forall the methods used by the participants, and only two outof 75 results were considered to be false positive results. Asubstantial proportion of the laboratories (20% on average)obtained values outside the accepted range (mean ±0.2 log10copies/mL), depending on the standard and on the methodused for quantification. A few errors were due to thetranscription of the analytical result. Repeatability was alsoacceptable but approximately 15% of laboratories failed thisevaluation. The HCV program consisted of two standardswith different viral load contents. Most of the participants(94.6%) obtained results within the accepted range (mean±1.96 SD log10 UI/mL), and interlaboratory variability was<0.5 log units for both standards and all techniques.CONCLUSIONS. Data from this analysis reinforce the utility ofproficiency programs to ensure the quality of the resultsobtained 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 samemethod and the same laboratory for patient follow-up isadvisable(AU)
Assuntos
Humanos , Infecções por HIV/microbiologia , Técnicas Microbiológicas/normas , HIV-1/isolamento & purificação , HIV/isolamento & purificação , Carga Viral/normas , Controle de Qualidade , Padrões de Referência , Hepacivirus/isolamento & purificaçãoRESUMO
FUNDAMENTOS. La determinación de la carga viral de los virus de la inmunodeficiencia humana tipo 1 (VIH-1) y de la hepatitis C (VHC) constituye una labor primordial del laboratorio de microbiología molecular, por su valor pronóstico y como guía en el tratamiento. Es crucial que el laboratorio disponga de herramientas para garantizar la fiabilidad de sus resultados. Se presentan el análisis del Programa de Control de Calidad SEIMC de carga viral de ambos virus remitido durante el año 2007. MÉTODOS Y RESULTADOS. En el control de VIH se remitieron 5 estándares, de los que uno (plasma humano seronegativo) no contenía el virus, y los otros consistían en plasma de 3 pacientes virémicos distintos en un intervalo de concentraciones de 2-5 log10 copias/ml; 2 de ellos eran idénticos, con el fin de analizar la repetitividad. La especificidad fue buena por todos los métodos comerciales, y sólo 2 de 75 resultados fueron falsos positivos. Una parte importante de los laboratorios obtuvo resultados fuera de límites (media ± 0,2 log10 copias/ml), dependiendo del estándar y del método empleado, en promedio el 20%. Se detectaron errores atribuibles a la transcripción de los resultados analíticos. La repetitividad también fue aceptable, pero en torno al 15% de los laboratorios no superó esta evaluación. En el control de VHC se remitieron 2 estándares con diferente contenido del virus. La mayor parte de los participantes (94,6%) obtuvo resultados dentro de los límites de la media ± 1,96 DE log10 UI/ml, y la variabilidad interlaboratorio fue inferior a 0,5 unidades logarítmicas para ambos estándares y con los distintos métodos. CONCLUSIONES. Estos resultados refuerzan la utilidad de los controles externos para asegurar la calidad de los resultados analíticos, incluyendo la fase postanalítica. Debido a la notable 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 areamong the most important tasks performed in themolecular microbiology laboratory, due to theirimportance 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 ofseronegative human plasma, while the remaining fourcontained plasma from three different viremic patients, in a range of 2-5 log10 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 log10 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 log10 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
