RESUMO
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
Infectologia/normas , Laboratórios/normas , Microbiologia/normas , Controle de Qualidade , Bacteriologia , Humanos , Micologia , EspanhaRESUMO
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
Infectologia/normas , Laboratórios/normas , Microbiologia/normas , Controle de Qualidade , Bacteriologia , Humanos , Micologia , EspanhaRESUMO
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
Infecções por HIV , Hepatite B , Hepatite C , Controle de Qualidade , Carga Viral , Infecções por HIV/diagnóstico , HIV-1 , Hepacivirus , Hepatite B/diagnóstico , Vírus da Hepatite B , Hepatite C/diagnóstico , Humanos , Infectologia/normasRESUMO
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
Infecções por HIV , Hepatite B , Hepatite C , Controle de Qualidade , Carga Viral , Infecções por HIV/diagnóstico , HIV-1 , Hepacivirus , Hepatite B/diagnóstico , Vírus da Hepatite B , Hepatite C/diagnóstico , Humanos , Infectologia/normasRESUMO
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 2012 controls. As a whole, the results obtained in 2012 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
Técnicas Microbiológicas/normas , Controle de Qualidade , HumanosRESUMO
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
The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2011 controls. Overall, the results obtained in 2011 confirm the excellent skill and good technical standards found in previous years. Nevertheless, 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 external controls, such as those offered by the SEIMC program, in order to ensure maximal quality of microbiological tests.
Assuntos
Técnicas Microbiológicas/normas , Humanos , Controle de Qualidade , 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 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
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
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 molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 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. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1).
Assuntos
Infectologia/normas , Laboratórios/normas , Ensaio de Proficiência Laboratorial , Microbiologia/normas , Parasitologia/normas , Testes Sorológicos/normas , Sociedades Científicas/normas , Virologia/normas , Anticorpos Antibacterianos/sangue , Anticorpos Antifúngicos/sangue , Anticorpos Anti-Helmínticos/sangue , Anticorpos Antivirais/sangue , Pré-Escolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Garantia da Qualidade dos Cuidados de Saúde , Padrões de Referência , Espanha , Sorodiagnóstico da Sífilis/normas , Adulto JovemRESUMO
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 3-5 log(10) 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 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 limits (Δ<0.5 log(10)copies/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 log(10)UI/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.
Assuntos
DNA Viral/sangue , Infecções por HIV/virologia , Hepatite B/virologia , Hepatite C/virologia , Infectologia/normas , Laboratórios/normas , Ensaio de Proficiência Laboratorial , Microbiologia/normas , RNA Viral/sangue , Sociedades Científicas/normas , Carga Viral , Viremia/virologia , Virologia/normas , HIV-1/genética , HIV-1/isolamento & purificação , Hepacivirus/genética , Hepacivirus/isolamento & purificação , Vírus da Hepatite B/genética , Vírus da Hepatite B/isolamento & purificação , Humanos , Plasma , Reação em Cadeia da Polimerase/métodos , Reação em Cadeia da Polimerase/normas , Polimorfismo de Fragmento de Restrição , Garantia da Qualidade dos Cuidados de Saúde , Reprodutibilidade dos Testes , EspanhaRESUMO
The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews).
Assuntos
Fidelidade a Diretrizes , Guias como Assunto , Infectologia/normas , Laboratórios/normas , Ensaio de Proficiência Laboratorial , Microbiologia/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Sociedades Científicas/normas , Acreditação/legislação & jurisprudência , Acreditação/normas , Laboratórios/legislação & jurisprudência , Auditoria Administrativa/organização & administração , Preservação Biológica/métodos , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Melhoria de Qualidade , Sociedades Científicas/legislação & jurisprudência , Sociedades Científicas/organização & administração , Espanha , Manejo de Espécimes/normasRESUMO
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 an external controls in order to assure the maximal quality of the microbiological tests.
Assuntos
Técnicas de Laboratório Clínico/normas , Infectologia/organização & administração , Laboratórios/normas , Microbiologia/organização & administração , Controle de Qualidade , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Humanos , Infecções/diagnóstico , Infecções/microbiologia , Infecções/parasitologia , Infecções/virologia , Infectologia/normas , Laboratórios/estatística & dados numéricos , Microbiologia/normas , Avaliação de Programas e Projetos de Saúde , Garantia da Qualidade dos Cuidados de Saúde , EspanhaRESUMO
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 five 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 log(10) 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 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 limits (D < 0.5 log(10) 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 log(10) 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
Técnicas de Laboratório Clínico/normas , HIV-1/isolamento & purificação , Hepacivirus/isolamento & purificação , Infectologia/organização & administração , Laboratórios/normas , Microbiologia/organização & administração , Controle de Qualidade , Carga Viral , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Reações Falso-Negativas , Infecções por HIV/sangue , Infecções por HIV/virologia , Hepatite C/sangue , Hepatite C/virologia , Humanos , Infectologia/normas , Laboratórios/estatística & dados numéricos , Microbiologia/normas , Avaliação de Programas e Projetos de Saúde , Garantia da Qualidade dos Cuidados de Saúde , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Sensibilidade e Especificidade , Espanha , Viremia/virologiaRESUMO
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.
