ABSTRACT
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.
Subject(s)
HIV Infections , Hepatitis B , Hepatitis C , Quality Control , Viral Load , HIV Infections/diagnosis , HIV-1 , Hepacivirus , Hepatitis B/diagnosis , Hepatitis B virus , Hepatitis C/diagnosis , Humans , Infectious Disease Medicine/standardsABSTRACT
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.
Subject(s)
HIV Infections , Hepatitis B , Hepatitis C , Quality Control , Viral Load , HIV Infections/diagnosis , HIV-1 , Hepacivirus , Hepatitis B/diagnosis , Hepatitis B virus , Hepatitis C/diagnosis , Humans , Infectious Disease Medicine/standardsABSTRACT
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.
Subject(s)
HIV-1/physiology , Hepacivirus/physiology , Quality Control , Societies, Scientific , Viral Load , Virology/standards , Humans , SpainABSTRACT
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)
Subject(s)
Humans , Viral Load/methods , HIV Infections/virology , Hepatitis C/virology , Hepacivirus/isolation & purification , HIV/isolation & purification , Outcome and Process Assessment, Health Care/methods , /methodsABSTRACT
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.
Subject(s)
DNA, Viral/blood , HIV Infections/virology , Hepatitis B/virology , Hepatitis C/virology , Infectious Disease Medicine/standards , Laboratories/standards , Laboratory Proficiency Testing , Microbiology/standards , RNA, Viral/blood , Societies, Scientific/standards , Viral Load , Viremia/virology , Virology/standards , HIV-1/genetics , HIV-1/isolation & purification , Hepacivirus/genetics , Hepacivirus/isolation & purification , Hepatitis B virus/genetics , Hepatitis B virus/isolation & purification , Humans , Plasma , Polymerase Chain Reaction/methods , Polymerase Chain Reaction/standards , Polymorphism, Restriction Fragment Length , Quality Assurance, Health Care , Reproducibility of Results , SpainABSTRACT
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.
