Orta Mira Nieves, Serrano María del Remedio Guna, Martínez José-Carlos Latorre, Ovies María Rosario, Poveda Marta, de Gopegui Enrique Ruiz, Cardona Concepción Gimeno
Programa de Control de Calidad Externo SEIMC, España.
Enferm Infecc Microbiol Clin. 2011 Dec;29 Suppl 5:8-14. doi: 10.1016/S0213-005X(11)70038-6.
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.
1型人类免疫缺陷病毒(HIV-1)以及乙型肝炎病毒(HBV)和丙型肝炎病毒(HCV)的病毒载量测定是这些病毒感染患者随访中最重要的标志物之一。外部质量控制工具对于确保微生物实验室所获结果的准确性至关重要。本文总结了西班牙传染病和临床微生物学会2010年HIV-1、HCV和HBV病毒载量及HCV基因分型外部质量控制项目的结果。在HIV-1项目中,共发送了五个标准品。一个标准品由血清阴性的人血浆组成,其余四个含有来自三名不同病毒血症患者的血浆,病毒载量范围为3 - 5 log(10)拷贝/毫升;其中两个标准品相同,目的是测定重复性。相当一部分实验室(平均22.6%)获得的值超出了可接受范围(均值±0.2 log(10)拷贝/毫升),这取决于标准品以及用于定量的方法。重复性非常好,高达95%的实验室报告的结果在限值范围内(Δ<0.5 log(10)拷贝/毫升)。HBV和HCV项目由两个病毒载量含量不同的标准品组成。大多数参与者,HCV项目为86.1%,HBV项目为87.1%,所获所有结果均在可接受范围内(均值±1.96 SD log(10)IU/毫升)。在这些对照中检测到了因结果转录错误导致的分析后误差。该分析数据强化了能力验证项目对于确保特定实验室所获结果质量的效用,以及分析后阶段在整体质量中的重要性。由于实验室间的变异性,建议在患者随访中使用相同方法并由同一实验室进行检测。