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[2009年西班牙传染病和临床微生物学会外部质量控制项目中HIV-1和HCV病毒载量结果分析]

[Analysis of the results of the HIV-1 and HCV viral load of the SEIMC External Quality Control Program. Year 2009].

作者信息

Orta Mira Nieves, del Remedio Guna Serrano María, Martínez José-Carlos Latorre, Ovies María Rosario, Poveda Marta, de Gopegui Enrique Ruiz, Pérez José L, Cardona Concepción Gimeno

机构信息

Programa de Control de Calidad Externo SEIMC, España.

出版信息

Enferm Infecc Microbiol Clin. 2011 Mar;29 Suppl 3:8-13. doi: 10.1016/S0213-005X(11)70021-0.

Abstract

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.

摘要

1型人类免疫缺陷病毒(HIV-1)和丙型肝炎病毒(HCV)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获得结果的准确性至关重要。本文总结了2009年西班牙传染病和临床微生物学会(SEIMC)HIV-1和HCV病毒载量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2-5 log(10)拷贝/毫升;其中两个标准品相同,旨在测定重复性。根据标准品和用于定量的方法,相当比例的实验室(平均21.5%)获得的值超出了可接受范围(平均值±0.2 log(10)拷贝/毫升)。重复性非常好,高达95%的实验室报告的结果在可接受限度内(Δ<0.5 log10拷贝/毫升)。检测到HIV-1存在因结果误转录导致的分析后误差。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(79.7%)获得的结果在可接受范围内(平均值±1.96 SD log(10) UI/毫升)。该分析的数据强化了能力验证项目对于确保特定实验室获得结果质量的效用,以及分析后阶段在整体质量中的重要性。由于实验室间存在显著差异,建议在患者随访中使用相同的方法和同一个实验室。

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