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[2013年SEIMC外部质量控制项目的HIV-1、HCV和HBV病毒载量结果分析]

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2013].

作者信息

Orta Mira Nieves, Del Remedio Guna Serrano María, Latorre Martínez José-Carlos, Medina González Rafael, Rosario Ovies María, Poveda Marta, Ruiz de Gopegui Enrique, Gimeno Cardona Concepción

机构信息

Programa de Control de Calidad Externo SEIMC; Servicio de Microbiología, Consorcio Hospital General Universitario de Valencia, Valencia, España.

Programa de Control de Calidad Externo SEIMC; Servicio de Microbiología, Consorcio Hospital General Universitario de Valencia, Valencia, España.

出版信息

Enferm Infecc Microbiol Clin. 2015 Jul;33 Suppl 2:9-14. doi: 10.1016/S0213-005X(15)30009-4.

Abstract

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.

摘要

1型人类免疫缺陷病毒(HIV-1)、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相关的标志物之一。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2013年西班牙传染病和临床微生物学会(SEIMC)HIV-1、HCV和HBV病毒载量外部质量控制计划的结果。在HIV-1计划中,总共发送了五个标准品。一个标准品为血清阴性的人血浆,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 log10拷贝/毫升;其中两个标准品相同,旨在测定重复性。相当一部分实验室(平均25%)获得的值超出了可接受范围(平均值±0.25 log10拷贝/毫升),这取决于标准品和用于定量的方法。重复性非常好,高达98.9%的实验室报告的结果在限值范围内(D<0.5 log10拷贝/毫升)。HBV和HCV计划包括两个病毒载量含量不同的标准品。大多数参与者,HCV方面为82%,HBV方面为78%,所有结果均在可接受范围内(平均值±1.96标准差log10 UI/毫升)。该分析的数据强化了能力验证计划对于确保特定实验室获得结果质量的效用,以及分析后阶段对整体质量的重要性。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实验室。

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