Programa de Control de Calidad Externo SEIMC; Servicio de Microbiología, Hospital Francesc de Borja, Gandía, Valencia, España.
Programa de Control de Calidad Externo SEIMC; Servicio de Microbiología, Consorcio Hospital General Universitario de Valencia alencia, España.
Enferm Infecc Microbiol Clin (Engl Ed). 2020 Jan;38 Suppl 1:61-66. doi: 10.1016/j.eimc.2020.02.010.
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.
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 log 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 log 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 log 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 log UI/mL).
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.
人类免疫缺陷病毒 1 型（HIV-1）和乙型肝炎（HBV）和丙型肝炎（HCV）病毒载量测定是监测感染这些病毒的患者的最重要标志物之一。外部质量控制工具对于确保微生物学实验室获得的结果的准确性至关重要。本文总结了 2017 年 SEIMC HIV-1、HCV 和 HBV 病毒载量和 HCV 基因分型外部质量控制计划的结果。
在 HIV-1 计划中，共发送了五个标准。一个标准由血清阴性的人类血浆组成，而其余四个标准包含来自三个不同病毒血症患者的血浆，范围在 2-5 对数拷贝/mL 之间；其中两个标准是相同的，目的是确定重复性。相当一部分实验室（平均 35%）的结果超出了可接受范围（平均±0.25 对数拷贝/mL），这取决于标准和用于定量的方法。重复性良好，多达 94%的实验室报告的结果在限值内（D<0.5 对数拷贝/mL）。HBV 和 HCV 计划包括两个具有不同病毒载量的标准。大多数参与者（HCV 为 82%，HBV 为 87%）获得了所有结果都在可接受范围内（平均±1.96 SD log UI/mL）。
这项分析的数据加强了能力验证计划的效用，以确保特定实验室获得的结果的质量。由于观察到明显的实验室间变异性，建议在患者随访中使用相同的方法和实验室。
