Mira Nieves Orta, Serrano María del Remedio Guna, Martínez José Carlos Latorre, Ovies María Rosario, Pérez José L, Cardona Concepción Gimeno
Hospital Francesc de Borja, Gandía, Valencia, España.
Enferm Infecc Microbiol Clin. 2010 Jan;28 Suppl 1:7-11. doi: 10.1016/S0213-005X(10)70002-1.
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.
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.
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.
人类免疫缺陷病毒1型(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2008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。一个标准品为血清阴性的人血浆,其余四个含有来自3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,用于测定重复性。所有商业方法的特异性均为100%,参与者均未报告假阳性结果。根据标准品和定量方法的不同,相当一部分实验室(平均24%)获得的值超出了可接受范围(均值±0.2 log₁₀拷贝/毫升)。重复性非常好,高达95%的实验室报告的结果在限值范围内(D<0.5 log₁₀拷贝/毫升)。HCV项目包括两个病毒载量含量不同的标准品。大多数参与者(88.7%)获得的结果在可接受范围内(均值±1.96标准差log₁₀国际单位/毫升)。在HCV项目中检测到了因结果转录错误导致的分析后误差,但在HIV-1项目中未检测到。
该分析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实用性,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个实验室。