Abdissa Alemseged, Wiesner Lubbe, McIlleron Helen, Friis Henrik, Andersen Ase Bengård, Kaestel Pernille
Department of Medical Laboratory Sciences & Pathology, Jimma University, Jimma, Ethiopia; Department of Infectious Diseases, Odense University Hospital, Odense, Denmark;
Division of Clinical Pharmacology, Department of Medicine and Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
J Int AIDS Soc. 2014 Jun 5;17(1):18979. doi: 10.7448/IAS.17.1.18979. eCollection 2014.
Therapeutic drug monitoring (TDM) may improve antiretroviral efficacy through adjustment of individual drug administration. This could result in reduced toxicity, prevent drug resistance, and aid management of drug-drug interactions. However, most measurement methods are too costly to be implemented in resource-limited settings. This study evaluated a commercially available immunoassay for measurement of plasma efavirenz.
The immunoassay-based method was applied to measure efavirenz using a readily available Humastar 80 chemistry analyzer. We compared plasma efavirenz concentrations measured by the immunoassay with liquid chromatography tandem mass spectrometry (LC-MS/MS) (reference method) in 315 plasma samples collected from HIV patients on treatment. Concentrations were categorized as suboptimal<1 µg/ml, normal 1-4 µg/ml or high>4 µg/ml. Agreement between results of the methods was assessed via Bland-Altman plot and κ statistic values.
The median Interquartile range (IQR) efavirenz concentration was 2.8 (1.9; 4.5) µg/ml measured by the LC-MS/MS method and 2.5 (1.8; 3.9) µg/ml by the immunoassay and the results were well correlated (ρ=0.94). The limits of agreement assessed by Bland-Altman plots were -2.54; 1.70 µg/ml. Although immunoassay underestimated high concentrations, it had good agreement for classification into low, normal or high concentrations (K=0.74).
The immunoassay is a feasible alternative to determine efavirenz in areas with limited resources. The assay provides a reasonable approximation of efavirenz concentration in the majority of samples with a tendency to underestimate high concentrations. Agreement between tests evaluated in this study was clinically satisfactory for identification of low, normal and high efavirenz concentrations.
治疗药物监测（TDM）可通过调整个体药物给药来提高抗逆转录病毒疗效。这可能会降低毒性、预防耐药性并有助于药物相互作用的管理。然而，大多数测量方法成本过高，无法在资源有限的环境中实施。本研究评估了一种用于测量血浆依非韦伦的市售免疫测定法。
基于免疫测定的方法应用于使用易于获得的Humastar 80化学分析仪测量依非韦伦。我们将免疫测定法测量的血浆依非韦伦浓度与液相色谱串联质谱法（LC-MS/MS）（参考方法）在从接受治疗的HIV患者收集的315份血浆样本中进行了比较。浓度分为次优<1μg/ml、正常1-4μg/ml或高>4μg/ml。通过Bland-Altman图和κ统计值评估方法结果之间的一致性。
通过LC-MS/MS方法测量的依非韦伦浓度中位数四分位间距（IQR）为2.8（1.9；4.5）μg/ml，通过免疫测定法为2.5（1.8；3.9）μg/ml，结果具有良好的相关性（ρ=0.94）。Bland-Altman图评估的一致性界限为-2.54；1.70μg/ml。尽管免疫测定法低估了高浓度，但在分类为低、正常或高浓度方面具有良好的一致性（K=0.74）。
免疫测定法是在资源有限地区测定依非韦伦的一种可行替代方法。该测定法在大多数样本中提供了依非韦伦浓度的合理近似值，但有低估高浓度的趋势。本研究中评估的测试之间的一致性在临床上对于识别低、正常和高依非韦伦浓度是令人满意的。
