Evaluation of an immunoassay for determination of plasma efavirenz concentrations in resource-limited settings
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Evaluation of an immunoassay for determination of plasma efavirenz concentrations in resource-limited settings. / Abdissa, Alemseged; Wiesner, Lubbe; McIlleron, Helen; Friis, Henrik; Andersen, Åse Bengård; Kæstel, Pernille.
In: International AIDS Society. Journal, Vol. 17, 18979, 2014.Research output: Contribution to journal › Journal article › Research › peer-review
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T1 - Evaluation of an immunoassay for determination of plasma efavirenz concentrations in resource-limited settings
AU - Abdissa, Alemseged
AU - Wiesner, Lubbe
AU - McIlleron, Helen
AU - Friis, Henrik
AU - Andersen, Åse Bengård
AU - Kæstel, Pernille
N1 - CURIS 2014 NEXS 205
PY - 2014
Y1 - 2014
N2 - INTRODUCTION: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.
AB - INTRODUCTION: 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.METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.
U2 - 10.7448/IAS.17.1.18979
DO - 10.7448/IAS.17.1.18979
M3 - Journal article
C2 - 24909561
VL - 17
JO - International AIDS Society. Journal
JF - International AIDS Society. Journal
SN - 1758-2652
M1 - 18979
ER -
ID: 119650998