Poor performance of laboratories assaying newly developed antiretroviral agents: Results for darunavir, etravirine and raltegravir from the international quality control program for measurement of antiretroviral drugs in plasma

Autor: Burger, D., Stefanie Krens, Robijns, K., Aarnoutse, R., Bruggemann, R., Touw, D.
Přispěvatelé: Nanomedicine & Drug Targeting, Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Groningen Research Institute for Asthma and COPD (GRIAC), Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Medicinal Chemistry and Bioanalysis (MCB)
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Zdroj: University of Groningen
Web of Science
Therapeutic Drug Monitoring, 35(5). LIPPINCOTT WILLIAMS & WILKINS
ISSN: 0163-4356
Popis: Background: The International Interlaboratory Quality Control Program for Measurement of Antiretroviral Drugs in Plasma was initiated in 1999. We have recently published our experience during the first 10 years of the Program (Burger et al, TDM 2011). Since 2010, 3 newly developed antiretroviral agents have been added to the Program: darunavir (DRV), etravirine (ETR) and raltegravir (RAL). The objective of this analysis is to describe the performance of participating laboratories measuring these newer agents in 2011- 2012. Materials and Methods: Each year laboratories received 2 blind samples of human plasma spiked with either a low (20% deviation, so “inadequate” (7.6% too low; 10.4% too high). The proportion of inadequate results in 2011 was 21.3% for DRV, 31.0% for ETR, and 26.3% for RAL; in 2012 these figures improved to 8.1%, 23.2% and 8.3% for DRV, ETR, and RAL, respectively. Taken DRV as the reference, performance for ETR was significantly lower: OR 0.462 (95% CI: 0.246- 0.866; P = 0.016); performance for RAL was not significantly different. Low concentrations were significantly more frequently reported as inadequate than medium or high concentrations: 28.6 versus 10.6 versus 8.8%, respectively (P
Databáze: OpenAIRE
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