J Lab Med Qual Assur 2020; 42(4): 183-193
Published online December 31, 2020
Copyright © Korean Association of External Quality Assessment Service.
Hyun-Ki Kim1, Dae-Hyun Ko2, Tae-Dong Jeong3, Eun Suk Shin4, Jeong-Ho Kim5, and Sail Chun2
1Department of Laboratory Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan; 2Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine; 3Department of Laboratory Medicine, Ewha Womans University School of Medicine; 4Department of Laboratory Medicine, Asan Medical Center; 5Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Correspondence to:Sail Chun
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Korean Association of External Quality Assessment Service offered to conduct a proficiency test program for therapeutic drug monitoring (TDM) and testing drugs of abuse (DOA), which was named as the TDM and Toxicology program. This report summarizes the results of the proficiency tests performed between 2015?2019. In the proficiency test program, low- and high-level control materials for TDM, and positive and negative control materials for testing DOA were examined in the participating laboratories. The number of participating laboratories for TDM increased from 105 in 2015 (1st trial) to 114 in 2019 (2nd trial). Valproic acid was the most commonly tested substance. The most widely used TDM analyzer was the Architect i System (Abbott Laboratories, USA). The TDM proficiency test coefficients of variation for each test substance exhibit a broad range (0%?300%), which is mainly attributed to the test substance, concentration, or number of participating laboratories. The number of participating laboratories for DOA testing markedly increased from 35 in 2015 (1st trial) to 123 in 2019 (2nd trial). The proportion of the acceptable results ranged between 84%?100%. In 2019, five laboratories reported false negative results in the first trial, but later, they reported correct results in the second trial. In the proficiency test program for TDM and testing DOA during 2015?2019, the performance of participating laboratories was generally decent. However, continuous efforts to monitor and improve the quality of testing are required, which can happen only with increased participation in the proficiency test program.
Keywords: Quality assurance, Laboratory proficiency testing, Therapeutic drug monitoring, Drug of abuse
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