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KMID : 0985420100320010115
Laboratory Medicine and Quality Assurance
2010 Volume.32 No. 1 p.115 ~ p.130
Annual Report on External Quality Assessment in Therapeutic Drug Monitoring and Drug of Abuse in Korea (2009)


Abstract
We performed two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Laboratory (KAQACL) in 2009. The number of participating laboratories were 110, which is similar with that of previous 3 years. Average response rates were 97.8% in both trials, similar to those of previous years. Two kinds of control materials were requested to be tested in each trial so that each institution could find the possible systematic errors. The average drug item responded was 6.2 per institution, which was decreased slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, carbamazepine, phenytoin, and theophylline which were peformed in more than 63.8% of participating laboratories, followed by phenobarbital, cyclosporine, tacrolimus, vancomycin, lithium, methotrexate, amikacin, gentamicin, acetaminophen, tobramycin, salicylate, free phenytoin, amitryptyline, ethosuximide, and primidone. The widely used TDM analyzers were Abbott AxSym (26.9%), followed by Abbott TDx/TDxFLx (24.8%), Roche Cobas Integra (15.1%), Siemens Diagnostics Viva-E (5.5%), Roche cobas c501 (5.1%), Siemens Diagnostics Dimension (3.4%), and many other analyzers. The inter-laboratory coefficients of variations showed similar tendency comparing with those of the previous years. The number of participating laboratories for drug of abuse (DOA) tests were 19, which was slightly increased compared to that of the previous year. Average DOA items were 3.8~4.2. We found the good performance of participating laboratories for DOA. In conclusion, the TDM and DOA external quality assessment of 2009 showed similar performance comparing with that of the recent 3 years.
KEYWORD
Quality assurance, External quality assessment, Therapeutic drug monitoring
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