J Lab Med Qual Assur.  2009 Jun;31(1):125-141.

Annual Report on 2008 External Quality Assessment in Therapeutic Drug Monitoring and Drug of Abuse in Korea (2008)

• Kim JH
• Lee W
• Kim BK
• Lee SY
• Chun S
• Kwon GC
• Yoon Y
• Shin DH
• Song KE
• Song SM
• Suh SP
• Kim JQ

Abstract

Two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Laboratory (KAQACL) were performed in 2008. The number of participating laboratories were 114, which is similar with that of the previous year. Average response rates were 97.8% in both trials slightly lower than that of the previous year. Two kinds of control materials were requested to be tested in each trial so that each laboratory could know the possible systematic error. The average drug item was 6.3 per laboratory, which was decreased slightly from 6.8 in recent 5 years, and the maximum was 18 items. The most common test items were valproic acid, digoxin, carbamazepine, theophylline, phenytoin, and phenobarbital which were peformed in more than 52.1% of participating laboratories, followed by cyclosporine, vancomycin, tacrolimus, lithium, methotrexate, amikacin, tobramycin, gentamycin, acetaminophen, salicylate, free phenytoin, primidone, and amitryptyline. The widely used TDM analyzers were Abbott TDx/TDxFLx (35.3%), followed by Abbott AxSym (26.5%) and Roche Cobas Integra (17.3%), Abbott IMx (3.3%), and Siemens Viva E (3.0%). 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 tests were 17, which is similar to that of the previous year. Average drug item were 3.7 for the 1st trial. We found the relatively good performance as we got the correct answers for all laboratories except 2 laboratories. In conclusion, the TDM external quality assessment of 2008 showed grossly similar pattern comparing with that of previous year.

Keyword

Quality assurance; External quality assessment; Therapeutic drug monitoring

MeSH Terms

Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Drug Monitoring
Gentamicins
Korea
Lithium
Methotrexate
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin
Acetaminophen
Amikacin
Carbamazepine
Cyclosporine
Digoxin
Gentamicins
Lithium
Methotrexate
Phenobarbital
Phenytoin
Primidone
Tacrolimus
Theophylline
Tobramycin
Valproic Acid
Vancomycin