약물분석장비 Viva-E의 평가 = Evaluation of Viva-E Drug Testing System

국문 초록 (Abstract)

배경 : 적정약물치료를 위한 치료적약물농도측정(Therapeuticdrug monitoring, TDM)의 중요성에 대한 인식이 높아짐에 따라,약물농도측정은 임상검사실에서 수행하는 보편적인 검사로서 그수요가 증가하고 있는 추세이다. 현재 다양한 측정시약 및 장비가소개 및 이용되고 있으나, 분석능이나 대상약물종목에 있어 부분적인 제한점들을 가지고 있다. 저자들은 최근 국내 새로이 소개된약물분석장비 Viva-E Drug Testing System (Dade BehringInc., USA)의 분석능 및유용성을 평가하였다.방법 : Cyclosporine, tacrolimus, mycophenolic acid, valproicacid, digoxin, theophylline, carbamazepine, phenytoin, pheno-barbital, vancomycin, gentamicin을 포함한 총 11종목의 약물에대해, 약물농도측정이 의뢰되었던 임상 환자 검체 및 정도관리물질을 이용하여 CLSI 지침에 따라 직선성, 정밀도 및 검체처리능력을 평가하였으며 기존 검사실 장비인 Cobas Integra800 (Roch eDiagnostics, Switzerland), API 4000 LC-MS/MS System(Applied Biosystems, USA)과 상관성 평가를 수행하였다.결과 : 평가한 모든 약물에 대해 임상적으로 의미 있는 농도범위에서 결정계수 0.97 이상의 우수한 직선성이 관찰되었다. 각약물별 3가지 농도에 대한 정밀도 평가에서 tacrolimus와 digoxin저농도군을 제외한 대부분의 약물에 대해 5% 이내의 검사차례내변이계수, 10% 이내의 총 변이계수를 보였다. 기존 장비와의 상관성 평가에서는 상관계수 0.9283-0.9778으로나타났다. 분석속도는 첫 검체의 검사결과가 나올 때까지 약 1분이 소요되었으며검사 당 소요 시간은 약 1.1분이었다.

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