Abbott ARCHITECT iPhenytoin assay versus similar ... | 合法醫療器材資訊網
Objective: To measure free phenytoin (FP) concentrations in filtered specimens using the Abbott ARCHITECT iPhenytoin assay and to compare results from this method with results from the Abbott TDx/FLx assays.
Methods: We verified accuracy, analytic measurement range, and precision for FP measurements. For correlation and therapeutic interval studies, we used filtered calibrators, controls, proficiency-testing materials, and surplus clinical samples. After implementation, we determined proficiency testing results.
Results: The analytic measurement range was 2.0 to 25.0 micromol/L. Quality control materials (6.1, 12.6, and 20.1 micromol/L) provided mean (SD) recoveries of 96.1 (5.0%), 99.2 (5.0%), and 99.3 (5.7%), respectively, and coefficients of variation of 5.2%, 5.0%, and 5.8%, respectively. Clinical specimens produced mean (SD) FP recovery levels of 103.7 (10.6%) (bias, 0.1 [0.3] micr...
(PDF) Abbott ARCHITECT iPhenytoin Assay Versus Similar ... | 合法醫療器材資訊網
Abbott ARCHITECT iPhenytoin assay versus similar ... | 合法醫療器材資訊網
Abbott ARCHITECT iPhenytoin Assay Versus Similar Assays ... | 合法醫療器材資訊網
Clinical evaluation of the Abbott TDx fluorescence polarization ... | 合法醫療器材資訊網
Cross | 合法醫療器材資訊網
Cyclosporine | 合法醫療器材資訊網
Phenytoin | 合法醫療器材資訊網
Validation of a Free Phenytoin Assay on Cobas c501 Analyzer ... | 合法醫療器材資訊網
西藥、醫療器材、化粧品許可證查詢 詳細處方成分 | 合法醫療器材資訊網
【亞培 TDx/TDxFLx 苯妥因檢驗試劑組】許可證字號:衛署醫器輸字第013233號
器材品名:亞培TDx/TDxFLx苯妥因檢驗試劑組許可證字號:衛署醫器輸字第013233號註銷狀態:已註銷註銷日期:2012/11/06註銷理由:...