[Evaluation of Viva-E drug testing system].
BACKGROUND
The importance and usefulness of therapeutic drug monitoring (TDM) have been emphasized, and analysis of drugs has been increased in clinical laboratories. We evaluated the analytical performance and clinical usefulness of a recently introduced enzyme multiplied immunoassay instrument, Viva-E Drug Testing System (Dade Behring Inc., USA).


METHODS
Using patients' samples and quality control material, we evaluated the analytical performance of Viva-E for a total of 11 drugs (cyclosporine, tacrolimus, mycophenolic acid, valproic acid, digoxin, theophylline, carbamazepine, phenytoin, phenobarbital, vancomycin, and gentamicin) with respect to linearity, precision, and correlations with other methods according to CLSI guidelines. Cobas Integra 800 (Roche Diagnostics, Switzerland) and API 4000 LC-MS/MS System (Applied Biosystems, USA) were used to make a comparison. In addition, we analyzed analysis time.


RESULTS
Viva-E showed a good linearity (r2 >or= 0.97) for all items. Within-run CVs were within 5% and total CVs were within 10% for all drugs except for tacrolimus and digoxin at low concentrations. The system correlated well with the other methods (r=0.9283-0.9778). The time required for reporting the first sample was 11 min and the analysis time was 1.1 min.


CONCLUSIONS
Since Viva-E showed a good analytical performance required for TDM in its linearity, precision, and accuracy with its wide drug menus including cyclosporine, tacrolimus, and mycophenolic acid, stat and random accessing functions, and the consolidation to a single workstation, it could be very useful in the clinical laboratory for various needs.
Chung
Hae-Sun
HS
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Lee
Seung-Tae
ST
Lee
Soo-Youn
SY
D003627:Data Interpretation, Statistical; D016903:Drug Monitoring / Q000295:instrumentation* / Q000379:methods; D017248:Enzyme Multiplied Immunoassay Technique / Q000295:instrumentation*; D006801:Humans; D007124:Immunoenzyme Techniques; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results
D004364:Pharmaceutical Preparations