Korean J Lab Med.  2007 Oct;27(5):330-337. 10.3343/kjlm.2007.27.5.330.

Evaluation of Viva-E Drug Testing System

• Chung HS
• Lee ST
• Lee SY

• KMID: 1781531
• DOI: http://doi.org/10.3343/kjlm.2007.27.5.330

Abstract

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.

Keyword

Therapeutic drug monitoring (TDM); Enzyme multiplied immunoassay (EMIT); Viva-E

MeSH Terms

Data Interpretation, Statistical
Drug Monitoring/*instrumentation/methods
Enzyme Multiplied Immunoassay Technique/*instrumentation
Humans
Immunoenzyme Techniques
Pharmaceutical Preparations/*analysis
Quality Control
Reference Standards
Reproducibility of Results

Figure

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  Fig. 1. Linearities of various drug assays using Viva-E.

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  Fig. 2. Comparison studies of various drug assays using Viva-E vs LC-MS/MS or Cobas Integra 800. Abbreviation: LC-MS/MS, liquid chromatographytandem mass spectrometry; Integra, Cobas integra 800.

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