Therapeutic drug monitoring analysis systems for the physician office laboratory: a review of the literature

Commercially available systems for therapeutic drug monitoring in the physician office laboratory (POL) are reviewed. The Abbott Vision, Kodak Ektachem, Syntex AccuLevel, Syva Emit QST, Ames Seralyzer ARIS, and Ames Clinimate ARIS have been found to be sensitive and accurate compared with more conventional laboratory assays, and are well-suited for the POL. The number of available drug assay is very limited with every system except the QST. The QST offers a large menu and would be appropriate for large practices. The Abbott TDx or other semiautomated system usually found in the clinical chemistry laboratory may be particularly useful and cost-effective in office practices with a large volume of specimens. AccuLevel or ARIS might be the best choices for clinics or pharmacies that generate few samples. The start-up time is the longest with the Vision and Ektachem systems (30 minutes). Most systems have the capacity to produce results within one to five minutes with the exceptions of the Vision (13 minutes for theophylline) and AccuLevel (20 minutes). The Vision is the most automated system and both AccuLevel and the Vision use whole blood, thereby bypassing the additional time required for centrifugation of the patient specimen. The Ektachem, Vision, and QST have an operator-independent pipetting step that offers a significant advantage when operated by semiskilled personnel. Although the AccuLevel eliminates the need for a large initial capital expenditure, the individual cost per test is higher. Leasing programs are available or certain systems. Increased government regulation will improve the quality control of therapeutic drug monitoring in the POL.