A REVIEW OF TWO ANTICOAGULATION MONITORING DEVICES
Anne M Stoysich, Firouzan Massoomi, Paula L Danekas, Thomas L Williams,
and Kay L Ryschon

OBJECTIVE:To evaluate the accuracy, precision, and clinical correlation of two point-of-care monitoring devices (PCMDs) for determination of the international normalization ratio (INR) compared with the standard laboratory method (SLM) and to assess the ease of use and cost of both monitors.

METHODS:Venous blood samples were processed by the SLM, and finger puncture capillary blood samples were processed by two PCMDs (CoaguChek System [CoaguChek] and ProTime Microcoagulation System [ProTime]). Accuracy and precision of the PCMDs were evaluated by comparing the mean and mean differences. Method agreement was assessed by correlation analysis. Clinical correlation was evaluated by comparing paired INRs that would result in the same therapeutic decision. Ease of use was evaluated by comparing testing errors and questionnaires. Costs associated with procurement and operation were assessed.

Results:No statistically significant difference was found in the mean INRs, mean differences, and clinical correlation. The methods were highly correlated (r > 0.90; p < 0.001). The CoaguChek was determined to be easier to use. Although the per-test cost was less with the ProTime, the number of tests performed and operators required need to be assessed to calculate total costs.

CONCLUSIONS:The PCMDs were comparable to the SLM, and the CoaguChek was judged to be easier to use. Costs need to be assessed for each unique setting.

J Pharm Technol 2001;17:209-16.