Objective: CoaguChek S is a point-of-care, whole-blood, prothrombin time monitor. The purpose of this study was to compare two different methods for external quality assessments of CoaguChek S.
Material and methods: In the traditional external quality assessment scheme, commercial control material was sent to office laboratories and the results were compared with a method-specific target value. In the alternative external quality assessment (the split-sample survey) patient samples were analyzed on CoaguChek S at office laboratories, and venous blood samples from the same patients were analyzed at a hospital laboratory using an assigned comparison method. To obtain comparable performance criteria for the two methods, the limits for "good", "acceptable" and "poor" performance evaluation in the split-sample survey had to be expanded because of uncertainties in preanalytical factors and the comparison method.
Results: In the traditional external quality assessment the total imprecision (between-office and within-office) was 8.0% at the low level (1.6 INR (International Normalized Ratio)) and 10.5% at the therapeutic level (3.4 INR). In the split-sample survey the total imprecision was 12.3% at the low level (2.1 INR) and 10.7 % at the high level (3.0 INR). Seventy-five percent of the participating office laboratories were characterized as "good" with the traditional external quality assessments, whereas the corresponding number was 73% using the split-sample model.
Conclusions: Available commercial control material for CoaguChek S is different from patient samples. This study demonstrates that split-sample survey is achievable, and is an acceptable alternative to traditional external quality assessment for point-of-care prothrombin time monitors where appropriate control material is difficult to obtain.