Point of care D-dimer testing in the emergency department: a bioequivalence study

Abstract

Background: D-dimer is used widely as a diagnostic aid in low- and moderate-risk patients with suspected venous thromboembolism (VTE). While our laboratory utilizes VIDAS D-dimer analyzer (bioMérieux SA, France), our emergency department (ED) recently procured a D-dimer analyzer AQT90 FLEX (Radiometer Medical ApS, Denmark) for point of care testing (POCT) to facilitate patient management. We aimed to determine whether the time taken to receive D-dimer results using the 2 different analyzers differed significantly and to quantify the limits of agreement between the results of the 2 methods measured on the same patient.

Methods: Adult patients presenting to the ED and requiring diagnostic workup for suspected VTE were included in this prospective observational study. Patients underwent simultaneous D-dimer measurements using the 2 different analyzers.

Results: The paired results from 104 patients were analyzed. The median time for the D-dimer results from triage by VIDAS was 258 min (Inter-quartile range [IQR], 173-360) and by POCT was 146 min (IQR, 55-280.5); the median time difference was 101.5 min (IQR, 82-125.5). On an average, POCT D-dimer values were 15% lower on the same sample (limits of agreement, 34-213%). POCT predicted 83% of VIDAS positive results (sensitivity, 83.3% [95% confidence interval (CI), 70.4-91.3%]; specificity, 100% [95% CI, 93.6-100%]). All patients with positive imaging were identified correctly by both methods.

Conclusions: POCT delivers D-dimer results in significantly shorter turnaround times than pathology services; however, poor bioequivalence between VIDAS and POCT raises the issue of acceptability for use in the ED.

Keywords: Bioequivalence; D-dimer; Length of stay; Point of care systems; Pulmonary embolism.

Fig. 1

Bland-Altman plot showing the limits of agreement between VIDAS and AQT90 FLEX.