Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study
نویسندگان
چکیده
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.
منابع مشابه
Response to the Comments on 'Point of Care D-Dimer Testing in the Emergency Department-A Bioequivalence Study' and Erratum to the Results
We have read with interest the comments made on our study titled ‘Point of care (POC) D-dimer testing in the Emergency department–a bioequivalence study’ [1]. Ekelund and Heilmann, referring to the results and conclusions of the study, have suggested that one of the discrepancies may be caused by a typographical error, and this inference probably stems from the use of the term ‘range’ in the pu...
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متن کاملComments on Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study
Dear Editor We read with interest the article “Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study” by Perveen et al. published in Ann Lab Med 2013;33:34-38 [1]. In this article, the authors compared the performance of the D-dimer assays on the AQT90 FLEX analyzer (Radiometer Medical Aps, Åkandevej, Denmark) and the VIDAS analyzer (bioMérieux SA, RCS Lyon, France)....
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