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Shuhana Perveen,Danielle Unwin,Amith L Shetty,Karen Byth 대한진단검사의학회 2014 Annals of Laboratory Medicine Vol.34 No.1
We have read with interest the comments made on our study ti- tled ‘Point of care (POC) D-dimer testing in the Emergency de- partment–a bioequivalence study’ [1]. Ekelund and Heilmann, referring to the results and conclu- sions of the study, have suggested that one of the discrepancies may be caused by a typographical error, and this inference prob- ably stems from the use of the term ‘range’ in the published arti- cle. This should have been termed ‘Bland-Altman limits of agree- ment’ (0.24-2.13) for all the cases where both tests were ordered and not just for the 8 POC-negative VIDAS (VIDAS D-dimer as- say; bioMérieux SA, RCS Lyon, France)-positive patients. The data have been reconfirmed by our database as not being a re- porting error.
Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study
Shuhana Perveen,Danielle Unwin,Amith Loknath Shetty 대한진단검사의학회 2013 Annals of Laboratory Medicine Vol.33 No.1
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 Ddimer 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.