Response to the Comments on ‘Point of Care D-Dimer Testing in the Emergency Department–A Bioequivalence Study’ and Erratum to the Results
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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.
Abstract
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.
참고문헌 (11)
- Shuhana Perveen, "Point of Care D-Dimer Testing in the Emergency Department: A Bioequivalence Study", Annals of Laboratory Medicine, 33(1), pp.34~38 (2013), 대한진단검사의학회
- Vossen JA, "Clinical usefulness of adjusted D-dimer cut-off values to exclude pulmonary embolism in a community hospital emergency department patient population", Acta Radiol, 53, pp.765~768 (2012)
- Leng O, "Application of age-adjusted D-dimer threshold for exclusion thromboembolism (PTE) in older patients: a retrospective study", Acute Med, 11, pp.129~132 (2012)
- Douma RA, "Potential of an age adjusted D-dimer cut-off value to improve the exclusion of pulmonary embolism in older patients: a retrospective analysis of three large cohorts", BMJ, 340, pp.1475~ (2010)
- Douma RA, "Clinical decision rule and D-dimer have lower clinical utility to exclude pulmonary embolism in cancer patients. Explanations and potential ameliorations", Thromb Haemost, 104, pp.831~836 (2010)
- Mochizuki S, "Therapeutic significance of a D-dimer cut-off level of >3 μg", ml in colorectal cancer patients treated with standard chemotherapy plus bevacizumab, 2010, pp.40, 933~937
- Duriseti RS, "Cost-effectiveness of strategies for diagnosing pulmonary embolism among emergency department patients presenting with undifferentiated symptoms", Ann Emerg Med, 56, pp.321~332 (2010)
- Sukhu K, "Comparison of an immuno-turbidometric method (STalia D-DI) with an established enzyme linked fluorescent assay (VIDAS) D-dimer for the exclusion of venous thromboembolism", Int J Lab Hematol, 30, pp.200~204 (2008)
- Guideline on the investigation of bioequivalence, "European Medicines Agency", European Medicines Agency, 1~27, pp.CPMP (2010), EWP[DOI]
- Bioavailability and bioequivalence studies for orally administered drug products-general considerations, "U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research", U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research, 1~23 (2003)
- Obuchowski NA, "Prospective studies of diagnostic test accuracy when disease prevalence is low", Biostatistics, 3, pp.477~492 (2002)