Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study
Por:
Pernod, G, Wu, H, de Maistre, E, Lazarchick, J, Kassise, J, Aguilar, C, Marco P, Palareti, G, D'Angelo, A and DiET Study Grp
Publicada:
1 abr 2017
Resumen:
Combined clinical pretest probability (PTP) and D-dimer testing have
great diagnostic value for pulmonary embolism exclusion. To harmonize
performance levels of D-dimer assays available on the market, the
Clinical and Laboratory Standard Institute (CLSI) has published a
guideline, endorsed by the US Food and Drug Administration (FDA). Such
guideline specifies the ideal D-dimer assay characteristic and target
population. This study was conducted following the CLSI guideline to
upgrade the assay-intended use and obtain FDA clearance of STA-Liatest
D-Di assay for pulmonary embolism exclusion in patient with low/moderate
PTP. This was an international, multicenter, prospective nonrandomized,
noninterventional clinical outcome management study conducted in a
standard of care setting. D-dimer assay was performed in consecutive,
ambulatory outpatients suspected of pulmonary embolism, with
low/moderate PTP, and without medical conditions or in clinical settings
known to alter default D-dimer values regardless of the presence of
thrombosis using a threshold of 0.5 mu g/ml (fibrinogen equivalent
units) for venous thromboembolism exclusion. Results were used to
determine test performance. Of 1141 patients who underwent D-dimer
testing, 1060 had valid results and completed study as planned.
STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance
requirements, with a sensitivity of 97.6% (95% confidence interval:
91.7-99.7%) and a negative predictive value of 99.7% (95% confidence
interval: 99.0-100%). STA-Liatest D-Di assay has an excellent
performance when used in combination with a PTP score in relevant
patients and has the potential to minimize the economic healthcare
burden avoiding unnecessary and expensive imaging tests. Copyright (C)
2017 The Author(s). Published by Wolters Kluwer Health, Inc.
Filiaciones:
Pernod, G:
Grenoble Univ Hosp, Dept Vasc Med, Grenoble, France
Wu, H:
Ohio State Univ, Pathol & Lab Med, Columbus, OH 43210 USA
de Maistre, E:
Univ Hosp, Hematol Lab, Dijon, France
Lazarchick, J:
Med Univ South Carolina, Pathol & Lab Med, Charleston, SC USA
Kassise, J:
Univ Montreal, Dept Haematol, Hop Maisonneuve Rosemont, Montreal, PQ, Canada
Aguilar, C:
Santa Barbara Gen Hosp, Dept Haematol, Soria, Spain
Marco P:
Hosp Gen Univ Alicante, Lab Coagulac, Ctr Sanitario, Alicante, Spain
Palareti, G:
Bologna Univ Hosp Corp, Dept Angiol & Blood Coagulat Marino Golinelli, Policlin S Orsola Malpighi, Bologna, Italy
D'Angelo, A:
Sci Inst San Raffaele, Coagulat Serv & Thrombosis Res Unit, Milan, Italy
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