Validation of the STA-Liatest DDi assay for exclusion of proximal deep vein thrombosis according to the latest Clinical and Laboratory Standards Institute/Food and Drug Administration guideline: results of a multicenter management study. Issue 6 (September 2018)

• Record Type: Journal Article
• Authors: Aguilar, Carlos; Sartori, Michelangelo; D'Angelo, Armando; Kabrhel, Christopher; Groce, James; de Maistre, Emmanuel; Wasan, Suman M.; Kassis, Jeannine; Lazarchick, John; Kaide, Colin; Vera, Pascual Marco; Kline, Jeffrey; Courtney, D. Mark; Rubin, Andrew; Sharafuddin, Melhem; Pernod, Gilles
• Is Part Of: Blood coagulation and fibrinolysis. Volume 29:Issue 6(2018)
• Publication Date: 2018-09
• Subjects: D-dimer -- deep venous thrombosis -- exclusion -- STA-Liatest DDi; Blood -- Coagulation -- Periodicals; Fibrinolysis -- Periodicals; Hemostasis -- Periodicals; Thrombosis -- Periodicals; Blood Coagulation -- Periodicals; Fibrinolysis -- Periodicals; Hemostasis -- Periodicals; Thrombosis -- Periodicals; 612.115
• DOI: 10.1097/MBC.0000000000000750
• Languages: English
• ISSNs: 0957-5235

Abstract

Abstract : N/A: Recommended strategy for venous thromboembolism (VTE) diagnosis includes the use of sensitive D-dimer (DDi) assays along with pretest probability (PTP) assessment. The Clinical and Laboratory Standards Institute (CLSI) recently issued a guideline (US FDA endorsed) on DDi in VTE exclusion. Such guideline specifies the ideal D-dimer assay characteristics and target population. Demonstrate STA-LiatestD-Di performance combined with a PTP score for proximal deep vein thrombosis (pDVT) exclusion in a CLSI compliant study. International, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard-of-care setting. DDi was measured in DVT-suspected consecutive low/moderate PTP outpatients, without conditions possibly impacting DDi values independently of thrombosis presence (age >80, pregnancy, postoperative, cancer) using a 0.5 μg/ml (FEU) threshold for DVT exclusion. Results were used to determine test performance. One thousand two hundred and thirty-four patients (17 centers) signed informed consent. Nine hundred and eighty (mean age: 55) with valid results (494 negative DDi) completed the study (DVT prevalence: 8.7%). STA-LiatestD-Di performance exceeded CLSI/FDA requirements: sensitivity: 100% (95% CI 95.8–100%), NPV: 100% (95% CI 99.3–100%). STA-LiatestD-Di associated with PTP score showed excellent performance for pDVT exclusion, as recently demonstrated for pulmonary embolism. The assay allows safe VTE exclusion, avoiding unnecessary imaging tests.