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

C Aguilar, M Sartori, A D'Angelo, C Kabrhel, J Groce, E De Maistre, SM Wasan, J Kassis, J Lazarchick, C Kaide, PM Vera, J Kline, DM Courtney, A Rubin, M Sharafuddin, G Pernod, on behalf of the DiET Study Group

Research output: Contribution to journalArticlepeer-review

Abstract

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 mg/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. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Original languageEnglish
Pages (from-to)562-566
Number of pages5
JournalBlood Coagulation and Fibrinolysis
Volume29
Issue number6
DOIs
Publication statusPublished - 2018

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this