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

Carlos Aguilar, Michelangelo Sartori, Armando D'Angelo, Christopher Kabrhel, James Groce, Emmanuel De Maistre, Suman M. Wasan, Jeannine Kassis, John Lazarchick, Colin Kaide, Pascual Marco Vera, Jeffrey Kline, D. Mark Courtney, Andrew Rubin, Melhem Sharafuddin, Gilles Pernod

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)562-566
Number of pages5
JournalBlood Coagulation and Fibrinolysis
Volume29
Issue number6
DOIs
StatePublished - Jan 1 2018

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United States Food and Drug Administration
Venous Thrombosis
Multicenter Studies
Guidelines
Venous Thromboembolism
Health Services Needs and Demand
Standard of Care
Informed Consent
Pulmonary Embolism
fibrin fragment D
Thrombosis
Outpatients
Cross-Sectional Studies
Outcome Assessment (Health Care)
Pregnancy
Neoplasms

Keywords

  • D-dimer
  • Deep venous thrombosis
  • Exclusion
  • STA-Liatest DDi

ASJC Scopus subject areas

  • Hematology

Cite this

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. / 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.

In: Blood Coagulation and Fibrinolysis, Vol. 29, No. 6, 01.01.2018, p. 562-566.

Research output: Contribution to journalArticle

Aguilar, C, Sartori, M, D'Angelo, A, Kabrhel, C, Groce, J, De Maistre, E, Wasan, SM, Kassis, J, Lazarchick, J, Kaide, C, Vera, PM, Kline, J, Courtney, DM, Rubin, A, Sharafuddin, M & Pernod, G 2018, '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', Blood Coagulation and Fibrinolysis, vol. 29, no. 6, pp. 562-566. https://doi.org/10.1097/MBC0000000000000750
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. / 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. In: Blood Coagulation and Fibrinolysis. 2018 ; Vol. 29, No. 6. pp. 562-566.
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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.",
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