Search results for "STA-Liatest D-Di"

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Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and …

2017

: 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, …

MalePediatricsmedicine.medical_specialtypulmonary embolism030204 cardiovascular system & hematologyFood and drug administrationFibrin Fibrinogen Degradation Products03 medical and health sciences0302 clinical medicinemedicineHumans030212 general & internal medicineProspective StudiesSTA-Liatest D-Dibusiness.industryUnited States Food and Drug AdministrationClinical and Laboratory Standard InstituteFood and Drug AdministrationHematologyGeneral MedicineGuidelineOriginal ArticlesMiddle Agedmedicine.diseaseThrombosisConfidence intervalUnited StatesPulmonary embolismPre- and post-test probabilityD-dimerEmergency medicineAmbulatoryBiological AssayFemalebusinessVenous thromboembolismBlood coagulationfibrinolysis : an international journal in haemostasis and thrombosis
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