: 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 μg/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.