Abstract
Abstract The aim of our prospective study on 246 consecutive outpatients with suspected acute venous thromboembolism (VTE) was to evaluate the actual performance of four D-dimer assays (D-dimer plus, Stratus CS, Innovance, Siemens Medical Solutions Diagnostics, and Tina-quant D-dimer, Roche Diagnostics) for exclusion of VTE. Analysis was initiated after false negative results in three patients with proven VTE were observed in routine diagnostics. Diagnostic sensitivity, specificity, negative and positive predictive values of the D-dimer tests were calculated based on recommended cut-off levels and on upper limits of corresponding 95% confidence intervals (95% CI). VTE was confirmed in 46 patients (18.7%) by imaging techniques. The D-dimer plus assay yielded seven false negative results (nine considering 95% CI) in 46 patients. A sensitivity of 84.8% and 80.4% and a negative predictive value of 93.8% and 93.0%, respectively, was achieved. In contrast, the alternative tests showed no false negative results (sensitivity and negative predictive value 100%), and a higher D-dimer result to cut-off ratio. Detection of performance deficiencies of established diagnostic assays requires close cooperation with the clinician and further evaluation by the medical laboratory in accordance with the requirements of DIN EN ISO 15189.
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