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. 2010 Jan;125(1):79-83.
doi: 10.1016/j.thromres.2009.04.009. Epub 2009 Jun 10.

Prospective diagnostic accuracy assessment of the HemosIL HS D-dimer to exclude pulmonary embolism in emergency department patients

D Mark Courtney  1 , Justin M Steinberg, Jennifer C McCormick
Affiliations

Prospective diagnostic accuracy assessment of the HemosIL HS D-dimer to exclude pulmonary embolism in emergency department patients

D Mark Courtney et al. Thromb Res. 2010 Jan.

Abstract

Introduction: Chest pain and shortness of breath are among the most common symptoms requiring immediate evaluation. Testing for pulmonary embolism (PE) has become easier and widespread due to D-dimer blood tests. Safe use of these tests is only possible if sensitivity is high and they are used in non-high probability patients. We evaluated diagnostic performance of the HemosIL HS D-dimer, which despite FDA approval in 2005, has been minimally reported in prospective standard clinical care.

Materials and methods: We used a prospective observational study design to follow patients in a single center with the HemosIL HS ordered for symptoms of possible PE with positive test result if >243 ng/ml. The outcome was PE or deep venous thrombosis (DVT) at the time of presentation or subsequent 45 days determined by structured evaluation of imaging tests, phone, or medical record follow-up in all patients.

Results: 529 patients received a D-dimer and 4.7% were ultimately diagnosed with PE or DVT. The sensitivity of the HemosIL HS was 96.0% (95% CI; 79.6 to 99.9%) specificity was 65.7% (95% CI; 61.4 to 69.8%) and likelihood ratio negative was 0.06 (95% CI; 0.01 to 0.42). The probability of PE in patients with a negative D-dimer was 1/332 or 0.3% (95% CI; 0.01% to 1.67%). The receiver operator curve had an area under the curve of 0.87 and supported the current cut-point as optimal.

Conclusions: The HemosIL HS D-dimer had high sensitivity, very low negative post-test probability and is useful in excluding PE in the acute care setting.

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Conflict of interest statement

Conflicts of Interest: None of the authors have any conflicts of interest.

Figures

Figure 1
Figure 1. Course of care
Standard algorithm guiding routine care and decision making for patients requiring testing for pulmonary embolism.
Figure 2
Figure 2. Patient outcomes
Figure 3
Figure 3. D-dimer receiver operator curve
receiver operator characteristic curve demonstrating overall diagnostic performance of the HemosIL HS D-dimer. The Y axis plots sensitivity (true positive rate); the X axis plots 1-specificity (the false positive rate). The area under the curve is 0.87 with 95% confidence interval of 0.84 to 0.90.
See this image and copyright information in PMC

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