Qualitative point-of-care D-dimer testing compared with quantitative D-dimer testing in excluding pulmonary embolism in primary care.

BACKGROUND General practitioners can safely exclude pulmonary embolism (PE) by using the Wells PE rule combined with D-dimer testing. OBJECTIVE To compare the accuracy of a strategy using the Wells rule combined with either a qualitative point-of-care (POC) D-dimer test performed in primary care or a quantitative laboratory-based D-dimer test. METHODS We used data from a prospective cohort study including 598 adults suspected of PE in primary care in the Netherlands. General practitioners scored the Wells rule and carried out a qualitative POC test. All patients were referred to hospital for reference testing. We obtained quantitative D-dimer test results as performed in hospital laboratories. The primary outcome was the prevalence of venous thromboembolism in low-risk patients. RESULTS Prevalence of PE was 12.2%. POC D-dimer test results were available in 582 patients (97%). Quantitative test results were available in 401 patients (67%). We imputed results in 197 patients. The quantitative test and POC test missed one (0.4%) and four patients (1.5%), respectively, with a negative strategy (Wells ≤ 4 points and D-dimer test negative) (P = 0.20). The POC test could exclude 23 more patients (4%) (P = 0.05). The sensitivity and specificity of the Wells rule combined with a POC test were 94.5% and 51.0% and, combined with a quantitative test, 98.6% and 47.2%, respectively. CONCLUSIONS Combined with the Wells PE rule, both tests are safe to use in excluding PE. The quantitative test seemed to be safer than the POC test, albeit not statistically significant. The specificity of the POC test was higher, resulting in more patients in whom PE could be excluded.