The Sensitivity and Specificity of a Red Blood Cell Agglutination D-Dimer Assay for Venous Thromboembolism When Performed on Venous Blood.

Autor: Chunilal, Sanjeev D., Brill-Edwards, Patrick A., Stevens, Pamela B., Joval, Jody P., McGinnis, Joanne A., Rupwate, Mala, Ginsberg, Jeffrey S.
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Zdroj: Archives of Internal Medicine; 1/28/2002, Vol. 162 Issue 2, p217, 4p
Abstrakt: Background: Studies evaluating the accuracy of the SimpliRED D-dimer assay for venous thromboembolism (VTE) have used a capillary fingerstick blood sample, which requires the test to be performed immediately at the bedside. Initial studies showed a sensitivity for VTE of 90% to 95% when the assay was performed by a finite number of experienced health care workers. However, because of the test's subjectivity, misinterpretation of the result is possible when performed by inexperienced staff. Recent reports by other investigators indicated a low sensitivity of this assay for VTE and noted a reduction in sensitivity (84%) for pulmonary embolism. Objective: To determine the sensitivity and specificity of the D-dimer test performed in the laboratory by experienced technologists on venous whole-blood samples in routine collection tubes. If D-dimer testing results accurately detect VTE when performed in this manner, concerns about the sensitivity of this assay would be solved. Methods: One hundred forty-eight consecutive patients with suspected VTE underwent D-dimer testing at the bedside using a fingerstick sample and venous blood collected into a plain tube. Venous blood was also collected into tubes containing tri-potassium EDTA, sodium citrate, or a combination of lithium and heparin for D-dimer testing in the laboratory. In addition, the EDTA tube was refrigerated overnight at 4°C for retesting at approximately 24 hours. The presence or absence of VTE was determined by means of objective results of testing and a 3-month follow-up. Results: Thirty-four subjects (23%) had confirmed VTE (25 with deep vein thrombosis; 9 with pulmonary embolism). All laboratory venous blood D-dimer results showed sensitivities of 97%, specificities of 61% to 64%, and negative predictive values of 99%, compared with 88%, 71%, and 95%, respectively, when the results were obtained by means of fingerstick at the bedside. Conclusions: The SimpliRED D-dimer assay performed in the... [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index