TY - JOUR
T1 - Diagnostic accuracy of four different D-dimer assays: A post-hoc analysis of the YEARS study
AU - Hamer, Henrike M.
AU - Stroobants, An K.
AU - Bavalia, Roisin
AU - Ponjee, Gabrielle A. E.
AU - Klok, Frederikus A.
AU - van der Hulle, Tom
AU - Huisman, Menno V.
AU - Hendriks, Henriët A.
AU - Middeldorp, Saskia
N1 - Funding Information: Prof. Dr. Huisman has received research grants from Pfizer-BMS, Boehringer Ingelheim, and Glaxo Smith Kline; and has provided lectures and consultations for Pfizer- Bristol-MyersSquibb, Bayer Health Care, Leo Pharma and Boehringer Ingelheim. Publisher Copyright: © 2021
PY - 2021/5/1
Y1 - 2021/5/1
N2 - Introduction: For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied. Currently available D-dimer assays are not standardized and it is unknown whether these differences have an impact on diagnostic management of suspected PE. Therefore, the aim is to explore differences between D-dimer assays and their impact on diagnostic outcome. Methods: Data from all patients included in the YEARS study were collected. The YEARS study is a prospective, multicentre, cohort outcome study evaluating 3462 patients with suspected PE in which four different D-dimer assays were applied (Liatest, Innovance, Tinaquant, Vidas). Median D-dimer concentrations were calculated for each D-dimer assay. Sensitivity, specificity, PPV and NPV for detection of PE of all four assays were determined in patients without YEARS items and in those with ≥1 YEARS items (i.e. symptomatic deep vein thrombosis, haemoptysis, and whether PE is the most likely diagnosis). Results: A total of 1323, 1100, 768 and 271 D-dimer concentrations were collected using the Liatest Innovance, Tinaquant and Vidas assay, respectively. Median D-dimer concentrations differed significantly between assays, with lowest values in the Tinaquant assay. In patients without YEARS items using a cutoff level of 1000 ng/mL, the NPV varied from 99,5 to 100%. In patients with ≥1 YEARS items using a 500 ng/mL cutoff, the NPV varied from 97,0 to 100% depending on the assay. Conclusions: The overall high NPV for all assays demonstrates the clinical value of the D-dimer assay. However, these results confirm differences between D-dimer assays, which have an impact on follow-up imaging. This emphasizes the need for standardization of D-dimer assays.
AB - Introduction: For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied. Currently available D-dimer assays are not standardized and it is unknown whether these differences have an impact on diagnostic management of suspected PE. Therefore, the aim is to explore differences between D-dimer assays and their impact on diagnostic outcome. Methods: Data from all patients included in the YEARS study were collected. The YEARS study is a prospective, multicentre, cohort outcome study evaluating 3462 patients with suspected PE in which four different D-dimer assays were applied (Liatest, Innovance, Tinaquant, Vidas). Median D-dimer concentrations were calculated for each D-dimer assay. Sensitivity, specificity, PPV and NPV for detection of PE of all four assays were determined in patients without YEARS items and in those with ≥1 YEARS items (i.e. symptomatic deep vein thrombosis, haemoptysis, and whether PE is the most likely diagnosis). Results: A total of 1323, 1100, 768 and 271 D-dimer concentrations were collected using the Liatest Innovance, Tinaquant and Vidas assay, respectively. Median D-dimer concentrations differed significantly between assays, with lowest values in the Tinaquant assay. In patients without YEARS items using a cutoff level of 1000 ng/mL, the NPV varied from 99,5 to 100%. In patients with ≥1 YEARS items using a 500 ng/mL cutoff, the NPV varied from 97,0 to 100% depending on the assay. Conclusions: The overall high NPV for all assays demonstrates the clinical value of the D-dimer assay. However, these results confirm differences between D-dimer assays, which have an impact on follow-up imaging. This emphasizes the need for standardization of D-dimer assays.
KW - D-dimer test
KW - Deep vein thrombosis
KW - Diagnostic accuracy
KW - Laboratory test
KW - Predictive value
UR - http://www.scopus.com/inward/record.url?scp=85101227466&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.thromres.2021.02.003
DO - https://doi.org/10.1016/j.thromres.2021.02.003
M3 - Article
C2 - 33626463
SN - 0049-3848
VL - 201
SP - 18
EP - 22
JO - Thrombosis research
JF - Thrombosis research
ER -