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Abbott D-dimer assay: analytical performance and diagnostic accuracy in management of venous thromboembolism
Ivana Lapić1, Anamarija Bogić1, Ivana Stojan2
1Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia.
Insights
The Abbott D-dimer assay demonstrates excellent precision and comparability for venous thromboembolism (VTE) diagnosis. It shows high negative predictive value, making it reliable for ruling out VTE in emergency departments.
Area of Science:
- Clinical Chemistry
- Diagnostic Accuracy
- Hematology
Background:
- Venous thromboembolism (VTE) diagnosis relies heavily on D-dimer testing in emergency settings.
- Evaluating new diagnostic assays is crucial for improving patient management and diagnostic efficiency.
Purpose of the Study:
- To assess the analytical performance and diagnostic accuracy of the Abbott D-dimer assay on the Alinity c analyzer.
- To compare the Abbott assay against the Siemens INNOVANCE D-dimer assay for VTE management.
Main Methods:
- Precision was evaluated using the CLSI EP15-A3 protocol at three concentration levels.
- Method comparison and diagnostic accuracy were determined using samples from 85 patients with suspected VTE.
- Passing-Bablok and Bland-Altman analyses were performed for method comparison.
Main Results:
- The Abbott assay exhibited excellent analytical precision, with between-run CVs < 3.4%, meeting biological variation criteria.
- A small proportional difference and significant negative bias were observed compared to the INNOVANCE assay.
- Diagnostic sensitivity, specificity, PPV, and NPV for Abbott were 100%, 9.2%, 25.3%, and 100%, respectively.
Conclusions:
- The Abbott D-dimer assay demonstrates excellent analytical precision and high comparability with the INNOVANCE D-dimer assay.
- The assay shows a high negative predictive value, supporting its utility in ruling out VTE.
- This assay is a viable option for VTE management in the emergency department.
Abstract:
This study aimed to assess analytical characteristics and diagnostic accuracy in management of venous thromboembolism (VTE) in the Emergency Department (ED) of the Abbott D-dimer assay applied on the Alinity c clinical chemistry analyzer (Abbott Laboratories, Chicago, IL) compared to the INNOVANCE D-dimer assay (Siemens Healthineers, Marburg, Germany). Precision was determined at three concentration levels following the CLSI EP15-A3 protocol. Method comparison and diagnostic accuracy were assessed using samples obtained from 85 patients who were referred for diagnostic imaging and D-dimer testing due to clinically suspected VTE. Within-run coefficients of variation (CVs) were 3.0%, 0.5% and 0.5% at D-dimer concentrations of 0.54, 1.42 and 2.68 mg/L FEU, while respective between-run CVs were 2.0%, 3.4% and 2.7%, hence fulfilling the desirable biological variation criteria for imprecision (<12.6%). Passing-Bablok regression analysis yielded a small proportional difference between the two compared assays (y = 1.09 (95% confidence interval (CI): 1.01-1.18) x + 0.09 (95%CI: -0.09 to 0.16)), while Bland-Altman analysis showed significant negative absolute (-0.6 mg/L FEU, 95%CI: -0.9 to -0.3) and relative mean bias (-14.1%, 95%CI: -20.3 to -7.9). Spearman's ρ was 0.979 (95%CI: 0.967-0.986). Inter-assay agreement relative to the cut-off was 92% (kappa coefficient = 0.547 (95%CI: 0.255-0.839)). Diagnostic sensitivity, specificity, positive and negative predictive values of the Abbott assay were 100%, 9.2%, 25.3% and 100%, respectively, compared to the following data for the INNOVANCE assay: 95.0%, 15.4%, 25.7% and 90.9%. Abbott D-dimer assay has shown excellent analytical precision, high comparability with the INNOVANCE D-dimer and high NPV at manufacturer's cut-off.
