PERFORMANCE OF A MICROFLUIDIC POINT-OF-CARE IMMUNOASSAY FOR D-DIMER COMPARED WITH THE SYSMEX CS-2500 ANALYZER IN THE EXCLUSION OF VENOUS THROMBOEMBOLISM: A COMPARATIVE ANALYSIS
DOI:
https://doi.org/10.55374/jseamed.v10.289Keywords:
D-dimer, point-of-care testing, venous thromboembolism, diagnostic accuracy, microfluidicsAbstract
Background: D-dimer testing is central to venous thromboembolism (VTE) exclusion pathways, but reliance on central laboratory analyzers may delay downstream diagnostic decisions, prolong time to imaging, and defer safe exclusion in patients with low or intermediate clinical pre-test probability.
Objectives: To evaluate the analytical agreement and clinical diagnostic performance of a novel microfluidic point-of-care D-dimer assay (mLabs®) against the Sysmex CS-2500 central laboratory analyzer.
Methods: In this prospective single-center method-comparison study, 195 paired patient specimens were analyzed using the mLabs® device with 250 µL whole blood and the Sysmex CS-2500 analyzer with 50 µL citrated plasma. For threshold-based categorical comparison, the Sysmex CS-2500 served as the reference method at the 500 ng/mL FEU cutoff. Correlation, agreement, and diagnostic accuracy were assessed using Pearson correlation, intraclass correlation coefficient (ICC), Bland–Altman analysis, and receiver operating characteristic (ROC) analysis, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results: The mLabs® assay correlated strongly with the reference method (r = 0.94; ICC = 0.96). Sensitivity and specificity at the 500 ng/mL FEU cutoff were 93.4% and 93.0%, respectively; PPV was 97.9%, and NPV was 80.0%; and the area under the ROC curve was 0.986. However, Bland–Altman analysis demonstrated a mean negative bias of −483.5 ng/mL, and 10 Sysmex reference-positive samples were classified as negative by mLabs®. In contrast, 3 Sysmex reference-negative samples were classified as positive.
Conclusion: Although the microfluidic point-of-care D-dimer assay (mLabs®) showed strong analytical agreement and excellent overall discrimination, the observed discordant mLabs®-negative/Sysmex-positive results and negative predictive value of 80.0% relative to the reference method indicate that mLabs® should not be assumed to be interchangeable with Sysmex CS-2500 at the 500 ng/mL FEU rule-out threshold. Its most appropriate role is within structured diagnostic algorithms that incorporate clinical pre-test probability.
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