Abstract Number: PB0616
Meeting: ISTH 2020 Congress
Background: Automation and the possibility of D-dimer analysis along with other coagulation tests on the same analytical platform makes the latex-enhanced particle immunoturbidimetric assays (LPIA) attractive to laboratory professionals.
Aims: The aim of the study was the analytical verification of the following automated LPIAs: INNOVANCE D-dimer on Sysmex CS-5100 and Atellica COAG360 analyzers (Siemens Healthineers, Germany), and HemosIL D-dimer HS500 on ACL TOP 550 (Instrumentation Laboratory, Italy).
Methods: Verification included: assessment of within-run and between-run precisions by analyzing commercial controls with low and high D-dimer concentrations in triplicate for five consecutive days, bias and measurement uncertainty (MU) estimation, verification of the cut-off and method comparison between all assessed assays as well as with the reference commercial enzyme-linked immunofluorescent assay (ELFA) VIDAS D-Dimer Exclusion II (bioMérieux, France) on a miniVidas analyzer.
Results: Within-run coefficients of variations (CVs) ranged from 1.6% (Atellica COAG360) to 7.9% (ACL TOP 550), while between-run CVs ranged from 1.7% (Sysmex CS-5100) to 6.9% (Atellica COAG360). Spearman´s rank correlation coefficients were >0.99 between LPIAs and ≥0.93 when comparing ELFA with LPIA. Passing-Bablok regression analysis yielded constant and proportional difference for comparison of ACL TOP 550 with both Sysmex CS-5100 [y=0.09(0.02-0.17)+0.88(0.82-0.94)x] and Atellica COAG360 [y=0.08(0.03-0.16)+0.85(0.79-0.89)x], as well as for miniVidas with Atellica COAG360 [y=-0.27(-0.48-(-0.05)+1.57(1.34-1.85)x]. Small proportional difference was found between miniVidas and both Sysmex CS-5100 [y=-0.33(-0.52-0.01)+1.6(1.27-1.82)x] and ACL TOP 550 [y=-0.16(-0.33-0.15)+1.37(1.05-1.6)x]. Calculated MUs using D-dimer HS 500 calibrator were 12.6% (Sysmex CS-5100) and 15.6% (Atellica COAG360), while with INNOVANCE D-dimer calibrator 12.0% (Sysmex CS-5100) and 10.0% (Atellica COAG360). MU for ACL TOP 550 using INNOVANCE D-dimer calibrator was 28.1%. Excellent agreement of results was obtained (weighted Cohen´s kappa coefficient: 0.85-1.00). The cut-off (0.5 mg/L FEU) was confirmed.
Conclusions: Obtained results prove the analytical validity of LPIAs, their high comparability and almost equal discriminatory characteristics, suggesting them as a valid alternative to ELFA.
To cite this abstract in AMA style:Lapić I, Prpić S, Prce A, Coen Herak D, Zadro R, Rogić D. Analytical Verification of Automated Latex-Enhanced Particle Immunoturbidimetric D-Dimer Assays on Diferent Analytical Platforms and Comparability of Test Results [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/analytical-verification-of-automated-latex-enhanced-particle-immunoturbidimetric-d-dimer-assays-on-diferent-analytical-platforms-and-comparability-of-test-results/. Accessed November 26, 2020.
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