Original scientific paper

https://doi.org/10.11613/BM.2020.030705

Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results

Ivana Lapić orcid.org/0000-0002-0854-4526 ; Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia
Désirée Coen Herak ; Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia
Snježana Prpić ; Medical Biochemistry Laboratory Dunja Horvat, Primary Care Center Sisak, Sisak, Croatia
Andrea Prce ; Department of Laboratory Diagnostics, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina
Vanja Raščanec ; Medical Biochemistry Laboratory, General Hospital “Dr. Tomislav Bardek”, Koprivnica, Croatia
Renata Zadro ; Medical Biochemistry Laboratory, St Catherine Specialty Hospital, Zagreb, Croatia
Dunja Rogić ; Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia

Abstract

Introduction: The aim of the study was the analytical verification of automated latex-enhanced particle immunoturbidimetric (LPIA) D-Dimer
assay INNOVANCE D-dimer on Sysmex CS-5100 and Atellica COAG 360 analysers, and HemosIL D-dimer HS500 on ACL TOP 550, as well as the comparison
with the enzyme-linked immunofluorescent assay (ELFA) on the miniVidas analyser.
Materials and methods: Verification included assessment of within-run and between-run precision, bias, measurement uncertainty (MU), verification
of the cut-off, method comparison between all assessed assays, and the reference commercial ELFA VIDAS D-Dimer Exclusion II.
Results: Within-run coefficients of variations (CVs) ranged from 1.6% (Atellica COAG 360) to 7.9% (ACL TOP 550), while between-run CVs ranged
from 1.7% (Sysmex CS-5100) to 6.9% (Atellica COAG 360). 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 and Atellica COAG360, and for miniVidas with Atellica COAG360. Small proportional difference was found between miniVidas
and both Sysmex CS-5100 and ACL TOP 550. Calculated MUs using D-dimer HS 500 calibrator were 12.6% (Sysmex CS-5100) and 15.6% (Atellica COAG
360), while with INNOVANCE D-dimer calibrator 12.0% (Sysmex CS-5100), 10.0% (Atellica COAG 360) and 28.1% (ACL TOP 550). Excellent agreement
of results was obtained, with occasional discrepancies near the cut-off. The cut-off (0.5 mg/L FEU) was confirmed.
Conclusions: The obtained results prove satisfactory analytical performance of LPIAs, their high comparability and almost equal discriminatory
characteristics, suggesting them as a valid alternative to ELFA.

Keywords

haemostasis; blood coagulation tests; D-Dimer; immunoturbidimetry; validation study

Hrčak ID:

244733

URI

https://hrcak.srce.hr/244733

Publication date:

15.10.2020.

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