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

Authors
  • Lapić, Ivana1
  • Coen Herak, Désirée1
  • Prpić, Snježana2
  • Prce, Andrea3
  • Raščanec, Vanja4
  • Zadro, Renata5
  • Rogić, Dunja1
  • 1 University Hospital Center Zagreb, Zagreb , (Croatia)
  • 2 Medical Biochemistry Laboratory Dunja Horvat, Primary Care Center Sisak, Sisak, Croatia , (Croatia)
  • 3 Department of Laboratory Diagnostics, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina
  • 4 General Hospital “Dr. Tomislav Bardek”, Koprivnica , (Croatia)
  • 5 St Catherine Specialty Hospital, Zagreb , (Croatia)
Type
Published Article
Journal
Biochemia Medica
Publisher
Croatian Society of Medical Biochemistry and Laboratory Medicine
Publication Date
Oct 15, 2020
Volume
30
Issue
3
Identifiers
DOI: 10.11613/BM.2020.030705
PMID: 33071556
PMCID: PMC7528643
Source
PubMed Central
Keywords
License
Green

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.

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