Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results.
D-Dimer
blood coagulation tests
haemostasis
immunoturbidimetry
validation study
Journal
Biochemia medica
ISSN: 1846-7482
Titre abrégé: Biochem Med (Zagreb)
Pays: Croatia
ID NLM: 9610305
Informations de publication
Date de publication:
15 Oct 2020
15 Oct 2020
Historique:
received:
21
04
2020
accepted:
20
07
2020
entrez:
19
10
2020
pubmed:
20
10
2020
medline:
7
5
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 33071556
doi: 10.11613/BM.2020.030705
pii: bm-30-3-030705
pmc: PMC7528643
doi:
Substances chimiques
Fibrin Fibrinogen Degradation Products
0
Latex
0
Reagent Kits, Diagnostic
0
fibrin fragment D
0
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
030705Informations de copyright
Croatian Society of Medical Biochemistry and Laboratory Medicine.
Déclaration de conflit d'intérêts
Potential conflict of interest None declared.
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