Verification of automated latex-enhanced particle immunoturbidimetric D-dimer assays on different analytical platforms and comparability of test results
Introduction: The aim of the study was the analytical verification of automated latex-enhanced particle immunoturbidimetric (LPIA) D-Dimerassay 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 comparisonwith the enzyme-link...
| Permalink: | http://skupni.nsk.hr/Record/nsk.NSK01001102455/Details |
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| Matična publikacija: |
Biochemia medica (Online) 30 (2020), 3 ; str. 457-465 |
| Glavni autori: | Lapić, Ivana (Author), Coen Herak, Désirée, Prpić, Snježana, biokemičarka, Prce, Andrea, Raščanec, Vanja, Zadro, Renata, Rogić, Dunja, biokemičarka |
| Vrsta građe: | e-članak |
| Jezik: | eng |
| Predmet: | |
| Online pristup: |
https://doi.org/10.11613/BM.2020.030705 Biochemia medica (Online) Hrčak |
| LEADER | 03490naa a22004334i 4500 | ||
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| 001 | NSK01001102455 | ||
| 003 | HR-ZaNSK | ||
| 005 | 20210716100520.0 | ||
| 006 | m d | ||
| 007 | cr|||||||||||| | ||
| 008 | 210527s2020 ci d |o |0|| ||eng | ||
| 024 | 7 | |2 doi |a 10.11613/BM.2020.030705 | |
| 035 | |a (HR-ZaNSK)001102455 | ||
| 040 | |a HR-ZaNSK |b hrv |c HR-ZaNSK |e ppiak | ||
| 041 | 0 | |a eng |b eng | |
| 042 | |a croatica | ||
| 044 | |a ci |c hr | ||
| 080 | 1 | |a 61 |2 2011 | |
| 080 | 1 | |a 577 |2 2011 | |
| 100 | 1 | |a Lapić, Ivana |4 aut | |
| 245 | 1 | 0 | |a Verification of automated latex-enhanced particle immunoturbidimetric D-dimer assays on different analytical platforms and comparability of test results |h [Elektronička građa] / |c Ivana Lapić, Désirée Coen Herak, Snježana Prpić, Andrea Prce, Vanja Raščanec, Renata Zadro, Dunja Rogić. |
| 300 | |b Graf. prikazi. | ||
| 504 | |a Bibliografija: 29 jed. | ||
| 504 | |a Summary. | ||
| 520 | |a Introduction: The aim of the study was the analytical verification of automated latex-enhanced particle immunoturbidimetric (LPIA) D-Dimerassay 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 comparisonwith 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), verificationof 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 rangedfrom 1.7% (Sysmex CS-5100) to 6.9% (Atellica COAG 360). Spearman’s rank correlation coefficients were >0.99 between LPIAs and ≥ 0.93 whencomparing ELFA with LPIA. Passing-Bablok regression analysis yielded constant and proportional difference for comparison of ACL TOP 550 withboth Sysmex CS-5100 and Atellica COAG360, and for miniVidas with Atellica COAG360. Small proportional difference was found between miniVidasand 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 COAG360), while with INNOVANCE D-dimer calibrator 12.0% (Sysmex CS-5100), 10.0% (Atellica COAG 360) and 28.1% (ACL TOP 550). Excellent agreementof 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 discriminatorycharacteristics, suggesting them as a valid alternative to ELFA. | ||
| 653 | 0 | |a Hemostaza |a Zgrušavanje krvi |a D-dimer |a Imunoturbidimetrija |a Validacijska analiza | |
| 700 | 1 | |a Coen Herak, Désirée |4 aut | |
| 700 | 1 | |a Prpić, Snježana, |c biokemičarka |4 aut | |
| 700 | 1 | |a Prce, Andrea |4 aut |9 HR-ZaNSK | |
| 700 | 1 | |a Raščanec, Vanja |4 aut | |
| 700 | 1 | |a Zadro, Renata |4 aut | |
| 700 | 1 | |a Rogić, Dunja, |c biokemičarka |4 aut | |
| 773 | 0 | |t Biochemia medica (Online) |x 1846-7482 |g 30 (2020), 3 ; str. 457-465 |w nsk.(HR-ZaNSK)000655372 | |
| 981 | |b Be2020 |b B03/20 | ||
| 998 | |b dalo2107 | ||
| 856 | 4 | 0 | |u https://doi.org/10.11613/BM.2020.030705 |
| 856 | 4 | 0 | |u https://www.biochemia-medica.com/en/journal/30/3/10.11613/BM.2020.030705 |y Biochemia medica (Online) |
| 856 | 4 | 1 | |y Digitalna.nsk.hr |
| 856 | 4 | 0 | |u https://hrcak.srce.hr/244733 |y Hrčak |