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Pregled bibliografske jedinice broj: 1090932

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


Lapić, Ivana; Coen Herak, Desiree; Prpić, Snježana; Prce, Andrea; Raščanec, Vanja; Zadro; Renata; Rogić, Dunja
Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results // Biochemia medica, 3 (2020), 1-9 (međunarodna recenzija, članak, stručni)


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

Autori
Lapić, Ivana ; Coen Herak, Desiree ; Prpić, Snježana ; Prce, Andrea ; Raščanec, Vanja ; Zadro ; Renata ; Rogić, Dunja

Izvornik
Biochemia medica (1330-0962) 3 (2020); 1-9

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, stručni

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

Sažetak
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.

Izvorni jezik
Engleski



POVEZANOST RADA


Profili:

Avatar Url Branka Zadro (autor)

Avatar Url Desiree Coen Herak (autor)

Avatar Url Ivana Lapić (autor)

Avatar Url Dunja Rogić (autor)

Avatar Url Renata Agapito (autor)

Citiraj ovu publikaciju

Lapić, Ivana; Coen Herak, Desiree; Prpić, Snježana; Prce, Andrea; Raščanec, Vanja; Zadro; Renata; Rogić, Dunja
Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results // Biochemia medica, 3 (2020), 1-9 (međunarodna recenzija, članak, stručni)
Lapić, I., Coen Herak, D., Prpić, S., Prce, A., Raščanec, V., Zadro, Renata & Rogić, D. (2020) Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results. Biochemia medica, 3, 1-9.
@article{article, year = {2020}, pages = {1-9}, keywords = {haemostasis, blood coagulation tests, D-Dimer, immunoturbidimetry, validation study}, journal = {Biochemia medica}, volume = {3}, issn = {1330-0962}, title = {Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results}, keyword = {haemostasis, blood coagulation tests, D-Dimer, immunoturbidimetry, validation study} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE





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