Naslov
Analytical verification of automated latex- enhanced particle immunoturbidimetric D-dimer assays on different analytical platforms and comparability of test results

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

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
Research and Practice in Thrombosis and Haemostasis / Cushman, Mary - : John Wiley & Sons, 2020, 300-301

Skup
XXVIII Congress of the International Society on Thrombosis and Haemostasis

Mjesto i datum
Virtual Congress, 12.-14.07.2020

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Verification ; D-Dimer ; latex immunoturbidimetry

Sažetak
Background: Automation and the possibility of D-dimer analysis along with other coagulation tests on the same analytical platform makes the latex- enhanced particle immunoturbidimetric assays (LPIA) attractive to laboratory professionals. Aims: The aim of the study was the analytical verication of the following automated LPIAs: INNOVANCE D-dimer on Sysmex CS-5100 and Atellica COAG360 analyzers (Siemens Healthineers, Germany), and HemosIL D-dimer HS500 on ACL TOP 550 (Instrumentation Laboratory, Italy). Methods: Verication included: assessment of within-run and between-run precisions by analyzing commercial controls with low and high D-dimer concentrations in triplicate for ve consecutive days, bias and measurement uncertainty (MU) estimation, verication of the cut-off and method comparison between all assessed assays as well as with the reference commercial enzyme-linked immunouorescent assay (ELFA) VIDAS D-Dimer Exclusion II (bioMérieux, France) on a miniVidas analyzer. Results: Within-run coefcients of variations (CVs) ranged from 1.6% (Atellica COAG360) to 7.9% (ACL TOP 550), while between-run CVs ranged from 1.7% (Sysmex CS-5100) to 6.9% (Atellica COAG360). Spearman´s rank correlation coefcients were >0.99 between LPIAs and ≥0.93 when comparing ELFA with LPIA. PassingBablok regression analysis yielded constant and proportional difference for comparison of ACL TOP 550 with both Sysmex CS-5100 [y=0.09(0.02- 0.17)+0.88(0.82-0.94)x] and Atellica COAG360 [y=0.08(0.03- 0.16)+0.85(0.79-0.89)x], as well as for miniVidas with Atellica COAG360 [y=-0.27(-0.48- (-0.05)+1.57(1.34- 1.85)x]. Small proportional difference was found between miniVidas and both Sysmex CS-5100 [y=-0.33(-0.52-0.01)+1.6(1.27-1.82)x] and ACL TOP 550 [y=-0.16(-0.33-0.15)+1.37(1.05-1.6)x]. 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) and 10.0% (Atellica COAG360). MU for ACL TOP 550 using INNOVANCE D-dimer calibrator was 28.1%. Excellent agreement of results was obtained (weighted Cohen´s kappa coefcient: 0.85-1.00). The cut-off (0.5 mg/L FEU) was conrmed. Conclusions: Obtained results prove the analytical validity of LPIAs, their high comparability and almost equal discriminatory characteristics, suggesting them as a valid alternative to ELFA.

Izvorni jezik
Engleski

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