Evidence map›Paper›PMID 33071556›Full record

ArticleBiochemia medica2020

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

Ivana Lapić, Désirée Coen Herak, Snježana Prpić, Andrea Prce, Vanja Raščanec, Renata Zadro, Dunja Rogić

Abstract readComparative Study
In one paragraph

Article in Biochemia medica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Ivana LapićDepartment of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia.
Désirée Coen HerakDepartment of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia.
Snježana PrpićMedical Biochemistry Laboratory Dunja Horvat, Primary Care Center Sisak, Sisak, Croatia.
Andrea PrceDepartment of Laboratory Diagnostics, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina.
Vanja RaščanecMedical Biochemistry Laboratory, General Hospital "Dr. Tomislav Bardek", Koprivnica, Croatia.
Renata ZadroMedical Biochemistry Laboratory, St Catherine Specialty Hospital, Zagreb, Croatia.
Dunja RogićDepartment of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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

methodsVerification 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.

resultsWithin-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.

conclusionsThe obtained results prove satisfactory analytical performance of LPIAs, their high comparability and almost equal discriminatory characteristics, suggesting them as a valid alternative to ELFA.

Indexed as

AutomationFibrin Fibrinogen Degradation ProductsHumansImmunoturbidimetryLatexReagent Kits, DiagnosticVenous ThromboembolismFibrin Fibrinogen Degradation Productsfibrin fragment DLatexReagent Kits, Diagnosticblood coagulation testsD-Dimerhaemostasisimmunoturbidimetryvalidation study

Identifiers

PMID33071556
PMCPMC7528643

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.