Analitička verifikacija lateks imunoturbidimetrijske metode određivanja D-dimera na biokemijskom analizatoru Alinity c

master's thesis

• Title (english): Analytical verification of the latex-enhanced immunoturbidimetric D-dimer assay on the Alinity C clinical chemistry analyzer
• Author: Ivana Stojan
• Mentor: Dunja Rogić (mentor)
• Mentor: Ivana Lapić (mentor)
• Committee member: Dunja Rogić (predsjednik povjerenstva)
• Committee member: Ivana Lapić (član povjerenstva)
• Committee member: Desiree Coen Herak (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2025, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

D-dimeri su razgradni produkti umreženog fibrina koji nastaju procesom fibrinolize. Njihovo određivanje iznimno je
važno za isključivanje venske tromboembolije (VTE) koja čini treću vodeću kardiovaskularnu dijagnozu. Testovi za
određivanje D-dimera temelje se na imunokemijskim metodama koje koriste monoklonska protutijela za specifične
epitope na fragmentima D-dimera. Zbog potrebe za pouzdanim rezultatima u što kraćem vremenu, na tržištu je dostupan
sve veći broj potpuno automatiziranih testova za određivanje D-dimera pri čemu većinu tih testova čine lateks
imunoturbidimetrijski testovi (LPIA). Cilj ovog rada bio je provesti analitičku verifikaciju lateks imunoturbidimetrijske
metode, Abbotova testa za D-dimere, na biokemijskom analizatoru Alinity c. Verifikacija je obuhvatila ispitivanje
preciznosti te usporedbu s INNOVANCE testom za D-dimere koji se koristi u rutinskom radu na koagulacijskom
analizatoru. Koeficijenti varijacije dobiveni ispitivanjem preciznosti metode zadovoljili su optimalne kriterije
prihvatljivosti prema EFLM bazi biološke varijabilnosti. Između Abbottova testa za D-dimere i INNOVANCE testa za
D-dimere utvrđena je snažna pozitivna korelacija (ρ = 0,975) bez značajnog odstupanja u linearnosti. Metode su pokazale
visoku usporedivost te je utvrđeno postojanje statistički značajnog konstantnog i proporcionalnog odstupanja koje nije
klinički značajno. Na temelju provedenih analiza i dobivenih rezultata zaključeno je da je ispitivana lateks
imunoturbidimetrijska metoda za određivanje D-dimera prikladna za uvođenje u rutinski rad laboratorija.

Abstract (english)

D-dimers are degradation products of cross-linked fibrin formed during the process of fibrinolysis. Their determination
is crucial for excluding venous thromboembolism (VTE), which is the third leading cardiovascular diagnosis. D-dimer
assays are based on immunochemical methods utilizing monoclonal antibodies targeting specific epitopes on D-dimer
fragments. Due to the need for reliable results in the shortest possible time, an increasing number of fully automated Ddimer assays are available on the market, the majority of which are latex-enhanced immunoturbidimetric assays (LPIA).
The aim of this study was to conduct an analytical verification of the latex-enhanced immunoturbidimetric method,
Abbott D-dimer assay, on the Alinity c clinical chemistry analyzer. The verification included precision testing and
comparison with the INNOVANCE D-dimer assay used in routine work on the coagulation analyzer. The coefficients
of variation obtained from precision testing met the optimal acceptance criteria according to the EFLM database of
biological variability. A strong positive correlation (ρ = 0.975) was found between Abbott's D-dimer assay and the
INNOVANCE D-dimer assay, with no significant deviation in linearity. Both methods demonstrated high comparability,
and a statistically significant constant and proportional deviation was observed, though it was not clinically significant.
Based on the conducted analyses and obtained results, it was concluded that the tested latex-enhanced
immunoturbidimetric method for D-dimer determination is suitable for implementation in routine laboratory practice.

• Keywords: D-dimeri; verifikacija; imunoturbidimetrija; hemostaza; venska tromboembolija
• Keywords (english): D-dimers; verification; immunoturbidimetry; hemostasis; venous thromboembolism
• Language: croatian
• URN:NBN: urn:nbn:hr:163:275052
• Study programme: Title: Medical biochemistry - integrated undergraduate and graduate - university study; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: sveučilišni magistar medicinske biokemije i laboratorijske medicine (sveučilišni magistar medicinske biokemije i laboratorijske medicine)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2025-04-24 09:25:16