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Utvärdering av INNOVANCE D-Dimer reagens
Jönköping University, School of Health and Welfare, HHJ, Department of Natural Science and Biomedicine.
Jönköping University, School of Health and Welfare, HHJ, Department of Natural Science and Biomedicine.
2023 (Swedish)Independent thesis Basic level (university diploma), 10 credits / 15 HE creditsStudent thesisAlternative title
Evaluation of the INNOVANCE D-Dimer reagent (English)
Abstract [sv]

D-Dimer är en nedbrytningsprodukt av fibrinogen som bland annat indikerar trombossjukdomar vid höga nivåer. D-Dimer är inte specifik nog för att användas för definitiv diagnos, därför används analys av D-Dimer vanligtvis som ett uteslutningstest då trombossjukdomar misstänks. Den enhet som idag används för att rapportera D-Dimer-resultat vid Klinisk kemi, Ryhov i Jönköping är D-Dimer Units. För att kunna standardisera metoderna som används för analys av D-Dimer utvärderades INNOVANCE® D-Dimer-reagenset vilket är baserat på rapportering av analysresultat i enheten Fibrinogen Equivalent Units. Analys av D-Dimer har orsakat problem på grund av dess heterogenitet och många olika befintliga analysmetoder. Dessutom skapas oklarhet kring resultatrapportering på grund av användning av olika enheter. Syftet med denna studie var att utvärdera INNOVANCE® D-Dimer reagens vid Klinisk kemi, Ryhov för att införa användningen av Fibrinogen Equivalent Units. Metodutvärderingen inkluderade repeterbarhetstest och mellanliggande precision med hjälp av INNOVANCE® kontroller och analys av patientprover. Resultaten av patientproverna jämfördes med resultaten från samma patientprover vid Lunds Universitetssjukhus och Sahlgrenska Universitetssjukhus. Korrelationen mellan samtliga resultat visade tydliga samband. Slutsatsen blev att INNOVANCE® D-Dimer reagens är godkänt för implementering på Klinisk kemi, Ryhov.

Abstract [en]

D-Dimer is a fibrinogen degradation product which indicates thrombotic diseases, amongst other conditions, when reported in high levels. It is more frequently used as an exclusion test when suspecting thrombotic diseases due to the occurrence of high levels of D-Dimer in various conditions. The unit which is currently used for D-Dimer analysis at Clinical chemistry, Ryhov Jönköping is D-Dimer Units. In attempt to standardize the method used for analysis of D-Dimer, the INNOVANCE® D-Dimer reagent was evaluated. INNOVANCE® D-Dimer reagent is reported in the unit Fibrinogen Equivalent Units. Analysis of D-Dimer causes problems due to its heterogeneity and the many existing methods of analysis. The many ways of reporting results in different units are also creating confusion. The purpose of this study was to evaluate INNOVANCE® D-Dimer reagent at Clinical chemistry, Ryhov to introduce usage of Fibrinogen Equivalent Units. The method evaluation included repeatability test and intermediate precision using the INNOVANCE® Controls and analyzing patient samples. The results of the patient samples were compared to the results obtained from the same samples at Lunds University hospital and Sahlgrenska University hospital. There was a clear correlation between all instruments and institutions. In conclusion, INNOVANCE® D-Dimer was approved for introduction at Clinical chemistry, Ryhov.

Place, publisher, year, edition, pages
2023. , p. 20
Keywords [en]
Coagulation, Clinical chemistry, Fibrinogen degradation product, Fibrinogen Equivalent Units, Validation
Keywords [sv]
Koagulation, Klinisk kemi, FIbrinogennedbrytningsprodukt, Fibrinogen Equivalent Units, Validering
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:hj:diva-61465ISRN: JU-HHJ-BLA-1-20230143OAI: oai:DiVA.org:hj-61465DiVA, id: diva2:1772644
Subject / course
HHJ, Biomedical Laboratory Science
Supervisors
Examiners
Available from: 2023-06-22 Created: 2023-06-21 Last updated: 2023-06-22Bibliographically approved

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