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Validering av Sysmex XN-550 ”Body Fluid” vid koncentrationsbestämning av erytrocyter i färsk fryst plasma
Malmö University, Faculty of Health and Society (HS).
2020 (Swedish)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [sv]

Färsk fryst plasma (FFP) är en blodkomponent som utvinns genom separation från helblod. FFP innehåller livsviktiga plasmaproteiner, immunoglobuliner och koagulationsfaktorer. Produkten används främst till patienter med omfattande skador som lett till större blodförlust samt vid större kirurgiska blödningar vid operationer. Enligt riktlinjer stiftade av European Directorate for the quality of Medicines and healtcare (EDQM) bör samtliga plasmaenheter understiga 6,0 × 109/L erytrocyter för att produkten klassificeras som godtagbar för transfusion. Syftet med denna studie var att undersöka om Sysmex XN-550 med applikation ”Body Fluid” (BF) kan tillförlitligt koncentrationsbestämma erytrocyter i FFP och därmed ersätta Bürkerkammare som är den nuvarande metoden för dessa mätningar. För detta ändamål utfördes en undersökning av linjäritet hos instrumentet, en statistisk jämförelse med mätning av 30 prover samt fem upprepade mätningar av en känd koncentration för undersökning av reproducerbarheten. Resultaten visade en tydlig korrelation mellan analyserna med en jämn stegring av värden. Korrelationskoefficienten erhöll ett värde på 0,99. Bland Altmananalys visade att 95% av uppmätta värden förelåg inom konfidensintervallet vilket påvisar en överensstämmelse mellan metoderna med p-värde på 0,98. Mätningarna påvisade p-värden på 0,0005 vid analys av den lägsta koncentrationen (1 × 109/L), 0,5 vid anays av näst högsta koncentrationen (3 × 109/L) samt 0,9 vid analys av den högsta koncentrationen (6 × 109/L).

Abstract [en]

Fresh frozen plasma (FFP) is a blood component derived from separation of whole blood. FFP contains essential plasma proteins, immunoglobulins and coagulation factors. The product is mainly used for patients with extensive injuries which have led to major blood loss or for major bleeding due to surgical procedures. According to guidelines established by the European Directorate for the quality of Medicines and healtcare (EDQM), all plasma components should have an erythrocyte concentration of less than 6 × 109/L for the product to be classified as acceptable for transfusion. The purpose of this study was to investigate whether Sysmex XN-550 with the application “Body Fluid” (BF) could reliably determine the concentration of erythrocytes in FFP and thus replace the current method of Bürker chamber for these measurements. For this purpose, the linearity of the instruments was studied and a statistical comparison including measurements of 30 samples and five repeated measurements of a known concentration for examination of the reproducibility. The results showed a clear correlation between the analyses with an even increase in value. The correlation coefficient provided a value of 0,99. Bland Altman analysis showed that 95% of the measured values were within the confidence interval, which shows a correlation between the used methods and the calculated p-value was 0.98. The reproducibility measurements revealed a p-value of 0,0005 when measuring the lowest concentration (1 × 109/L), 0,5 when measuring the second to highest concentration (3 × 109/L) and 0,9 when measuring the highest concentration (6 × 109/L).

Place, publisher, year, edition, pages
Malmö universitet/Hälsa och samhälle , 2020. , p. 18
Keywords [sv]
Bürkerkammare, Erytrocyter, Färsk fryst plasma, Kvalitetskontroll, Sysmex XN-550, Transfusion
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:mau:diva-25017Local ID: 31684OAI: oai:DiVA.org:mau-25017DiVA, id: diva2:1486440
Educational program
HS Biomedicinsk laboratorievetenskap
Supervisors
Examiners
Available from: 2020-11-02 Created: 2020-11-02Bibliographically approved

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