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Prestandaundersökning av den patientnära analysmetoden Biosynex® D-dimer via jämförelse med den laborativa analysmetoden STA-Liatest® D-Di PLUS
Linnaeus University, Faculty of Health and Life Sciences, Department of Chemistry and Biomedical Sciences.
2019 (Swedish)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [en]

The fibrinogen degradation product D-dimer is released in plasma during fibrinolysis. D-dimer analysis is mainly ordered for the exclusion of venous thromboembolism (VTE) in combination with a pre-test probability (PTP) score. D-dimer below 0,5 mg/L fibrinogen equivalent units (FEU) and a low PTP rules out VTE. D-dimer analysis contributes to the reduction of invasive and expensive imaging analyses, such as ultrasound and computed tomography. The Blekinge region primary care used a qualitative D-dimer point of care test (POCT) whose performance the clinical chemistry of Blekinge hospital had no insight into. The aim of the study was to investigate whether the qualitative D-dimer POCT was an adequate complement to the quantitative method used in the hospital laboratory. Fifty patients, whose blood samples arrived the laboratory in tubes with sodium citrate- and ethylenediaminetetraacetic acid (EDTA) additives, were chosen for the study. Citrate plasma was analyzed with the D-dimer laboratory method. Plasma and whole blood were analyzed with the D-dimer POCT. Quantitative results were converted to qualitative based on the cutoff value 0,5 mg/L FEU. POCT performance was computed and compared with the manufacturer’s specified values. A potential difference between the methods was evaluated with a Chi-squared test. A survey was performed where open care units answered questions regarding D-dimer POCT. The POCT performance was slightly lower than the manufacturer’s specifications. No statistically significant difference was seen between the methods. However, there were several sources of error with the latter. Some open care units mentioned weak lines in the reading area due to blood interference.

Abstract [sv]

Vid fibrinolys av blodkoagel frisätts fibrinnedbrytningsprodukten D-dimer. D-dimeranalyser utförs främst för uteslutning av venös tromboembolism (VTE) i kombination med ett poängsystem för preanalytisk sannolikhet (PTP) för VTE. D-dimerhalter under 0,5 mg/L fibrinogenekvivalenta enheter (FEU) och en låg PTP utesluter med stor säkerhet VTE. Använd på rätt sätt bidrar D-dimeranalysen till att minimera onödiga invasiva och dyra undersökningar som ultraljud och datortomografi. I region Blekinge används en kvalitativ, patientnära analysmetod (PNA) för D-dimer vars prestanda Blekingesjukhusets laboratorium för klinisk kemi inte har någon insyn i. Studiens syfte var att undersöka om den kvalitativa PNA-metoden för D-dimer utgjorde ett lämpligt komplement till den kvantitativa metod som utfördes på klinisk kemi. Femtio patienter vars blodprov anlände laboratoriet i provrör med tillsats av natriumcitrat respektive etylendiamintetraättiksyra (EDTA) blev utvalda att delta i studien. D-dimer analyserades i citratplasma med laboratoriets analysmetod varefter plasma och tillhörande EDTA-blod analyserades med PNA-metoden. Kvantitativa resultat konverterades till kvalitativa efter beslutsvärdet 0,5 mg/L FEU. PNA-prestandan beräknades och jämfördes med tillverkarens angivna motsvarigheter. Med ett chi-squaretest undersöktes en eventuell signifikant skillnad mellan metodresultaten. En undersökning utfördes där regionens öppenvårdsenheter svarade på diverse frågor kring PNA-metoden. PNA-metodens beräknade prestanda var något lägre än tillverkarens. Ingen statistiskt signifikant skillnad förekom mellan laboratoriets metod och PNA-metoden, däremot fanns det flera potentiella felkällor hos den senare. Några öppenvårdsenheter vittnade om svåravlästa avläsningsområden på grund av blodinterferens.

Place, publisher, year, edition, pages
2019. , p. 31
Keywords [sv]
Koagulation, D-dimer, venös tromboembolism, kvalitativ D-dimeranalys
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:lnu:diva-85649OAI: oai:DiVA.org:lnu-85649DiVA, id: diva2:1327660
External cooperation
Avdelningen för klinisk kemi och transfusionsmedicin, Region Blekinge
Educational program
Biomedical Laboratory Science Programme, 180 credits
Supervisors
Examiners
Available from: 2019-06-24 Created: 2019-06-19 Last updated: 2019-06-24Bibliographically approved

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