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Non-vitamin K dependent oral anticoagulants (NOACs) controls
Linköping University, Department of Physics, Chemistry and Biology.
2018 (English)Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

In recent years non-vitamin K dependent oral anticoagulants (NOACs) have started to replace warfarin for treatment and prevention of deep venous thrombosis (DVT), pulmonary embolism (PE) and stroke in patients with and without atrial fibrillation. There is a need for a simple and rapid method to detect the presence of these drugs in patient plasma. To meet these new demands, MediRox is developing a screening assay based on a novel prothrombin time (PT) method for rapid detection of NOACs in plasma. The assay is semi-quantitative and by dividing the International Normalised Index (INR) from a NOAC sensitive PT method with the INR from a NOAC insensitive PT method, NOAC containing samples be detected while plasma from normal donors and with warfarin are excluded.

 

The purpose of this project is to develop prototypes of assay quality controls for detection of NOACs in plasma.

 

The results show that the method used for the NOAC control prototypes is applicable and the PT ratio is comparable to patient samples for the low, medium and high concentrations of NOAC. The effect of lyophilisation indicates that the PT ratios for the NOAC control prototypes were nearly unaffected by the lyophilisation. The in-use stability at room temperature (20-25oC) for all NOAC control prototypes were at least 24 hours.

 

The methodology for production needs to be further optimised to increase the commutability to patient samples with very high concentrations of NOAC. The data indicates that the effect of lyophilisation is minimal and the stability of the NOAC control prototypes are satisfying, which is promising for future product development of NOAC controls. 

Place, publisher, year, edition, pages
2018. , p. 31
Keywords [en]
Product development, assay controls
National Category
Medical Biotechnology
Identifiers
URN: urn:nbn:se:liu:diva-148558ISRN: LITH-IFM-A-EX--18/3492--SEOAI: oai:DiVA.org:liu-148558DiVA, id: diva2:1217684
External cooperation
MediRox
Subject / course
Biotechnology
Presentation
2018-06-05, Jordan Fermi, Fysikhuset, Campus Valla, Linköpings universitet, Linköping, 13:00 (Swedish)
Supervisors
Examiners
Available from: 2018-06-15 Created: 2018-06-13 Last updated: 2018-06-15Bibliographically approved

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