Optimization of modified moisture measurement with Karl Fischer to measure moisture content in freeze-dried enzyme beads for improvement of diagnostic kits

Sammanfattning: Cepheid provides instruments and tests for molecular diagnostic testing of bacterial and viral diseases. Their goal is to deliver a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere. These test kits are used in warm and humid countries which may challenge the stability of the kits. The test kits containly ophilized beads, which contain enzymes for the polymerase chain reaction, which usually ages first. The ageing of the beads is effected by the initial water content in them since it defines the quality. Therefore, it is of great importance to have a very precise and exact water measurement method. The degree project covers the optimization of the Standard Operating Procedure used today at Cepheid with the research question: Can optimization of the Karl Fischer method improve the precision when measuring the initial moisture content of freeze-dried enzyme beads? The method for measuring the water content was the Karl Fischer titration method and the instrument used was the Mettler Toledo C30S Compact Karl Fischer-coulometer. The different optimized parameters were the sample preparation, extraction process and how the measurement was proceeded. It can be concluded that optimized method provides significantly different results compared with the old method and therefore the new method is better.