Simplified Quality Control of Coating Efficiency for a Cancer Monitoring Assay

Abstract: The aim of this report is to present a basis for development of an alternative quality control method for a part of the cancer monitoring technique DiviTum® by Biovica. The methods recommended are direct implementation of bromodeoxyuridine (BrdUTP), as well as biotin and digoxigenin systems. All methods show great potential since they do not require acquisition of new instruments or a change of microtiter plate. Further, all have specificity for the poly-A templates, include fewer steps, and are relatively cheap which aligns with the delimitations of the project. Additional methods are discussed to gain an overview of possible quality controls. However, these methods do not align with all the delimitations and are thus not recommended. An ethical analysis was conducted in which issues related to the suggested quality control methods were discussed. These were for example the potential for reusability of materials, and some ethical considerations that arise when handling biological samples from patients or donors. The results obtained are based on a literature study as well as a complementary interview.