Traceability for Biologically Relevant Molecules and Entities

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Accurate counting of biological entities underpins many sectors including healthcare, security, environment, biotechnology, and food. Examples include viral load monitoring in patients, circulating tumour cells in cancer, presence of GMOs, allergens and pathogens in foods, host cell contamination in vaccines and biopharmaceuticals, QC of tissue engineered products etc. These biomeasurements lend themselves to description in terms of number of discrete entities such as DNA copies or number of cells. However, a lack of higher order reference methods and materials is a major hindrance for deriving traceability and measurement comparability, and impacts upon accreditation and regulatory compliance.

This project aims to improve the state of the art in two key techniques for providing higher order traceability in biological measurement: the application of purified calibration materials and the use of enumeration technologies.

In order to determine accurate DNA/RNA copy number, an important step is the determination of DNA/RNA purity. TÜBİTAK UME Bioanalysis Laboratory will perform the experiments on DNA/RNA purity determination by using different absorbance techniques and define the best method. Additionally, accurate number of cells will be determined by flow cytometry and the studies will be performed in a collaboration with German Metrology Institute, PTB, Flow Cytometry and Microscopy Group.

 (in progress)