Table 4.
Challenges for clinical validation of EV diagnostics.
Challenges | Solutions |
---|---|
Lack of International Reference Preparation to determine Trueness | Setting up and use of EQA schemes |
Overlap between patients and healthy controls | Setting an appropriate cut-off using ROC analysis |
Interference from lipaemic, haemolytic and platelet contaminated samples | Applying strict, but achievable sample requirements for assays |
Issues with sample stability | Determining appropriate collection and storage conditions that minimise EV generation and contaminating fractions of blood components |
Issues with sample diversity | Stringent guidelines for sample acceptance criteria |
Establishing uncertainty of measurement | Consideration of pre-analytical variables to ensure accurate reporting of EV levels |