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. 2019 Mar 27;8(1):1593755. doi: 10.1080/20013078.2019.1593755

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
HHS Vulnerability Disclosure