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Clinical requirements for extracellular vesicle assays
Lisa Ayers1,2, Ryan Pink2, David Raul Francisco Carter2
1Department of Clinical and Laboratory Immunology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Journal of Extracellular Vesicles
|April 6, 2019
Summary
Clinical use of extracellular vesicles (EVs) requires validated assays meeting ISO 15189 standards. This review highlights key performance characteristics and challenges for EV analysis accreditation to ensure reliable diagnostics and therapeutics.
Area of Science:
- Biomedical research
- Clinical diagnostics
- Extracellular vesicle (EV) analysis
Background:
- Extracellular vesicles (EVs) show significant promise for diagnostics, prognostics, and therapeutics.
- Clinical adoption of EV measurement necessitates standardized and validated assays.
- International Organization for Standardization (ISO) 15189 accreditation is crucial for medical laboratory tests.
Purpose of the Study:
- To review the essential performance characteristics for validating EV assays.
- To discuss challenges specific to EV analysis in clinical settings.
- To emphasize the requirements for achieving ISO 15189 accreditation for EV biomarker assays.
Main Methods:
- Discussion of assay validation processes for clinical laboratory use.
- Analysis of specific performance characteristics relevant to EV detection.
- Examination of challenges impacting the reliability of EV measurements.
Main Results:
- Assay validation requires comprehensive data on defined performance characteristics.
- Specific analytical issues unique to EVs must be addressed for accurate measurement.
- Stringent accreditation standards are essential for reliable clinical laboratory assays.
Conclusions:
- Meeting ISO 15189 standards through thorough validation is critical for clinical EV assay implementation.
- Addressing EV-specific analytical challenges ensures assay quality and clinical utility.
- High-quality EV assays are vital for accurate disease diagnosis, monitoring, and patient outcomes.
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