Table 3.
Reportable quantities in EV analysis and relevant calibrators and standards
| Measurement | Derived from | Calibrator or standards | Reportable Values |
|---|---|---|---|
| EV concentration | Number of events detected per volume of fluid | Beads of known concentration to calibrate sample flow rate | EVs/uL |
| EV size | Signal intensity | EV preps of known size (determined by orthogonal method, such as NTA or TRPS) or by calculation using standards of known size and refractive index. | Diameter, surface area, or volume of detected EVs |
| EV fluorescence positive concentration | Number of events detected above a threshold per volume of fluid | Beads of known concentration to calibrate sample flow rate plus negative control sample to set threshold for positivity | Positive EVs/uL above a threshold |
| EV fluorescence brightness/antibody number | Signal intensity | Standard particles with calibrated intensity or antibody capture capacity | Mean fluorescence intensity (MESF) or antibodies bound per EV |