Current and IBS product volume and yield
| Acceptance criteria . | Single collection . | Double collection . | Triple collection . |
|---|---|---|---|
| Current product yield (platelet count) | 3.0-6.19 × 1011 | 6.2-9.29 × 1011 | >9.3 × 1011 |
| Current product volume, mL | 250-300 | 450-500 | 600-660 |
| IBS product yield* (platelet count) | 3.4-6.19 × 1011 | 6.8-7.9 × 1011 | N/A |
| IBS product volume,† mL | 270-420 | 375-420 | N/A |
| Acceptance criteria . | Single collection . | Double collection . | Triple collection . |
|---|---|---|---|
| Current product yield (platelet count) | 3.0-6.19 × 1011 | 6.2-9.29 × 1011 | >9.3 × 1011 |
| Current product volume, mL | 250-300 | 450-500 | 600-660 |
| IBS product yield* (platelet count) | 3.4-6.19 × 1011 | 6.8-7.9 × 1011 | N/A |
| IBS product volume,† mL | 270-420 | 375-420 | N/A |
NA, not applicable.
The IBS product yield range is tighter than the guard-bands cited by IBS package insert, which allows IBS PRT treatment of single apheresis platelet collections starting at 3.0 × 1011. It also allows treatment of double apheresis platelet collections falling between 6.2 and 6.8 × 1011. Assuming a 10% to 15% loss of platelets during the PRT process, the NYBC modified the IBS platelet yield range to ensure each component contains ≥3.0 × 1011 platelets after IBS treatment per the FDA licensing requirement.
Product volume is dependent on the IBS PRT processing kit to be used. There are 3 processing kits that can be used for single collections based on the volume and yield. One of them is also used for the double collections.