Question 1 · Hard
To license a red cell storage system, FDA requires that at the end of storage:
- AHemolysis is below 5%
- BAt least 75% of transfused red cells are still circulating 24 hours after transfusion
- C2,3-DPG is at least 90% of normal
- DAt least 95% of transfused red cells are still circulating 24 hours after transfusion
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Answer: B · At least 75% of transfused red cells are still circulating 24 hours after transfusion
A storage system is acceptable only if, at the end of its shelf life, an average of at least 75% of the transfused red cells survive 24 hours after transfusion. Cells that survive the first day then have a near-normal lifespan. FDA also requires hemolysis below 1% at the end of storage. These two limits set the 21-, 35- and 42-day shelf lives.
- A: The hemolysis limit is below 1%, not 5%.
- C: 2,3-DPG falls to very low levels during storage and is not a licensing criterion.
- D: 95% is higher than any current storage system achieves at the end of storage.