1) Artifact from hemo-concentration or hemo-dilution |
Yes |
No |
Both capillary and venous (or arterial) blood can be used with BioRBC54
|
2) Duration of accurate measurement of labeled RBC after reinfusion |
30 d |
>120+ d |
Problem of variable 51Cr elution4
|
3) Ability to use multicolor flow cytometry to track transfused BioRBC changes by recovering these for ex vivo analysis |
No |
Yes |
Useful for investigation of RBC senescence and age-dependent changes of normal and pathological RBC3
|
4) Ability to study >1 RBC population concurrently |
No |
Yes |
Direct comparison to eliminate subject-to-subject variability |
5) Use in vulnerable patient populations |
No |
Yes |
Ethical considerations prohibit radiation exposure for research in vulnerable populations, e.g., fetuses, infants, children and pregnant women55
|
6) Volume of blood required by assay (mL) |
0.1-1.0 |
0.01 |
BioRBC are suitable for fetuses and infants53
|
7) Radioactive waste disposal |
Yes |
No |
51Cr disposal is a hazard and expense |
8) Complexity of labeling procedure |
1 wash |
4-6 washes |
4 h for biotin versus 1.5 h for 51Cr |
9) Development of antibodies |
No |
Infrequent |
There is no evidence of harm from anti-BioRBC antibodies25,56
|
10) Requirement for FDA IND (in U.S.A.) |
No |
Yes |
Immunogenicity testing (https://www.federalregister.gov/documents/2016/04/25/2016-09449/assay-development-and-validation-for-immunogenicity-testing-of-therapeutic-protein-products-revised) |