The performance characteristics of this test were determined by ARUP Laboratories, Inc.
|% Fetal RBCs||The fetal RBC percentage is directly measured by flow cytometry and gives the percentage of fetal RBCs in maternal circulation resulting from recent fetal-maternal hemorrhage. Post-partum, some fetal cells are expected (0.04% plus or minus 0.024%, mean plus or minus SD).|
|Fetal Blood Volume||Fetal blood volume is the volume of feto-maternal hemorrhage and is calculated from the % Fetal RBCs by multiplying by 50, assuming a maternal blood volume of 5000 mL and a hematocrit of 50%. Post-partum, some feto-maternal hemorrhage is expected (2.0 mL plus or minus 1.2 mL, mean plus or minus SD).|
|RhIg Required||Given the delivery of an RhD+ fetus from an RhD- mother, the amount of IM RhIg (anti-RhD immunoglobulin) required to avoid sensitization is 10 µg for each mL of feto-maternal hemorrhage.|
|RhIg Vials Required||Given the delivery of an RhD+ fetus from an RhD- mother, one (1) vial of RhD (300 µg vial administered IM) is recommended when the amount of RhD required is <300 µg. From 300-600 µg, 2 vials are recommended; from 600-900 µg, 3 vials are recommended; from 900-1200 µg, 4 vials are recommended; from 1200-1500 µg, 5 vials are recommended and so forth.|
Compliance Statement B
: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.