We developed a specific, simple, and rapid RIA for the direct quantifi
cation of estrone sulfate (E1S) and established its performance charac
teristics. The assay has a dynamic range of 0.05-90 mu g/L with a dete
ction limit of 0.009 mu g/L. Intraassay CVs were 9.2%, 4.5%, and 4.6%
at 0.35, 9.0, and 60 mu g/L, respectively. Interassay CVs were 8.8%, 5
.1%, and 5.5% at 0.076, 0.5, and 12 mu g/L, respectively. Linearity of
dilution studies showed values of 80-105% of expected, and recovery o
f E1S added to serum samples ranged from 82% to 102%. Cross-reactiviti
es with structurally related estrogens were <5%. When compared with a
conventional assay (involving hydrolysis of E1S and indirect measureme
nt of estrone), the present RIA showed excellent correlation (r = 0.99
, slope = 1.54, S-y\x = 2.14, n = 71). Mean E1S concentrations measure
d with this RIA for normal men (n = 20) and women in follicular (n = 2
0) and luteal (n = 25) phases of their menstrual cycle were 0.96, 0.96
, and 1.74 mu g/L, respectively. Mean E1S concentrations for oral cont
raceptive users (n = 20) and postmenopausal women without hormone repl
acement therapy (n = 21) or on hormone replacement therapy (n = 22) we
re 0.74, 0.13, and 2.56 mu g/L, respectively. Serum concentrations of
E1S in pregnant women in their first (n = 14), second (n = 17), and th
ird (n = 15) trimesters were 20, 66, and 105 mu g/L, respectively. Ava
ilability of this simple RIA should provide a useful tool for the asse
ssment of estrogen status in women.