Measurement of total testosterone in women: comparison of a direct radioimmunoassay versus radioimmunoassay after organic solvent extraction and celite column partition chromatography
Abstract
OBJECTIVE: To evaluate the clinical usefulness for the measurement of testosterone (T) values in the "low" female range with a direct radioimmunoassay (RIA) for total T by comparing total T values measured by this assay with values determined by conventional RIA after organic solvent extraction/column chromatography.
DESIGN: Cross-sectional study.
SETTING: Victoria, Australia.
PATIENT(S): Two hundred fifty-nine healthy women, aged 18-75 years, recruited from the community.
INTERVENTION(S): Fasting serum samples were obtained and stored at -80 degrees C.
MAIN OUTCOME MEASURE(S): Total T measurement. Total T was measured by the direct RIA method using antibody-coated tubes and iodine-labeled T tracer. For comparison, total T levels were also measured using the conventional RIA method after organic solvent (ethyl acetate:hexane [3:2]) extraction and celite column partition chromatography before RIA.
RESULT(S): The mean T level by direct RIA was 0.76 nmol/L (median, 0.70; SD, 0.54; minimum, 0.10; maximum, 3.2). The mean difference between the two measurements (direct RIA - conventional RIA) was -0.28 (SD, 0.3). The direct RIA value was 63% (95% confidence interval, 26%-155%) of the conventional RIA estimate. For the classification of values at the lower end of the range, there was very good agreement beyond chance (kappa = 0.68-0.74) for values in approximately the lowest 10th-40th percentiles.
CONCLUSION(S): The direct RIA is a clinically useful assay for the study of the issue…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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