Assay reproducibility and within-person variation of Müllerian inhibiting substance.

OBJECTIVES: To assess reproducibility of a commercial müllerian inhibiting substance (MIS) assay and evaluate within-person variation in serum MIS levels.
DESIGN: Assay reproducibility was evaluated by measuring MIS in multiple serum aliquots from the same blood collection. Within-person variation was assessed by measuring MIS in serum collected twice from the same individuals.
SETTING: Cancer Prevention Biomarker and Genotyping Facility, fox Chase Cancer Center, Philadelphia, Pennsylvania. PATIENT(S): Assay reproducibility was evaluated using serum from five volunteers with regular menstrual cycles. Within-person variation was evaluated in serum from 20 premenopausal women who donated blood twice at least 1 year apart. INTERVENTION(S): For both studies, samples were randomly ordered in batches and laboratory personnel were blinded to which aliquots were from the same subject. MAIN OUTCOME MEASURE(S): The MIS was measured by ELISA. RESULT(S): Within- and between-batch coefficients of variation (CVs) of the assay were 7.9% and 12.3%, respectively. After deleting one subject with extreme values, these CVs decreased to 7.6% and 7.7%, respectively. Within- and between-subject variance in MIS measurements were 2.19 and 0.31, respectively, and the intraclass correlation coefficient was 0.88 (95% confidence interval .77-.98). CONCLUSION(S): The MIS serum concentration is relatively stable over 1 year in premenopausal women and can be measured with good reproducibility using a commercial kit. Copyright (c) 2010 American Society for Reproductive Medicine. All rights reserved.

RCT Entities:   Population Interventions Outcomes