Gail M H, Fears T R, Hoover R N, Chandler D W, Donaldson J L, Hyer M B, Pee D, Ricker W V, Siiteri P K, Stanczyk F Z, Vaught J B, Ziegler R G
Biostatistics Branch, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA.
Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):835-44.
We conducted studies to measure sources of assay variability for estrone, estradiol, estrone sulfate, and progesterone for postmenopausal women (n = 5) and for women in the mid-follicular (n = 5) and mid-luteal (n = 5) phases of the menstrual cycle. A single blood sample from each woman was divided into 2.5-ml aliquots and stored at -70 degrees C, and sets of two aliquots were sent at monthly intervals to each of three laboratories (four for progesterone). Each aliquot was analyzed in duplicate. Thus, within each menstrual category, we were able to estimate the components of variance due to variation among women, variation among aliquots, variation among duplicate measurements, and variation among the 4 analysis days. Using the logarithm of assay measurements, we estimated the percentage of variance attributable to variation among women in each menstrual category, 100 rho, is the estimated intraclass correlation. For each assay, 100 rho exceeded 90% for mid-follicular and mid-luteal women. For postmenopausal women, values of 100 rho exceed 84% for estrone in two laboratories. Values of 100 rho were lower for progesterone in postmenopausal women, although a value of 84% was estimated from one laboratory. These studies indicate that estrogen assays over a period of 3 months permit reliable comparisons among women in a given menstrual category. Progesterone measurements are likewise reliable for women in the mid-follicular and mid-luteal phases but somewhat less satisfactory for postmenopausal women. These assessments of variability pertain only to laboratory techniques and do not allow for secular variation in intra-woman hormone levels. Moreover, although these measurements tend to be reliable enough for making comparisons among women, estimates of coefficients of variation for estrogens are about 10% for mid-follicular and mid-luteal phase women and about 11-20% for postmenopausal women. Coefficients of variation for progesterone are about 10% for mid-luteal, 20% for mid-follicular, and 30% for postmenopausal women.
我们开展了多项研究，以测定绝经后女性（n = 5）以及处于月经周期卵泡中期（n = 5）和黄体中期（n = 5）的女性体内雌酮、雌二醇、硫酸雌酮和孕酮的检测变异性来源。从每位女性采集的一份血样被分成2.5毫升的等分试样，并储存在-70℃，每组两份等分试样每月定期送往三个实验室中的每一个（孕酮样本送往四个实验室）。每个等分试样均进行双份分析。因此，在每个月经类别中，我们能够估计出因女性个体差异、等分试样差异、双份测量差异以及4个分析日之间的差异所导致的方差成分。利用检测测量值的对数，我们估计了每个月经类别中因女性个体差异导致的方差百分比，100ρ为估计的组内相关系数。对于每项检测，卵泡中期和黄体中期女性的100ρ均超过90%。对于绝经后女性，两个实验室中雌酮的100ρ值超过84%。绝经后女性孕酮的100ρ值较低，不过一个实验室估计的值为84%。这些研究表明，在3个月的时间段内进行雌激素检测能够在给定月经类别中的女性之间进行可靠的比较。对于卵泡中期和黄体中期的女性，孕酮测量同样可靠，但对于绝经后女性则稍显不足。这些变异性评估仅涉及实验室技术，并未考虑女性体内激素水平的长期变化。此外，尽管这些测量对于女性之间的比较往往足够可靠，但卵泡中期和黄体中期女性雌激素变异系数的估计值约为10%，绝经后女性为11 - 20%。黄体中期女性孕酮的变异系数约为10%，卵泡中期为20%，绝经后女性为30%。
