Table 1.
Accuracies, precisions (expressed as CVs), matrix effects, and recoveries for the simultaneous analysis of NES and endogenous steroid hormones (n=5).
| Analyte | Spiked Value (ng/mL) | Expected Value (ng/mL) | Assayed Value (ng/mL) | Intra-assay CV | Inter-assay CV | Accuracy | Matrix Effect | Recovery |
|---|---|---|---|---|---|---|---|---|
| Nestorone® QC1Nestorone® QC2 | 0.100 | 0.100 | 0.087 | 10.7% | 14.0% | 87.0% | 93.2% | 83.5% |
| Nestorone® QC2 | 0.500 | 0.500 | 0.480 | 11.1% | 13.5% | 96.0% | ||
| Estradiol QC1 | 0.000 | 0.124 | 0.122 | 5.8% | 6.9% | 98.4% | 105.9% | 92.8% |
| Estradiol QC2 | 0.500 | 0.624 | 0.621 | 6.0% | 6.4% | 99.5% | ||
| Progesterone QC1 | 0.000 | 3.530 | 3.706 | 12.6% | 14.4% | 105.0% | 64.9% | 84.4% |
| Progesterone QC2 | 0.500 | 4.030 | 4.048 | 14.0% | 14.5% | 100.4% | ||
| Estrone QC1 | 0.100 | 0.166 | 0.184 | 5.9% | 6.9% | 110.8% | 102.5% | 93.1% |
| Estrone QC2 | 0.500 | 0.566 | 0.574 | 5.8% | 6.8% | 101.4% | ||
Expected values for QC1 and QC2 for Nestorone were created using spikes of unlabeled standard. Expected values for QC1 for estradiol and progesterone were endogenous values; expected values for QC2 for estradiol, progesterone, and estrone, as well as for QC1 for estrone, are the sum of endogenous and spiked amounts as listed in the table above. QC, quality control; CV, coefficient of variation.