Assay Dynamic Range
The range of the assay is between 3.6 - 1000 pg/mL. Specificity of Antibodies (Cross Reactivity)
The following materials have been evaluated for cross reactivity. The percentage indicates cross reactivity at 50% displacement compared to 17α-OHP. Sensitivity
The analytical sensitivity of the CD ELISA was calculated by subtracting 2 standard deviations from the mean of 20 replicate analyses of the Zero Standard (S0).
Analytical sensitivity is: 2.5 pg/mL
Functional sensitivity of the assay is: 3.6 pg/mL Reproducibility Intra-Assay
The intra-assay reproducibility was determined by replicate measurements of 6 saliva samples using CD ELISA kit. The within assay precision is shown below: Inter-Assay
The inter-assay variation was determined by duplicate measurements of six saliva samples on 10 different days using this ELISA kits. Mean of the duplicate measurements is given below. Inter-Lot
The inter-assay (between-lots) variation was determined by repeated measurements of six saliva samples in three different kit lots. Recovery
Recovery of the CD ELISA was determined by adding increasing amounts of the analyte up to 500 pg/mL to three different saliva samples containing different amounts of endogenous analyte. Each sample (non-spiked and spiked) was assayed and analyte concentrations of the samples were calculated from the standard curve. The percentage recoveries were determined by comparing expected and measured values of the samples. Linearity
Six saliva samples containing different amounts of analyte (spiked and unspiked) were serially diluted with zero standard and assayed with the CD ELISA. Three native samples were serially diluted up to 1:128, and 3 samples were spiked with 17α-OHP and then serially diluted up to 1:10. The percentage recovery was calculated by comparing the expected and measured values for 17α-OHP. An assay linearity of 3.6 - 1000 pg/mL has been identified as the usable range. Samples above this range must be diluted and re-run.