CLIA Kit for Ethinylestradiol (EE)

The microplate provided in this kit has been pre-coated with a monoclonal antibody specific to Ethinylestradiol (EE) . A competitive inhibition reaction is launched between biotin labeled Ethinylestradiol (EE) and unlabeled Ethinylestradiol (EE) (Standards or samples) with the pre-coated antibody specific to Ethinylestradiol (EE) . After incubation the unbound conjugate is washed off. Next, avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. The amount of bound HRP conjugate is reverse proportional to the concentration of Ethinylestradiol (EE) in the sample. Then the mixture of substrate A and B is added to generate glow light emission kinetics. Upon plate development, the intensity of the emitted light is reverse proportional to the Ethinylestradiol (EE) level in the sample or standard.

Intra-assay Precision (Precision within an assay) : 3 samples with low, middle and high level Ethinylestradiol (EE) were tested 20 times on one plate, respectively. Inter-assay Precision (Precision between assays) : 3 samples with low, middle and high level Ethinylestradiol (EE) were tested on 3 different plates, 8 replicates in each plate. CV (%) = SD/meanX100 Intra-Assay: CV Inter-Assay: CV Inter-Assay: CV

The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition. To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.

This assay has high sensitivity and excellent specificity for detection of Ethinylestradiol (EE) . No significant cross-reactivity or interference between Ethinylestradiol (EE) and analogues was observed.