Intended Use
The EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum.
Storage
Store all kit components at 2-8°C except the Wash Concentrate.
Performance Characteristics
Accuracy
Eighty five (85) samples, with EPO values ranging from 3.8 to 304 mIU/mL, were assayed by the CD ELISA procedure and an ELISA EPO kit. Linear regression analysis gives the following statistics:
CD ELISA = 0.94 ELISA Kit – 0.41 mIU/mL r = 0.989 N = 85
High Dose Hook Effect
The EPO ELISA kit has exhibited no "high dose hook effect" in standard diluent spiked with 200,000 mIU/mL of EPO. Additionally, three samples with known high EPO values (1,920 mIU/mL, 1,520 mIU/mL, and 966 mIU/mL) were tested without dilution and their results read much greater than the highest standard. Samples with EPO levels greater than the highest calibrator, however, should be diluted and re-assayed for correct values.
Precision
The Intra-assay precision of the EPO ELISA Test was calculated from 22 replicate determinations on each of the two samples.
Intra-Assay Variation
The inter-assay precision of the EPO ELISA Test was calculated from data on two samples obtained in 22 different assays.
Inter-Assay Variation
Sensitivity
The sensitivity, or minimum detection limit, of this assay is defined as the smallest single value, which can be distinguished from zero at the 95% confidence limit.
The EPO ELISA has a calculated sensitivity of 1.2 mIU/mL when using Calibrator B as the lowest calibrator. Hence, sample results below 1.2 mIU/mL should be reported as "Less than 1.2 mIU/mL".
The EPO ELISA with Calibrator G and Calibrator H has a calculated sensitivity of 0.6 mIU/mL Hence, sample results below 0.6 mIU/mL should be reported as "Less than 0.6 mIU/mL".
Citations
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