Test principle
The microtiter plate provided in this kit has been pre-coated with an antibody specific to this index. Standards or samples are then added to the appropriate microtiter plate wells with a biotin-conjugated polyclonal antibody preparation specific for this index and Avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. Then a TMB substrate solution is added to each well. Only those wells that contain the index, biotin-conjugated antibody and enzyme-conjugated Avidin will exhibit a change in color. The enzyme-substrate reaction is terminated by the addition of a sulphuric acid solution and the color change is measured spectrophotometrically at a wavelength of 450 nm ± 2 nm. The concentration of the index in the samples is then determined by comparing the O.D. of the samples to the standard curve
Recovery
Matrices listed below were spiked with certain level of recombinant the index and the recovery humanes were calculated by comparing the measured value to the expected amount of the index in samples.
Linearity
The linearity of the kit was assayed by testing samples spiked with appropriate concenthumanion of the index and their serial dilutions. The results were demonsthumaned by the percentage of calculated concenthumanion to the expected.
Precision
Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level the index were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level the index were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
Intra-Assay: CV<10%
Inter-Assay: CV<10%
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