This assay has high sensitivity and excellent specificity for detection of Immunoglobulin G (IgG).
No significant cross-reactivity or interference between Immunoglobulin G (IgG) and analogues was observed.
Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Immunoglobulin G (IgG) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Immunoglobulin G (IgG) were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
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.