Sample Type: Serum and plasma Intended Use: For the qualitative determination of human islet cell antibody (ICA) concentrations in serum and plasma. Specificity: This assay has high sensitivity and excellent specificity for detection of human ICA. No significant cross-reactivity or interference between human ICA and analogues was observed. Test Principle: This BioAssay(TM) employs the qualitative enzyme immunoassay technique. The microtiter plate provided in this kit has been pre-coated with purified antigen. Samples are pipetted into the wells with anti-human IgG conjugated Horseradish Peroxidase (HRP). Any antibodies specific for the antigen present will bind to the pre-coated antigen. Following a wash to remove any unbound reagent, a substrate solution is added to the wells and color develops in proportion to the amount of human ICA bound in the initial step. The color development is stopped and the intensity of the color is measured. Detection Wavelength: 450nm Precision: Intra-assay: CV% <15% Inter-assay: CV% <20% Kit Components: Coated assay plate, 1x96 wells Negative Control, 1x1ml Positive Control, 1x1ml HRP-conjugate, 1x12ml Sample Diluent, 1x12ml Wash Buffer (20X), 2x15ml Substrate A, 1x7ml Substrate B, 1x7ml Stop Solution, 1x7ml Storage and Stability: Store powder at 4C liquid at -20C. Store other components at 4C. Stable for at least 6 months For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.
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