Sample Type:Serum and plasmaIntended 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 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: 450nmPrecision:Intra-assay: CV% <15%Inter-assay: CV% <20%Kit Components:Coated assay plate, 1x96 wellsNegative Control, 1x1mlPositive Control, 1x1mlHRP-conjugate, 1x12mlSample Diluent, 1x12mlWash Buffer (20X), 2x15mlSubstrate A, 1x7mlSubstrate B, 1x7mlStop Solution, 1x7mlAdhesive Strip (For 96 wells), 4x stripsInstruction manualStorage and Stability:Store powder at 4°C liquid at -20°C. Store other components at 4°C. Stable for at least 6 months For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.