Trastuzumab (Herceptin®) is a humanized recombinant monoclonal antibody used for the treatment of primary breast cancers overexpressing human epidermal growth factor 2 (HER2). ||Intended Use:|This kit allows researchers to qualitatively monitor the presence of anti-Trastuzumab antibodies in biological matrices like serum and plasma.||Precision:\t|Intra-assay CV: <10% |Inter-assay CV: <10%||Principle of the Assay: |This immunogenicity assay employs the bridging ELISA technique. Capture antibody has been pre-coated onto a 96-well microplate. Quality control and test samples are pipetted into the appropriate wells. Anti-Trastuzumab present in biological matrices is bound by the immobilized capture antibody. After washing away any unbound substances, secondary antibody is added to the wells and after a final wash a detection reagent is added. The plate is washed to remove any unbound antibody-enzyme reagent and a substrate solution is added to the wells for color development. Color development is stopped and the color intensity (absorbance) is measured at 450nm. The absorbance is proportional to the amount of anti-Trastuzumab present in test samples. Five levels of QC samples give a qualitative reference signal which can be used to determine the level of anti-Trastuzumab antibody in the unknown samples. ||Kit Components:|384869A: Microtiter Strips, 1x96 wells|Quality Control Samples (QC1-QC6; ready to use; contain various levels of anti-Trastuzumab antibody):|384869B: QC1: 0ng/ml, 1x350ul |384869C: QC2: 31.25ng/ml, 1x350ul|384869D: QC3: 62.5ng/ml, 1x350ul|384869E: QC4: 125ng/ml, 1x350ul|384869F: QC5: 250ng/ml, 1x350ul|384869G: QC4: 500ng/ml, 1x350ul|384869H: Wash Buffer, 20X, 1x50ml|384869I: Assay Buffer, 1x50ml|384869J: Secondary Antibody, 1000X, 1x17ul|384869K: Detection Reagent, 1000X, 1x17ul |384869L: TMB, 1x12ml|384869M: Stop Solution, 1x12ml||Storage and Stability:|Store all components at -20°C. Unopened kit is stable for 6 months after receipt. For maximum recovery of product, centrifuge small tubes on pulse setting prior to opening.

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