Trastuzumab (Herceptin) Immunogenicity ELISA

Trastuzumab (Herceptin) Immunogenicity ELISA

• Description: Trastuzumab (Herceptin® ) is a humanized recombinant monoclonal antibody used for the treatment of primary breast cancers overexpressing human epidermal growth factor 2 (HER2). HER2 protein is overexpressed in 25-30% of breast cancers.
• Gene ID: 2064
• Reaction Volume: 15 µL
• Target Antigen: Trastuzumab (Herceptin) Immunogenicity
• Detection Method: Bridging ELISA
• Assay Principle: Quantification of antibodies to Trastuzumab
• Assay Protocol: This immunogenicity assay employs the bridging ELISA technique. Capture antibody is precoated onto a 96 well microplate. Quality control and test samples are pipetted into the appropriate wells. AntiTrastuzumab 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. The color development is proportional to the amount of anti-Trastuzumab present in test samples. Three 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. The color development is stopped and the intensity of the color is measured.
• Assay Performance Time: 3.5 Hours
• Sample Type: Serum Plasma
• Detection Range: 125ng/mL - 31.25ng/mL
• Precision: <10%, <10%
• Sensitivity: Anti-Trastuzumab antibodies
• Limit Of Detection: 31.25 ng/mL
• Components: Coated microtiter plate, 96 wells QC samples - 4x50ul 10X wash buffer - 25mL Assay buffer - 50mL 1000X secondary antibody - 17ul 1000X detection reagent - 17ul TMB - 12mL TMB stop solution - 12mL Plate sealers - 3
• Shipping Conditions: Blue Ice
• Storage Conditions: -20°C
• Shelf Life: 12 months