Introduction:
Trastuzumab emtansine, formerly called Trastuzumab -DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech’s Anti-Trastuzumab antibody linked to ImmunoGen’s cell-killing agent, DM1. T-DM1 combines two strategies– anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative)–to produce cell cycle arrest and apoptosis. Anti- Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or Trastuzumab Emtansine for metastatic disease or had their cancer recur within 6 months of adjuvant treatment.
Intended Use:
The KRIBIOLISA Anti-Trastuzumab Emtansine ELISA is used as an analytical tool for quantitative determination of Anti-Trastuzumab Emtansine in human serum and plasma.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Anti-HER2-ECD are precoated onto microwells. Samples and standards are pipetted into microwells and human Anti-Trastuzumab Emtansine present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated to DM1 is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Anti-Trastuzumab Emtansine in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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