Intended Use
Zolbetuximab ELISA Kit is an enzyme immunoassay developed for detection and quantitation of the Zolbetuximab from plasma and serum. Each kit provides sufficient reagents to perform up to 96 assays including standard curve and samples.
Contents of Kit
1. Anti- Zolbetuximab Antibody Coated Plate: One strip well 96-well plate.
2. Biotinylated Anti- Zolbetuximab Antibody (100×): One 120 μL vial.
3. Streptavidin-Enzyme Conjugate (100×): One 120 μL vial.
4. Zolbetuximab Standard (1000 ng/mL): One 150 μL vial.
5. Assay Diluent: One 50 mL bottle.
6. 20× Wash Buffer: One 50 mL bottle.
7. Substrate Solution: Two 6 mL bottles.
8. Stop Solution: One 7 mL bottle.
Storage
After you receive the kit, all the components should be stored in the refrigerator (4-8°C) also up to 1 year. Long term storage, improper storage conditions and large temperature fluctuation cycles may cause precipitates in the TMB solution. These precipitates should not affect the assay noticeably. Nevertheless, if you observe such precipitates, we recommend avoiding them by allowing them to sink to the bottom.
Detection Range
0.39 - 50 ng/mL.
Detection Limit
The kit has detection sensitivity limit of 0.13 ng/mL Zolbetuximab.
General Description
Zolbetuximab (trade name VYLOY®) is a first-in-class chimeric (mouse/human) IgG1 monoclonal antibody that targets the tight-junction protein Claudin 18.2 (CLDN18.2). This protein is highly expressed in a variety of gastrointestinal tumors—especially gastric and gastro-esophageal junction adenocarcinomas—while its expression in normal tissues is restricted, making it a promising tumor-specific target. Zolbetuximab binds to the first extracellular loop of CLDN18.2 and mobilizes the immune system to attack tumor cells primarily through two mechanisms, antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Using Zolbetuximab-specific antibodies as both coating and capture reagents, we have developed a highly sensitive ELISA kit for quantifying free Zolbetuximab. The lower limit of detection is 0.13 ng/mL, providing a reliable tool for pharmacokinetic studies of the drug.
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