Atezolizumab-MMAE (ADC) ELISA Kit

Sample

Serum, plasma

Detection Method

sELISA

Intended Use

This sandwich test kit is intended for use in the quantitative determination of Atezolizumab-MMAE Antibody Drug Conjugate level in human serum or plasma.

Contents of Kit

1. Anti-Naked Antibody Coated Microplate: One microplate with twelve by eight strips (96 wells total) coated with a highly specific capture antibody against the naked monoclonal antibody component of the ADC. The plate is framed and sealed in a foil zipper bag with a desiccant. This reagent should be stored at 2–8 °C and is stable until the expiration date on the kit box.
2. Anti-Payload HRP-Conjugated Detection Antibody (Tracer): One vial containing 12 mL of ready-to-use detection antibody, specific for the drug payload (e.g., linker-payload complex) of the ADC, conjugated to horseradish peroxidase (HRP) in a stabilized protein matrix. This reagent should be stored at 2–8 °C and is stable until the expiration date on the kit box.
3. ELISA Wash Concentrate: One bottle containing 50 mL of 20-fold concentrate. Before use, the contents must be diluted with 950 mL of deionized or distilled water and mixed well. Upon dilution, this yields a working wash solution containing a surfactant in phosphate-buffered saline with a non-azide, non-mercury preservative. The diluted wash solution may be stored at room temperature and is stable until the expiration date on the kit box.
4. ELISA HRP Substrate: Two bottles containing 6 mL each of tetramethylbenzidine (TMB) substrate with hydrogen peroxide. This reagent should be stored at 2–8 °C and is stable until the expiration date on the kit box. Protect from light.
5. ELISA Stop Solution: One bottle containing 12 mL of stop solution. This reagent may be stored at 2–8 °C or room temperature and is stable until the expiration date on the kit box.
6. Assay Buffer: One bottle containing 12 mL of ready-to-use assay buffer. It should be used according to the assay procedures for sample and standard dilution. This reagent should be stored at 2–8 °C and is stable until the expiration date on the kit box.
7. Calibrator Diluent (Matrix Zero): One vial containing 30 mL of calibrator diluent, representing the zero standard (matrix blank). This reagent is used for diluting the calibrator stock to prepare assay standards, as well as for diluting test samples. This reagent should be stored at 2–8 °C and is stable until the expiration date on the kit box.
8. ADC Calibrator Stock (Optional/Provided Separately): One vial containing the calibration stock of the specific Antibody-Drug Conjugate (ADC) for assay calibration. Refer to the vial label for the exact concentration and Drug-to-Antibody Ratio (DAR). This reagent should be stored at 2–8 °C and is stable until the expiration date on the vial or kit box.

Storage

2-8°C (for sealed box), please do not freeze! See kit label for expiry date.

Performance Characteristics

1. Reference samples: The detection results of negative enterprise reference samples please refer to COA; the detection rate of the limit of detection reference samples is more than 90%; the CV of the repeatability reference samples is less than ±15%; after serial dilution of the linearity reference samples.
2. Lower limit of detection: please refer to COA.
3. Precision: For negative reference samples and lower limit of detection reference samples, statistics were performed for 20 days within batches, between batches, within days, and between days. The precision of negative reference samples is not higher than 30%, and the precision of the lower limit of detection is not higher than 15%.
4. Linear range: High-value samples were serially diluted to at least 5 concentrations.

General Description

Atezolizumab-MMAE is an anti-PD-L1 antibody-drug conjugate (ADC) with an EC50 of 1.1 nM. It consists of a humanized anti-PD-L1 antibody (Atezolizumab), a lysosome-cleavable dipeptide linker (valine-citrulline), and a tubulin inhibitor (MMAE), with the drug-linker conjugate being VcMMAE. This ADC exhibits potent cytotoxicity (EC50: 9.75-11.94 nM) and immune activation effects. In the MC38 xenograft humanized PD-1 immune system mouse model, Atezolizumab-MMAE demonstrates significant antitumor activity.