KRIBIOLISA™ Anti-Nivolumab (OPDIVO) ELISA

SKU: KBI2050 Category:

72,450.00

Enzyme Immunoassay for the Quantitative Determination of Anti-Nivolumab antibodies in human serum and plasma.

Key features:
1. Quantitative estimation of anti-drug antibodies
2. Validated as per international bioassay validation guidelines
3. Recovery: 80-120%
4. Precision CV <10%


Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells



Description

Introduction:
Nivolumab is a genetically engineered anti-PD-1 mAb that binds to PD-1 with high affinity and blocks its interactions with both PD-L1 and PD-L2, thereby stimulates memory response to tumor antigen-specific T cell proliferation. It is a prescription medicine used in combination with ipilimumab as a first treatment for adults with a non-small cell lung cancer that are positive for PD-L1, but do not have an abnormal EGFR or ALK gene. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Nivolumab antibodies and may be used for monitoring immunogenicity.

Intended Use:
The KRIBIOLISA Anti-Nivolumab ELISA is used as an analytical tool for quantitative determination of Anti-Nivolumab antibodies in human serum and plasma.

Principle:
The method employs the sandwich enzyme immunoassay technique. Nivolumab is pre-coated onto microwells. Samples or standards are pipetted into microwells and antibodies to Nivolumab present in the standards or sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Nivolumab is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of AntiNivolumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm

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Additional information

Species

Human

Biomarker Estimation

measures antibodies to the drug

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

10 ng/ml – 640 ng/ml

Sensitivity

8.75 ng/ml

Detection Method

Colorimetric

Regulatory Status

Research Use Only

Research Area

Immune Checkpoints, Therapeutic Drug Monitoring, Cancer

Entez Gene ID

BMS 936558 Human

Alternate Names / Synonyms

Nivolumab

Alternate Drug Brand Names

Opdivo, Opdualag

Drug Bank Accession Number

DB09035

ELISA Type

Direct Sandwich Assay

Storage Temperature

Store the unopened product at 2-8 Deg C. Opened products to be stored as per temperatures indicated on the datasheet.

Validation

The kit has been validated against international bioassay validation guidelines. Refer to the IFU for more details.

Disclaimer

Trade name indicated is for reference purposes only. It does not reflect any licences or patent usage. The tradename is the registered trademark of the respective owners only.