KRIBIOLISA™ Anti-Ustekinumab (STELARA) ELISA

SKU: KBI2014 Category:

58,000.00

Enzyme Immunoassay for the quantitative Determination of Anti-Ustekinumab 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:
Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis. 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 preclinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Etanercept and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Ustekinumab antibodies and may be used for monitoring immunogenicity.

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

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Ustekinumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Ustekinumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Ustekinumab 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-Ustekinumab 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

5ng/ml

Detection Method

Colorimetric

Regulatory Status

Research Use Only

Research Area

Therapeutic Drug Monitoring, Inflammation

Entez Gene ID

CNTO 1275 Human

Alternate Names / Synonyms

Stelera, Ustekinumab

Alternate Drug Brand Names

Stelara

Drug Bank Accession Number

DB05679

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.