KRIBIOLISA™ Ustekinumab (STELARA) ELISA

SKU: KBI1014 Category:

66,000.00

Enzyme Immunoassay for the estimation of Ustekinumab (STELARA) in serum and plasma.

Key features:
1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format
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

Background:
Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated nflammatory disorders. In two Phase III trials for moderate to severe psoriasis, the longest 76 weeks, ustekinumab was safe and effective. A third Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis.

Intended Use:
For Estimation of Ustekinumab (STELARA) in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

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

Sample Type

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

Calibration Range

40 ng/ml – 640 ng/ml

Sensitivity

20 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Ustekinumab (STELARA)

Cross Reactivity

< 0.5% cross-reactivity observed with related biomarker.

Interference

No significant interference observed with available related molecules.

Regulatory Status

Research Use Only

Research Area

Biosimilars / Therapeutic Drug Monitoring

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 uses a biosimilar research grade standard / calibrator. The standard / calibrator has been validated against WHO/NIBSC standard and/or against commercially sourced innovator drug where available. Please 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.

Long Name

Protein Based Therapies – Monoclonal Antibody