ELISA/assay

KRIBIOLISA™ Ustekinumab ELISA (STELARA)

KBI1014

1 x 96 wells

950 USD

KRIBIOLISA™ Ustekinumab ELISA (STELARA)

ELISA

1 x 96 wells

950 USD

Sensitivity: 20 ng/ml Sample Type: Serum, Plasma Calibrator Range: 0 - 640 ng/ml The Ustekinumab (Stelara) ELISA kit is intended for the quantitative determination of Ustekinumab (Stelara) in serum, plasma and cell culture samples. CE IVD marked. Pharmacokinetics (PK) is a branch of science dedicated to the quantitative analysis of absorption, distribution, metabolism and excretion of drug molecules within the body of a living organism. All pre-clinical and clinical studies include the measurement of serum drug concentration, both in animals and in patients, at different points after drug administration. The result is an important indicator of the drug’s pharmacokinetic properties and is pertinently relevant to dosing recommendations while developing the drug, and even while using in clinical therapy. Krishgen PK kits are used for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will help optimize drug dosing regimens. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are 80 - 120% - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity.

Human

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 inflammatory 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.

This ELISA kit comes with a pre-coated plate, concentrated or lyophilized standards, wash solution, subtrate, stop solution and all the required diluents. For the exact contents of the kit, please refer to the datasheet / IFU.

2-8 Deg C

0 ng/ml - 640 ng/ml

20 ng/ml

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.

Ustekinumab

CE IVD

2-8 degrees C