KRIBIOLISA™ Anti-Darbepoetin (ARANESP) ELISA

SKU: KBI2030 Category:

46,200.00

Enzyme Immunoassay for quantitative detection of Anti-Darbepoetin antibodies in 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:
Darbepoetin alfa is a re-engineered form of erythropoietin that binds to the erythropoietin receptor on erythroid progenitor cells, stimulating RBC production and differentiation. It stimulates erythropoiesis (increases red blood cell levels) by the same mechanism as rHuEpo (binding and activating the Epo receptor) and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy. 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-Darbepoetin Alfa antibodies and may be used for monitoring immunogenicity.

Intended Use:
The KRIBIOLISA Anti-Darbepoetin ELISA is used for quantitative detection of Anti-Darbepoetin antibodies in human serum and plasma.

Principle:
The method employs enzyme linked immunoassay technique. Standard or samples are pipetted into microwells pre-coated with Darbepoetin and A nti- Darbepoetin present in the sample and standards are bound by Darbapoetin. In the second step, HRP conjugate is pipetted and incubated. Free HRP conjugate will be removed by washing. Addition of TMB substrate will develop blue color and and reaction is stopped by addition of stop solution. Colour of the solution turns yellow. Intensity of yellow colour in wells is directly proportional to the concentration of Anti-Darbepoetin present in Standard or sample. Absorbance is measured at 450 nm.

If you have published a paper by using any of our ELISA since 01/01/2023, kindly fill out the “Krishgen Publication Reward Application Form” with complete information and send it by at email: info@krishgen.com, with the subject “Krishgen Publication Reward”. We will get back to you with the Amazon / Krishgen Credit Reward after we confirm it ASAP!

View more details about our Publication Reward

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 ng/ml

Detection Method

Colorimetric

Regulatory Status

Research Use Only

Research Area

Cancer

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.