KRIBIOLISA™ Daratumumab (DARZALEX) ELISA

SKU: KBI1028 Category:

66,000.00

Enzyme Immunoassay for the estimation of Daratumumab (DARZALEX) 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:
Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells overexpress. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. Daratumumab was given breakthrough therapy drug status in 2013 for multiple myeloma. It was awarded orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma.

Intended Use:
For Estimation of Daratumumab (DARZALEX) 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 Daratumumab are pre-coated onto microwells. HRP Conjugate, Samples / Standards are pipetted into microwells and human Daratumumab present in the sample are bound by the capture antibody. 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 Daratumumab 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

80 ng/ml – 2560 ng/ml

Sensitivity

0.12 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Daratumumab (DARZALEX)

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

Cancer

Entez Gene ID

HuMax-CD 38 Human

Alternate Names / Synonyms

Daratumumab

Alternate Drug Brand Names

Darzalex, Darzalex Faspro

Drug Bank Accession Number

DB09331

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