KRIBIOLISA Neutralizing Antibodies to Etarnacept (ENBREL) ELISA

SKU: KBN4013

Rs 105,000.00

Enzyme Immunoassay for the estimation of Neutralizing Antibodies to Etarnacept (ENBREL) in human serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.

Assay Range: Qualitative | Sensitivity: Qualitative

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells, break-apart

 

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All our kits are manufactured under ISO 13485.

KRIBIOLISA Neutralizing Antibodies to Etarnacept (ENBREL) ELISA includes features like:
– Ready to use protocol with break-apart wells for ease of use
– Standardisation and High Reproducibility
– Lot to Lot Consistency
– Accuracy and Precision

Validated against seven points for a ?GOLD RING? Standard Quality ELISA – the benchmark sign for Krishgen Quality. KRIBIOLISA ELISA kit is used for assessing the specific biomarker in samples analytes which may be human serum, plasma, biological fluids and cell culture supernatant. The kit uses indirect sandwich assay with double antibodies / recombinant proteins – capture and detection to ensure a high degree of sensitivity and specificity in the estimation of the analyte. Extensive validation has been done on these kits. Please ask for our validation guide if not availableon our product page. Incase you wish us to customize the kit, connect with us at sales1@krishgen.com

Background: This ELISA detects functional neutralizing antibodies that inhibit the biological activity of the referenced therapeutic, supporting immunogenicity risk assessment and clinical monitoring.

Additional information

Pack Type

1 x 96 wells, break-apart wells

Species Reactivity

Homo Sapiens (Human)

Sample Type

Serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids. For tear samples, please connect with us to discuss further. Note the kit has been validated using human matrices only. For any other animal matrix, pleas connect with us to optimize the kit accordingly.

Biomarker / Protein

Neutralizing Antibodies to Etarnacept

Sample Dilution

Dilute at 1:1000 with the Sample Diluent provided in the kit. Please refer to the IFU enclosed with the kit supplied for specific guidance.

Neutralizing Antibodies to Etarnacept (ENBREL) ELISA

Short Name

Standards Available

Controls – Positive, Negative

Calibration Curve

NA

Sensitivity

Qualitative

Interference

Preparations of the known factors were assayed for interference. No significant interference was observed.

Specificity

The assay uses anti idiotypic (humanized) antibody for capture and / or recombinant protein expressed in mamalian cells, The standards used are research grade biosimilars referenced to the innovator product. In specfic cases where vailable the kit has also been validated against the innovator / reference product. Refer our detailed validation guide for the same.

Principle Of Assay

This ELISA is a ligand-receptor complex capture assay.The reference biosimilar is coated on 96 well plates. The antigen protein present in sample and standard respectively bind to the coated wells. The wells are washed and an antibody:HRP Conjugate is added which binds to the bound complex in the well. Washing is performed to remove any unbound material. TMB substrate is added and the enzyme reaction is stopped by dispensing of stop solution into the wells. The optical density (OD) of the solution at 450 nm is directly proportional to the amount of antigen protein present in the standard or samples.

Detection Method

Colorimetric, Absorbance measured at 450nm

Conjugate-Enzyme Reaction

Uses stable HRP Enzyme Conjugate with (single component kinetic) and TMB Chromogenic Substrate for color development.

Regulatory Status

Research Use Only. Kit is developed and validated as per ICH/EMA/FDA guidelines. Ask for our detailed validation guide at sales1@krishgen.com

Shipping Temperature

Shipped at Room Temperature or in gel pack

Storage Temperature

The kit and its components are to be stored at 2-8 Degree Celsius. Please refer specific components storage conditions in the IFU.

ELISA Type

Sandwich ELISA, Double Antibody

ELISA Interpretation

Qualitative Results

Product Catalog

Other

Therapeutic / Biology Type

General

Biological Pathway

Neutralizing ADA vs etanercept (TNF inhibitor)

KEGG Target Pathway

NA

Reactome Pathway ID

NA

Active Molecule

Etarnacept (ENBREL)

Shelf Life Available

8 -10 months at time of shipping

Alternate Names / Synonyms

Etarnacept; ENBREL

Research Area

Immune Molecule; Cell Biology; Immunology, Tumor

Disclaimer

The data indicated herein with specifications are changed from time to time at time of production of the assay. We request you to confirm the specifications including the assay range and procedure as per the most current IFU (instructions for use) accompanying the assay kit. 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. References towards clinical trials, pathways, research areas are for informational purpose only.