KRIBIOLISA Neutralizing Antibodies to Evolocumab (REPATHA) ELISA

SKU: KBN1323

Rs 138,000.00

Enzyme Immunoassay for the estimation of Neutralizing Antibodies to Evolocumab (REPATHA) 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 Evolocumab (REPATHA) 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: The KRIBIOLISA? ELISA kits are used for assessing the specific biomarker in samples analytes which may be serum and cell culture supernatant as validated with the kit. The kit employs a blocking ELISA technique which engages the blocking pathway to estimate the neutralizing antibodies. Evolocumab is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody used as an adjunct to LDL cholesterol reducing therapies, aiding in the prevention of cardiovascular events and cardiovascular revascularization procedures. A neutralizing antibody (NAb) is an antibody that is responsible for defending cells from pathogens and are produced naturally by the body as part of its immune response. Their production is triggered by both infections and vaccinations against infections. In an immunogenetic context it will bind to a drug and neutralize its therapeutic effect. Intended Use: The KRIBIOLISA? Neutralizing Antibodies to Evolocumab (Repatha) ELISA kit is used as an analytical tool for the qualitative detection of neutralizing antibodies against Evolocumab in serum or plasma. Principle: The method employs sandwich ELISA technique. The protein-protein interaction between HRP-Evolocumab and PCSK9 can be blocked by Evolocumab. The neutralizing antibodies against Evolocumab binds to Evolocumab and thus a competitive inhibition is created. Samples and controls are pipetted in a blank microtitre plate and incubated with neutralizing antibody to Evolocumab (NAb) and Evolocumab. This complex of bound and unbound Evolocumab is then incubated with HRP conjugated Evolocumab protein. The unbound Evolocumab will bind to the PCSK9. The bound Nab Evolocumab will not bind to the HRP conjugated Evolocumab. This complex solution of bound antibodies to Evolocumab and unbound Evolocumab is then pipetted into PCSK9 coated microplate. After washing, the substrate solution (TMB) is added to the microwells. Post incubation, color develops proportionate to the amount of bound Evolocumab. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.









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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 Evolocumab

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 Evolocumab (REPATHA) 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

Monoclonal Antibodies

Therapeutic / Biology Type

Immunology / Biologics

Biological Pathway

Antibody-mediated immune modulation

KEGG Target Pathway

hsa04640

Reactome Pathway ID

R-HSA-913531

Active Molecule

Evolocumab (REPATHA)

Shelf Life Available

8 -10 months at time of shipping

Alternate Names / Synonyms

Evolocumab; REPATHA

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.

Documents

ELISA nAb Orthogonal AAI Immunology 2026 Poster