GENLISA™ Human Cytokeratin 18-M65 (CK18-M65 / CK18M65) ELISA

SKU: KBH1666 Category:

36,000.00

Enzyme Immunoassay for the estimation of Human Cytokeratin 18-M65 (CK18-M65 / CK18M65) in human serum, plasma, cell culture supernatant and other biological samples. Validated for citrated/EDTA plasma only.


Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells



Description

Cytokeratin 18-M65 (CK18-M65), also known as CK18M65, is a marker used in the assessment of cell death and liver injury, particularly in the context of liver diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and liver fibrosis. CK18-M65 is a specific fragment of cytokeratin 18, a protein found in epithelial cells, including hepatocytes.

Background:
Cytokeratin 18 is a structural protein found in epithelial tissues, including the liver. During cell death processes such as apoptosis and necrosis, cytokeratin 18 is cleaved by caspases, leading to the release of various fragments into the bloodstream. CK18-M65 is a specific fragment released during cell death and is considered a marker of hepatocyte apoptosis and liver injury.

Pathways and Relevance:
CK18-M65 has emerged as a valuable biomarker for assessing liver injury and disease progression in conditions such as NAFLD, NASH, alcoholic liver disease, and viral hepatitis. Elevated levels of CK18-M65 in serum are indicative of increased hepatocyte apoptosis and are associated with the severity of liver damage, inflammation, and fibrosis. Monitoring CK18-M65 levels can provide insights into disease prognosis, treatment response, and risk stratification for liver-related complications.
Research on CK18-M65 is ongoing, with studies focusing on its utility in diagnosing and monitoring liver diseases, predicting disease progression, and evaluating the efficacy of therapeutic interventions. Additionally, researchers are exploring the potential of CK18-M65 as a non-invasive biomarker for assessing liver fibrosis and guiding treatment decisions in clinical practice. As the understanding of liver disease pathophysiology continues to evolve, CK18-M65 remains a promising marker for improving the management of patients with liver disorders.
In summary, CK18-M65 serves as a valuable tool in the assessment of liver injury and disease progression, offering insights into hepatocyte apoptosis and liver pathophysiology. Its relevance in clinical practice underscores its importance as a biomarker for improving the diagnosis, monitoring, and management of liver diseases.

Validated against seven points for a “GOLD RING” Standard Quality ELISA – the benchmark sign for Krishgen Quality. The The GENLISA ELISA kits are 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 – capture and detection to ensure a high degree of sensitivity and specificity in the estimation of Cytokeratin 18-M65 (CK18-M65 / CK18M65);









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Additional information

Pack Type

1 x 96 wells, break-apart wells

Species Reactivity

Human

Sample Type

Serum, Plasma, Cell Culture Supernatant and other biological samples. Validated for citrated/EDTA Plasma only.

Assay Range

200 – 3200 pg/ml

Sensitivity

197 pg/ml

Interference

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

Specificity

This assay recognises both the recombinant and natural protein for Cytokeratin 18-M65 (CK18-M65 / CK18M65)

Principle Of Assay

This ELISA is a sandwich immunoassay . Antibodies are 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) TMB Chromogenic Substrate for color development.

Quality Certification

Validated as per KRISHGEN's Quality Program. GOLD PLUS (GOLD+) validation done. The kit is calibrated against NIBSC calibrator.

KRISHGEN Mandate

High Performance Assays at Affordable Prices

Regulatory Status

Research Use Only.

Shipping Temperature

Shipped at Room Temperature or in gel pack to maintain temperature at 2-8 degrees Celsius

Storage Temperature

The kit (2-8 Degree Celsius) and its components are to be stored as indicated in the IFU (instructions for use). To ensure quality of your results, if all the wells in the kit are not being used, store the unused wells in the foil pouch containing the desiccant pack, well sealed and store at the indicated temperature. Similary aliquot and store the reconstituted standard at -20 Degree Celsius for long term storage (maximum 6 months from reconstitution) and to avoid deterioration in the activity.

ELISA Type

Sandwich ELISA, Double Antibody

ELISA Interpretation

Quantitative Results Intepretation, 4PL (2nd order) or Cubic Spline Graph. Software (MS Excel) available, on request, to support interpretation of results.

Shelf Life Available

8 -10 months at time of shipping

Alternate Names / Synonyms

Cytokeratin 18-M65 (CK18-M65 / CK18M65);

Research Area

Immune molecule

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.