Cardiolipin ELISA Kit

Description

Cardiolipin ELISA Kit

Product Overview: The Cardiolipin ELISA Kit is a highly sensitive and reliable immunoassay designed to detect and quantify cardiolipin antibodies (aCL) in human serum or plasma samples. This kit is essential for the diagnosis and monitoring of various autoimmune disorders, particularly systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). It uses enzyme-linked immunosorbent assay (ELISA) technology to provide accurate results in a straightforward, easy-to-use format.

Key Features:

• High Sensitivity: Detects low concentrations of cardiolipin antibodies, providing reliable results for both clinical and research settings.
• Rapid Results: The assay can be completed in approximately 2-3 hours, offering timely diagnostic information.
• Wide Detection Range: Suitable for detecting cardiolipin antibodies at varying levels, facilitating comprehensive analysis of sample profiles.
• Specificity: Specifically designed for the detection of IgG, IgM, and IgA isotypes of cardiolipin antibodies.
• User-Friendly: The kit includes all necessary reagents, including pre-coated plates, enzymes, substrates, and controls, for easy setup and operation.
• Validated for Clinical Use: Designed in compliance with relevant regulatory standards for use in clinical diagnostics and research applications.

Applications:

• Autoimmune Disease Diagnosis: Essential for detecting cardiolipin antibodies in patients suspected of having autoimmune conditions like SLE, APS, or rheumatoid arthritis.
• Monitoring Disease Progression: Used to assess the presence of cardiolipin antibodies over time, supporting patient management and treatment decisions.
• Research: Valuable in research on autoimmune diseases, immunology, and cardiovascular conditions.

Test Principle: The Cardiolipin ELISA Kit operates on the principle of antigen-antibody interaction. Cardiolipin is coated on the wells of the microplate. When a sample containing cardiolipin antibodies is added, these antibodies bind to the cardiolipin antigens. After washing to remove unbound components, a secondary antibody, conjugated with an enzyme, binds to the captured antibodies. Upon addition of the substrate, a colorimetric change occurs, indicating the presence of cardiolipin antibodies in the sample. The intensity of the color is proportional to the amount of cardiolipin antibody present.

Contents:

• Microplate (12 x 8 wells)
• Standard solutions (for generating a standard curve)
• Positive and negative control sera
• Enzyme conjugate solution
• Substrate solution
• Wash buffer
• Stop solution
• Instruction manual

Storage and Handling:

• Store kit components at 2-8°C.
• Ensure reagents are brought to room temperature before use.
• Do not freeze any components of the kit.

Performance Characteristics:

• Sensitivity: ≥ 95% (depending on sample type and processing)
• Specificity: ≥ 98% for cardiolipin antibodies
• Precision: Intra-assay and inter-assay coefficients of variation (CV) typically <10%.

Regulatory Information:

• CE marked (for European market)
• Compliant with IVD (In Vitro Diagnostic) regulations