Autoimmune

Autoimmune Overview

Three Technologies, One Solution: IFA, EIA, Multiplex

From Kallestad^® IFA and EIA products to the revolutionary BioPlex^® 2200, Bio-Rad provides laboratories and clinicians with over 30 years of expertise and innovation.

As the market leader for autoimmune instrumentation, tests and educational materials, Bio-Rad offers complete solutions for the laboratory. Innovative Bio-Rad products provide consistently reliable results, covering an array of methods for enhanced autoimmune disease diagnosis.

As new therapies enter the marketplace, physicians are becoming more aware of the need to diagnose and treat these diseases.

Autoimmune Immunofluorescence Assay (IFA) Products

Kallestad^® — The Name You Know. The Quality You Trust.

Laboratories have used indirect fluorescent antibody (IFA) procedures to detect autoantibodies since 1957. In these procedures, a fluorescent antibody serves as a marker for an antigen-antibody binding reaction which occurs on a substrate surface. Among the substrates frequently used in the IFA procedure are human epithelial (HEp-2) cells. Other common subtrates include mouse kidney and stomach, and Crithidia luciliae (a hemoflagellate). Observation of a specific pattern of fluorescence on the substrate indicates the presence of autoantibodies in the patient's serum.

Our “Gold Standard” Bio-Rad Kallestad^® kits and components are manufactured to meet rigorous standards for consistent, accurate results. Bio-Rad provides your laboratory with a wide range of ordering options to meet all your testing needs. In addition, our ergonomic well spacing and automation options provide you with opportunities to improve your laboratory’s workflow and efficiency.

Autoimmune Enzyme Immunoassay (EIA) Products

Simple, Objective, Sensitive.

As a worldwide leader in autoimmune diagnostics, Bio-Rad Laboratories provides complete autoimmune solutions for any test volume. In addition to our comprehensive IFA product range, we offer CE-marked and FDA-cleared EIA assays by means of two well-established product families—Bio-Rad Autoimmune EIA and Bio-Rad Kallestad^® EIA. Our full panel of autoantibody assays allows you to identify and characterize individual or multiple autoantibodies associated with autoimmune disease.

Bio-Rad offers a comprehensive menu of assays, and continues to expand the menu to include new clinically relevant assays, as they are developed.

Multiplex Testing with the BioPlex^® 2200 System

Patented Multiplex Detection Magnetic Bead Technology

BioPlex^®2200 immunoassays use heterogeneous sets of magnetic 8 µm beads. The beads are infused with varying ratios of fluorescent dyes, creating unique bead sets. Beads within each set are coated with a ligand (i.e., antigen, antibody, analyte, etc.) specific to a particular assay. Bead sets are then mixed together in a single reagent pack allowing for simultaneous detection of multiple analytes from a single sample.

Each microsphere is dyed with a unique combination of 2 colors.

Up to 25 color-coded microspheres (bead regions), can be bound with a unique antigen

Example: ANA Screen Kit

The ANA Screen Reagent Pack uses 16 microspheres: 13 assay beads and 3 quality control checks.

	13 Assay Microspheres 1 dsDNA 2 Chromatin 3 Ribosomal P 4 SS-A (52 kD)* 5 SS-A (60 kD)* 6 SS-B 7 Sm 8 Sm/RNP 9 RNP (A)* 10 RNP{ (68)* 11 Scl-70 12 Jo-1 13 Centromere B * Individual SS-A and RNP results not available in the U.S. Reported as SS-A and RNP for a total of 11 individual results.
3 Quality Control Microspheres A Serum Verification Bead (SVB) B Internal Standard Bead (ISB) C Reagent Blank Bead (RBB)

Multiplex Chemistry Detection Method

The dual-laser, multiplex flow detection method processes a minimum of 150 individual bead results for each analyte,representing more than 150 assay readings. This enhances the overall quality of each result, compared to standard immunoassays, which rely on a single reading.

Detection 1. A sample of the final reaction mixture is aspirated to the detector.

Detection 2. Bead mixture passes through the detector where one laser identifies the bead analyte and another measures the analyte concentration.

Detection 3. The system detector performs a minimum of 150 measurements per analyte at the rate of 100,000 measurements per minute.