
Tests for determination of autoimmune markers in human specimen by microplate enzyme immunoassay, colorimetric.
Part #: Refer to the IFUs
Manufacturers:
“Autoimmune disease” refers to a diverse group of disorders that involve almost every organ and system of the body. It encompasses diseases of the nervous, gastrointestinal, endocrine systems as well as skin and other connective tissues, eyes, blood and blood vessels. In all of these autoimmune diseases, the underlying problem is “autoimmunity” where the body’s immune system is misdirected and attacks the organs it was designed to protect. It involves the loss of normal immune homeostasis in which the body produces an abnormal response to its own self tissue.
Technical specifications
| Analyte | Principle | Calibrator Concentration | Measurement Range | Assay Time |
| Anti-Cyclic Citrullinated Peptide (CCP) | Indirect assay | 0, 12.5, 25, 50, 100, 200 U/mL | 0.054 – 200 U/mL | 65 minutes |
| Anti-Cardiolipin IgG/IgM | Indirect assay | Combi calibrators containing IgG: 0, 6.25, 12.5, 25, 50, 100 GPL-U/mL IgM: 0, 6.25, 12.5, 25, 50, 100 MPL-U/mL | IgG: 1 – 100 GPL- U/mL IgM: 0.5 –100 MPL-U/mL | 65 minutes |
| Anti-Phospholipid Screen IgG/IgM | Indirect assay | Combi calibrators containing IgG: 0, 6.25, 12.5, 25, 50, 100 GPL-U/mL IgM: 0, 6.25, 12.5, 25, 50, 100 MPL-U/mL | IgG: 0.5 – 100 GPL- U/mL IgM: 0.5 –100 MPL-U/mL | 65 minutes |
| Anti-tissue Transglutaminase (tTG) IgA | Indirect assay | 0, 5, 10, 25, 75, 200 U/mL | 1 – 200 U/mL | 65 minutes |
| Anti-Double Stranded DNA (dsDNA) Screen | Indirect assay | 0,12.5, 25, 50, 100, 200 U/mL | 1 – 200 U/mL | 65 minutes |
| Antinuclear Antibody (ANA) Detect | Indirect assay | Anti-ANA negative control, ANA calibrator | Qualitative | 65 minutes |
Refer to the product Instruction-For-Use (IFU) for complete details.