This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human anti-mouse IgG antibody (HAMA) levels in patient serum or plasma samples. It detects both HAMA-IgG and HAMA-IgM subtypes. This test might be used as an aid in the detection of patients with positive HAMA that may affect prescribed diagnosis and treatment involving monoclonal murine IgG.
For in-vitro diagnostic use.
Background:
Clinically, mouse monoclonal antibodies (IgG) and their fragments are used during in-vivo diagnosis procedures (radionuclides) and treatment for patients with various diseases. In patients, even a single dose injection of murine monoclonal IgG may induce immune response directed against this foreign protein (immunogen). In circulation, the presence of human antibody against murine IgG would bind to the injected murine IgG and therefore diminish the efficacy of either in-vivo diagnosis or treatment. HAMA is likely to increase the risk of anaphylactic complications to subsequent administration of the murine IgG-based therapy.
The presence of HAMA in patient serum or plasma specimens causes both false positive and false negative immunoassay test results depending on assay principles and monoclonal antibodies used in the assay system.
Specifications:
| Target | Human anti-mouse IgG/IgM |
|---|---|
| Species | Human |
| Method | Sandwich ELISA |
| Tests Per Kit | 96 tests |
| Detection | Colorimetric |
| Sensitivity / LLOD | 2 ng/mL |
| Dynamic Range | 0 - 1500 ng/mL |
| Total Incubation Time | 1 hour, 50 minutes |
| Sample Type | Serum, plasma |
| Sample Volume | 50 µL |
| Storage Temperature | 2-8 °C |