This test is intended for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA)

• The presence of Rheumatoid Factor (RF) and/or heterophilic antibodies in the sample may interfere with the assay and could result in false-positive values.
• Lipemic serum samples may interfere with the assay and could result in false-positive values.

Gold serum separator (SST) tube

Immediatley following collection, mix sample by inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin 
3. Transfer to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as serum.
4. Freeze

 Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp)

Red serum vial/tube, 5 mL

1. Allow sample to clot
2. Spin
3. Transfer serum to a Transfer vial/tube with cap - 4mL (LabCorp), labelled as serum
4. Freeze

Frozen (preferred) - 3 months

Refrigerated - 24 hours

• Gross lipemia
• Non-serum specimen

Enzyme-linked immunosorbent assay (ELISA).

The ImmuSTRIP® HAMA ELISA Test System employs a control mouse polyclonal antibody as the capture antibody and a mouse anti-isotypic monoclonal IgG1 to detect HAMA. The test has been calibrated with baboon anti-mouse IgG serum. Final patient values are reported as nanograms of precipitable antibody present in the sample per mL.

0−74 ng/mL

The presence of human anti-mouse antibody (HAMA) has been associated with injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.Circulating levels of HAMA can bind to the injected IgG and reduce the efficacy of the antibody therapy. HAMA also can cause anaphylactic complications to subsequent administration of murine monoclonal IgG. Several studies have shown a correlation between HAMA status and clinical outcomes and prognosis. HAMA reactivity has been reported to occur in some individuals without known exposure to murine IgG. Such responses may be due to polyclonal rheumatoid factors, heterophilic antibodies, dietary, or other exposure. HAMA has been shown to interfere with some two-site immunometric assays utilizing murine monoclonal antibodies, resulting in both false positive or false-negative results.