Test Details
Methodology
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.16,17 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.
Result Turnaround Time
6 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is intended for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA).
Limitations
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.
Custom Additional Information
The presence of human anti-mouse antibody (HAMA) has been associated with injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.1-13 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.6-13 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.14,15
Specimen Requirements
Specimen
Serum
Volume
0.4 mL
Minimum Volume
0.2 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Collection Instructions
Once the serum has been separated from the clot, it may be stored at 2-8ºC for up to 24 hours. If the serum specimen cannot be tested within one day of collection, the specimen should be stored at -70ºC until tested. Serum samples are stable at -70ºC for at least three months. Freeze and thaw only once.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | Not established (stability provided by manufacturer or literature reference) |
Refrigerated | 24 hours (stability provided by manufacturer or literature reference) |
Frozen | 3 months (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Stable x1 (stability provided by manufacturer or literature reference) |
Reference Range
0−74 ng/mL
Storage Instructions
Freeze.
Causes for Rejection
Nonserum specimen; gross lipemia
References
Footnotes
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 140657 | Human Anti-mouse Antibodies | 14975-7 | 140684 | Human Anti-mouse Antibodies | ng/mL | 14975-7 |
| Order Code | 140657 | |||||
| Order Code Name | Human Anti-mouse Antibodies | |||||
| Order Loinc | 14975-7 | |||||
| Result Code | 140684 | |||||
| Result Code Name | Human Anti-mouse Antibodies | |||||
| UofM | ng/mL | |||||
| Result LOINC | 14975-7 |