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For hours, walk-ins and appointments.Synonyms
- HAMA
Expected 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.
Related Documents
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
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.
Storage Instructions
Freeze.
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) |
Causes for Rejection
Nonserum specimen; gross lipemia
Test Details
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.
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.
Reference Interval
0−74 ng/mL
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
Footnotes
1. Schroff RW, Foon KA, Beatty SM, Oldham, RK, Morgan AC Jr. Human anti-murine immunoglobulin responses in patients receiving monoclonal antibody therapy. Cancer Res. 1985 Feb;45(2):879-885.3871353
2. Hasholzner U, Stieber P, Meier W, Lamerz R. Value of HAMA-determination in clinical practice-an overview. Anticancer Res. 1997 Jul-Aug;17(4B):3055-3058.9329600
3. Courtenay-Luck NS, Epenetos AA, Moore R, et al. Development of primary and secondary immune responses to mouse monoclonal antibodies used in the diagnosis and therapy of malignant neoplasms. Cancer Res. 1986 Dec;46(12 Pt.1): 6489-6493.2430699
4. Heiss MM, Murawa P, Koralewski P, et al. The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial. Int J Cancer. 2010 Nov 1;127(9):2209-2221.20473913
5. Sabbatini P, Dupont J, Aghajanian C, et al. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-5510.17000686
6. Sakahara H, Saga T, Onodera H, et al. Anti-murine antibody response to mouse monoclonal antibodies in cancer patients. Jpn J Cancer Res. 1997 Sep;88(9):895-899.9369938
7. Zbar AP, Thomas H, Wilkinson RW, et al. Immune responses in advanced colorectal cancer following repeated intradermal vaccination with the anti-CEA murine monoclonal antibody, PR1A3: results of a phase I study. Int J Colorectal Dis. 2005 Sep;20(5):403-414.15864608
8. DeNardo GL, Bradt BM, Mirick GR, DeNardo S. Human antiglobulin response to foreign antibodies: therapeutic benefit? Cancer Immunol Immunother. 2003 May;52(5):309-316.12700946
9. Azinovic I, DeNardo GL, Lamborn KR, et al. Survival benefit associated with human anti-mouse antibody (HAMA) in patients with B-cell malignancies. Cancer Immunol Immunother. 2006 Dec;55(12):1451-1458.16496145
10. Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-1045.24952307
11. Gordon AN, Schultes BC, Gallion H, et al. CA125-and tumor-specific T-cell responses correlate with prolonged survival in oregovomab-treated recurrent ovarian cancer patients. Gynecol Oncol. 2004 Aug;94(2):340-351.15297171
12. Möbus VJ, Baum RP, Bolle M, et al. Immune responses to murine monoclonal antibody-B43.13 correlate with prolonged survival of women with recurrent ovarian cancer. Am J Obstet Gynecol. 2003 Jul;189(1):28-36.12861134
13. Ott MG, Marme F, Moldenhauer G, et al. Humoral response to catumaxomab correlates with clinical outcome: results of the pivotal phase II/III study in patients with malignant ascites. Int J Cancer. 2012 May 1;130(9):2195-2203.21702044
14. Boscato LM, Stuart MC. Heterophilic antibodies: A problem for all immonoassays. Clin Chem. 1988 Jan; 34(1):27-33.3338181
15. Klee GG. Human anti-mouse antibodies. Arch Pathol Lab Med. 2000 Jun;124(6):921-923.10835540
16. ZEUS ELISA HAMA IgG Test System (R2806) Package Insert; 2/19/2016.
17. La Fontaine GS, Hansen HJ, Weiss BF, et al. Enzyme immunoassay for the detection of circulating immunoglobulins in human to mouse monocolonal antibody (HAMA). Presented at the Third International Conference of Monocolonal Antibody Immunoconjugates for Cancer, San Diego, February 4-6, 1988.
References
Boscato LM, Stuart MC. Heterophilic antibodies: A problem for all immunoassays. Clin Chem. 1988 Jan; 34(1):27-33. 3338181
Dillman RO, Beauregard JC, Halpern SE, Clutter M. Toxicities and side effects associated with intravenous infusions of murine monoclonal antibodies. J Biol Response Mod. 1986 Feb; 5(1):73-84. 3514799
Kricka LJ, Schmerfeld-Pruss D, Senior M, Goodman DB, Kaladas P. Interference by human antimouse antibody in two-site immunoassays. Clin Chem. 1990 Jun; 36(6):892-894. 2192822
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 |
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