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1
USA hCG Reference Service, Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM 87131.
2
Obstetrics and Gynecology, Yale University, New Haven,
CT 06510.
3
Medical Oncology, Charing Cross Hospital, London W68RF,
United Kingdom.
4
Department of Pathology, Hurley Medical Center, Flint,
MI 48501.
a Address correspondence to this author at: Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Lomas Blvd., Albuquerque, NM 87131. Fax 505-272-6385; e-mail
larry{at}hCGlab.com.
Background: Patients with trophoblastic diseases produce ordinary and irregular forms of human chorionic gonadotropin (hCG; e.g., nicked hCG, hCG missing the ß-subunit C-terminal segment, hyperglycosylated hCG, and free ß subunit) that are recognized to differing extents by automated immunometric hCG (or hCGß) assays. This has led to low or false-negative results and misdiagnosis of persistent disease. False-positive hCG immunoreactivity has also been detected, leading to needless therapy for trophoblastic diseases. Here we compare seven commonly used hCG assays.
Methods: Standards for five irregular forms hCG produced in trophoblastic diseases, serum samples from 59 patients with confirmed trophoblastic diseases, and serum samples from 12 women with previous false-positive hCG results (primarily in the Abbott AxSYM assay) were blindly tested by commercial laboratories in the Beckman Access hCGß, the Abbott AxSYM hCGß, the Chiron ACS:180 hCGß, the Baxter Stratus hCG test, the DPC Immulite hCG test, the Serono MAIAclone hCGß tests, and in the hCGß RIA.
Results: Only the RIA and the DPC appropriately detected the five irregular hCG standards. Only the Beckman, DPC, and Abbott assays gave results similar to the RIA in the patients with confirmed trophoblastic diseases (values within 25% of RIA in 49, 49, and 54 of 59 patients, respectively). For samples that were previously found to produce false-positive hCG results, no false-positive results were detected with the DPC and Chiron tests (5 samples, median <2 IU/L), but up to one-third of samples were false positive (>10 IU/L) in the Beckman (1 of 5), Serono (2 of 9), and Baxter assays (1 of 5), and the hCGß RIA (3 of 9; median for all assays, <5 IU/L). These samples, which produced false-positive results earlier in the Abbott AxSYM assay, continued to produce high values upon reassessment (median, 81 IU/L).
Conclusions: Of six frequently used hCG immunometric assays, only the DPC detected the five irregular forms of ßhCG, agreed with the RIA, and avoided false-positive results in the samples tested. This assay, and similarly designed assays not tested here, seem appropriate for hCG testing in the diagnosis and management of trophoblastic diseases.
The following articles in journals at HighWire Press have cited this article:
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C. M. Preissner, L. A. Dodge, D. J. O'Kane, R. J. Singh, and S. K.G. Grebe Prevalence of Heterophilic Antibody Interference in Eight Automated Tumor Marker Immunoassays Clin. Chem., January 1, 2005; 51(1): 208 - 210. [Full Text] [PDF]
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P. von Lode, J. Rainaho, and K. Pettersson Quantitative, Wide-Range, 5-Minute Point-of-Care Immunoassay for Total Human Chorionic Gonadotropin in Whole Blood Clin. Chem., June 1, 2004; 50(6): 1026 - 1035. [Abstract] [Full Text] [PDF]
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U.-H. Stenman Standardization of Assays for Human Chorionic Gonadotropin Clin. Chem., May 1, 2004; 50(5): 798 - 800. [Full Text] [PDF]
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L. A. Cole, J. M. Sutton, T. N. Higgins, and G. S. Cembrowski Between-Method Variation in Human Chorionic Gonadotropin Test Results Clin. Chem., May 1, 2004; 50(5): 874 - 882. [Abstract] [Full Text] [PDF]
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S. A. Butler, S. A. Khanlian, and L. A. Cole Detection of Early Pregnancy Forms of Human Chorionic Gonadotropin by Home Pregnancy Test Devices Clin. Chem., December 1, 2001; 47(12): 2131 - 2136. [Abstract] [Full Text] [PDF]
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S. A. Butler and L. A. Cole Use of Heterophilic Antibody Blocking Agent (HBT) in Reducing False-Positive hCG Results Clin. Chem., July 1, 2001; 47(7): 1332 - 1333. [Full Text] [PDF]
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