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Clinical Chemistry 55: 1389-1394, 2009. First published April 24, 2009; 10.1373/clinchem.2008.121210
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(Clinical Chemistry. 2009;55:1389-1394.)
© 2009 American Association for Clinical Chemistry, Inc.

Endocrinology and Metabolism

False-Negative Results in Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Due to Excess hCGβ Core Fragment

Ann M. Gronowski1,a, Mark Cervinski1, Ulf-Håkan Stenman2, Alison Woodworth3, Lori Ashby4 and Mitchell G. Scott1

1 Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO; 2 Department of Clinical Chemistry, Helsinki University Central Hospital, Helsinki, Finland; 3 Department of Pathology, Vanderbilt University, Nashville, TN; 4 Barnes-Jewish Hospital, St. Louis, MO.

aAddress correspondence to this author at: Washington University School of Medicine, Department of Pathology and Immunology, Box 8118, 660 S. Euclid, St. Louis, MO 63110. Fax 314-362-1461; e-mail gronowski{at}wustl.edu.

Background: During pregnancy, human chorionic gonadotropin (hCG) immunoreactivity in urine consists of intact hCG as well as a number of hCG variants including the core fragment of hCGβ (hCGβcf). We identified 3 urine specimens with apparent false-negative results using the OSOM® hCG Combo Test (Genzyme Diagnostics) qualitative hCG device and sought to determine whether an excess of 1 of the fragments or variants might be the cause of the interference.

Methods: We measured concentrations of hCG variants in the urine from 3 patients with apparent false-negative hCG results. Purified hCG variants were added to urines positive for hCG and tested using the OSOM, ICON® 25 hCG (Beckman Coulter), and hCG Combo SP® Brand (Cardinal Health) devices.

Results: Dilution of these 3 urine samples resulted in positive results on the OSOM device. Quantification of hCG variants in each of the 3 patient urine specimens demonstrated that hCGβcf occurred in molar excess of intact hCG. Addition of purified hCGβcf to hCG-positive urines caused false-negative hCG results using the OSOM and ICON qualitative urine hCG devices.

Conclusions: Increased concentrations of hCGβcf can cause false-negative results on the OSOM and ICON qualitative urine hCG devices. .




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Home page
 Clin. Chem.Home page
A. M. Gronowski, M. Powers, U. H. Stenman, L. Ashby, and M. G. Scott
False-Negative Results from Point-of-Care Qualitative Human Chorionic Gonadotropin (hCG) Devices Caused by Excess hCG{beta} Core Fragment Vary with Device Lot Number
Clin. Chem., October 1, 2009; 55(10): 1885 - 1886.
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