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1 College of Physicians and Surgeons of Columbia University, New York, NY 10032.
2
Institute for Biomedical Aging Research, Austrian Academy of Sciences, A6020 Innsbruck, Austria.
3
Department of Clinical Biology, Institut Gustave-Roussy, 94805 Villejuif Cedex, France.
4
Klinikum Grosshadern, University of Munich, D-81377 Munich, Germany.
5
National Institute of Biological Standards and Control, Potters Bar, Herts EN6 3QG, United Kingdom.
6
Reproductive Medicine Unit, Department of Obstetrics and Gynaecology, University of Adelaide, The Queen Elizabeth Hospital, Woodville, South Australia 5011, Australia.
7
Department of Clinical Biochemistry, Royal Infirmary, Edinburgh EH3 9YW, United Kingdom.
8
Department of Clinical Chemistry, Helsinki University Central Hospital, Helsinki 00290, Finland.
aAuthor for correspondence. Fax 212-305-1599; e-mail sb18{at}columbia.edu.
Background: The currently used standards for human chorionic gonadotropin (hCG) and its 
and ß subunits (hCG and hCGß) contain substantial amounts of contaminating variants of hCG and other impurities. Furthermore, some partially degraded forms of hCG and its subunits have become of potential clinical importance, e.g., "nicked" forms of hCG (hCGn) and hCGß (hCGßn), which contain cuts in the peptide backbone between amino acids 44–45 or 47–48 in hCGß, and a fragment of hCGß (hCGßcf) consisting of amino acids 6–40 and 55–92 bound together by disulfide bridges. The IFCC appointed a working group with the aim of preparing new standards for hCG and related substances to improve standardization of their immunoassays.
Methods: Large amounts of hCG and its subunits as well as of hCGn, hCGßn, and hCGßcf were prepared by previously developed purification methods in combination with hydrophobic interaction chromatography and reversed-phase HPLC. Each preparation was characterized on the basis of amino acid and sequence analyses, carbohydrate composition, and electrophoretic patterns. Immunoassays for relevant contaminating proteins were also performed.
Results: The major preparations were homogeneous and free of contaminating proteins. Concentrations of the final preparations were determined by amino acid analysis.
Conclusions: Calibrated in substance concentrations (mol/L) based on amino acid analyses, these preparations will facilitate improved standardization of immunoassays for hCG and its metabolites. The six preparations have now been established by the WHO as new 1st Reference Reagents for immunoassays with the following codes: hCG 99/688, hCGß 99/650, hCG 99/720, hCGn 99/642, hCGßn 99/692, and hCGßcf 99/708. In contrast to the 3rd International Standard (75/537), the clinically most important Reference Reagent for hCG (99/688) contains no hCGn and negligible amounts of free subunits.
The following articles in journals at HighWire Press have cited this article:
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  C. M. Sturgeon, P. Berger, J.-M. Bidart, S. Birken, C. Burns, R. J. Norman, U.-H. Stenman, and on behalf of the IFCC Working Group on hCG Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin Clin. Chem., August 1, 2009; 55(8): 1484 - 1491. [Abstract] [Full Text] [PDF]
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A. M. Gronowski and D. G. Grenache Characterization of the hCG Variants Recognized by Different hCG Immunoassays: An Important Step Toward Standardization of hCG Measurements Clin. Chem., August 1, 2009; 55(8): 1447 - 1449. [Full Text] [PDF]
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 S. J. Osterfeld, H. Yu, R. S. Gaster, S. Caramuta, L. Xu, S.-J. Han, D. A. Hall, R. J. Wilson, S. Sun, R. L. White, et al. Multiplex protein assays based on real-time magnetic nanotag sensing PNAS, December 30, 2008; 105(52): 20637 - 20640. [Abstract] [Full Text] [PDF]
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C. M. Sturgeon, M. J. Duffy, U.-H. Stenman, H. Lilja, N. Brunner, D. W. Chan, R. Babaian, R. C. Bast Jr., B. Dowell, F. J. Esteva, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast, and Ovarian Cancers Clin. Chem., December 1, 2008; 54(12): e11 - e79. [Abstract] [Full Text] [PDF]
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 M. R Rubin, J. P Bilezikian, S. Birken, and S. J Silverberg Human chorionic gonadotropin measurements in parathyroid carcinoma Eur. J. Endocrinol., October 1, 2008; 159(4): 469 - 474. [Abstract] [Full Text] [PDF]
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 E. P. Lin, S. Bhatt, and V. S. Dogra Diagnostic Clues to Ectopic Pregnancy1 RadioGraphics, October 1, 2008; 28(6): 1661 - 1671. [Abstract] [Full Text] [PDF]
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Z. Cao and R. Rej Are Laboratories Reporting Serum Quantitative hCG Results Correctly? Clin. Chem., April 1, 2008; 54(4): 761 - 764. [Abstract] [Full Text] [PDF]
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 I. Casella, H. Lindner, C. Zenzmaier, D. Riitano, P. Berger, and T. Costa Non-Gonadotropin-Releasing Hormone-Mediated Transcription and Secretion of Large Human Glycoprotein Hormone {alpha}-Subunit in Human Embryonic Kidney-293 Cells Endocrinology, March 1, 2008; 149(3): 1144 - 1154. [Abstract] [Full Text] [PDF]
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C. S. Sigel and D. G. Grenache Detection of Unexpected Isoforms of Human Chorionic Gonadotropin by Qualitative Tests Clin. Chem., May 1, 2007; 53(5): 989 - 990. [Full Text] [PDF]
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 U.-H. Stenman, A. Tiitinen, H. Alfthan, and L. Valmu The classification, functions and clinical use of different isoforms of HCG Hum. Reprod. Update, November 1, 2006; 12(6): 769 - 784. [Abstract] [Full Text] [PDF]
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 D. J. Handelsman The Rationale for Banning Human Chorionic Gonadotropin and Estrogen Blockers in Sport J. Clin. Endocrinol. Metab., May 1, 2006; 91(5): 1646 - 1653. [Abstract] [Full Text] [PDF]
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D. M. Bunk and M. J. Welch Characterization of a New Certified Reference Material for Human Cardiac Troponin I Clin. Chem., February 1, 2006; 52(2): 212 - 219. [Abstract] [Full Text] [PDF]
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A. Bristow, P. Berger, J.-M. Bidart, S. Birken, R. Norman, U.-H. Stenman, C. Sturgeon, and on behalf of the IFCC Working Group on hCG Establishment, Value Assignment, and Characterization of New WHO Reference Reagents for Six Molecular Forms of Human Chorionic Gonadotropin Clin. Chem., January 1, 2005; 51(1): 177 - 182. [Abstract] [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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J.-L. Frendo, J. Guibourdenche, G. Pidoux, M. Vidaud, D. Luton, Y. Giovangrandi, D. Porquet, F. Muller, and D. Evain-Brion Trophoblast Production of a Weakly Bioactive Human Chorionic Gonadotropin in Trisomy 21-Affected Pregnancy J. Clin. Endocrinol. Metab., February 1, 2004; 89(2): 727 - 732. [Abstract] [Full Text] [PDF]
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P. T.A. Borrelli, S. A. Butler, S. M. Docherty, E. M. Staite, A. L. Borrelli, and R. K. Iles Human Chorionic Gonadotropin Isoforms in the Diagnosis of Ectopic Pregnancy Clin. Chem., December 1, 2003; 49(12): 2045 - 2049. [Abstract] [Full Text] [PDF]
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U.-H. Stenman Standardization as a Private Enterprise Clin. Chem., April 1, 2003; 49(4): 535 - 536. [Full Text] [PDF]
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