Falsely decreased human chorionic gonadotropin (hCG) results due to increased concentrations of the free β subunit and the β core fragment in quantitative hCG assays

Clinical Chemistry

Volumn 56, Issue 12, 2010, Pages 1839-1844

  Grenache, David G ^a   Greene, Dina N ^a   Dighe, Anand S ^b   Fantz, Corinne R ^c   Hoefner, Daniel ^d   McCudden, Christopher ^e   Sokoll, Lori ^f   Wiley, Carmen L ^g   Gronowski, Ann M ^h  

^a UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d MARSHFIELD CLINIC   (United States)

^e UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^f DEPARTMENT OF PATHOLOGY   (United States)

^g SACRED HEART MEDICAL CENTER   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHORIONIC GONADOTROPIN; CHORIONIC GONADOTROPIN BETA SUBUNIT; CHORIONIC GONADOTROPIN BETA SUBUNIT CORE FRAGMENT; UNCLASSIFIED DRUG;

ARTICLE; DEVICE; FALSE NEGATIVE RESULT; FEMALE; HORMONE BLOOD LEVEL; HORMONE DETERMINATION; HORMONE URINE LEVEL; HUMAN; IMMUNOASSAY; QUANTITATIVE ANALYSIS;

CHORIONIC GONADOTROPIN; CHORIONIC GONADOTROPIN, BETA SUBUNIT, HUMAN; FALSE NEGATIVE REACTIONS; FEMALE; HUMANS; IMMUNOASSAY; NEOPLASMS; PEPTIDE FRAGMENTS; PREGNANCY; REFERENCE VALUES;

EID: 78649889996     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2010.143479     Document Type: Article

References (23)

1. Cole LA, Kardana A, Park SY, Braunstein GD. The deactivation of hCG by nicking and dissociation. J Clin Endocrinol Metab 1993;76:704-10.
2. Alfthan H, Haglund C, Dabek J, Stenman UH. Concentrations of human choriogonadotropin, its beta-subunit, and the core fragment of the betasubunit in serum and urine of men and nonpregnant women. Clin Chem 1992;38:1981-7.
3. Kovalevskaya G, Birken S, Kakuma T, O'Connor JF. Early pregnancy human chorionic gonadotropin (hCG) isoforms measured by an immunometric assay for choriocarcinoma-like hCG. J Endocrinol 1999;161:99-106. (Pubitemid 29170196)
4. Kato Y, Braunstein GD. Beta-core fragment is a major form of immunoreactive urinary chorionic gonadotropin in human pregnancy. J Clin Endocrinol Metab 1988;66:1197-201.
5. McChesney R, Wilcox AJ, O'Connor JF, Weinberg CR, Baird DD, Schlatterer JP, et al. Intact HCG, free HCG beta subunit and HCG beta core fragment: longitudinal patterns in urine during early pregnancy. Hum Reprod 2005;20:928-35. (Pubitemid 40667837)
6. Stenman U-H, Tiitinen Alfthan H, Valmu L. The classification, functions and clinical use of different isoforms of hCG. Hum Reprod Update 2006; 12:769-84. (Pubitemid 44605514)
7. Stenman U-H, Alfthan H, Hotakainen K. Human chorionic gonadotropin in cancer. Clin Biochem 2004;37:549-61.
8. Lempiainen A, Stenman UH, Blomqvist C, Hotakainen K. Free beta-subunit of human chorionic gonadotropin in serum is a diagnostically sensitive marker of seminomatous testicular cancer. Clin Chem 2008;54:1840-3.
9. Gronowski AM, Cervinski MA, Stenman U-H, Woodworth A, Ashby L, Scott MG. False negative results in point-of-care qualitative hCG devices due to excess hCG beta core fragment. Clin Chem 2009;55:1389-94.
10. Gronowski AM, Powers M, Stenman U-H, Ashby LA, Scott M. False negative results from point-ofcare qualitative devices due to excess hCG beta core fragment varies with device lot number. Clin Chem 2009;55:1885-6.
11. Bristow A, Berger P, Bidart J-M, Birken S, Norman R, Stenman U-H, et al. Establishment, value assignment, and characterization of new WHO reference reagents for six molecular forms of human chorionic gonadotropin. Clin Chem 2005;51: 177-82.
12. Whittington J, Fantz CR, Gronowski AM, Mc-Cudden C, Mullins R, Sokoll L, et al. The analytical specificity of human chorionic gonadotropin assays determined using WHO international reference reagents. Clin Chim Acta 2010;411:81-5.
13. Sturgeon CM, Berger P, Bidart J-M, Birken S, Burns C, Norman RJ, et al. Differences in recognition of the 1st WHO international reference reagents for hCG-related isoforms by diagnostic immunoassays for human chorionic gonadotropin. Clin Chem 2009;55:1484-91.
14. College of American Pathologists. Ligand (general) K/KN: a survey. Northfield (IL): College of American Pathologists; 2008.
15. Madersbacher S, Berger P. Antibodies and immunoassays. Methods 2000;21:41-50.
16. Khazaeli MB, Buchina ES, Pattillo RA, Soong SJ, Hatch KD. Radioimmunoassay of free beta-subunit of human chorionic gonadotropin in diagnosis of high-risk and low-risk gestational trophoblastic disease. Am J Obstet Gynecol 1989; 160:444-917.
17. Berger P, Sturgeon C, Bidart JM, Paus E, Gerth R, Niang M, et al. The ISOBM TD-7 workshop on hCG and related molecules: towards useroriented standardization of pregnancy and tumor diagnosis: assignment of epitopes to the three-dimensional structure of diagnostically and commercially relevant monoclonal antibodies directed against human chorionic gonadotropin and derivatives. Tumour Biol 2002;23:1-38.
18. Grenache DG, Moller KA, Groben PM. Endometrial adenocarcinoma associated with elevated serum concentrations of the free b subunit of human chorionic gonadotropin. Am J Clin Pathol 2004;121:748-53.
19. Cole LA, Khanlian SA. The need for a quantitative urine hCG assay. Clin Biochem 2009;42:676-83.
20. Klee GG. Interferences in hormone immunoassays. Clin Lab Med 2004;24:1-18.
21. Ajubi NE, Nijholt N, Wolthuis A. Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche). Clin Chem Lab Med 2005; 43:68-70. (Pubitemid 40287503)
22. Gronowski AM, Grenache DG. Characterization of the hCG variants recognized by different hCG immunoassays: an important step toward standardization of hCG measurements. Clin Chem 2009;55:1447-9.
23. Gronowski AM. Clinical assays for human chorionic gonadotropin: what should we measure and how? Clin Chem 2009;55:1900-4.