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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

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Volume 50, Issue 4


The hCG assay or pregnancy test

Laurence A. Cole
  • USA hCG Reference Service, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM, USA
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Published Online: 2011-12-07 | DOI: https://doi.org/10.1515/cclm.2011.808


This review examines human chorionic gonadotropin (hCG) or pregnancy tests from multiple perspectives. It first investigates the molecule hCG and shows that the term represents five independent molecules differing in carbohydrate and meric structure that share a common amino acid sequence. The review goes on to show that multiple degradation produces also the need to be tested for an hCG or pregnancy test to be optimally efficient. The review then carefully examines the literature showing the sensitivity and specificity of automated laboratory tests. Point-of-care pregnancy tests are then investigated along with over-the-counter pregnancy tests. Appropriate detection of hyperglycosylated hCG, nicked hCG, nicked hCG missing the β-subunit C-terminal peptide and nicked hyperglycosylated hCG is a limitation on all pregnancy tests. In the opinion of the author, just one automated laboratory test, the Siemen’s Immulite, one point-of-care test, the Beckman-Coulter Icon 25, and one brand of over-the-counter device, First Response, are suitable for early pregnancy detection and possibly other applications.

Keywords: hCG; hCG test; hyperglycosylated hCG; pregnancy; pregnancy test

About the article

Corresponding author: Laurence A. Cole, PhD, USA hCG Reference Service Department of Obstetrics and Gynecology, MSC10 4410 1, University of New Mexico, Albuquerque, NM 87131, USA

Received: 2011-09-12

Accepted: 2011-11-09

Published Online: 2011-12-07

Published in Print: 2012-04-01

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 50, Issue 4, Pages 617–630, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm.2011.808.

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