Jump to ContentJump to Main Navigation
Show Summary Details

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 / Tate, Jillian R.

12 Issues per year


IMPACT FACTOR increased in 2015: 3.017
Rank 5 out of 30 in category Medical Laboratory Technology in the 2014 Thomson Reuters Journal Citation Report/Science Edition

SCImago Journal Rank (SJR) 2015: 0.873
Source Normalized Impact per Paper (SNIP) 2015: 0.982
Impact per Publication (IPP) 2015: 2.238

Online
ISSN
1437-4331
See all formats and pricing
Volume 43, Issue 1 (Jan 2005)

Issues

Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche)

Nasser E. Ajubi
  • Department of Clinical Chemistry, Stichting KCL, Leeuwarden, The Netherlands
/ Nine Nijholt
  • Department of Clinical Chemistry, Stichting KCL, Leeuwarden, The Netherlands
/ Albert Wolthuis
  • Department of Clinical Chemistry, Stichting KCL, Leeuwarden, The Netherlands

Abstract

Ongoing demands on laboratory performance require optimization of processes. An obvious way to achieve this is to reduce manual labor in favor of automated methods. We describe the validation of an automated quantitative urine human chorionic gonadotropin (hCG) analysis on the Roche Modular E170 analyzer to replace the manual qualitative pregnancy test in urine. At urine hCG concentrations of 476, 45 and 11 U/L, we found inter-assay variation of 4.3%, 4.3% and 6.8% and average intra-assay variation of 3.0%, 2.6% and 3.0%, respectively. The analytical detection limit was 0.7 U/L. We did not detect any loss (due to degradation or adsorption) during a storage period of 5 days at 4°C or at −20°C. Recoveries of hCG in urine of a pregnant woman diluted with urine of a pre-menopausal non-pregnant woman (concentration range between 6 and 800 mU/L) were between 93% and 112% (y=0.997x−3.843, r 2=0.999). Diluting a serum sample (hCG 42,000 U/L) with urine (negative for hCG) up to 8000-fold yielded a completely linear hCG response, indicating that the assay was not affected by the urine matrix. In a correlation study with 60 urine samples (of which 10 were of male origin), we did not find any discrepancies between results for the manual pregnancy test and the hCG test on the Roche Modular E170 (using a cutoff value of 50 U/L).

Keywords: cost effectiveness; human chorionic gonadotropin (hCG); logistics; pregnancy tests; urinalysis

References

  • 1

  • 2

  • 3

  • 4

  • 5

  • 6

  • 7

About the article

Corresponding author: Albert Wolthuis, Department of Clinical Chemistry, Stichting KCL, P.O. Box 850, 8901 BR Leeuwarden, The Netherlands Fax: +31-58-2882227,


Received: August 6, 2004

Accepted: October 5, 2004

Published in Print: 2005-01-01


Citation Information: Clinical Chemical Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2005.010. Export Citation

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
S. Nickmans, P. Vermeersch, J. Van Eldere, and J. Billen
Acta Clinica Belgica, 2014, Volume 69, Number 4, Page 277
[2]
Laurence A. Cole and Sarah A. Khanlian
Clinical Biochemistry, 2009, Volume 42, Number 7-8, Page 676
[3]
Tze-Kiong Er, Li-Yu Tsai, Ruiz Ginés MA, Bai-Hsiun Chen, and Yuh-Jyh Jong
The American Journal of Emergency Medicine, 2008, Volume 26, Number 1, Page 103
[4]
JoDell Whittington, Corinne R. Fantz, Ann M. Gronowski, Christopher McCudden, Richard Mullins, Lori Sokoll, Carmen Wiley, Andy Wilson, and David G. Grenache
Clinica Chimica Acta, 2010, Volume 411, Number 1-2, Page 81
[5]
M. Fátima Reis, Pedro Aniceto, Pedro Aguiar, Filipa Simão, and Susana Segurado
International Journal of Hygiene and Environmental Health, 2007, Volume 210, Number 3-4, Page 419
[6]
Laurence A Cole
Expert Review of Molecular Diagnostics, 2009, Volume 9, Number 1, Page 51

Comments (0)

Please log in or register to comment.
Log in