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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 / Tate, Jillian R.

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Volume 43, Issue 1 (Jan 2005)


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


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


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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

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