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Clinical Chemistry and Laboratory Medicine (CCLM)

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

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Determination of median levels of the free β subunit of human chorionic gonadotropin in women from mainland China using a new time-resolved fluoroimmunoassay

Yong-Ping Tang1 / Ying-Song Wu1 / Ai-Hua Yin2 / Wei-Wen Xu1 / Peng-Hui Yuan3 / Ming Li1

1School of Biotechnology, Southern Medical University, Guangzhou, Guangdong Province, P.R. China

2Prenatal Diagnosis Center, Guangdong Women and Children Hospital and Health Institute, Guangzhou, Guangdong Province, P.R. China

3Guangzhou Darui Antibody Engineering and Technology Co., Ltd, Guangzhou, Guangdong Province, P.R. China

Corresponding author: Prof. Ming Li, School of Biotechnology, Southern Medical University, 1838 Northern Guangzhou Ave, Guangzhou, 510515, P.R. China Phone/Fax: +86 20 6164 8550,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 1, Pages 109–114, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.005, November 2009

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Background: The free β subunit of human chorionic gonadotropin (free β-hCG) is an important serum marker for biochemical screening. Its weekly median value varies with ethnicity. Most of the fluorometers for lanthanide chelates are designed for the detection of signals from europium (Eu3+) chelates only.

Methods: We developed a two-site, one-step assay using two monoclonal antibodies (MAbs) against free β subunit and β subunit with Eu3+ chelates as labels. Using the present assay, we evaluated 24,634 normal serum samples in Chinese pregnant women during 8–20 weeks of gestation.

Results: The detection limit using this assay was <0.05 ng/mL. The within-run and between-run imprecision was <6.0% and 7.0% using control material. Free β-hCG concentrations measured using the current assay in 999 maternal serum samples correlated well with those obtained by samarium (Sm3+)-labeled DELFIA free hCGβ assay (r=0.987). The medians for 8–20 weeks for maternal serum free β-hCG were higher in the women from mainland China compared to reports from other countries.

Conclusions: The present assay is suitable for use in biochemical screening of women in mainland China. Our study on the median concentrations of free β-hCG will help establish reference values that are specific for ethnic populations from the Chinese mainland. These will be useful for studying the importance of ethnic factors in biochemical screening.

Clin Chem Lab Med 2010;48:109–14.

Keywords: Down syndrome; free β subunit of human chorionic gonadotropin; median; prenatal screening; time-resolved fluoroimmunoassay

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