Clinical Chemistry
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Clinical Chemistry 51: 1093-1101, 2005; 10.1373/clinchem.2004.044305
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(Clinical Chemistry. 2005;51:1093-1101.)
© 2005 American Association for Clinical Chemistry, Inc.

Special Report

Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

Chantal Tse1,a,2, Didier Brault1,2, Joseph Gligorov2,2, Martine Antoine3,2, Rainer Neumann4, Jean-Pierre Lotz2,2 and Jacqueline Capeau1,2

1 Laboratoire de Biochimie, 2 Service d’Oncologie, and 3 Service d’Anatomopathologie, Hôpital Tenon, Paris, France.
4 Bayer Vital GmbH, Leverkusen, Germany.

aAddress correspondence to this author at: Laboratoire de Biochimie, Hôpital Tenon, 4 rue de la Chine, Paris 75020, France. Fax 33-01-5601-6017; e-mail chantal.tse{at}wanadoo.fr.

Background: HER-2 status is generally determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Both methods are only semiquantitative, require a tumor sample, and can be difficult to reproduce. We compared these methods with 2 quantitative approaches, one measuring HER-2 gene copy number in tissue by real-time quantitative PCR (qPCR), and the other measuring shed HER-2 protein in serum by ELISA in patients with metastatic disease.

Methods: We analyzed 52 cases of metastatic breast cancer for which both serum collected at the diagnosis of metastasis and stored primary breast tumor specimens were available. The within- and between-run imprecision of real-time qPCR and ELISA were evaluated according to Clinical and Laboratory Standards Institute (formerly known as NCCLS) recommendations. Concordance among the 4 methods was assessed by calculating the {kappa} statistic and its 95% confidence interval (95% CI).

Results: The CVs for within- and between-run imprecision were both <10% with qPCR and ELISA. There was good agreement of results between qPCR and IHC ({kappa} = 0.81; 95% CI, 0.64–0.99), qPCR and FISH ({kappa} = 0.77; 95% CI, 0.58–0.96), ELISA and IHC ({kappa} = 0.65; 95% CI, 0.41–0.89); and ELISA and FISH ({kappa} = 0.69; 95% CI, 0.46–0.92).

Conclusions: Measurements of HER-2 gene expression by qPCR and of serum HER-2 protein by ELISA are highly reproducible approaches for determining HER-2 status in metastatic breast cancer. In addition, ELISA eliminates the need for biopsy.




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