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Research ArticleClinical Studies

Evaluation of a Manual ELISA Kit for Determination of HER2/neu in Serum of Breast Cancer Patients

ANNE-SOPHIE GAUCHEZ, NADIA RAVANEL, DANIÈLE VILLEMAIN, FRANÇOIS-XAVIER BRAND, DOMINIQUE PASQUIER, RAOUL PAYAN and MIREILLE MOUSSEAU
Anticancer Research September 2008, 28 (5B) 3067-3073;
ANNE-SOPHIE GAUCHEZ
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  • For correspondence: ASGauchez@chu-grenoble.fr
NADIA RAVANEL
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DANIÈLE VILLEMAIN
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FRANÇOIS-XAVIER BRAND
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DOMINIQUE PASQUIER
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RAOUL PAYAN
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MIREILLE MOUSSEAU
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Abstract

Background: Our aim was to conduct an analytical validation in a routine laboratory setting of the cerb-B2/c-neu ELISA assay kit from Calbiochem® used to measure the extracellular domain (ECD) of HER2/neu in the serum of breast cancer patients. Materials and Methods: The evaluation was based on three different production lots used in a routine laboratory setting. The reference value was based on a population of 217 patients with breast cancer not overexpressing HER2. Results: The detection limit, below that given by the manufacturer, was 0.34 ng ml-1 and the quantification limit was 0.90 ng ml-1. Reproducibility and repeatability were at least 95%, precision coefficients of variation varied between 6 and 8.5% and trueness measured by dilution tests and the standard additions method varied between 97 and 107% . The threshold was estimated at 5 ng ml-1. Conclusion: This technique presents satisfactory levels of accuracy for routine laboratory use.

  • HER2/neu ECD
  • breast carcinoma
  • tumor marker
  • trastuzumab
  • HER2

Footnotes

  • Received March 20, 2008.
  • Revision received June 6, 2008.
  • Accepted June 16, 2008.
  • Copyright© 2008 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved
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Anticancer Research: 28 (5B)
Anticancer Research
Vol. 28, Issue 5B
September-October 2008
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Evaluation of a Manual ELISA Kit for Determination of HER2/neu in Serum of Breast Cancer Patients
ANNE-SOPHIE GAUCHEZ, NADIA RAVANEL, DANIÈLE VILLEMAIN, FRANÇOIS-XAVIER BRAND, DOMINIQUE PASQUIER, RAOUL PAYAN, MIREILLE MOUSSEAU
Anticancer Research Sep 2008, 28 (5B) 3067-3073;

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Evaluation of a Manual ELISA Kit for Determination of HER2/neu in Serum of Breast Cancer Patients
ANNE-SOPHIE GAUCHEZ, NADIA RAVANEL, DANIÈLE VILLEMAIN, FRANÇOIS-XAVIER BRAND, DOMINIQUE PASQUIER, RAOUL PAYAN, MIREILLE MOUSSEAU
Anticancer Research Sep 2008, 28 (5B) 3067-3073;
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