Multicenter evaluation of the Elecsys® CA 125 II assay

Habil W. Hubl, D. W. Chan, H. E. Van Ingen, H. Miyachi, R. Molina, X. Filella, L. Pitzel, A. Ruibal, J. C. Rymer, G. Bagnard, I. Domke

Research output: Contribution to journalArticle

Abstract

The technical performance and clinical usefulness of the newly developed Elecsys® CA 125 II assay (Boehringer Mannheim) was evaluated in a multicanter study. Imprecision studies were carried out using control sera and human pool sera with CA 125 concentrations from 11 to 1026 U/ml. Within-run CVs between 0.7 to 4.8% (median 1.7%) and between-day CVs between 2.4 to 10.9% (median 5.7%) were found. Method comparison studies with ENzymun-Test® CA 125 II carried out in four laboratories yielded slopes between 0.94 to 1.07 and intercepts < 3 U/ml. A good comparability of the Elecsys® CA 125 II assay was also found with one MEIA and the Centocor' IRMA. For a second MEIA and a second IRMA the slopes were 1.23 and 1.42, and the corresponding correlation coefficients were 0.987 and 0.977, respectively. The ELecsys® CA 125 II concentrations are clearly related to the tumor stage of avarian carcinoma patients. The maximum of diagnostic efficiency of ovarian carcinoma patients compared with patients of benign gynecological diseases is reached at 150 U/ml with a specificity of 93% and a sensitivity of 69%. Follow-up studies of avarian carcinoma patients reflect the status of the disease and the effect of various therapeutic applications. The technical and clinical evaluation of the Elecsys® CA 125 II assay show a superior analytical performance with a broad measuring range up to 5000 U/ml and a short measuring time of 18 minutes.

Original languageEnglish (US)
Pages (from-to)2727-2733
Number of pages7
JournalAnticancer Research
Volume19
Issue number4 A
StatePublished - Aug 30 1999

Keywords

  • CA 125
  • Elecsys®
  • Ovarian carcinoma
  • Tumor marker

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Hubl, H. W., Chan, D. W., Van Ingen, H. E., Miyachi, H., Molina, R., Filella, X., Pitzel, L., Ruibal, A., Rymer, J. C., Bagnard, G., & Domke, I. (1999). Multicenter evaluation of the Elecsys® CA 125 II assay. Anticancer Research, 19(4 A), 2727-2733.