Improvement and multicenter evaluation of the analytical performance of an automated chemiluminescent immunoassay for alpha fetoprotein

Kaori Morota, Makoto Komori, Ryo Fujinami, Koji Yamada, Kageaki Kuribayashi, Naoki Watanabe, Lori J. Sokoll, Debra Elliott, Daniel W. Chan, Frans Martens, Annemieke C. Heijboer, Marinus A. Blankenstein, Stefan J. Hershberger, Zachary A. Pfeiffer, Shyam V. Vaidya, Barry L. Dowell

Research output: Contribution to journalArticle

Abstract

Background: A new ARCHITECT® alpha fetoprotein (AFP) assay was developed to improve the linearity at the upper end of the calibration curve and to enhance other performance characteristics. In addition, this reformulation eliminated the possibility of falsely depressed samples at high AFP concentrations. The purpose of this study was to evaluate its analytical performance at multiple sites. Methods: The assay configuration, the diluent formulation, and the manufacturing process were redesigned. Analytical performance was evaluated at Abbott Laboratories, Sapporo Medical University, VU University Medical Center, and Johns Hopkins University. Results: The limit of quantitation of the assay was 1.00-1.30 ng/mL. Total precision (%CV) across the assay range varied between 1.41 and 3.52. The assay was linear from 1.19 to 2535 ng/mL, and the range of the assay was expanded from 200 ng/mL to 2000 ng/mL. Comparison of this assay with the on-market ARCHITECT, AxSYM, ADVIA Centaur, DxI, AIA-1800, and E 170 systems yielded regression slopes of 0.91-1.08 and correlation coefficients of ≥0.99 for serum samples. No falsely depressed results were observed in 174 serum samples with AFP concentrations of 2018-1,196,856 ng/mL and in a spiked sample containing up to 10 mg/mL of purified AFP. Conclusions: The new AFP assay has improved an issue of the on-market ARCHITECT AFP assay and demonstrated excellent assay performance.

Original languageEnglish (US)
Pages (from-to)39-46
Number of pages8
JournalInternational Journal of Biological Markers
Volume27
Issue number1
DOIs
StatePublished - Jan 2012

Keywords

  • AFP
  • Chemiluminescent microparticle immunoassay
  • Hepatocellular carcinoma
  • Nonseminomatous testicular cancer
  • Prenatal testing

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Oncology
  • Clinical Biochemistry
  • Cancer Research

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  • Cite this

    Morota, K., Komori, M., Fujinami, R., Yamada, K., Kuribayashi, K., Watanabe, N., Sokoll, L. J., Elliott, D., Chan, D. W., Martens, F., Heijboer, A. C., Blankenstein, M. A., Hershberger, S. J., Pfeiffer, Z. A., Vaidya, S. V., & Dowell, B. L. (2012). Improvement and multicenter evaluation of the analytical performance of an automated chemiluminescent immunoassay for alpha fetoprotein. International Journal of Biological Markers, 27(1), 39-46. https://doi.org/10.5301/JBM.2011.8738