Improvement and multicenter evaluation of the analytical performance of an automated chemiluminescent immunoassay for alpha fetoprotein
| Autor: | Lori J. Sokoll, Frans Martens, Makoto Komori, Kaori Morota, Debra J. Elliott, Zachary A. Pfeiffer, Barry L. Dowell, Annemieke C. Heijboer, Kageaki Kuribayashi, Naoki Watanabe, Daniel W. Chan, Koji Yamada, Shyam V. Vaidya, Ryo Fujinami, Stefan J. Hershberger, Marinus A. Blankenstein |
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| Přispěvatelé: | Other departments, Clinical chemistry, CCA - Disease profiling |
| Rok vydání: | 2012 |
| Předmět: |
0301 basic medicine
Cancer Research medicine.medical_specialty Carcinoma Hepatocellular Calibration curve Clinical Biochemistry Sensitivity and Specificity Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine Testicular Neoplasms Pregnancy Chemiluminescent immunoassay Internal medicine Biomarkers Tumor medicine Humans ADVIA Centaur University medical Mathematics Immunoassay Detection limit Chromatography Manufacturing process Liver Neoplasms Neoplasms Germ Cell and Embryonal 030104 developmental biology Endocrinology Oncology 030220 oncology & carcinogenesis Luminescent Measurements Immunologic Techniques Female alpha-Fetoproteins Alpha-fetoprotein |
| Zdroj: | Morata, 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, vol. 27, no. 1, pp. 39-46 . https://doi.org/10.5301/JBM.2011.8738 International journal of biological markers, 27(1), 39-46. Wichtig Publishing International Journal of Biological Markers, 27(1), 39-46. Wichtig Publishing |
| ISSN: | 0393-6155 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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