Evaluation of a new immunoassay for chromogranin A measurement on the Kryptor system

Autor: R.H.P. van der Knaap, D.J. Kwekkeboom, C.R.B. Ramakers, Y.B. de Rijke
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Practical Laboratory Medicine, Vol 1, Iss , Pp 5-11 (2015)
Druh dokumentu: article
ISSN: 2352-5517
DOI: 10.1016/j.plabm.2015.03.002
Popis: Background: Chromogranin A (CgA) is a biomarker for neuroendocrine tumors (NETs). The aims of this study were to evaluate differences in measurement between the ThermoFisher Brahms CgA Kryptor assay and the CisBio assay and to investigate the influence of patient covariates. Temperature stability of CgA using both assays was determined. Design and Methods: 406 patients were analyzed for serum CgA using both assays. We performed a comparison study to determine whether several patient covariates (gender, use of protein pump inhibitors, impaired kidney function, referral department and tumor location) influenced the results. For the stability study, pooled serum samples were aliquoted and stored at different storage temperatures (room temperature, 4 °C and â20 °C) until assayed. In addition, 15 individual samples were evaluated after storage at 4 °C using the Kryptor assay. Results: Differences in measured concentrations between the assays were statistically significant. Passing & Bablok fit showed ln Y(Kryptor)=1.05 ln X(CisBio) â 0.20 with a bias of 1.0% after logarithmic transformation. Patient covariates were not associated. Patients׳ sera showed variable stability for CgA in the Kryptor assay at room temperature and 4 °C, whereas the recovery in the CisBio assay was stable at both temperatures. Conclusion: Differences in measured CgA concentration between the assays could not be explained by the investigated patient covariates. Serum should be stored at â20 °C prior to determination using the Kryptor assay. Keywords: Chromogranin A methods, Tumor markers, Temperature stability, Neuroendocrine tumors
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