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Issue 2, 2015
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Analytical validation of a Biochip prototype for integrated analysis of AFP-IgM and SCCA-IgM serum biomarkers in patients with liver cirrhosis and hepatocellular carcinoma

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Abstract

Aim: this study evaluates the analytical and clinical performances of a new technology, CompleXima HCC Biochip, for the simultaneous serum measurement of alpha-fetoprotein-IgM (AFP-IgM) and squamous cell carcinoma antigen-IgM (SCCA-IgM). Methods: AFP- and SCCA-IgM were measured by both ELISA and CompleXima HCC Biochip in 39 blood donors and in 174 patients (102 liver cirrhosis – LC – and 72 hepatocellular carcinoma – HCC). Results: the intra-assay coefficients of variation were lower than 12% and the inter-assay variations comprised between 14% and 21%. The linearity interval for the CompleXima HCC Biochip was 50–300 AU mL−1 for AFP-IgM and SCCA-IgM. The comparison between the prototype and the ELISA test was studied by using the Bland–Altman method and Passing–Bablok regression analyses. Passing–Bablok showed that the Biochip under-estimated AFP-IgM (Intercept A: −165.06; 95% CI: −313.11 to −51.32) and overestimated SCCA-IgM (Intercept A: 26.83; 95% CI: 14.47–35.86) with respect to ELISAs. Both biomarkers were higher in LC and HCC with respect to controls (p < 0.001) with no difference between LC and HCC (p = 0.864 for AFP-IgM and p = 0.214 for SCCA-IgM). The thresholds for AFP-IgM and SCCA-IgM were calculated by means of ROC curves, fixing the specificity at 95%. The sensitivity of AFP-IgM and SCCA-IgM associated with CompleXima in detecting patients with liver diseases was 47% and 46%, respectively. The combined evaluation of macrocomplexes with CompleXima in diagnosing HCC with respect to LC was associated with a sensitivity of 51.4% and a specificity of 48%. Conclusions: AFP-IgM and SCCA-IgM increase in chronic liver disease. The prototype CompleXima HCC Biochip allows their measurement with a good analytical reproducibility.

Graphical abstract: Analytical validation of a Biochip prototype for integrated analysis of AFP-IgM and SCCA-IgM serum biomarkers in patients with liver cirrhosis and hepatocellular carcinoma

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The article was received on 20 Oct 2014, accepted on 21 Nov 2014 and first published on 24 Nov 2014


Article type: Paper
DOI: 10.1039/C4AY02495H
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Citation: Anal. Methods, 2015,7, 629-637
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    Analytical validation of a Biochip prototype for integrated analysis of AFP-IgM and SCCA-IgM serum biomarkers in patients with liver cirrhosis and hepatocellular carcinoma

    M. Crescenzi, A. Tessari, A. Biasiolo, A. Padoan, A. Gallotta, G. Fassina, C. Panciatichi, O. Rossetto, P. Pontisso, D. Basso and M. Plebani, Anal. Methods, 2015, 7, 629
    DOI: 10.1039/C4AY02495H

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