Analytical assessment of the novel Maglumi squamous cell carcinoma antigen (SCCA) immunoluminometric assay

Background: The demand for routine measurement of squamous cell carcinoma antigen (SCCA) is rapidly increasing in clinical laboratories, due to the central role that this biomarker plays in staging and monitoring patients with various forms of squamous cell carcinomas (SCCs). Methods: The present analytical evaluation of Maglumi SCCA was aimed to assess the imprecision, linearity and comparability against a widely used technique. Results: The intra-and inter-assay imprecision was comprised between 2.6-4.2% and between 5.0-7.3%, respectively. The linearity of the test was excellent in the range of SCC values comprised between 1.0 and 18.0 ng/mL (r=0.998; P<0.001). A highly significant correlation was observed between Maglumi SCCA and BRAHMS Kryptor SCC in the range of values comprised between 0.44 and 15.18 ng/mL (r=0.960; P<0.001). The mean bias was 0.79 ng/mL (95% CI, 0.61-0.97) and the diagnostic agreement at the respective diagnostic cut-offs was 95%. Conclusions: The results of this study confirm that Maglumi SCCA may be regarded as a suitable alternative to Kryptor SCC for routine and fully-automated assessment of SCCA in clinical laboratories.