%0 Journal Article
%T Technical and clinical performance of a new assay to detect squamous cell carcinoma antigen levels for the differential diagnosis of cervical, lung, and head and neck cancer
%A Catharina M Korse
%A Christine Engel
%A Farshid Dayyani
%A Ling Qiu
%A Pia Kasper-Sauer
%A Rafael Molina
%A Sandra Rutz
%A Stefan Holdenrieder
%A Xiuyi Zhi
%J Tumor Biology
%@ 1423-0380
%D 2018
%R 10.1177/1010428318772202
%X In squamous cell carcinoma, squamous cell carcinoma antigen levels are often elevated. This multi-center study evaluated the technical performance of a new Elecsysˋ squamous cell carcinoma assay, which measures serum squamous cell carcinoma antigen 1 and 2 levels in an equimolar manner, and investigated the potential of squamous cell carcinoma antigen for differential diagnosis of cervical, lung, and head and neck squamous cell carcinoma.Assay precision and method comparison experiments were performed across three European sites. Reference ranges for reportedly healthy individuals were determined using samples from banked European and Chinese populations. Differential diagnosis experiments determined whether cervical, lung, or head and neck cancer could be differentiated from apparently healthy, benign, or other malignant cohorts using squamous cell carcinoma antigen levels alone. Squamous cell carcinoma antigen cut-off levels were calculated based on squamous cell carcinoma antigen levels at 95% specificity. Repeatability coefficients of variation across nine analyte concentrations were ≒5.3%, and intermediate precision coefficients of variation were ≒10.3%. Method comparisons showed good correlations with Architect and Kryptor systems (slopes of 1.1 and 1.5, respectively). Reference ranges for 95th percentiles for apparently healthy individuals were 2.3ˋng/mL (95% confidence interval: 1.9每3.8; European cohort, nˋ=ˋ153) and 2.7ˋng/mL (95% confidence interval: 2.2每3.3; Chinese cohort, nˋ=ˋ146). Strongest differential diagnosis results were observed for cervical squamous cell carcinoma: receiver operating characteristic analysis showed that squamous cell carcinoma antigen levels (2.9ˋng/mL cut-off) differentiate cervical squamous cell carcinoma (nˋ=ˋ127) from apparently healthy females (nˋ=ˋ286; area under the curve: 86.2%; 95% confidence interval: 81.8每90.6; sensitivity: 61.4%; specificity: 95.6%), benign diseases (nˋ=ˋ187; area under the curve: 86.3%; 95% confidence interval: 81.2每91.3; sensitivity: 61.4%; specificity: 95.0%), and other cervical cancers (nˋ=ˋ157; area under the curve: 78.9%; 95% confidence interval: 70.8每87.1; sensitivity: 61.4%; specificity: 86.7%). Squamous cell carcinoma may also aid in the differential diagnosis of lung cancer. The Elecsys squamous cell carcinoma assay exhibited good technical performance and is suitable for differential diagnosis of cervical squamous cell carcinoma in clinical practice
%K Squamous cell carcinoma
%K immunoassay
%K cervical
%K lung
%K head
%K neck
%U https://journals.sagepub.com/doi/full/10.1177/1010428318772202