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

Abstract

In squamous cell carcinoma, squamous cell carcinoma antigen levels are often elevated. This multi-center study evaluated the technical performance of a new Elecsys Ò 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 2.3 ng/mL (95% confidence interval: 1.9-3.8; European cohort, n = 153) and 2.7 ng/mL (95% confidence interval: 2.2-3.3; Chinese cohort, n = 146). Strongest differential diagnosis results were observed for cervical squamous cell carcinoma: receiver operating characteristic analysis showed that squamous cell carcinoma antigen levels (2.9 ng/mL cut-off) differentiate cervical squamous cell carcinoma (n = 127) from apparently healthy females (n = 286; area under the curve: 86.2%; 95% confidence interval: 81.8-90.6; sensitivity: 61.4%; specificity: 95.6%), benign diseases (n = 187; area under the curve: 86.3%; 95% confidence interval: 81.2-91.3; sensitivity: 61.4%; specificity: 95.0%), and other cervical cancers (n = 157; area under the curve: 78.9%; 95% confidence interval: 70.8-87.1; 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.

Evaluation of 2 Commercially Systems for Detection of Serum Squamous Cell Carcinoma Antigen in Pan Squamous Cell Carcinoma

“…[15][16][17] At present, few studies of serum SCCA have been reported in various types of pan squamous cell cancer and the difference between different detect system remains to be clarified. Although Holdenrieder et al study 13 evaluated the clinical value of biomarker As a first step, we evaluated the method's precision using the controls provided by the manufacturer. The precision studies showed the accuracy of both instruments with the control values within the specified range (<10%).…”

“… 15 - 17 At present, few studies of serum SCCA have been reported in various types of pan squamous cell cancer and the difference between different detect system remains to be clarified. Although Holdenrieder et al study 13 evaluated the clinical value of biomarker for the differential diagnosis of squamous cell carcinoma of cervical, lung, head and neck, this study did not analyze other squamous cell carcinomas. In the present study, Abbott I2000 and Roche e 602 detection systems were the first time compared among various squamous cell carcinomas, including squamous cell carcinoma of NPC, head and neck, esophageal, lung, bladder and cervical.…”

Diagnostic value analysis of combined detection of Trx, CYFRA21-1 and SCCA in lung cancer

“…The oxidative active amino acid composition of Trx is Cys-Gly-Pys-Cys, and Trx can catalyze the redox reaction and also maintain intracellular homeostasis, regulate apoptosis and resist oxidative stress response under biological functions (11). A number of studies have demonstrated that the expression of Trx is increased in a variety of malignant tumors, such as gastric, breast, liver, lung, rectal and cervical cancers (7,12), indicating that Trx is closely related to malignant tumors. It was found in related studies that Trx can inhibit apoptosis of tumor cells, promote cell proliferation and disturb normal cell cycle (13).…”

“…Therefore, CYFRA21-1 is considered as one of the best tumor markers for detecting lung cancer (6). Serum squamous cell carcinoma antigen (SCCA) is a tumor-associated antigen, and its levels in serum and specificity are higher in lung cancer patients (7). No lung cancer marker with good specificity and sensitivity has been found yet.…”

The kinetic profile and clinical implication of SCC-Ag in squamous cervical cancer patients undergoing radical hysterectomy using the Simoa assay: a prospective observational study

“…Currently, the most widely used SCC-Ag assay in clinical settings is proposed by Abbott on the Architect instrument (Abbott Laboratories, Abbott Park, IL, USA) [7,8]. SCC-Ag assays are also available on other wellknown platforms, such as the Elecsys® SCC assay used on the Roche Elecsys and cobase analyzer (Roche Diagnostics, China) [9].…”