Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma
Jianwei Wang,1,2,* Lili Yu,1,3,* Yulong Sun,4,* Liangming Zhang,1,3 Mingshu Tu,1,3 Liqing Cai,1,3 Xiaoqing Yin,3,5 Xiaojie Pan,1,6 Tao Wang,4 Yi Huang1,3,7,8 1Provincial Clinical College, Fujian Medical University, Fuzhou, 350001, People’s Republic of China; 2Department of Cl...
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Dove Medical Press
2021
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oai:doaj.org-article:b1ec2c7c78b5496299de8729d3f906e22021-11-07T18:42:56ZDevelopment and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma1179-1322https://doaj.org/article/b1ec2c7c78b5496299de8729d3f906e22021-11-01T00:00:00Zhttps://www.dovepress.com/development-and-evaluation-of-serum-cst1-detection-for-early-diagnosis-peer-reviewed-fulltext-article-CMARhttps://doaj.org/toc/1179-1322Jianwei Wang,1,2,* Lili Yu,1,3,* Yulong Sun,4,* Liangming Zhang,1,3 Mingshu Tu,1,3 Liqing Cai,1,3 Xiaoqing Yin,3,5 Xiaojie Pan,1,6 Tao Wang,4 Yi Huang1,3,7,8 1Provincial Clinical College, Fujian Medical University, Fuzhou, 350001, People’s Republic of China; 2Department of Clinical Laboratory, Fujian Provincial Hospital South Branch, Fuzhou, 350008, People’s Republic of China; 3Department of Clinical Laboratory, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 4Shanghai Liangrun Biomedicine Technology Limited Company, Shanghai, 200000, People’s Republic of China; 5Integrated Chinese and Western Medicine College, Fujian University of Traditional Chinese Medicine, Fuzhou, 350001, People’s Republic of China; 6Department of Thoracic Surgery, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 7Central Laboratory, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 8Center for Experimental Research in Clinical Medicine, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yi Huang; Tao Wang Email hyi8070@126.com; wangtao@microdiag.comPurpose: Our pilot study has shown that cystatin SN (CST1) protein is highly expressed in esophageal squamous cell carcinoma (ESCC) tissues. We intend to develop a chemiluminescent enzyme immunoassay (CLEIA) available for serum CST1 detection and define the diagnostic value of CST1 detection for early ESCC patients, and establish a panel of CST1 with traditional tumor markers to improve the diagnostic sensitivity for early ESCC.Methods: Detection performance of CLEIA for CST1 was evaluated by linearity, detection limit, accuracy, precision, anti-interference and stability. Diagnostic performance of CST1 for early ESCC was evaluated by detecting CST1 of 112 early ESCC, 107 esophageal benign lesions (EBL), and 151 healthy controls (HC). CEA, CYFRA21-1 and SCC-Ag were detected by chemiluminescence immunoassay (CLIA).Results: The linear range and detection limit of CLEIA for CST1 were 6.25– 400 pg/mL and 1.35 pg/mL, respectively; the average recovery rate was 102.65%; CVs of intra-batch precision and inter-batch precision were < 1/4 TEa and < 1/3 TEa, respectively; 8 interferents including 7 common interferents and CST4 had no interference on CST1 detection; stability evaluation showed good sample and reagent stability. The level and positive rate of CST1 in early ESCC group were significantly higher than those in EBL/HC groups (P< 0.05). The diagnostic sensitivity of CST1 for early ESCC was 31.25% (specificity 92.64%, AUC 0.654). The diagnostic sensitivity of traditional tumor markers ranged from 16.07% to 28.57%, at > 93.0% specificity, and SCC-Ag showed the highest AUC (0.709). Combination of CST1 and CEA, SCC-Ag exhibited the highest AUC up to 0.736 (sensitivity 49.11%, specificity 89.53%).Conclusion: CLEIA has excellent detection performance for CST1. CST1 might be a prospective serological biomarker for early diagnosis of ESCC, while combination of CST1 and CEA, SCC-Ag might improve the early diagnostic performance.Keywords: esophageal squamous cell carcinoma, cystatin SN, chemiluminescence enzyme immunoassay, methodological evaluation, early diagnosisWang JYu LSun YZhang LTu MCai LYin XPan XWang THuang YDove Medical Pressarticleesophageal squamous cell carcinomacystatin snchemiluminescence enzyme immunoassaymethodological evaluationearly diagnosisNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Management and Research, Vol Volume 13, Pp 8341-8352 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
esophageal squamous cell carcinoma cystatin sn chemiluminescence enzyme immunoassay methodological evaluation early diagnosis Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 |
| spellingShingle |
esophageal squamous cell carcinoma cystatin sn chemiluminescence enzyme immunoassay methodological evaluation early diagnosis Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Wang J Yu L Sun Y Zhang L Tu M Cai L Yin X Pan X Wang T Huang Y Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| description |
Jianwei Wang,1,2,* Lili Yu,1,3,* Yulong Sun,4,* Liangming Zhang,1,3 Mingshu Tu,1,3 Liqing Cai,1,3 Xiaoqing Yin,3,5 Xiaojie Pan,1,6 Tao Wang,4 Yi Huang1,3,7,8 1Provincial Clinical College, Fujian Medical University, Fuzhou, 350001, People’s Republic of China; 2Department of Clinical Laboratory, Fujian Provincial Hospital South Branch, Fuzhou, 350008, People’s Republic of China; 3Department of Clinical Laboratory, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 4Shanghai Liangrun Biomedicine Technology Limited Company, Shanghai, 200000, People’s Republic of China; 5Integrated Chinese and Western Medicine College, Fujian University of Traditional Chinese Medicine, Fuzhou, 350001, People’s Republic of China; 6Department of Thoracic Surgery, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 7Central Laboratory, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China; 8Center for Experimental Research in Clinical Medicine, Fujian Provincial Hospital, Fuzhou, 350001, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yi Huang; Tao Wang Email hyi8070@126.com; wangtao@microdiag.comPurpose: Our pilot study has shown that cystatin SN (CST1) protein is highly expressed in esophageal squamous cell carcinoma (ESCC) tissues. We intend to develop a chemiluminescent enzyme immunoassay (CLEIA) available for serum CST1 detection and define the diagnostic value of CST1 detection for early ESCC patients, and establish a panel of CST1 with traditional tumor markers to improve the diagnostic sensitivity for early ESCC.Methods: Detection performance of CLEIA for CST1 was evaluated by linearity, detection limit, accuracy, precision, anti-interference and stability. Diagnostic performance of CST1 for early ESCC was evaluated by detecting CST1 of 112 early ESCC, 107 esophageal benign lesions (EBL), and 151 healthy controls (HC). CEA, CYFRA21-1 and SCC-Ag were detected by chemiluminescence immunoassay (CLIA).Results: The linear range and detection limit of CLEIA for CST1 were 6.25– 400 pg/mL and 1.35 pg/mL, respectively; the average recovery rate was 102.65%; CVs of intra-batch precision and inter-batch precision were < 1/4 TEa and < 1/3 TEa, respectively; 8 interferents including 7 common interferents and CST4 had no interference on CST1 detection; stability evaluation showed good sample and reagent stability. The level and positive rate of CST1 in early ESCC group were significantly higher than those in EBL/HC groups (P< 0.05). The diagnostic sensitivity of CST1 for early ESCC was 31.25% (specificity 92.64%, AUC 0.654). The diagnostic sensitivity of traditional tumor markers ranged from 16.07% to 28.57%, at > 93.0% specificity, and SCC-Ag showed the highest AUC (0.709). Combination of CST1 and CEA, SCC-Ag exhibited the highest AUC up to 0.736 (sensitivity 49.11%, specificity 89.53%).Conclusion: CLEIA has excellent detection performance for CST1. CST1 might be a prospective serological biomarker for early diagnosis of ESCC, while combination of CST1 and CEA, SCC-Ag might improve the early diagnostic performance.Keywords: esophageal squamous cell carcinoma, cystatin SN, chemiluminescence enzyme immunoassay, methodological evaluation, early diagnosis |
| format |
article |
| author |
Wang J Yu L Sun Y Zhang L Tu M Cai L Yin X Pan X Wang T Huang Y |
| author_facet |
Wang J Yu L Sun Y Zhang L Tu M Cai L Yin X Pan X Wang T Huang Y |
| author_sort |
Wang J |
| title |
Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| title_short |
Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| title_full |
Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| title_fullStr |
Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| title_full_unstemmed |
Development and Evaluation of Serum CST1 Detection for Early Diagnosis of Esophageal Squamous Cell Carcinoma |
| title_sort |
development and evaluation of serum cst1 detection for early diagnosis of esophageal squamous cell carcinoma |
| publisher |
Dove Medical Press |
| publishDate |
2021 |
| url |
https://doaj.org/article/b1ec2c7c78b5496299de8729d3f906e2 |
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