BACKGROUND The multi-target stool DNA test(MT-sDNA)has potential utility in the detection of colorectal cancer(CRC),but validation of its clinical accuracy has been limited in China.AIM To evaluate the diagnostic perf...BACKGROUND The multi-target stool DNA test(MT-sDNA)has potential utility in the detection of colorectal cancer(CRC),but validation of its clinical accuracy has been limited in China.AIM To evaluate the diagnostic performance of MT-sDNA and investigate the combined diagnostic value of alpha-fetoprotein(AFP),carcinoembryonic antigen(CEA),and carbohydrate antigen 199(CA199)with MT-sDNA in CRC and adenomas.METHODS We evaluated the performance of the MT-sDNA kit based on a hospital clinical trial.In this case-control study,135 participants from the Affiliated Hospital of Medical School of Ningbo University,including 51 CRC patients,23 patients with adenomas,and 61 healthy controls were enrolled.We used a risk scoring system to determine the positivity of tests with histological diagnosis or colonoscopy as the reference standard.RESULTS The main indices of sensitivity,specificity and accuracy were evaluated.The sensitivity and specificity for CRC detection were 90.2%and 83.3%,respectively,with an accuracy of 89.8%.For adenoma,the sensitivity and specificity were 56.5%and 68.9%,respectively,with an accuracy of 73.1%.The sensitivity and specificity of MT-sDNA combined with CEA in the diagnosis of adenoma were 78.3%and 60.7%,respectively.CONCLUSION The MT-sDNA test showed better performance in the detection of CRC,which was superior to AFP,CEA,and CA199 separately,but not for predicting adenomas.The combination of MT-sDNA with CEA further improved the sensitivity for adenoma diagnosis.展开更多
基金Supported by The Health Science and Technology Project of Zhejiang Province,No.2021KY1048 and No.2022KY1142The Ningbo Health Young Technical Backbone Talents Training Program,No.2020SWSQNGG-02Key Science and Technology Project of Ningbo City,No.2021Z133.
文摘BACKGROUND The multi-target stool DNA test(MT-sDNA)has potential utility in the detection of colorectal cancer(CRC),but validation of its clinical accuracy has been limited in China.AIM To evaluate the diagnostic performance of MT-sDNA and investigate the combined diagnostic value of alpha-fetoprotein(AFP),carcinoembryonic antigen(CEA),and carbohydrate antigen 199(CA199)with MT-sDNA in CRC and adenomas.METHODS We evaluated the performance of the MT-sDNA kit based on a hospital clinical trial.In this case-control study,135 participants from the Affiliated Hospital of Medical School of Ningbo University,including 51 CRC patients,23 patients with adenomas,and 61 healthy controls were enrolled.We used a risk scoring system to determine the positivity of tests with histological diagnosis or colonoscopy as the reference standard.RESULTS The main indices of sensitivity,specificity and accuracy were evaluated.The sensitivity and specificity for CRC detection were 90.2%and 83.3%,respectively,with an accuracy of 89.8%.For adenoma,the sensitivity and specificity were 56.5%and 68.9%,respectively,with an accuracy of 73.1%.The sensitivity and specificity of MT-sDNA combined with CEA in the diagnosis of adenoma were 78.3%and 60.7%,respectively.CONCLUSION The MT-sDNA test showed better performance in the detection of CRC,which was superior to AFP,CEA,and CA199 separately,but not for predicting adenomas.The combination of MT-sDNA with CEA further improved the sensitivity for adenoma diagnosis.
