Qingbing Wang1, Jiwu Wang2, Zeru Xiao3, Zhiling Shen1, Yanjun Wang1, Yong Zhang1, Tianyuan Pan4, Jianan Xiao1, Xiyuan Sun2. 1. Anyang Tumor Hospital Anyang 455000, Henan, China. 2. Jiangsu Yuancheng Biotechnology Inc. Taizhou 225312, Jiangsu, China. 3. Medical Research Center, Beijing Chao-Yang Hospital, Capital Medical University Beijing 100020, China. 4. Department of Family Medicine, The First Affiliated Hospital, Zhejiang University Hangzhou 310000, Zhejiang, China.
Abstract
Background: Colorectal cancer (CRC) represents a major health concern that can be screened for by the fecal immunochemical test (FIT), which detects blood in the stool. CRC detection sensitivity for hemoglobin (Hb) combined with transferrin (Tf) is higher than for hemoglobin alone. Methods: We developed a europium fluorescent microsphere-based quantitative lateral flow immunochromatography strip to detect fecal Hb and Tf. Performance was tested using fecal samples from 51 patients with CRC and 122 normal subjects. Test strips were generated using paired mouse anti-human Hb and mouse anti-human Tf monoclonal antibodies and tested using standard Hb and Tf samples. Fluorescence was observed at 365 nm and quantitatively measured using a portable fluorescent strip reader. Results: At cutoff values of 100 ng/mL (10 µg/g feces) and 25 ng/mL (2.5 µg/g feces) for Hb and Tf, respectively, the positive rates for Hb, Tf, and Hb+Tf in normal subjects were 6.56%, 5.74%, and 10.66%, respectively, compared to 88.24%, 64.71%, and 94.12% in patients with CRC. The sensitivity and specificity of the FIT combined detection technique were 87.5% and 89.2%, respectively, and the area under the curve (AUC) was 0.92. The sensitivity, specificity, and AUC for the Tf assay were 63.8%, 68.4%, and 0.759, respectively, and those for Hb testing were 69.7%, 70.2%, and 0.774, respectively. The AUC for Hb+Tf was significantly higher than those for Tf or Hb alone (P < 0.001). Conclusions: Fluorescent microsphere-based immunochromatographic strips sensitively detect fecal Hb and Tf, and sensitivity and specificity are improved for Hb+Tf. This system represents a rapid and portable alternative for on-site early CRC screening. AJTR
Background: Colorectal cancer (CRC) represents a major health concern that can be screened for by the fecal immunochemical test (FIT), which detects blood in the stool. CRC detection sensitivity for hemoglobin (Hb) combined with transferrin (Tf) is higher than for hemoglobin alone. Methods: We developed a europium fluorescent microsphere-based quantitative lateral flow immunochromatography strip to detect fecal Hb and Tf. Performance was tested using fecal samples from 51 patients with CRC and 122 normal subjects. Test strips were generated using paired mouse anti-human Hb and mouse anti-human Tf monoclonal antibodies and tested using standard Hb and Tf samples. Fluorescence was observed at 365 nm and quantitatively measured using a portable fluorescent strip reader. Results: At cutoff values of 100 ng/mL (10 µg/g feces) and 25 ng/mL (2.5 µg/g feces) for Hb and Tf, respectively, the positive rates for Hb, Tf, and Hb+Tf in normal subjects were 6.56%, 5.74%, and 10.66%, respectively, compared to 88.24%, 64.71%, and 94.12% in patients with CRC. The sensitivity and specificity of the FIT combined detection technique were 87.5% and 89.2%, respectively, and the area under the curve (AUC) was 0.92. The sensitivity, specificity, and AUC for the Tf assay were 63.8%, 68.4%, and 0.759, respectively, and those for Hb testing were 69.7%, 70.2%, and 0.774, respectively. The AUC for Hb+Tf was significantly higher than those for Tf or Hb alone (P < 0.001). Conclusions: Fluorescent microsphere-based immunochromatographic strips sensitively detect fecal Hb and Tf, and sensitivity and specificity are improved for Hb+Tf. This system represents a rapid and portable alternative for on-site early CRC screening. AJTR
Authors: James Turvill; Samantha Mellen; Laura Jeffery; Sarah Bevan; Ada Keding; Daniel Turnock Journal: Scand J Gastroenterol Date: 2019-01-08 Impact factor: 2.423