The Usefulness of a Novel Screening Kit for Colorectal Cancer Using the Immunochromatographic Fecal Tumor M2 Pyruvate Kinase Test

• Published in: Gut and liver Vol. 9; no. 5; pp. 641 - 648
• Main Authors: Kim, Yong Cheol, Kim, Jeong Ho, Cheung, Dae Young, Kim, Tae Ho, Jun, Eun Jung, Oh, Jung-Whan, Kim, Chang Whan, Chung, Woo Chul, Kim, Byung-Wook, Kim, Sung Soo, Kim, Jin Il, Park, Soo-Heon, Kim, Jae Kwang
• Format: Journal Article
• Language: English
• Published: Korea (South) Gut and Liver 01.09.2015; Gastroenterology Council for Gut and Liver; 거트앤리버 소화기연관학회협의회
• Subjects: Adenoma - diagnosis; Adult; Aged; Aged, 80 and over; Biomarkers, Tumor - analysis; Clinical Enzyme Tests - instrumentation; colorectal neoplasms; Colorectal Neoplasms - diagnosis; Enzyme-Linked Immunosorbent Assay; fecal occult blood test; Feces - enzymology; Female; Healthy Volunteers; Humans; Immunochromatography - methods; Male; mass screening; Middle Aged; Occult Blood; Original; Precancerous Conditions - diagnosis; Precancerous Conditions - enzymology; Predictive Value of Tests; Pyruvate Kinase - analysis; Reagent Kits, Diagnostic; Republic of Korea; Sensitivity and Specificity; tumor m2 pyruvate kinase; 내과학; Republic of Korea; Colorectal neoplasms; Tumor M2 pyruvate kinase; Fecal occult blood test; Mass screening
• ISSN: 1976-2283; 2005-1212; 2005-1212
• DOI: 10.5009/gnl13457

M2 pyruvate kinase (M2-PK) is an enzyme that is produced in undifferentiated and proliferating tissues. This study aims to evaluate the usefulness of the immunochromatographic M2 pyruvate kinase (iM2-PK) for the screening of colorectal cancer (CRC) and premalignant lesions. Healthy volunteers and patients with colorectal neoplasia were enrolled in six academic hospitals in the capital province of Korea. The iM2-PK value was compared with the immunochromatographic fecal occult blood test (iFOBT) and fecal tumor M2-PK enzyme-linked immunosorbent assay (ELISA). A total of 323 subjects were enrolled. The sensitivity of iM2-PK for CRC was 92.8%, which was superior to iFOBT (47.5%, p<0.0001). For adenomatous lesions, the sensitivity of iM2-PK was 69.4%, which was also superior to iFOBT (12.1%, p<0.001). Compared with M2-PK ELISA, iM2-PK exhibited significantly enhanced sensitivity for CRC (97.5% vs 80.0%, p=0.0289). The sensitivity of iM2-PK was higher in advanced stages of CRC compared with cancers confined to the mucosa and submucosa (p<0.05). However, lymph node metastasis had no influence on the sensitivity of iM2-PK. The iM2-PK exhibited increased sensitivity for identifying CRC and adenomatous lesions compared with iFOBT. Given its rapid results and convenience, CRC screening using iM2-PK is promising.