The Usefulness of a Novel Screening Kit for Colorectal Cancer Using the Immunochromatographic Fecal Tumor M2 Pyruvate Kinase Test.
- Author:
Yong Cheol KIM
1
;
Jeong Ho KIM
;
Dae Young CHEUNG
;
Tae Ho KIM
;
Eun Jung JUN
;
Jung Whan OH
;
Chang Whan KIM
;
Woo Chul CHUNG
;
Byung Wook KIM
;
Sung Soo KIM
;
Jin Il KIM
;
Soo Heon PARK
;
Jae Kwang KIM
Author Information
- Publication Type:Original Article ; Comparative Study ; Evaluation Studies ; Multicenter Study ; Research Support, Non-U.S. Gov't
- Keywords: Colorectal neoplasms; Fecal occult blood test; Mass screening; Tumor M2 pyruvate kinase
- MeSH: Adenoma/*diagnosis; Adult; Aged; Aged, 80 and over; Biomarkers, Tumor/*analysis; Clinical Enzyme Tests/*instrumentation; Colorectal Neoplasms/*diagnosis; Enzyme-Linked Immunosorbent Assay; Feces/*enzymology; Female; Healthy Volunteers; Humans; Immunochromatography/methods; Male; Middle Aged; Occult Blood; Precancerous Conditions/diagnosis/enzymology; Predictive Value of Tests; Pyruvate Kinase/*analysis; Reagent Kits, Diagnostic; Republic of Korea; Sensitivity and Specificity
- From:Gut and Liver 2015;9(5):641-648
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
