Gut Liver.  2015 Sep;9(5):641-648. 10.5009/gnl13457.

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

• Kim YC
• Kim JH
• Cheung DY
• Kim TH
• Jun EJ
• Oh JW
• Kim CW
• Chung WC
• Kim BW
• Kim SS
• Kim JI
• Park SH
• Kim JK

• KMID: 2234071
• DOI: http://doi.org/10.5009/gnl13457

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.

Keyword

Colorectal neoplasms; Fecal occult blood test; Mass screening; Tumor M2 pyruvate kinase

MeSH Terms

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
Biomarkers, Tumor
Pyruvate Kinase
Reagent Kits, Diagnostic