title: The Usefulness of a Novel Screening Kit for Colorectal Cancer Using the Immunochromatographic Fecal Tumor M2 Pyruvate Kinase Test.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Yong Cheol
authors.initials: YC
authors.lastname: Kim
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Myongji Hospital, Seonam University College of Medicine, Goyang, Korea.
authors.forename: Jeong Ho
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Cheung
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Tae Ho
authors.initials: TH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Eun Jung
authors.initials: EJ
authors.lastname: Jun
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jung-Whan
authors.initials: JW
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Chang Whan
authors.initials: CW
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Woo Chul
authors.initials: WC
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Byung-Wook
authors.initials: BW
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Sung Soo
authors.initials: SS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jin Il
authors.initials: JI
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Soo-Heon
authors.initials: SH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jae Kwang
authors.initials: JK
authors.lastname: Kim
mesh_terms: D000236:Adenoma / Q000175:diagnosis*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000032:analysis*; D002846:Chromatography, Affinity / Q000379:methods; D004796:Clinical Enzyme Tests / Q000295:instrumentation*; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000201:enzymology*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D009780:Occult Blood; D011230:Precancerous Conditions / Q000175:diagnosis / Q000201:enzymology; D011237:Predictive Value of Tests; D011770:Pyruvate Kinase / Q000032:analysis*; D011933:Reagent Kits, Diagnostic; D056910:Republic of Korea; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic; D011770:Pyruvate Kinase
keywords: Colorectal neoplasms; Fecal occult blood test; Mass screening; Tumor M2 pyruvate kinase