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Comparative Study
. 2015 Sep 23;9(5):641-8.
doi: 10.5009/gnl13457.

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

Yong Cheol Kim  1 , Jeong Ho Kim  2 , Dae Young Cheung  1 , Tae Ho Kim  1 , Eun Jung Jun  1 , Jung-Whan Oh  1 , Chang Whan Kim  1 , Woo Chul Chung  1 , Byung-Wook Kim  1 , Sung Soo Kim  1 , Jin Il Kim  1 , Soo-Heon Park  1 , Jae Kwang Kim  1
Affiliations
Comparative Study

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

Yong Cheol Kim et al. Gut Liver. .

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.

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

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Figures

Fig. 1
Fig. 1
The receiver-operating characteristic curves for predicting adenoma (A) and colorectal cancer (B). Each line present receiver-operating characteristic curve for predicting adenoma and colorectal cancer by immunochromatographic M2 pyruvate kinase, immunochromatographic fecal occult blood test and carcinoembryonic antigen. All the curves are statistically significnt (p<0.001), with the areas beneath the curves being greater than 50%. iM2-PK, immunochromatographic M2 pyruvate kinase; AUC, area under the curve; iFOBT, immnochromatographic fecal occult blood test; CEA, carcinoembryonic antigen.
Fig. 2
Fig. 2
The sensitivity of immunochromatographic M2 pyruvate kinase (iM2-PK) according to cancer stages based on Dukes and TNM classification. The sensitivity of iM2-PK of Dukes A stage cancer was 80.6%. Cancers classified as Dukes B and Dukes C stages exhibited sensitivity of 100% and 94.8%, respectively. These values were significantly increased compared with cancers categorized as Dukes A stage (p<0.05). Similarly, cancers that were T2 or beyond exhibited significantly increased positivity compared with Tis and T1 cancers. The sensitivity for Tis and T1 cancers was 82.8%, and the sensitivity for T2, T3, and T4 cancers was 95.1% (p=0.019). CI, confidence interval. *p<0.05.
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