Evaluation of the Performance of a Fecal Tumor M2-PK Rapid Kit Using Stool Specimens for Detection of Colorectal Tumors.

BACKGROUND: In gastrointestinal tumors, only subunits of pyruvate kinase isoenzyme type M2 are detectable, and mainly in the dimeric form termed tumor M2-PK. A rapid test for the detection of M2-PK in stool has been developed. We evaluated the performance of the M2-PK rapid kit for the detection of colorectal tumors compared with colonoscopy

DESIGN: Stool specimens (n=268) were obtained from patients who had a fecal occult blood test and colonoscopy performed for clinical evaluation or routine health checkup. Collected stool specimens were kept frozen at -20°C until testing. The fecal tumor M2-PK test was performed using a ScheBo M2-PK Quick test (ScheBo(®)•Biotech AG, Giessen, Germany)

RESULTS: A total of 236 patients were analyzed, including 87 with tubular adenoma and 126 controls. In tumor M2-PK testing, 37 of 87 tubular adenoma specimens (42.5%) and 2 of 4 sessile serrated adenoma specimens (50%) tested positive. The specificity of the M2-PK rapid test was 87.3%

CONCLUSIONS: The tumor M2-PK test demonstrated moderate sensitivity for detection of colorectal adenoma. M2-PK test could be considered as a useful point-of-care testing device for detection of colorectal tumors.