The Diagnostic Accuracy of the M2 Pyruvate Kinase Quick Stool Test--A Rapid Office Based Assay Test for the Detection of Colorectal Cancer.

Abstract

BACKGROUND: M2 pyruvate kinase (M2PK) is an oncoprotein secreted by colorectal cancers in stools. This the first report on the accuracy of a rapid stool test in the detection of colorectal cancer (CRC). OBJECTIVE: To determine the sensitivity, specificity and positive and negative predictive value of a rapid, point of care stool test M2 PK- the M2PK Quick. METHODS: Consecutive cases of endoscopically diagnosed and histological proven CRC were recruited. Stools were collected by patients and tested with the immunochromatographic M2PK Quick Test (Schebo Biotech AC, Giessen, Germany). Controls were consecutively chosen from patients without any significant colorectal or gastrointestinal disease undergoing colonoscopy. CRC was staged according to the AJCC staging manual (7th Edition) and location of tumor defined as proximal or distal. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy were: 93%, 97.5%, 94.9%, 96.5% and 96.0% respectively. The positive predictive value for proximal tumors was significantly lower compared to distal tumors. No differences were seen between the different stages of the tumor. CONCLUSIONS: The M2-PK Quick, rapid, point-of-care test is a highly accurate test in the detection of CRC. It is easy and convenient to perform and a useful diagnostic test for the detection of CRC in a clinical practice setting.