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Open AccessArticle

A Simple and Highly Specific MassARRAY-Based Stool DNA Assay to Prioritize Follow-up Decisions in Fecal Immunochemical Test-Positive Individuals

Department of Laboratory Medicine, Chang Gung Memorial Hospital at LinKou Taoyuan 33305, Taiwan
Department of Medical Biotechnology and Laboratory Science, Chang Gung University, Taoyuan 33302, Taiwan
Molecular Medicine Research Center, Chang Gung University, Taoyuan 33305, Taiwan
Department of Colorectal Surgery, Chang Gung Memorial Hospital at Linkou, Taoyuan 33305, Taiwan
Author to whom correspondence should be addressed.
Cancers 2019, 11(3), 423;
Received: 3 March 2019 / Revised: 19 March 2019 / Accepted: 22 March 2019 / Published: 25 March 2019
(This article belongs to the Collection Cancer Biomarkers)
Background: Seventy-five percent of fecal immunochemical test (FIT)-positive individuals are false positives and undergo unnecessary colonoscopies. Here, we established a stool DNA (sDNA) test that uses the Single Allele Base Extension Reaction (SABER) MassARRAY platform to improve the accuracy of FIT-based CRC detection. Methods: Twenty-one variants in five CRC-associated genes were selected for the sDNA panel. Cell line DNA and matched mutation-confirmed tissue and stool samples from 34 patients were used for accuracy assessment (cohort 1). The clinical performance of the sDNA assay was further evaluated in 101 independent FIT-positive stool samples (cohort 2). Results: In cohort 1, we obtained a 62% mutation concordance rate in paired tissue and stool samples of the CRC group, regardless of the FIT status. In cohort 2, 100% specificity in normal controls with positive FIT results was observed. By weighting the FIT value and the presence of a given variant type in stool and then summing the two scores, we found that a one-increment increase in the score was associated with a 4.538-fold risk (95% CI = 2.121–9.309) for malignancy in the FIT-positive setting. Conclusions: Our highly specific sDNA assay can help prioritize the most at-risk FIT-positive persons to receive prompt colonoscopic confirmation of CRC. View Full-Text
Keywords: colorectal cancer; stool DNA; MassARRAY; risk-stratifying algorithm colorectal cancer; stool DNA; MassARRAY; risk-stratifying algorithm
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Chang, P.-Y.; Chen, C.-C.; Chiang, J.-M.; Chang, S.-C.; Wang, M.-C.; Chen, J.-S.; Tsai, W.-S.; You, J.F.; Lu, J.-J. A Simple and Highly Specific MassARRAY-Based Stool DNA Assay to Prioritize Follow-up Decisions in Fecal Immunochemical Test-Positive Individuals. Cancers 2019, 11, 423.

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