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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

1
Department of Laboratory Medicine, Chang Gung Memorial Hospital at LinKou Taoyuan 33305, Taiwan
2
Department of Medical Biotechnology and Laboratory Science, Chang Gung University, Taoyuan 33302, Taiwan
3
Molecular Medicine Research Center, Chang Gung University, Taoyuan 33305, Taiwan
4
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; https://doi.org/10.3390/cancers11030423
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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