Analytical validation of a novel multiplex test for detection of advanced adenoma and colorectal cancer in symptomatic patients.

Roslyn Dillon,Lisa J Croner, John Bucci,Stefanie N Kairs,Jia You, Sharon Beasley, Mark Blimline, Rochele B Carino, Vicky C Chan, Danissa Cuevas, Jeff Diggs, Megan Jennings, Jacob Levy, Ginger Mina, Alvin Yee,Bruce Wilcox

Journal of Pharmaceutical and Biomedical Analysis（2018）

引用 11|浏览10

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摘要

•Multiplexed immunoassays for a novel CRC and AA test were developed.•Analytical validation of the 15-analyte test was performed in accordance with CLSI guidelines.•Validation studies included assay quality metrics which provided analytical rigor beyond CLIA or CAP requirements.•Clinical validation successfully met the CLIA and CAP regulatory and accreditation requirements for implementation of a LDT.

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关键词

Colorectal cancer,Protein biomarkers,Multiplex immunoassay,Analytical validation

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