title: Performance evaluation comparison of 3 commercially available PCR-based KRAS mutation testing platforms.
abstract: The identification of KRAS mutations in patients with certain types of cancer, including colonic adenocarcinoma and non-small cell lung carcinoma, has become increasingly important as these patients are contraindicated from receiving epidermal growth factor receptor-targeted therapies. Several polymerase chain reaction (PCR)-based tests are commercially available for KRAS mutation testing including Applied Biosystems KRAS Mutation Analysis on the ABI3130xl, Qiagen therascreen KRAS RGQ PCR on the Rotor-Gene Q MDx, and Qiagen KRAS Pyro on the PyroMark Q24; however, these tests have not been compared side by side. The purpose of this study was to evaluate the performance characteristics and workflow for 3 PCR-based methods of detecting KRAS mutation status. We evaluated the performance characteristics and workflow for 3 commercially available KRAS mutation detection platforms. All of the 188 samples run were successful, with 29% being positive for the KRAS mutation. Of the positive tests, Applied Biosystems detected 84% of the positive cases, whereas Qiagen therascreen RGQ and Qiagen KRAS Pyro detected 100% of the positive cases. In cases of discrepancy between Applied Biosystems and therascreen RGQ, Pyro agreed with therascreen RGQ 95% of the time. Qiagen therascreen RGQ and Pyro were comparable in terms of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy, with all values being 100%. All 3 techniques accurately identified the appropriate mutation in the known control specimens. In summary, all 3 tests are relatively comparable for detecting the KRAS mutation, with Applied Biosystems having a slightly lower sensitivity, negative predictive value, and accuracy than therascreen RGQ and Pyro.
authors.affiliation: Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Adams
authors.forename: Kristin M
authors.initials: KM
authors.lastname: Post
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Bilbo
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Wang
authors.forename: Joyashree D
authors.initials: JD
authors.lastname: Sen
authors.forename: Anita J
authors.initials: AJ
authors.lastname: Cornwell
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Malek
authors.forename: Liang
authors.initials: L
authors.lastname: Cheng
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis*; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D004252:DNA Mutational Analysis / Q000379:methods; D004273:DNA, Neoplasm / Q000032:analysis*; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis*; D009154:Mutation / Q000235:genetics; D009367:Neoplasm Staging; D016133:Polymerase Chain Reaction; D011518:Proto-Oncogene Proteins / Q000235:genetics*; D016283:Proto-Oncogene Proteins p21(ras); D011933:Reagent Kits, Diagnostic; D018631:ras Proteins / Q000235:genetics*
chemical_list: D004273:DNA, Neoplasm; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D011933:Reagent Kits, Diagnostic; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins