Performance evaluation comparison of 3 commercially available PCR-based KRAS mutation testing platforms

Julia A. Adams, Kristin M. Post, Sarah A. Bilbo, Xiaoyan Wang, Joyashree D. Sen, Anita J. Cornwell, Amanda J. Malek, Liang Cheng

Research output: Contribution to journalArticle

9 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)231-235
Number of pages5
JournalApplied Immunohistochemistry and Molecular Morphology
Issue number3
StatePublished - Jan 1 2014


  • Adenocarcinoma
  • Colorectal cancer
  • KRAS mutation
  • Lung cancer KRAS mutation
  • Molecular diagnostics
  • Personalized medicine
  • Targeted therapy
  • Test validation

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology
  • Medical Laboratory Technology

Fingerprint Dive into the research topics of 'Performance evaluation comparison of 3 commercially available PCR-based KRAS mutation testing platforms'. Together they form a unique fingerprint.

Cite this