| Abstrakt: |
The identification of KRASmutations 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 KRASmutation testing including Applied Biosystems KRASMutation Analysis on the ABI3130xl, Qiagen therascreen KRASRGQ PCR on the Rotor-Gene Q MDx, and Qiagen KRASPyro 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 KRASmutation status. We evaluated the performance characteristics and workflow for 3 commercially available KRASmutation detection platforms. All of the 188 samples run were successful, with 29 being positive for the KRASmutation. Of the positive tests, Applied Biosystems detected 84 of the positive cases, whereas Qiagen therascreen RGQ and Qiagen KRASPyro 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 KRASmutation, with Applied Biosystems having a slightly lower sensitivity, negative predictive value, and accuracy than therascreen RGQ and Pyro. |
