Department of Chest Surgery, St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Department of Pathology, St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Clin Lung Cancer. 2018 Mar;19(2):170-174. doi: 10.1016/j.cllc.2017.10.015. Epub 2017 Oct 28.
The reliability of the cobas EGFR assay to detect epidermal growth factor receptor (EGFR) mutations in non-small-cell lung cancer (NSCLC) as an in vitro diagnostic test was compared with 3 laboratory-developed tests (LDTs).
After screening for EGFR mutations using formalin-fixed-paraffin-embedded NSCLC tissue sections using the cobas EGFR assay, 151 samples were further tested with 3 LDTs; the peptide nucleic acid-locked nucleic acid polymerase chain reaction (PCR) clamp, PCR invader, and Cycleave assays. The cobas EGFR assay performance was evaluated by determining the concordance rate and κ-coefficient between the assays. In samples exhibiting discrepancies in the EGFR mutation status in the 4 assays, next-generation sequencing was performed to confirm mutated sequences.
Concordance rates and κ-coefficients between the cobas EGFR assay and the other tests were 96.0% and 0.921 for the peptide nucleic acid-locked nucleic acid PCR clamp assay, 94.0% and 0.881 for the PCR invader assay, and 96.7% and 0.934 for the Cycleave assay, respectively. Data showed very good agreement with the other assays. Precise mutated sequences or exons in the EGFR gene matched in 137 samples (90.7%). Different results were obtained in 4 samples (2.6%), owing to systemic limitations of the assay. Next-generation sequencing of 10 (6.6%) samples with discordant results exhibited a concordance rate of 60% to 80% in each assay.
The cobas EGFR assay showed high concordance rates and κ-coefficients between the 3 compared LDTs and can be used to select patients who would benefit from EGFR-tyrosine kinase inhibitors.
cobas EGFR 检测试剂盒作为一种体外诊断检测方法，其检测非小细胞肺癌（NSCLC）中表皮生长因子受体（EGFR）突变的可靠性与 3 种实验室开发的检测方法（LDT）进行了比较。
在使用 cobas EGFR 检测试剂盒对福尔马林固定石蜡包埋的 NSCLC 组织切片进行 EGFR 突变筛选后，对 151 个样本进一步用 3 种 LDT（肽核酸锁核酸聚合酶链反应（PCR）夹、PCR 入侵物和 Cycleave 检测）进行检测。通过确定各检测之间的一致性率和 κ 系数来评估 cobas EGFR 检测试剂盒的性能。在 4 种检测方法中 EGFR 突变状态不一致的样本中，进行下一代测序以确认突变序列。
cobas EGFR 检测试剂盒与其他检测方法的一致性率和 κ 系数分别为肽核酸锁核酸 PCR 夹检测 96.0%和 0.921、PCR 入侵物检测 94.0%和 0.881、Cycleave 检测 96.7%和 0.934。数据显示与其他检测方法具有非常好的一致性。在 137 个样本（90.7%）中，精确的 EGFR 基因突变序列或外显子相匹配。在 4 个样本（2.6%）中，由于检测方法的系统局限性，得到了不同的结果。在有差异的 10 个样本（6.6%）中进行的下一代测序显示，在每个检测中，一致性率为 60%至 80%。
cobas EGFR 检测试剂盒与 3 种比较的 LDT 之间具有较高的一致性率和 κ 系数，可用于选择将从 EGFR-酪氨酸激酶抑制剂中获益的患者。
