Screening for ALK in non-small cell lung carcinomas: 5A4 and D5F3 antibodies perform equally well, but combined use with FISH is recommended.

摘要: Abstract Objectives Immunohistochemistry (IHC) has become a promising method for pre-screening ALK-rearrangements in non-small cell lung carcinomas (NSCLC). Various ALK antibodies, detection systems and automated immunostainers are available. We therefore aimed to compare the performance of monoclonal 5A4 (Novocastra, Leica) D5F3 (Cell Signaling, Ventana) antibodies using two different immunostainers. Additionally we analyzed accuracy prospective IHC-testing routine diagnostics. Materials methods Seventy-two NSCLC with available FISH results enriched FISH-positive were retrospectively analyzed. IHC was performed on BenchMarkXT (Ventana) D5F3, respectively, additionally Bond-MAX (Leica). Data from our diagnostics ALK-testing parallel IHC, 5A4, 303 NSCLC. Results All three protocols showed congruent results. Only 1/25 (4%) false negative by IHC. For all sensitivity, specificity, positive (PPV) predictive values (NPV) compared 96%, 100%, 100% 97.8%, respectively. In cohort 3/32 (9.4%) 2/271 FISH-negative (0.7%) PPV NPV 90.6%, 99.3%, 93.5% 98.9%, Conclusions equally well suited detecting ALK-rearranged BenchMark BOND-MAX can be used 5A4. True discrepancies between do exist need addressed when implementing an algorithm.