Immunohistochemistry Assays Based on Ready-To-Use Antibodies and Vendor-Recommended Protocol Settings Often Perform Suboptimally.

Abstract

The use of ready-to-use (RTU) antibodies in pathology laboratories has increased due to regulatory changes and the need for standardized, efficient diagnostic workflows. This study compares the performance of RTU antibodies from 2 major suppliers, Agilent (Dako Omnis platform) and Roche (BenchMark Ultra Plus system) in a Norwegian hospital setting. A total of 125 RTU antibodies were evaluated using vendor-recommended protocol settings (VRPS) and scored according to NordiQC standards. Results showed that 58 out of 62 antibodies on the Dako Omnis platform were rated as "optimal" or "good," compared with 37 out of 63 on the BenchMark Ultra Plus. Notably, 26 (41.3%) of Roche antibodies were rated "borderline" or "poor." Our study shows that several RTU antibodies perform suboptimally with VRPS. This highlights the importance of thorough validation and verification of RTU antibodies before diagnostic use. The findings underscore the need for reliable protocols from manufacturers and encourage interlaboratory collaboration to improve diagnostic consistency and quality assurance.