Validation of a Novel Automated Immunohistochemistry Technology Using 13 Common IHC Antibodies in Routine Surgical Pathology
A Cotrell, J Alexis, RJ Poppiti, LM Howard, L Schiffhauer, D Hicks, E Saiz, H Yaziji. Mount Sinai Medical Center, Miami Beach, FL; University of Rochester, Rochester, NY; Vitro Molecular Laboratories, Miami, FL
Background: Several immunohistochemistry automation systems are currently employed for diagnostic applications of IHC in surgical pathology , which had drastically improved standardization of IHC assays. The main common problem is a prolonged automated run time that varies from 1.5 to 3.5 hours. A novel automated platform has recently been developed, which is based on capillary gap technology and vacuum/motion (Celerus Diagnostics, Santa Barbara, CA). This platform claims significantly shorter run time. We wished to test this hypothesis and validate our in-vitro testing of common IHC markers on this platform.
Design: Three institutions participated in this study. 168 previously diagnosed tumors were included [breast cancers (n = 131), B-cell lymphoma (n = 5), lung adenocarcinoma (n = 15), melanoma (n = 17)]. The previously validated methodology consists of two similar types of robotic reagent-dispensing systems (Autostainer, Dako, Carpenteria and Autostainer 360, Thermo Scientific, Fremont, CA). 13 diagnostic and predictive markers (HER2, Ki-67, p53, p16, S100, MART-1, tyrosinase, vimentin, Keratin AE1/AE3, Keratin 7, CD20, PAX5) were used. Tumor sections were pretreated in pressure cooker (citrate pH=6) prior to incubating with the primary antibody, followed by a two-step polymer detection (Dako, Carpenteria, CA), followed by enzyme chromogenic localization. Parallel testing on the new technology was performed using pressure cooker pretreatment (EDTA/Tris pH = 8) and employing a similar polymer detection. Slides were scored using previously established scoring criteria for each marker.
Results: Perfect (100%) correlation was observed between the two systems, showing very similar results between the two platforms. This is also true for the predictive markers (HER2, p53, Ki-67). There was no significant quantitative or intensity difference between the two platforms. The average turnaround time on the pre-existing platform is 2.5 hours, compared to 20 minutes on the new platform.
Conclusions: The Celerus Wave technology showed identical results compared to the more established, automated IHC platform using a broad range of predictive and diagnostic antibodies. This technology offers the advantage of significantly shorter turnaround time and continuous throughput.
Tuesday, March 10, 2009 2:00 PM
Platform Session: Section G, Tuesday Afternoon