Real-World Evaluation of Nine Infectious Disease Assays on Roche Cobas E 801 Versus Abbott ARCHITECT Or Diasorin Liaison XL Platforms

This study aimed to compare the performance of nine infectious disease assays on different high-throughput platforms. Samples for fertility/pregnancy and trisomy screening were assessed for HBsAg, anti-HBc, anti-HCV, HIV ((th generation assay), rubella IgM and IgG, CMV IgM and IgG and CMV avidity at a single centre, using the cobas e 801 platform and either the ARCHITECT, Liaison XL, or VIDAS platforms. Indeterminate/discrepant samples were confirmed using bioMerieux VIDAS and/or immunoblot testing, or LiPA (for hepatitis). For HBsAg, specificity in the two sample groups was 100% for the cobas e 801 platform and 99.71% for the ARCHITECT platform (N=1052 fertility/pregnancy samples), and was 100% for both platforms (N=200 trisomy-testing samples). For anti-HBc, specificity was 100% for both the cobas e 801 and ARCHITECT platforms (N=1051 fertility/pregnancy samples and N=200 trisomy-testing samples). For anti-HCV, specificity was 100% for the cobas e 801 platform and 99.5% for the ARCHITECT platform (N=200 trisomy-testing samples), and 99.73% for both platforms (N=1051 fertility/pregnancy samples). For HIV, specificity was 99.82% for the cobas e 801 platform and 99.73% the ARCHITECT platform (N=1102). For rubella IgG (N=429), specificity was 100% for the cobas e 801 and Liaison XL platforms. For rubella IgM (N=92), specificity was 99% for both the cobas e 801 and Liaison XL platforms. For CMV IgG (N=687), specificity was 98.94% for the cobas e 801 platform and 97.18% for the ARCHITECT platform. For CMV IgM (N=680), specificity was 97.16% for both platforms. For CMV avidity low (N=25) and high (N=29), 96% and 93% correlation was observed between cobas e 801 and VIDAS platforms. This study concluded that in routine samples, performance of the cobas e 801 platform was superior or equal to performance of the ARCHITECT, Liaison XL, or VIDAS platforms.