A-300 Comparative Analysis of Serology Test Performance: Evaluation of Elecsys Platform for Hepatitis Markers

Background Serology tests that target markers such as: anti-hepatitis A IgM virus (anti-HAV IgM), anti-HAV total antibody, anti-hepatitis B core IgM (anti-HBc IgM), anti-HBc total, anti-HB surface (anti-HBs), HBs antigen and anti-hepatitis C virus (anti-HCV) total play a pivotal role in understanding the stage of infection, immunity and vaccination effectiveness. Here, we evaluated these markers on our new total laboratory automation line that uses the Roche Elecsys platform. Methods The existing reference method used was the Siemens Centaur. Precision was evaluated by running a negative and a positive sample a minimum of 25 times. Method comparison was performed by using human samples with negative and positive values as outlined in Table 1 below. Analysis was performed by EP Evaluator. Results Samples for precision were 100 % concordant. Method comparison for each test yielded the results outlined in Table 1. Tests such as anti-HBs and HBsAg had 100% agreement between the two methods. Anti-HAV total had only one sample classified as positive by Elecsys that was negative by the reference (Centaur), resulting in 99% overall agreement. Anti-HAV IgM had had 4 results positive by Centaur that were negative by Elecsys. Upon further investigation, of the four samples, one was confirmed to be a true negative by chart review, two samples were run on the Abbott platform and were confirmed to be negative matching Elecsys. Anti-HBc IgM had 54% positive agreement and 100% negative agreement with Elecsys giving 6 discordant samples. These results were evaluated by clinical review and ruled to be true negative. Anti-HBc total and anti-HCV total had 99% and 96% overall agreement respectively. Conclusions We conclude that the Roche Elecsys platform for infectious serology tests is precise and accurate to be used in the clinical laboratory.