Siemens Healthineers cross-platform verification: Analytical and clinical analysis of HIV Antigen/Antibody Combo assay across ADVIA Centaur and Atellica analyzers

HIV is a major global public health concern. Accurate serological testing in the clinical laboratory using high-performing, automated analyzers is critical for preventing transmission. This study evaluated the performance of the Atellica CI analyzer, utilizing the Atellica IM HIV Antigen/Antibody Combo (CHIV) assay to determine if this new analyzer's performance was reliable and comparable to existing systems. Multicenter reproducibility and cross-platform (Atellica CI, Atellica IM, ADVIA Centaur XP) comparison studies were performed. Clinical concordance analysis comprised 3374 samples which were derived from: native retrospective samples and prospectively collected samples at multiple United States sites representing diverse HIV positive and presumed negative individual categories including subjects at increased risk for HIV exposure. HIV seroconversion sensitivity was assessed using 20 commercially available panels. Regression analyses were performed between analyzers using p24 antigen dilutions. Maximum reproducibility %CV was less than 8.8% on the Atellica CI analyzer for all samples at or above 1.00 Index. Cross-platform agreement ranged from 98.0% to 100% across all subject samples and seroconversion panels tested. Regression analyses showed strong linear relationships between the analyzers (slope ranging from 0.96 to 1.02, correlation (r) >0.999). This is the first report on analytical and clinical performance of the Atellica IM CHIV assay on the Atellica CI analyzer. The findings demonstrate its reliability for CHIV serological testing comparable to the Atellica IM analyzer and ADVIA Centaur XP system. It enables interchangeability of Atellica analyzers in hub-and-spoke laboratory operations while supporting transition to the latest Siemens Healthineers analyzers.