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PERFORMANCE EVALUATION OF ROCHE ELECSYS SEROLOGICAL SCREENING ASSAYS ON THE NEW COBAS e 801 AMONG BLOOD DONORS IN COMPARISON TO ABBOTT PRISM/ARCHITECT ASSAYS

Background: The Croatian Institute of Transfusion Medicine routinely screens all regular and first-time-donors with serology assays for HIV (HIV antigen/antibody), HCV (anti-HCV), HBV (HBsAg) and Syphilis (anti-TP) in addition to the respective ID-NAT assay. A method comparison between Roche Cobas e 801 and Abbott Prism/Architect on these parameters were carried out between October 2017 and January 2018. Aim: The aim of the study was to evaluate the specificity as one of the key performance criteria for the platforms, Roche Cobas e 801 and Abbott Prism/Architect on the main four screening serology parameters. Methods: The following assays were used: Elecsys® HIV Duo, Elecsys® Anti-HCV II, Elecsys® HBsAg II, Elecsys® Syphilis and Prism HIV Ag/Ab Combo, Prism HCV, Prism HBsAg as well as Architect Syphilis TP. The following verification methods were used to decide on false or correct positive results: immunoblot, HIV-1 Ag, 3rd HIV combination assay (HIV) ; immunoblot, HCV Ag, 3rd anti-HCV assays (HCV) ; HBsAg Confirmatory tests, hepatitis B serological profile (HBsAg) ; immunoblot, TPHA, RPR, 3rd syphilis ELISA (syphilis) ; in addition to triplex ID-NAT (HBV DNA, HCV RNA and HIV 1/2 RNA). Results: The specificity results on Cobas e 801 Elecsys® HIV Duo were 99.85% (n=4073), 99.90% for Elecsys® Anti-HCV II (n=4006), 100% for Elecsys® HBsAg II (n=4073) and 99.93% (n=4052) for Elecsys® Syphilis. For Abbott Prism, the specificity for HIV Ag/Ab Combo was 100%, 99.93% for HCV and 99.98% for HBsAg ; Abbott Architect Syphilis TP revealed a specificity of 100%. Summary/Conclusions: The observed specificity performance data of the Roche Cobas e 801 Elecsys screening assays were similar to the respective Abbott Prism/Architect assays which showed a slightly higher specificity, but not statistically different. Taking into consideration, that the tested blood donor population was unselected and comprised of approx. 85%-repeat, regular donors and approx. 15% first-time donors, a certain, however very difficult to quantify bias due to a cleaning-out process over many years of routine use can be a putative cause of slightly different specificity results of new and established screening assays. Both platforms can be considered suitable for blood donor screening.

Elecsys e 801 ; Prism tests: Blood Donor Screening Assays

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