Clinical performance evaluation of Elecsys HIV Duo, Anti-HCV II, HBsAg II, Anti-HBc II, and Syphilis assays for routine screening of first-time blood donor samples at a French blood donation center.

OBJECTIVES: Implementing fully automated analyzers has become a crucial safety step in blood donation centers. The Elecsys® assays were evaluated on the cobas e 801 module (Roche Diagnostics) for routine first-time blood donor screening. MATERIALS & METHODS: Five Elecsys infectious disease assays were tested on the cobas e 801 module at Etablissement Français du Sang, Montpellier, France (March-April 2018). The performance of Elecsys HIV Duo, Anti-HCV II, HBsAg II, Anti-HBc II, and Syphilis assays was compared with PRISM HIV O Plus, HCV, HBsAg, HBcore, and newbio pk TPHA assays (specificity analyses)/ARCHITECT Syphilis TP (sensitivity analyses), respectively. Specificity was determined in residual fresh serum samples from unselected first-time blood donors (n≥5195 per parameter). Elecsys assay sensitivity was tested using 30 preselected, positively characterized samples per assay and compared with archived routine testing data for comparator assays. RESULTS: Across all parameters, specificities for repeatedly reactive samples ranged from 99.81-100.00% for Elecsys assays and 99.71-99.98% for comparator assays. Sensitivities of Elecsys and comparator assays were the same for hepatitis C (85.19%), hepatitis B surface antigen (70.00%), hepatitis B core antigen antibodies (100.00%), and syphilis (100.00%). The sensitivity of the Elecsys HIV Duo assay was higher than the comparator assay (83.33% vs. 76.67%), but the difference was not statistically significant. CONCLUSIONS: Elecsys infectious disease assays on the cobas e 801 module demonstrated high specificity and sensitivity for screening first-time blood donor samples, and were comparable with other commercially available assays. The Elecsys assays are reliable tests for screening blood donations.

A multicentre evaluation of the Elecsys® HIV Duo assay.

BACKGROUND: Fourth generation HIV assays, which detect both HIV p24 antigen and HIV antibodies are widely used in HIV screening. The combination of markers enables the fourth generation assays to shorten the window of detection, which is important in real-world testing scenarios. The Elecsys® HIV Duo assay is a fourth generation assay, which provides an overall result based on both the detection of the p24 antigen and HIV antibodies, and lists the sub-results for the antibody and antigen units. OBJECTIVES AND STUDY DESIGN: The performance of the Elecsys® HIV Duo assay was assessed at five international centres and compared with other available fourth generation assays. RESULTS: The specificity of the Elecsys® HIV Duo assay in 13,328 blood donor samples was 99.87% (95% confidence interval [CI] 99.80-99.93) and was 100% (95% CI 99.63-100) in 1000 routine diagnostic samples. Sensitivity was assessed in 139 seroconversion panels; the Elecsys® HIV Duo assay detected a greater number of positive samples/number of bleeds compared with other assays investigated. An individual analysis of those seroconversion panels also shows that the Elecsys® HIV Duo assay compared to other fourth generation assays detected HIV up to 2 days earlier than other assays. The Elecsys® HIV Duo assay also detected 125/130 'early seroconversion' samples assessed, which was greater than the number detected with comparator fourth generation assays. CONCLUSION: These results indicate that the Elecsys® HIV Duo assay is appropriate for use in the diagnosis of HIV and for screening of blood donations and is sensitive for the early detection of HIV.