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.

[Post-transfusion malaria: is the risk irreconciliable with biological silence?]. / Le risque de paludisme transfusionnel confronté à celui de la mutité biologique: deux données irréconciliables?

Despite the relatively high frequency of imported malaria in metropolitan France, the transmission of malaria by transfusion is exceptional. The screening of donations to determine those at risk is performed by an interview, and by the testing of serology for defined groups of donors. However, the exclusion of a candidate 'at risk' as a blood donor, by a pre-donation interview, is not completely mastered and the discrimination by biological examination lacks sensitivity, as much for methodological reasons as for reasons linked to the complex parasitic pathogenic agent (Plasmodium ssp.), as for the specific host defence system. The risk of introducing an unsafe-potentially dangerous (transfusion-transmitted malaria is often lethal)-element into the transfusional circuit is not completely covered. Is serology testing the most adequate test to avoid the risk of infected donations, in particular by Plasmodium falciparum; what are the alternatives and what will be the eventual added-costs of the biological qualification of such donations? The transfusional risk linked to Plasmodium seems, however, to be reduced to a minimum, concerning the circulation of plasma, which could represent an alternative for donors at real risk (rare) and those with a supposed risk (relatively numerous).