Clinical performance of a new multiplex assay for the detection of HIV‐1, HIV‐2, HCV, HBV, and HEV in blood donations in Catalonia (Spain)

Abstract

AbstractBackgroundCommercial multiplex nucleic acid tests (NATs) for HIV‐1/HIV‐2/HCV/HBV are widely used in developed countries to screen blood donations. HEV NAT screening has been implemented in some blood banks but is tested with a different assay.Study Design and MethodsThis study describes the clinical sensitivity and specificity of the Procleix® UltrioPlex E (UPxE) assay on the automated Procleix Panther® system for the simultaneous detection of HIV‐1/HIV‐2/HCV/HBV/HEV. To evaluate routine performance, 10,138 donations were tested in parallel with UPxE (in ID‐NAT) and current assays (Procleix Ultrio Elite [UE] assay in ID‐NAT and Procleix HEV assay in pool of 16). To assess clinical sensitivity, archived donations positive for HCV, HIV‐1, HBV, HEV, or occult HBV infection (OBI) were tested (n = 104–186).ResultsFive donations were initially reactive (IR) with UPxE; none of them were reactive with current assays. Two of the three samples IR for HIV‐1/HIV‐2/HCV/HBV were confirmed positive for HBV (HBV NAT and/or anti‐HBV core positive) and classified as OBI. The two samples IR for HEV were confirmed positive (Procleix HEV assay in ID‐NAT and in‐house RT‐PCR HEV assay). One sample IR for HIV‐1/HIV‐2/HCV/HBV with UPxE and another with UE were not confirmed. UPxE showed a specificity of 99.99% for HIV‐1/HIV‐2/HCV/HBV and 100% for HEV. Comparable sensitivities were observed for HIV‐1, HCV, HBV, OBI, and HEV samples tested in the UPxE, UE, and Procleix HEV assays.DiscussionUPxE may provide an efficient solution for the simultaneous detection of HIV‐1, HIV‐2, HCV, HBV, and HEV in blood donations in a single test.