Comparison of Procleix Ultrio Elite and Procleix Ultrio NAT Assays for Screening of Transfusion Transmitted Infections among Blood Donors in India

Abstract

Background. Introduction of nucleic acid testing (NAT) has helped in decreasing window period donations, resulting in increased safety of blood supplies. NAT combines the advantages of direct and highly sequence-specific detection of viral genomes. We analysed the performance of newer Procleix Ultrio Elite (PUE) and Procleix Ultrio assay (PUA) for the screening of the viral markers in our donor population. Material and Methods. 10,015 donor samples were screened by routine immunoassays and both versions of NAT. NAT yields detected were subjected to viral load estimation and to other serological markers. Results. A total of 21 NAT yields were detected; three were positive by both NAT systems, whereas 18 samples were reactive by PUE only. NAT yields include 18 HBV and 3 HCV yields, of which 17 HBV yields were occult infections and 1 was window period (WP) infection. All 3 HCV yields were WP infections. No HIV-1/HIV-2 yield was found. Conclusion. Efficient target capture chemistry in the new TMA assay version significantly improved sensitivity. NAT is superior to serological immunoassays for screening of the viral markers; and the efficient target capture system in the newer TMA assay, namely, the PUE system, has significantly improved sensitivity over the earlier versions.

A Pilot Study to Assess Transfusion Transmission of Hepatitis C Virus

“…Second/third generation HCV antibody screening EIAs coupled with HCV RNA detection by NAT has resulted in marked reduction in transfusion transmission risk [8]. The Alexandria University blood bank adopted dual technique of HCV screening (PRISM, Abbott Ò anti-HCV immunoassay) followed by NAT (Procleix Ò Ultrio Elite, version: 2.4.5 NOVARTIS Ò ) with a very high sensitivity ranging from 96 to 99.96% in literature [11,12]. This meticulous screening has resulted in the not-astonishing results of the current study where no patients acquired HCV infection even after multi-transfusion.…”

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting

“…Simultaneous ID‐NAT testing was performed in parallel for all donor samples using Procelix ultrio plus assay in enhanced Semi‐Automated System (Novartis Diagnostics, United States) for qualitative detection of the genomic sequences of HCV, HBV and HIV‐1. The testing algorithm for donor screening has been described previously 9 . Confirmatory testing was not done for serologically positive samples.…”

“…An adjustment ratio of 1:18 was used to calculate the number of pre‐NAT WP HBV infections among total HBV NAT yields and differentiate them from occult HBV infections. This adjustment ratio was based on a previous small study of 10 000 samples from our centre where 19 HBV NAT yield cases were detected by ID‐NAT assay among which 18 NAT yield cases tested anti‐HBc‐reactive and one NAT yield case tested anti‐HBc nonreactive 9 …”

“…The testing algorithm for donor screening has been described previously. 9 Confirmatory testing was not done for serologically positive samples. All reactive units were discarded as per departmental standard operating procedure and donors were called back for postdonation counselling.…”

The impact of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus yields from a single blood center in China with 10-years review

“…Its sensitivity is several orders of magnitude greater than that of antigen and/or antibody immunological assays. Besides, NAT has markedly reduced the assay window for immunological assays [7]. In the present study, we assess the results of NAT over 10 years and analyze their effects on blood safety at the Blood Center of Zhejiang Province, China, where the infection rate of HBV is higher than that in the general population.…”