Procleix Ultrio transcription-mediated amplification vs. serological blood screening in south-western Greece

• Published in: Transfusion medicine (Oxford, England) England), 2008-04, Vol.18 (2), p.104-111
• Main Authors: Sgourou, A., Karakantza, M., Theodori, E., Papadimitriou, C., Theodorou, G. L., Davanos, N., Thymianou, S., Zoumbos, N. C., Mouzaki, A.
• Format: Article
• Language: English
• Subjects: blood donation; Blood Donors; Blood Transfusion - standards; Gene Amplification; HBV; HCV; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis B virus; Hepatitis B virus - genetics; Hepatitis B virus - isolation & purification; Hepatitis C virus; HIV; HIV-1 - genetics; HIV-1 - isolation & purification; Human immunodeficiency virus 1; Humans; NAT; Patient Selection; Serologic Tests - methods; TMA; Transcription, Genetic
• ISSN: 0958-7578; 1365-3148
• DOI: 10.1111/j.1365-3148.2008.00847.x

summary We present here our overall experience after 27 months of performance of the Procleix Ultrio [HIV‐1, hepatitis C virus (HCV), hepatitis B virus (HBV)] transcription‐mediated amplification (TMA) assay. The aim of this report is to assess the impact of nucleic acid testing (NAT) implementation in blood screening of south‐western Greek blood donors. We processed 38 264 units of blood as neat samples with the Procleix Ultrio TMA assay (Chiron/GenProbe, Emeryville/San Diego, CA, USA) between 1 January 2005 and 31 March 2007. NAT results were compared to those obtained from routine serology tests and quantitative polymerase chain reaction (PCR) assays. Overall, 52 units of blood tested positive for HBV (1·4‰), 8 for HCV (0·2‰) and none for HIV or multiple infections. The yield of TMA was 0·183‰ for HBV (7/38 264) and 0 for HCV. The TMA HBV‐positive donations were tested for HBV DNA by a quantitative PCR assay and were found negative (below the detection limit of the method, 200 copies/mL). Follow‐up testing showed that the TMA HBV‐positive donations were positive for anti‐hepatitis B core antigen immunoglobulin G antibodies. Implementation of the TMA assay in the individual donation configuration increased HBV detection compared to serological screening or a commonly used quantitative PCR assay. Follow‐up studies will determine the impact of NAT implementation in HBV transmission in countries with an intermediate HBV incidence.