The validation and implementation of donor screening for hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1/2 and syphilis by ultrio elite assay (Panther system) and chemiluminescence assay (Abbott Architect i2000SR system) in Namibia

Abstract

Infectious disease screening of Namibia blood donations for infectious diseases was contracted to the South African National Blood Service (SANBS) since 2004 and needed to be relocated back to Namibia. A cost analysis conducted showed that by introducing certain strategies, it was cost‐effective to implement ID‐NAT in Namibia. NAMBTS chose Ultrio Elite assay/Panther System (Gen‐Probe and Novartis, USA) for ID‐NAT for HIV 1/2 RNA, HBV DNA and HCV RNA and Chemiluminescent immunoassay done on the Architect i2000SR system (Abbott, Delkenheim, Germany) for HIV 1/2 Ag/Ab, anti‐HCV, HBsAg and Syphilis. For performance evaluation, the Panther System was compared with the Procleix TIGRIS system—Ultrio Plus assay (Gen‐Probe and Novartis, USA) while the Architect system was compared with the Abbott PRISM. The results of this evaluation demonstrated a 100% sensitivity and 100% specificity of the Ultrio Elite assay while the Architect also demonstrated 100% sensitivity and specificity of above 99% for detecting viral markers for HBV, HIV and HCV, and 97% sensitivity and 99·7% specificity for detecting syphilis. We found both the Procleix Panther and Architect systems to be flexible, robust and effective in screening blood for transfusion in our setting. Donor screening for HIV 1/2, HBV, HCV and syphilis for ID‐NAT and serology using the Procleix Panther and Architect systems was successfully relocated from South Africa and implemented in February 2014 in Namibia.