Human immunodeficiency virus 1 dual‐target nucleic acid technology improves blood safety: 5 years of experience of the German Red Cross blood donor service Baden‐Württemberg–Hessen

BACKGROUND RNA viruses are associated with a high frequency of mutations because of the missing proofreading function of polymerases, such as reverse transcriptase. Between 2007 and 2010, six blood donations with false‐negative nucleic acid technology (NAT) results were reported in Germany. Therefore, NAT screening in two viral genome regions was introduced by our blood donation service in 2010 on a voluntary basis and became mandatory in Germany since the beginning of 2015. STUDY DESIGN AND METHODS Blood donor screening was done using, in parallel, the German Red Cross (GRC) HIV‐1 CE long terminate repeats (LTR) PCR kit and the GRC HIV‐1 gag CE PCR kit. In total, 7 million blood donations were screened during the study period from 2010 to 2014 with the GRC dual‐target human immunodeficiency virus 1 (HIV‐1) NAT system. Additionally, three suspicious specimens were analyzed by four monotargeted NAT assays and by five dual‐target NAT assays. RESULTS Three of 7 million donations tested negative using the 5’LTR–polymerase chain reaction, but they were positive if amplification was performed in the gag region. HIV antibodies were detected in all three donations. Nucleic acid sequence analysis identified a deletion of 22 bases within the 5’LTR probe binding region. Three different ltr‐based monotargeted assays missed two donations, except for a low‐reactive result obtained by one of the assays. In total, the detection rates for HIV‐1–positive donations were 37.5% (3/8) for monotargeted assays and 100% (10/10) for dual‐target assays. CONCLUSION The current data demonstrate that dual‐target NAT systems reduce the risk of false‐negative HIV‐1 NAT screening results.