First report of human immunodeficiency virus transmission via a blood donation that tested negative by 20‐minipool nucleic acid amplification in <scp>J</scp>apan

Sobata, Rieko; Shinohara, Naoya; Matsumoto, Chieko; Uchida, Shigeharu; Igarashi, Shigeru; Hino, Satoru; Satake, Masahiro; Tadokoro, Kenji

doi:10.1111/trf.12769

Cited by 9 publications

(17 citation statements)

References 4 publications

(5 reference statements)

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“…In Japan, the number of HIV-1 infections remains relatively low (5,21,22). Nevertheless, the annual incidence of HIV-1 infection has not decreased, therefore, new infections remain a great concern.…”

Section: Introductionmentioning

confidence: 99%

Genetic Analysis of HIV-1 in Japan: a Comprehensive Analysis of Donated Blood

et al. 2017

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SUMMARY:In Japan, the number of human immunodeficiency virus (HIV)-1 infections remains relatively low; nevertheless, the annual incidence of HIV-1 infection has not decreased. New infections remain a great concern, and an improved understanding of epidemiological trends is critical for public health. The env C2V3 and pol sequences of HIV-1 RNA from 240 early (1996)(1997)(1998)(1999)(2000)(2001) and 223 more recent (2010-2012) blood donations were used to compare the distribution of virus subtypes and to generate phylogenetic trees. Subtype B was clearly predominant in both early and more recent donations (both were 88.3z), and CRF01_AE was the second most common subtype. Phylogenetic analysis revealed a peculiar epidemiological transition. Compared to early subtype B isolates from 2 major endemic areas (Tokyo and Osaka), the more recent subtype B isolates formed fewer tight clusters in phylogenetic trees (from 8 to 2 clusters in Tokyo and 5 to zero clusters in Osaka). Furthermore, mixing of HIV-1 infections between these 2 endemic areas appear to increase. Analysis of phylogenetic trees suggested that local outbreaks have become smaller in Japan; however, intermixing of viral types between these 2 areas was more evident in the more recent samples.

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Section: Introductionmentioning

confidence: 99%

Genetic Analysis of HIV-1 in Japan: a Comprehensive Analysis of Donated Blood

et al. 2017

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“…Between 2000 and 2018, more than 20 HIV‐infected blood components that tested HIV antibody and NAT negative, were reported worldwide, with or without transmission to the recipients . These cases correspond to two particular situations: 1) the presence of polymorphism in HIV strain, leading to mismatches between primers/probes and the viral sequence, and 2) failure to detect HIV RNA when NAT is performed in minipools . In some cases, the convergence of both situations dramatically reduced the NAT sensitivity, yielding false‐negative results .…”

Section: Discussionmentioning

confidence: 99%

“…This case is also consistent with HIV residual risk in blood transfusion in France, which is currently estimated at 1 in 5.9 million donations, that is, one donation every 2 years. Although the last HIV seroconversion of a blood recipient was notified in 2002, hemovigilance data are not inconsistent with the estimation of the residual risk, when considering underreporting (e.g., no systematic testing for seroconversion and premature death of recipients) and the fact that contamination through infected blood products does not occur systematically, as shown by the differential transmission of HIV when several blood products are prepared from the same infected donation …”

Section: Discussionmentioning

confidence: 99%

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Transfusion of HIV‐infected blood products despite highly sensitive nucleic acid testing

et al. 2019

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BACKGROUND In France, the risk of HIV transmission by transfusion was reduced by implementing pooled nucleic acid testing (NAT) in 2001 and individual NAT in 2010. We report here the first case in France of transfusion of human immunodeficiency virus (HIV)‐infected blood donated during HIV pre–ramp‐up phase that tested individual NAT negative. METHODS Blood donations are screened for HIV antibodies and HIV RNA (ProcleixUltrio, Grifols; limit of detection at 95%, 23 copies/mL). When a repeat donor tests positive for HIV, a repository sample from the previous donation is tested with the Cobas Taqman HIV‐1 test (CTM, Roche; limit of detection at 95%, 17 copies/mL). RESULTS In August 2017, a 57‐year‐old male repeat donor was screened positive for HIV antibodies and RNA (plasma viral load, 11,599 copies/mL). The previous donation had tested negative with Ultrio in March 2017 but was positive with an unquantifiable plasma viral load when tested with CTM. Sequencing showed no mismatch between Ultrio primers/probes and the target sequence. HIV transmission was excluded by lookback studies in the recipient of platelets, which had been pathogen reduced, but not in the recipient of RBCs due to premature death. CONCLUSION This case demonstrates that the risk of contaminated donations due to the early HIV infection phase going undetected by highly sensitive NAT is real but exceptional. The absence of transmission to the platelets recipient could be due to the very low viral inoculum and/or to the efficacy of the viral inactivation. This case also highlights the additional value of a systematic donation archiving and the importance of donor education and predonation selection.

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“…Ab screened have also occurred in numerous other countries, due either to (1) donations given during the very early infectious WP, including by large volume plasma components from donations that tested negative by ID-NAT [31,32] or (2) divergent HIV variants or recombinant viruses that were missed by single target HIV NAT tests [33,34], a problem that has subsequently been corrected by the major NAT test manufacturers by adopting multitarget assays for HIV RNA.…”

Section: Reports Of Hiv-breakthrough Cases Missed By Nat Andmentioning

confidence: 99%

Testing for HIV – the first three decades

Busch

2015

ISBT Science Series

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Background HIV was discovered in 1984, with high rates of virus isolation and antibody (Ab) detection in haemophiliacs and recipients of blood from HIV‐infected donors, demonstrating the critical need to develop tests for donor screening. Aims/Methods Review evolution of HIV‐donor screening, and broader applications of HIV tests and infected‐donor surveillance to research and public health. Results In mid‐1984, scientists in governments and industry collaborated to develop HIV‐Ab tests that were implemented in blood banks ~1 year following discovery of HIV. Initial Ab screening did not eliminate TT‐HIV, however, with numerous breakthrough cases detected following introduction of first‐generation assays, which were determined to have an infectious pre‐seroconversion (SC) window period (WP) of ~56 days. Improvements in sensitivity of second‐generation tests in the late‐1980s and third‐generation tests in the mid‐1990s reduced the pre‐SC WP to approximately 3 weeks. Subsequent additions of p24 antigen and then nucleic acid technology (NAT)‐screening in the late 1990s closed the infectious WP to 5–10 days. NAT‐screening assays and algorithms and fourth‐generation Ag/Ab serological tests developed for blood bank screening and staging of early HIV infections are now in widespread use in clinical diagnostic, research and public health settings. NAT assays developed for donor screening have been applied to detect persistent low‐level viral replication in studies of patients on HAART, ‘elite controllers’ and ‘HIV‐eradication’ research. Conclusions Progressive improvements in HIV screening assays have virtually eliminated TT‐HIV infections, and consequent advances in HIV testing have contributed to HIV diagnostics, research and public health.

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First report of human immunodeficiency virus transmission via a blood donation that tested negative by 20‐minipool nucleic acid amplification in Japan

Cited by 9 publications

References 4 publications

Genetic Analysis of HIV-1 in Japan: a Comprehensive Analysis of Donated Blood

Genetic Analysis of HIV-1 in Japan: a Comprehensive Analysis of Donated Blood

Transfusion of HIV‐infected blood products despite highly sensitive nucleic acid testing

Testing for HIV – the first three decades

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