Département des Agents Transmissibles par le Sang, Centre National de Référence Risques Infectieux Transfusionnels, Institut National de la Transfusion Sanguine (INTS), Paris, France.
ETS Auvergne Rhône Alpes, Laboratoire de qualification biologique des dons Est, Etablissement Français du Sang, Metz-Tessy, France.
Transfusion. 2019 Jun;59(6):2046-2053. doi: 10.1111/trf.15203. Epub 2019 Feb 19.
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.
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).
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.
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.
在法国，通过 2001 年实施 pooled nucleic acid testing（NAT）和 2010 年实施 individual NAT，降低了经输血传播 HIV 的风险。我们在此报告法国首例在 HIV 预扩增阶段采集的经 individual NAT 检测为阴性的 HIV 感染血液的输血病例。
血液捐献均进行 HIV 抗体和 HIV RNA 筛查（ProcleixUltrio，Grifols；检测限 95%，23 拷贝/mL）。当重复献血者 HIV 检测呈阳性时，用 Cobas Taqman HIV-1 检测（CTM，Roche；检测限 95%，17 拷贝/mL）对前次捐献的储存样本进行检测。
2017 年 8 月，一名 57 岁男性重复献血者 HIV 抗体和 RNA 筛查阳性（血浆病毒载量 11599 拷贝/mL）。前次捐献 Ultrio 检测于 2017 年 3 月为阴性，但 CTM 检测为不可定量的血浆病毒载量阳性。测序结果显示 Ultrio 引物/探针与目标序列之间无错配。通过对接受经病原体减少处理的血小板的受血者进行回溯性研究排除了 HIV 传播，但由于受血者过早死亡，对接受 RBC 的受血者则无法排除。
该病例表明，由于高度敏感的 NAT 无法检测到早期 HIV 感染阶段的污染献血，导致 HIV 传播的风险确实存在，但很罕见。血小板受血者未发生传播可能归因于极低的病毒接种量和/或病毒灭活的效果。该病例还突出了系统的献血存档的额外价值，以及供者教育和献血前选择的重要性。
