Tosswill J H C, Taylor G P
Virus Reference Department, Public Health England, London, UK.
Retrovirology and GU Medicine, Section of Virology, Department of Medicine, Imperial College London, London, UK.
Transfus Med. 2018 Aug;28(4):326-330. doi: 10.1111/tme.12482. Epub 2017 Oct 24.
The objective of this study is to reduce donor tissue wastage.
The aim of this study is to determine, in the case of the Abbott Architect rHTLV I/II assay, whether a signal/cut-off (S/CO) ratio higher than the manufacturer's recommendation of 1·0 could be applied to diagnose significant HTLV-1 seroreactivity.
The detection of human T cell leukaemia virus type 1 (HTLV-1) infection is primarily based on serology often utilising random access platforms. Although current assays have high sensitivity and specificity, in low-prevalence regions, significant numbers of false-positive reactions occur. A comprehensive follow-up is difficult within the time frame of organ donation. This can lead to donor tissue wastage.
A retrospective analysis of 12 250 samples previously tested on the Abbott Architect rHTLV I/II platform and further tested by confirmatory serology/molecular detection to determine the sensitivity and positive predictive value in the S/CO ratio range was conducted.
Where the sample S/CO ratio was >20 (n = 498), HTLV infection was confirmed in all but eight subjects. All of these eight had indeterminate confirmatory results, and none were found to be uninfected. Conversely, in the samples within the S/CO ratio range 1-4 (n = 271), no subject was subsequently found to be HTLV-infected although HTLV infection could not be excluded in all cases, primarily due to lack of follow-up samples (n = 60/271).
Samples with an S/CO ratio of <4·0 on the Abbott Architect rHTLV I/II platform represent a low risk of HTLV infection in the UK, and organs from such donors might reasonably be considered for transplantation, within the context of appropriate risk-benefit assessment.
本研究的目的是减少供体组织浪费。
本研究的目标是确定，对于雅培Architect rHTLV I/II检测法，是否可以应用高于制造商推荐的1.0的信号/临界值（S/CO）比值来诊断显著的HTLV-1血清反应性。
人类T细胞白血病病毒1型（HTLV-1）感染的检测主要基于血清学，通常使用随机存取平台。尽管当前检测法具有高灵敏度和特异性，但在低流行地区，会出现大量假阳性反应。在器官捐赠的时间框架内进行全面随访很困难。这可能导致供体组织浪费。
对先前在雅培Architect rHTLV I/II平台上检测过的12250份样本进行回顾性分析，并通过确证性血清学/分子检测进一步检测，以确定S/CO比值范围内的灵敏度和阳性预测值。
样本S/CO比值>20（n = 498）时，除8名受试者外，所有受试者均确诊为HTLV感染。这8名受试者的所有确证结果均不确定，且未发现未感染的情况。相反，在S/CO比值范围为1-4的样本（n = 271）中，随后未发现受试者感染HTLV，尽管在所有情况下都不能排除HTLV感染，主要是由于缺乏随访样本（n = 60/271）。
在英国，雅培Architect rHTLV I/II平台上S/CO比值<4.0的样本代表HTLV感染风险较低，在进行适当的风险效益评估的情况下，可以合理考虑使用来自此类供体的器官进行移植。
