Seed Clive R, Cheng Anthea, Ismay Susan L, Bolton Wayne V, Kiely Philip, Cobain Trevor J, Keller Anthony J
Australian Red Cross Blood Service, 290 Wellington Street, Perth, Western Australia 6000.
Transfusion. 2002 Oct;42(10):1365-72. doi: 10.1046/j.1537-2995.2002.00204.x.
Risk modeling is now the most practical method of estimating the residual risk of viral transmission in developed countries. One method of assessing the accuracy of a risk model is to measure the observed against the predicted outcome after implementing a new screening method. The primary objective of this paper is to assess the accuracy of three published models in predicting the impact of implementing HIV and HCV NAT in Australia.
Viral screening data on Australian donors for 2000 and 2001 were retrospectively analyzed. The data were applied to the three models to estimate the risk of transmission and predicted NAT yield for HIV, HCV, and HBV.
The median risk estimates for the three models were 1 in 3,415,000 for HIV NAT, 1 in 911,000 for HCV NAT, and 1 in 483,000 for HBsAg. The predicted NAT yield for the three models ranged from 0.17 to 0.30 per million donations for HIV, 1.20 to 5.55 for HCV, and 0.47 to 1.01 for HBV. The observed NAT yield was not significantly different from the expected yield with any of the three models for either HIV or HCV.
First, the residual risk in Australian donors is small in comparison with other transfusion complications and comparable to or lower than the risk in US and European nonremunerated donors. Second, mathematical risk modeling has sufficient precision to be used as a predictive tool for risk-benefit assessments of novel screening procedures. Finally, in relation to the case for implementing HBV NAT and/or anti-HBc in Australia, we conclude that at present, there is inadequate information about our donor population to perform an evidence-based risk-benefit analysis.
风险建模是目前发达国家估算病毒传播残余风险最实用的方法。评估风险模型准确性的一种方法是在实施新的筛查方法后，将观察到的结果与预测结果进行对比。本文的主要目的是评估三个已发表模型在预测澳大利亚实施HIV和HCV核酸检测（NAT）影响方面的准确性。
对2000年和2001年澳大利亚献血者的病毒筛查数据进行回顾性分析。将这些数据应用于三个模型，以估算HIV、HCV和HBV的传播风险及预测NAT检出率。
三个模型的风险估计中位数分别为：HIV NAT为1/3,415,000，HCV NAT为1/911,000，HBsAg为1/483,000。三个模型预测的HIV每百万次献血NAT检出率为0.17至0.30，HCV为1.20至5.55，HBV为0.47至1.01。对于HIV或HCV，三个模型中任何一个模型观察到的NAT检出率与预期检出率均无显著差异。
第一，与其他输血并发症相比，澳大利亚献血者中的残余风险较小，与美国和欧洲无偿献血者的风险相当或更低。第二，数学风险建模具有足够的精度，可作为新筛查程序风险效益评估的预测工具。最后，关于在澳大利亚实施HBV NAT和/或抗-HBc的情况，我们得出结论，目前关于我国献血者群体的信息不足，无法进行基于证据的风险效益分析。
