背景:消除乙型肝炎病毒(HBV)的母婴传播需要婴儿免疫预防和高病毒载量孕妇的抗病毒预防。由于实时聚合酶链反应(RT-PCR),评估抗病毒资格的黄金标准,生活在低收入和中等收入国家(LMICs)的妇女既无法获得也无法负担得起,可能需要快速诊断测试(RDT)检测替代HBV标志物。为RDT的目标产品概况(TPP)的未来发展提供信息,以识别高病毒血症的女性,我们使用了离散选择实验(DCE),并在以下四个虚构RDT属性之间引发了非洲医护人员(HCW)的偏好和权衡:价格,时间到结果,诊断灵敏度,和特异性。
方法:通过在线问卷调查,我们要求参与者从7项选择任务中的2项RDT中的4项属性级别不同的一组RDT中指出他们的首选测试.我们使用混合多项Logit模型来量化每个属性产生的效用损益。我们试图为可以满足≥70%和≥90%的HCW的测试属性定义最小和最佳标准,分别,作为RT-PCR的替代方法。
结果:共有来自41个非洲国家的555名HCWs参加。灵敏度和特异性的增加产生了显着的效用,成本和时间的增加产生了显着的无用性。最高属性级别相对于参考级别的系数大小依次为:灵敏度(β=3.749),成本(β=-2.550),特异性(β=1.134),和时间到结果(β=-0.284)。医生最关心测试灵敏度,而公共卫生从业者关心成本,助产士关心结果时间。对于具有95%特异性的RDT,花费1美元,并在20分钟内产生结果,最低可接受测试灵敏度为82.5%,最佳可接受灵敏度为87.5%.
结论:非洲HCW更喜欢具有以下优先顺序的RDT:更高的灵敏度,更低的成本,更高的特异性,和更短的时间到结果。迫切需要开发和优化能够满足标准的RDT,以扩大LMIC中HBV母婴传播的预防。
Elimination of mother-to-child transmission of hepatitis B virus (HBV) requires infant immunoprophylaxis and antiviral prophylaxis for pregnant women with high viral loads. Since real-time polymerase chain reaction (RT-PCR), a gold standard for assessing antiviral eligibility, is neither accessible nor affordable for women living in low-income and middle-income countries (LMICs), rapid diagnostic tests (RDTs) detecting alternative HBV markers may be needed. To inform future development of the target product profile (TPP) for RDTs to identify highly viremic women, we used a discrete choice experiment (DCE) and elicited preference and trade-off of healthcare workers (HCW) in Africa between the following four attributes of fictional RDTs: price, time-to-result, diagnostic sensitivity, and specificity.
Through an online questionnaire survey, we asked participants to indicate their preferred test from a set of two RDTs in seven choice tasks with varying levels of the four attributes. We used mixed multinomial logit models to quantify the utility gain or loss generated by each attribute. We attempted to define minimal and optimal criteria for test attributes that can satisfy ≥ 70% and ≥ 90% of HCWs, respectively, as an alternative to RT-PCR.
A total of 555 HCWs from 41 African countries participated. Increases in sensitivity and specificity generated significant utility and increases in cost and time-to-result generated significant disutility. The size of the coefficients for the highest attribute levels relative to the reference levels were in the following order: sensitivity (β = 3.749), cost (β = -2.550), specificity (β = 1.134), and time-to-result (β = -0.284). Doctors cared most about test sensitivity, while public health practitioners cared about cost and midwives about time-to-result. For an RDT with 95% specificity, costing 1 US$, and yielding results in 20 min, the minimally acceptable test sensitivity would be 82.5% and the optimally acceptable sensitivity would be 87.5%.
African HCWs would prefer an RDT with the following order of priority: higher sensitivity, lower cost, higher specificity, and shorter time-to-result. The development and optimization of RDTs that can meet the criteria are urgently needed to scale up the prevention of HBV mother-to-child transmission in LMICs.