Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France.
EHESP French School of Public Health, Rennes, France.
BMC Med. 2023 Jul 4;21(1):243. doi: 10.1186/s12916-023-02939-y.
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.
消除乙型肝炎病毒（HBV）母婴传播需要对高病毒载量的孕妇进行婴儿免疫预防和抗病毒预防。由于实时聚合酶链反应（RT-PCR）是评估抗病毒药物适用性的金标准，对于生活在低收入和中等收入国家（LMICs）的女性来说，既不可用也负担不起，因此可能需要快速诊断检测（RDT）来检测替代的 HBV 标志物。为了为 RDT 确定高病毒血症女性的目标产品概况（TPP）提供信息，我们使用离散选择实验（DCE），并征求了非洲医疗保健工作者（HCW）对虚构 RDT 以下四个属性之间的偏好和权衡：价格、结果时间、诊断灵敏度和特异性。
通过在线问卷调查，我们要求参与者在七个选择任务中从两组 RDT 中选择他们更喜欢的测试，这些任务具有四个属性的不同水平。我们使用混合多项逻辑回归模型来量化每个属性产生的效用收益或损失。我们试图定义测试属性的最小和最佳标准，以满足分别为 70%和 90%以上的 HCW，作为 RT-PCR 的替代方法。
共有来自 41 个非洲国家的 555 名 HCW 参加了研究。灵敏度和特异性的提高产生了显著的效用，而成本和结果时间的增加则产生了显著的负效用。与参考水平相比，最高属性水平的系数大小顺序为：灵敏度（β=3.749）、成本（β=-2.550）、特异性（β=1.134）和结果时间（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。对于特异性为 95%、成本为 1 美元、结果时间为 20 分钟的 RDT，可接受的最低测试灵敏度为 82.5%，可接受的最佳灵敏度为 87.5%。
非洲 HCW 最希望优先考虑以下顺序的 RDT：更高的灵敏度、更低的成本、更高的特异性和更短的结果时间。迫切需要开发和优化能够满足这些标准的 RDT，以扩大 LMIC 中乙型肝炎母婴传播的预防。
