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Abstract：
Point-of-care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV-positive infants compared to centralized laboratory testing. As governments in sub-Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same-day result delivery on rapid ART initiation within national programmes across six countries.
This pre-/post-evaluation compared centralized laboratory-based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country-dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time-to-event outcomes, visualized with Kaplan-Meier curves, and the Somers\' D test was used to compare continuous outcomes.
Data were collected for 2892 EID tests conducted on centralized laboratory-based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV-positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV-positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV-positive infants with a same-day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85).
Same-day diagnosis and treatment initiation for infants is possible with POC EID within routine government-led and -supported public sector healthcare facilities in resource-limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization\'s recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.
This pre-/post-evaluation compared centralized laboratory-based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country-dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time-to-event outcomes, visualized with Kaplan-Meier curves, and the Somers\' D test was used to compare continuous outcomes.
Data were collected for 2892 EID tests conducted on centralized laboratory-based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV-positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV-positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV-positive infants with a same-day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85).
Same-day diagnosis and treatment initiation for infants is possible with POC EID within routine government-led and -supported public sector healthcare facilities in resource-limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization\'s recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.
摘要：
与集中的实验室测试相比，已经显示出定点护理（POC）早期婴儿诊断（EID）测试显着减少了从样本收集到护理人员结果接收的周转时间以及HIV阳性婴儿的ART启动时间。随着撒哈拉以南非洲地区政府实施POCEID技术，我们报告了POCEID检测的可行性和有效性,以及当天结果交付对6个国家国家方案中快速启动ART的影响.
本评估前/后评估比较了喀麦隆52个设施中基于实验室的集中式（预）和POC（后）EID测试，刚果民主共和国,埃塞俄比亚,肯尼亚,塞内加尔和津巴布韦在2017年4月至2019年10月之间（取决于国家）。数据是从医疗机构的常规记录中收集的，所有两岁以下婴儿的测试。计算危险比和95%置信区间来比较事件发生时间的结果，用Kaplan-Meier曲线可视化，Somers\'D检验用于比较连续结局。
收集了在集中式实验室平台上进行的2892项EID测试和在POC设备上进行的4610项EID测试的数据，其中确定了127例（4％）和192例（4％）HIV阳性婴儿，分别。POCEID显着减少了从样品收集到护理者结果接收的时间（POC中位数：0天，IQR：0到0vs.集中：35天，IQR：26至56）和从样本收集到HIV阳性婴儿开始ART的时间（POC中位数：1天，IQR：0至7vs.集中：39天，IQR：26至57）。通过POC测试，72％的婴儿在样本收集的同一天收到结果；与样本收集后一天或更多天被诊断的婴儿相比，同一天诊断的HIV阳性婴儿的ART启动率是其六倍（HR：6.39；95％CI：3.44至11.85）。
在资源有限的环境中，在政府主导和支持的常规公共部门医疗保健设施中，POCEID可以为婴儿提供当天的诊断和治疗。鉴于POCEID允许快速ART启动，符合世界卫生组织关于在七天内开始ART的建议，在公共部门方案中使用它有可能通过早期开始治疗来降低感染艾滋病毒婴儿的总体死亡率。
本评估前/后评估比较了喀麦隆52个设施中基于实验室的集中式（预）和POC（后）EID测试，刚果民主共和国,埃塞俄比亚,肯尼亚,塞内加尔和津巴布韦在2017年4月至2019年10月之间（取决于国家）。数据是从医疗机构的常规记录中收集的，所有两岁以下婴儿的测试。计算危险比和95%置信区间来比较事件发生时间的结果，用Kaplan-Meier曲线可视化，Somers\'D检验用于比较连续结局。
收集了在集中式实验室平台上进行的2892项EID测试和在POC设备上进行的4610项EID测试的数据，其中确定了127例（4％）和192例（4％）HIV阳性婴儿，分别。POCEID显着减少了从样品收集到护理者结果接收的时间（POC中位数：0天，IQR：0到0vs.集中：35天，IQR：26至56）和从样本收集到HIV阳性婴儿开始ART的时间（POC中位数：1天，IQR：0至7vs.集中：39天，IQR：26至57）。通过POC测试，72％的婴儿在样本收集的同一天收到结果；与样本收集后一天或更多天被诊断的婴儿相比，同一天诊断的HIV阳性婴儿的ART启动率是其六倍（HR：6.39；95％CI：3.44至11.85）。
在资源有限的环境中，在政府主导和支持的常规公共部门医疗保健设施中，POCEID可以为婴儿提供当天的诊断和治疗。鉴于POCEID允许快速ART启动，符合世界卫生组织关于在七天内开始ART的建议，在公共部门方案中使用它有可能通过早期开始治疗来降低感染艾滋病毒婴儿的总体死亡率。
