Conventional early infant diagnosis in Lesotho from specimen collection to results usage to manage patients: Where are the bottlenecks?

IntroductionEarly infant diagnosis is an important step in identifying children infected with HIV during the perinatal period or in utero. Multiple factors contribute to delayed antiretroviral treatment initiation for HIV-infected children, including delays in the early infant HIV diagnosis cascade.MethodsWe conducted a retrospective study to evaluate early infant diagnosis turnaround times in Lesotho. Trained staff reviewed records of HIV-exposed infants (aged-6-8 weeks) who received an HIV test during 2011. Study sites were drawn from Highlands, Foothills and Lowlands regions of Lesotho. Central laboratory database data were linked to facility and laboratory register information. Turnaround time geometric means (with 95% CI) were calculated and compared by region using linear mixed models.Results1,187 individual infant records from 25 facilities were reviewed. Overall, early infant diagnosis turnaround time was 61.7 days (95%CI: 55.3–68.7). Mean time from specimen collection to district laboratory was 14 days (95%CI: 12.1–16.1); from district to central laboratory, 2 days (95%CI 0.8–5.2); results from central laboratory to district hospital, 23.3 days (95%CI: 18.7–29.0); from district hospital to health facility, 3.2 days (95%CI 1.9–5.5); and from health facility to caregiver, 10.4 days (95%CI, 7.9–13.5). Mean times from specimen transfer to the central laboratory and for result transfer from central laboratory to district hospital were significantly shorter in the Lowlands Region (0.9 and 16.2 days, respectively), compared to Highlands Region (6.0 [P = 0.030] and 34.3 days [P = 0.0099]. Turnaround time from blood draw to receipt of results was significantly shorter for HIV infected infants compared to HIV uninfected infants [p = 0.0036] at an average of 47.1 days (95%CI: 38.9–56.9) and 62 days (95%CI: 55.9–68.7) respectively. Of 47 HIV-infected infants, 36 were initiated on antiretroviral therapy at an average of 1.3 days (95%CI: 0.3, 5.7) after caregiver received the result.ConclusionHIV-infected infants received results earlier and were rapidly initiated on antiretroviral therapy once the result was delivered to caregiver. However, average early infant diagnosis turnaround time was two months; the longest period of delay was transfer of results from central laboratory to district hospital. Turnaround time of results based on geographical regions or between hospitals and health centres varied but did not reach statistical significance.引言 早期婴儿诊断（Early Infant Diagnosis）是识别围产期或宫内感染艾滋病病毒（HIV）儿童的重要环节。多种因素可导致HIV感染儿童的抗逆转录病毒治疗启动延迟，其中包括早期婴儿HIV诊断流程中的各环节延迟。 方法 本研究为回顾性研究，旨在评估莱索托的早期婴儿诊断周转时间。经过培训的工作人员回顾了2011年期间接受HIV检测的HIV暴露婴儿（年龄6~8周）的病历记录。研究站点覆盖莱索托的高地、丘陵与低地地区。将中心实验室数据库数据与医疗机构及实验室登记信息进行关联。采用线性混合模型（linear mixed model）计算各环节周转时间的几何均数（附带95%置信区间，95% CI），并按地区进行比较。 结果 本研究共回顾了来自25家医疗机构的1187份婴儿病历记录。总体而言，早期婴儿诊断周转时间为61.7天（95% CI：55.3~68.7）。从标本采集至地区实验室的平均时间为14天（95% CI：12.1~16.1）；从地区实验室至中心实验室为2天（95% CI：0.8~5.2）；从中心实验室至地区医院为23.3天（95% CI：18.7~29.0）；从地区医院至医疗机构为3.2天（95% CI：1.9~5.5）；从医疗机构至照护者为10.4天（95% CI：7.9~13.5）。与高地地区（分别为6.0天，P=0.030和34.3天，P=0.0099）相比，低地地区的标本转运至中心实验室以及结果从中心实验室转运至地区医院的平均时间均显著更短（分别为0.9天和16.2天）。HIV感染婴儿从采血至获取检测结果的周转时间显著短于HIV未感染婴儿（P=0.0036），二者平均周转时间分别为47.1天（95% CI：38.9~56.9）和62天（95% CI：55.9~68.7）。在47名HIV感染婴儿中，有36名在照护者收到检测结果后的平均1.3天（95% CI：0.3~5.7）启动了抗逆转录病毒治疗。 结论 HIV感染婴儿可更早获取检测结果，且在照护者收到结果后可快速启动抗逆转录病毒治疗。但总体早期婴儿诊断平均周转时长达到2个月，最长的延迟环节为中心实验室向地区医院传递检测结果。不同地理区域以及医院与医疗机构之间的检测结果周转时间存在差异，但未达到统计学显著性水平。